Clinical Efficacy of Ezetimibe as an Add-on to Atorvastatin: Effects on HDL Cholesterol and Triglycerides in Post-PCI Patients from a South Indian Population

Clinical Efficacy of Ezetimibe as an Add-on to Atorvastatin: Effects on HDL Cholesterol and Triglycerides in Post-PCI Patients from a South Indian Population | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Clinical Efficacy of Ezetimibe as an Add-on to Atorvastatin: Effects on HDL Cholesterol and Triglycerides in Post-PCI Patients from a South Indian Population Srividya S, Abisha Judie K, Nanda Kumar R, Nishanthi M G, Pravin Selvi Saravanan, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8999676/v1 This work is licensed under a CC BY 4.0 License Status: Under Revision Version 1 posted 26 You are reading this latest preprint version Abstract Background Cardiovascular diseases often cause severe ischemic block or narrowing of coronary arteries, obstructing blood flow to the myocardium. Percutaneous coronary intervention (PCI) is a nonsurgical, invasive procedure for treating these conditions. Statins are the standard secondary preventive measure due to their pleiotropic effects. Research on therapeutic efficacy of the Atorvastatin–ezetimibe combination in improving the quality of life of post-PCI patients, especially in the south Indian population, is limited. This study aimed to compare the safety and effectiveness ezetimibe when it is added to atorvastatin in patients with a history of PCI in terms of HDL and Triglycerides levels. Results Among 80 randomized patients 72 patients’ data lasted for the final analysis. Compared the atorvastatin monotherapy (Group A) with the atorvastatin–ezetimibe group (Group B). Only HDL (High-density lipoprotein), LDL (Low-density lipoprotein), TG (Triglycerides) remained significant after Bonferroni correction whereas total cholesterol and VLDL did not meet adjusted threshold; between-group differences were significant with the improvement of HDL (44.2 ± 2.3 vs 37.5 ± 1.9 mg/dL) and lowering TG (70.3 ± 2.8 vs 84.6 ± 3.1 mg/dL). Analyses were intention-to-treat (ITT) with LOCF and pre-protocol principles (PPP). CRP level is highly significant (18 ± 1.9 vs 8 ± 1.9). Conclusion Compared with atorvastatin alone, ezetimibe, when used as an add-on therapy to atorvastatin improved the lipid profile and CRP levels, specifically in decreasing triglycerides and an increasing HDL cholesterol level in post-PCI patients. This combination therapy was associated with improved quality of life, and long-term trials are needed to confirm these findings and assess the impact on clinical events. percutaneous coronary intervention ezetimibe atorvastatin triglycerides HDL cholesterol Figures Figure 1 Figure 2 INTRODUCTION Coronary artery disease (CAD), a major form of cardiovascular diseases (CVDs), include maladies such as stable angina, unstable angina, myocardial infarction (MI), acute coronary Syndrome and arrythmias remain the leading cause of death globally with a 68% increase in the number of deaths from 1990–2021, whereas in South Asia, 181% increase 1 . In India, from 2000–2017, total IHD mortality increased from 851,000 to 1,540,000 deaths (+ 81.1%) which indicates an increasing burden 2 . Acute coronary syndrome (ACS), a severe clinical presentation of coronary artery disease (CAD), remains a major global cause of morbidity and mortality. Plaque rupture inside coronary arteries triggers events such as platelet activation, thrombosis, and arterial obstruction, often necessitating immediate revascularization. Since its inception, percutaneous coronary intervention (PCI), a highly evolved, minimally invasive modality, has been the primary approach for restoring blood flow. Treatment involves expanding the constricted area, often by inserting a stent, to reestablish coronary blood flow. PCI is a standard procedure in the treatment of angina or IHD and is used for myocardial ischemia or myocardial infarction. Atherogenic lipids and vascular inflammation drive residual risk after PCI, despite guideline-directed therapy. Effective lipid management and a reduction in inflammation are therefore key components of post-PCI care 3 . Despite the effects of statins on LDL-C levels, statins are also very effective in lowering HDL-C levels and lowering TG. Drugs that lower cholesterol mostly target low-density lipoprotein cholesterol (LDL-C), which initiates vascular inflammation. High cholesterol levels are considered an indirect indicator of increased inflammation in CVD patients, as cholesterol contributes to thrombus formation, leading to the release of inflammatory biomarkers such as CRP. Compared with statin monotherapy (34.7%), statin plus ezetimibe therapy can decrease cholesterol levels by 32.7%, demonstrating its antiatherosclerotic effect 4 . Statin medication or combination cholesterol-lowering therapy may be necessary for patients with increased CRP levels, who are at high risk for cardiovascular disease, to reach appropriate lipid levels and reduce inflammation 5 . Statins are the first drug of choice for reducing lipids, but ezetimibe is often needed to further increase cholesterol reduction. Ezetimibe is a cholesterol absorption inhibitor that reduces blood cholesterol levels by preventing the intestinal absorption of cholesterol. Ezetimibe with statin medication has been shown in studies to be effective in increasing HDL and reducing TG levels. Despite the known benefits of combination therapy in reducing LDL and the importance of managing lipids and inflammation post-PCI, few studies have specifically evaluated the therapeutic efficacy of atorvastatin combined with ezetimibe in post-PCI patients. There is lack of studies emphsising on the HDL and Triglycerides level after the procedure for ensuring the improved quality of life especially in south Indian cohort. The primary goals of this study were to ascertain the safety and therapeutic effectiveness of ezetimibe when used in conjunction with atorvastatin as a post-PCI treatment in terms of HDL and triglycerides. This study compared the impact of combining ezetimibe with atorvastatin versus atorvastatin in patients after percutaneous coronary intervention (PCI) was evaluated over a period of 12 weeks. METHODS Study design Single-center, prospective, randomized, two-arm parallel design, open-label study included patients referred to the Department of Cardiology for a period of six months at the SRM Medical College Hospital & Research Centre, Kattankulathur. The ethics committee of SRM Medical College Hospital and Research Center (Ethics approval number: SRMIEC-ST0922-170) approved the study. This study was conducted in accordance with the principles of the Declaration of Helsinki. Inclusion criteria This study included patients aged over 20 years who underwent percutaneous coronary intervention (PCI) within 30 days of the procedure. The patients had a history of acute coronary syndrome (ACS) or stable coronary disease and consistently high LDL cholesterol levels (≥70 mg/dL) and were also receiving atorvastatin monotherapy daily for at least two weeks before the procedure. All participants had to be clinically stable, without any ongoing ischemic symptoms, and have a preserved left ventricular ejection fraction (LVEF ≥40%). Exclusion criteria Patients with a prior history of hypersensitivity or intolerance to statins or ezetimibe, active liver disease or markedly elevated hepatic enzymes (AST or ALT >3 times the upper normal limit), patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) or those on long-term dialysis were excluded from the study. To minimize the risk of cardiovascular instability, patients with severe heart failure (NYHA class III or IV), a reduced ejection fraction (LVEF <40%), uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg) or those recovering from a significant cardiovascular event or operation in the past 30 days were prohibited. The use of other lipid-lowering therapies, including fibrates or proprotein convertase subtilisin/Kexin type 9 (PCSK9) inhibitors, within the four weeks preceding enrollment was excluded. Patients with target vessel revascularization and with a current malignancy diagnosed in the preceding two years, known substance abuse, or life expectancy of less than one year because of any noncardiac disease were also excluded. The progression of participants through each phase of the study—from enrollment to analysis—is depicted in the CONSORT flow diagram. Sample size determination A prior power analysis for parallel-group clinical trials with two parallel groups was used for determining the sample size where the calculation was performed via G*power software (version 3.1). After Bonferroni adjustment (two-tailed α = 0.01) and assuming 80% power, a sample size of 40 participants per group would allow detection of a standardized effect size of approximately 0.5, indicating that only large treatment effects could be reliably identified under this correction. Due to dropouts, final analyzed sample size was lower than planned, reducing statistical power. Procedure of the study At a tertiary care hospital, routine post-PCI follow-up visits were used to screen consecutive patients who had recently undergone successful PCI for either acute coronary syndrome or stable coronary artery disease. Eighty patients were evaluated for eligibility. After applying the study’s inclusion and exclusion criteria, 80 patients met all the requirements and were enrolled following the provision of written informed consent. Randomization was performed via computer-generated sequence with block randomization to ensure balanced allocation. The randomization was performed by an impartial third party that was not engaged in patient recruitment or clinical management, ensuring allocation concealment. The participants were randomly assigned at a 1:1 ratio into two treatment groups: Group A was given atorvastatin 40 mg once daily and Group B was given atorvastatin 40 mg plus ezetimibe 10 once daily. Baseline demographics, cardiovascular history, and lipid profiles (LDL-C, HDL-C, total cholesterol, triglycerides) were noted. Moreover, CRP reduction was also measured to determine systemic inflammation. Patient Questionnaires were also completed to evaluate medication compliance, which was assessed via the Medication Adherence Rating Scale (MARS) and health-related quality of life (HRQoL) was assessed, via the SF-36 Questionnaire. Follow-up visits were scheduled at 6 weeks and 12 weeks. Throughout the study, patients were monitored for adverse drug reactions, clinical stability, and adherence to therapy. A total of 80 patients were screened and randomized. At 12 weeks, 72 patients completed the study (Group A: n = 37; Group B: n = 35). Eight participants were lost to follow-up or excluded after randomization. The participant flow is illustrated in Figure 1. Biochemical assessments Biochemical assessments were conducted at the institution laboratory to evaluate the lipid-lowering efficacy and systemic inflammatory response associated with the intervention. Basal measurements were obtained and repeated after the 6 th week and 12 th week of treatment, and the measurements were recorded again. Approximately 5 ml of venous blood was drawn from each subject after an overnight fast period of at least 8 hours under sterile precautions. The samples were drawn in plain vacutainers, left to clot, and then centrifuged at 3,500 rpm for 10 minutes. The obtained serum was aliquoted and tested on the same day to preserve sample integrity. The lipid parameters such as, total cholesterol, HDL and triglyceride levels were determined via an automated enzymatic colorimetric assay. In addition, C-reactive protein (CRP) was assessed by a turbidimetric immunoassay as a nonspecific but clinically useful marker of systemic inflammation, most notably for cardiovascular risk. Blinding In order ensure the safety of post-surgical patients both participants and care provider was not blinded but the laboratory personnel and the data analyst was blinded to group assignments. Statistical analysis All statistical analyses were performed using SPSS version 31.0.1.0 (IBM Corp., Armonk, NY, USA). Analysis followed both ITT and PPP. Data distributions had tested for normality using the Shapiro-Wilk test. Heteroscedasticity was assessed using Levene's test. In order to control for type 1 error due to multiple comparisons of five lipid parameters (total cholesterol, HDL-C, LDL-C, VLDL-C, and triglycerides), a Bonferroni correction was applied in which the p -value for statistical significance was set at p < 0.01 (0.05/5) and for SF-36, a p-value of < 0.00625 (0.05/8) is considered statistically significant. For within-group comparisons paired t-tests, while between-group comparisons of atorvastatin (A) and atorvastatin plus ezetimibe (B) were made using Welch's t-test due to unequal variance. For categorical variable comparison and to compare treatment group distributions with respect to categorical variables, the χ² test was used. A thorough statistical analysis provided a sound basis for the interpretation of lipid parameter changes as adjacently related to the effects of efficacy and safety outcomes. Analysis was performed on participants who completed the 12-week, final 72 participants and intention to treat (ITT) analysis was performed with LOCF as calculated in supplementary. RESULTS Baseline clinical characteristics: The 72 patients demonstrated a balanced distribution between groups with comparable baseline characteristics, 37 patients (51.38%) in the atorvastatin only group (Group A) with a mean age of 51 ± 8.79 years and 35 patients (48.61%) in the atorvastatin plus ezetimibe group (Group B) with a mean age of 55 ± 10.79 years. The sex distribution revealed a male predominance in both groups, with 72.97% males in Group-A and 77.14% in Group-B, as represented in Table 1. The average body mass index (BMI) showed that most patients were overweight (25–29.9 kg/m²), comprising 59.45% of Group-A patients and 48.57% of Group-B patients. The study participants were categorized as follows: ST-elevated myocardial infarction (STEMI, 33.33%), non-ST-elevated myocardial infarction (NSTEMI, 30.55%), coronary artery disease with double vessel disease (CAD-DVD, 15.27%), CAD with single vessel disease (CAD-SVD, 12.5%), and unstable angina (8.33%). Changes in blood lipid parameters Lipid profiles improved substantially in both groups. In both groups, lipid profiles improved from baseline. The significance level was set at p < 0.01 via a Bonferroni correction to account for multiple comparisons across the five-lipid metrics. Table 1 : There were no statistically significant differences in baseline characteristics between groups (p > 0.05 for all variables). PARAMETERS GROUP - A (N = 37) GROUP – B (N = 35) p – VALUE AGE DISTRIBUTION 0.991 30-40 07 05 40-50 10 10 50-60 15 14 >60 05 06 PAST MEDICAL HISTORY 0.998 SHTN 08 06 T2DM 10 09 BOTH 14 15 OTHERS 02 03 NONE 03 02 GENDER 0.68 MALE 27 27 FEMALE 10 08 Primary endpoint: After this correction, HDL, LDL, triglyceride levels were statistically significant where the VLDL and total cholesterol levels not significant after the correction as indicated in Figure 2 and Table 2. Health-related quality of life assessments favor Group-B, After Bonferroni adjustment for eight SF-36 domains (adjusted α = 0.00625), statistically significant between-group differences were retained for Energy/Fatigue (p = 0.001), Physical Functioning (p = 0.004), Emotional Well-being (p = 0.003), and Pain (p = 0.006). The remaining domains did not meet the corrected threshold for statistical significance as presented in Table 5. These findings are revealed at confidence intervals (95%) and highlight the broader benefits of combination therapy in enhancing patients’ functional and emotional well-being. Secondary endpoint: Inflammatory markers revealed CRP reduction in Group- B which are highly significant (8±1.9 vs 18±1.9 mg/L), as mentioned previously Table 3. Medication adherence improved similarly with the statistical significance (MARS scores: 7±1.4 vs 7±1.7) as depicted in Table 4, Table 2 : Lipid profile comparisons at follow- up and baseline among Group A and Group B. Clinical Parameters (mg/dl) Baseline (A) (N = 37) (Mean ± SD) Follow-up (A) (N = 37) (Mean ± SD) Baseline (B) (N = 35) (Mean ± SD) Follow-up (B) (N = 35) (Mean ± SD) p-value (Follow-up (A) v/s Follow-up (B) ) Total Cholesterol 245.2 ± 9.8 196.4 ± 6.9 244.1 ± 8.7 181.6 ± 7.2 0.031 HDL 31.0 ± 2.5 37.5 ± 1.9 31.2 ± 2.4 44.2 ± 2.3 0.004 LDL 139.3 ± 3.4 84.6 ± 3.1 139.0 ± 3.0 70.3 ± 2.8 0.009 VLDL 51.0 ± 4.3 36.8 ± 3.2 51.1 ± 4.4 34.7 ± 2.9 0.021 Triglycerides (TG) 142.0 ± 8.3 101.4 ± 5.0 142.2 ± 7.5 85.6 ± 3.7 0.003 Table 3 : Comparison of C- reactive protein reduction between Group A and Group B. CRP (mg/L) Group-A (N = 37) (Mean ± SD) Group-B (N = 35) (Mean ± SD) p-value (Group-A v/s Group-B) Baseline 37 ± 3.6 37 ± 2.4 0.748 Follow-up 18 ± 1.9 8 ± 1.9 < 0.0001 p-value (Baseline v/s Follow-up) < 0.0001 < 0.0001 Table 4 : Comparison of medication adherence between Group-A and Group-B. MARS Group-A (N = 37) Group-B (N = 35) p- value (Group-A v/s Group-B) Baseline 4 ± 1.1 4 ± 1.0 0.900 Follow-up 7 ± 1.7 7 ± 1.4 0.785 p-value (Baseline v/s Follow-up) < 0.0001 < 0.0001 Table 5 : Assessment of HRQoL by comparing follow-up in Group- A and Group- B. Domains / Parameters Follow-up (Group A) (N = 37) Follow-up (Group B) (N = 35) p-value Physical Functioning 42.1 ± 3.1 49.0 ± 4.0 0.004 Role Limitations – Physical 54.2 ± 4.3 60.0 ± 4.5 0.012 Role Limitations – Emotional 57.2 ± 4.6 63.0 ± 4.2 0.015 Energy / Fatigue 50.3 ± 2.6 56.5 ± 3.0 0.001 Emotional Well-Being 48.5 ± 3.0 53.5 ± 2.8 0.003 Social Functioning 55.4 ± 2.7 61.0 ± 3.5 0.008 Pain 59.0 ± 3.0 64.0 ± 3.0 0.006 General Health 45.3 ± 1.9 52.0 ± 2.9 0.002 Health Change 47.8 ± 2.5 52.5 ± 3.2 0.021 DISCUSSION This interventional randomized control study was conducted in a tertiary care hospital. This finding advocates for the integration of ezetimibe into standard lipid-lowering regimens for post-PCI patients, particularly those with suboptimal lipid control on statin monotherapy, involving the investigation of the use of atorvastatin 40 mg alone to that of atorvastatin 40 mg + ezetimibe 10 mg in post PCI patients, This study compares the efficacy and safety of treatment using parameters like lipid profile, C-reactive protein, MARS and SF- 36. The results highlight not only the potential advantages of this combined therapeutic strategy in optimizing LDL control and alleviating the inflammatory burden in patients following PCI, as in previous studies. 6 However, there was also a significant decrease in triglyceride levels and an increase in HDL cholesterol levels. This is among the few Indian prospective trials evaluating atorvastatin–ezetimibe post-PCI with HRQoL outcomes. HDL and TG levels The reduction in LDL and TG levels and increase in HDL after combination therapy aligns with the results of previous studies. 7 The combination of a moderate dosage of ezetimibe with statins had a positive effect 8 . The results of Tsujita et al.'s investigation, which also examined the combined effects of ezetimibe and atorvastatin, showed a regression of atherosclerotic plaques and a considerable decrease in LDL and TG and increase in HDL levels. It is possible that their 9- and 12-month follow-up periods were very important to their results 9 . The decrease in TG and increase in HDL cholesterol are consistent with studies involving different elective cholesteryl ester transfer protein (CETP) inhibitors when given with statins. 10 , 11 Clinicians should consider combination therapy in patients with persistent dyslipidemia as it offers a more comprehensive lipid profile optimization without compromising adherence 12 . The pronounced reduction in CRP may play a role in mitigating inflammation-driven atherosclerosis progression, a key consideration for post-PCI patients prone to recurrent events. From a public health perspective, this study underscores the potential of ezetimibe as a cost-effective adjunct to improve cardiovascular outcomes in post-PCI patients, a group with significant morbidity and healthcare burdens. The enhanced lipid control and anti-inflammatory effects of combination therapy could reduce the incidence of recurrent cardiovascular events, thereby decreasing hospitalizations and associated costs. The findings of this study also highlight the need for public health research to explore equitable access to advanced lipid-lowering therapies, ensuring that underserved populations benefit from these advancements. While this study provides compelling evidence for the role of ezetimibe in post-PCI care, several limitations warrant consideration. Differences between PP and ITT analyses may reflect imputation effects inherent to LOCF methodology, which may attenuate variance and influence significance estimates. Study limitations The small sample size (n = 72 completers) of the single-center design with a short follow-up period (12 weeks) limits the generalizability of the data however, the observed significant and rapid reductions in LDL-C and the accompanying decrease in the inflammatory marker C-reactive protein (CRP), although surrogate endpoints, provide strong biological and pharmacological justification for a long-term clinical outcome. This finding is rigorously supported by definitive, large-scale clinical evidence. The IMPROVE-IT trial demonstrated that the strategy of adding ezetimibe to statin therapy to achieve lower LDL-C levels directly translates into a reduced incidence of major adverse cardiovascular events (MACE) in high-risk post-acute coronary syndrome patients 13 . Therefore, the potent lipid-lowering and anti-inflammatory effects demonstrated over the 12 weeks of our study serve as crucial early indicators (or proofs of concept), suggesting that this intensive regimen is may translate into improved long-term cardiovascular outcomes, as suggested by large-scale trials such as IMPROVE-IT, in line with the established ‘lower is better’ paradigm for LDL-C reduction. Moreover, insights into long-term outcomes, such as recurrent events or mortality, are lacking. Additionally, while we applied Bonferroni correction for multiple comparisons of lipid parameters, the numerous secondary endpoints tested, particularly across the eight SF-36 domains, raise concerns about potential type I errors. The 7.5% dropout rate, may introduce bias, and the lack of Group- A safety data hinders comprehensive risk- benefit assessment, which raises concerns about type I errors, given the numerous endpoints tested. Future Scope Future research should involve larger, multicenter trials with extended follow-up to confirm these findings and assess clinical endpoints as myocardial infarction or revascularization rates. Stratified analyses by age, sex, BMI, or comorbidities could identify subgroups with optimal benefit, informing personalized medicine approaches in Indian populations. Additionally, cost-effectiveness studies are needed to evaluate the public health feasibility of widespread ezetimibe use, particularly in low resource settings. Incorporating broader safety assessments, including liver function and creatine kinase levels, would provide a more complete risk profile for both treatment arms. The findings of this study have broader implications for cardiovascular disease management and health policy. Health policy makers should prioritize integrating of such therapies into national cardiovascular disease prevention programs, ensuring that diagnostic and monitoring infrastructure supports their implementation. Collaborative efforts between governments, healthcare systems and pharmaceutical stakeholders are essential to address access barriers, ensuring the benefits of ezetimibe reach diverse populations. Ultimately, this study contributes to the growing evidence base for intensified lipid-lowering strategies, paving the way for improved outcomes in one of the most vulnerable cardiovascular patient groups. CONCLUSION Overall, the combination of ezetimibe with atorvastatin in post-PCI patients improves lipid profile optimization, inflammation reduction, and HRQoL over atorvastatin therapy alone, and long-term trials are needed to confirm these findings and assess the impact on clinical events. These observations highlight the clinical and public health value of combination therapy for secondary prevention and provide a strategy to decrease cardiovascular risk and enhance patient quality of life. The incorporation of these findings into practice and public health policy can promote coronary artery disease management, eventually reducing its burden worldwide. Abbreviations ACS Acute coronary syndrome ALT Alanine aminotransferase AST Aspartate aminotransferase BMI Body mass index BP Blood pressure CAD Coronary artery disease CAD-DVD Coronary artery disease - double vessel disease CAD-SVD Coronary artery disease – single vessel disease CETP Cholesteryl ester transfer protein CRP C-Reactive protein CTRI Clinical trials registry - India CVD Cardiovascular disease eGFR estimated glomerular filtration rate HDL High-density lipoprotein HDL-C High-density lipoprotein cholesterol HRQoL Health-Related Quality of Life IHD Ischemic Heart Disease ITT Intention-to-treat LDL Low-density lipoprotein LDL-C Low-density lipoprotein cholesterol LVEF Left ventricular ejection fraction LOCF Last Observation Carried Forward MARS Medication Adherence Rating Scale NSTEMI Non-ST-Segment Elevation Myocardial Infarction NYHA New York Heart Association PAD Peripheral artery disease PCI Percutaneous Coronary Intervention PCSK9 Proprotein Convertase Subtilisin/Kexin type 9 SHTN Systemic hypertension SF-36 Short Form 36 STEMI ST-Segment elevation myocardial infarction T2DM Type 2 Diabetes Mellitus TG Triglycerides VLDL Very-low-density lipoprotein Declarations Ethics approval and consent to participate The Institutional Ethics Committee of SRM Medical College Hospital & Research Centre, with reference number SRMIEC-ST0922-170 provided approval. Informed consent was obtained from every participant in the study. After an exhaustive explanation of the purposes of the study, procedures, potential risks and benefits, and confidentiality of the data, each participant signed written informed consent. All participants were clearly informed that participation in the study was entirely at their own discretion and that they were free to withdraw at any point without adverse effects on their medical care or penalty. All the information collected was anonymized and solely for use within this research. Consent for publication The authors affirm that signed informed consent was obtained from the participants for the publishing of their data presented in this manuscript. Availability of data and materials The data that support the findings of this study are available from Aosta BackBone Hospital Management System (HMS) but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Aosta BackBone HMS. Competing Interests: Not Applicable Funding: Not Applicable Authors' contributions: S. Srividya, Abisha Judie K, and Nishanthi M.G. were responsible for getting approval from ethical committee and conducting the research project, patient recruitment, and data collection. Pravin Selvi Saravanan and Aishwaryaa Anand performed the data analysis and prepared the manuscript. Dr. Sarumathy S and Dr. Nanda Kumar R contributed to the clinical assessment of the patients, provided critical guidance during the study, and reviewed the manuscript. All authors read and approved the final manuscript. Acknowledgements: The authors would like to express their sincere gratitude to Dr. Sarumathy S and Dr. Nanda Kumar R for their valuable guidance and support in the clinical assessment and overall supervision of the study. The authors also thank the staff of SRM Medical College Hospital and Research Centre for their assistance during patient recruitment and data collection. References Martin SS, Aday AW, Allen NB, et al. 2025 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation . 2025;151(8). doi:10.1161/CIR.0000000000001303 Kiran G, Mohan I, Kaur M, Ahuja S, Gupta S, Gupta R. Escalating ischemic heart disease burden among women in India: Insights from GBD, NCDRisC and NFHS reports. Am J Prev Cardiol . 2020;2:100035. doi:10.1016/j.ajpc.2020.100035 Forzano I, Florimonte D, Narciso V, et al. 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J Atheroscler Thromb . 2024;31(10):1386-1397. doi:10.5551/jat.64828 Nelson AJ, Sniderman AD, Ditmarsch M, et al. Cholesteryl Ester Transfer Protein Inhibition Reduces Major Adverse Cardiovascular Events by Lowering Apolipoprotein B Levels. Int J Mol Sci . 2022;23(16):9417. doi:10.3390/ijms23169417 Rubino J, MacDougall DE, Sterling LR, Hanselman JC, Nicholls SJ. Combination of bempedoic acid, ezetimibe, and atorvastatin in patients with hypercholesterolemia: A randomized clinical trial. Atherosclerosis . 2021;320:122-128. doi:10.1016/j.atherosclerosis.2020.12.023 Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. New England Journal of Medicine . 2015;372(25):2387-2397. doi:10.1056/NEJMoa1410489 Additional Declarations No competing interests reported. Supplementary Files Supplementarymaterialezetamibeatorvastatin.docx Cite Share Download PDF Status: Under Revision Version 1 posted Editorial decision: Revision requested 24 Apr, 2026 Reviews received at journal 20 Apr, 2026 Reviews received at journal 19 Apr, 2026 Reviews received at journal 14 Apr, 2026 Reviewers agreed at journal 14 Apr, 2026 Reviews received at journal 13 Apr, 2026 Reviewers agreed at journal 11 Apr, 2026 Reviews received at journal 11 Apr, 2026 Reviewers agreed at journal 10 Apr, 2026 Reviews received at journal 10 Apr, 2026 Reviewers agreed at journal 10 Apr, 2026 Reviews received at journal 09 Apr, 2026 Reviewers agreed at journal 09 Apr, 2026 Reviewers agreed at journal 09 Apr, 2026 Reviews received at journal 09 Apr, 2026 Reviewers agreed at journal 09 Apr, 2026 Reviews received at journal 09 Apr, 2026 Reviewers agreed at journal 09 Apr, 2026 Reviewers agreed at journal 09 Apr, 2026 Reviewers agreed at journal 09 Apr, 2026 Reviewers agreed at journal 09 Apr, 2026 Reviewers invited by journal 02 Apr, 2026 Editor assigned by journal 31 Mar, 2026 Editor invited by journal 09 Mar, 2026 Submission checks completed at journal 08 Mar, 2026 First submitted to journal 08 Mar, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8999676","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":617101219,"identity":"6dc8f67a-8575-4969-853d-bafe3be151a2","order_by":0,"name":"Srividya S","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Srividya","middleName":"","lastName":"S","suffix":""},{"id":617101220,"identity":"7e29fee8-e844-4541-8833-3a48bc6de8ac","order_by":1,"name":"Abisha Judie K","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Abisha","middleName":"Judie","lastName":"K","suffix":""},{"id":617101221,"identity":"fe67c64a-884b-40e9-9568-1185e24e3ab7","order_by":2,"name":"Nanda Kumar R","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Nanda","middleName":"Kumar","lastName":"R","suffix":""},{"id":617101222,"identity":"1279fda1-22aa-4990-b91a-a19a4253c7e3","order_by":3,"name":"Nishanthi M G","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Nishanthi","middleName":"M","lastName":"G","suffix":""},{"id":617101224,"identity":"6f6e5f54-2229-4bca-ae00-6e5dbf835b53","order_by":4,"name":"Pravin Selvi Saravanan","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Pravin","middleName":"Selvi","lastName":"Saravanan","suffix":""},{"id":617101225,"identity":"55e6c88e-5ba2-479d-abcd-72bf2f04fda5","order_by":5,"name":"Aishwaryaa Anand","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Aishwaryaa","middleName":"","lastName":"Anand","suffix":""},{"id":617101226,"identity":"adace857-f1e2-404f-a2b8-90e7ef705c05","order_by":6,"name":"Sarumathy S","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA40lEQVRIiWNgGAWjYDADfhCRwAAlEwhrMGCQbAArNiBBi8EBKIOgevn2s8+kbtT8sTc+f/bphgd//jDws+cYMDzcgcf4M+lm0jnHDBK33Ug3u5HYBnRhzxsDhsQz+FyUxiadw2aQYHaDje1GYgPQhTeAtiS24XFY/zOgln8G9sb9x9huJPwxYLAnpIXhBtCW3DYDxg1A624ksAFtkSCgxeDGM2br3D7jxBlAvUC/GPNInHlWcAC/w9IYb+d8k7PnBzrs5o8/cnL87ckbH/7E5zB0wAMiDpCgYRSMglEwCkYBFgAADa5NqI2TIjcAAAAASUVORK5CYII=","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":true,"prefix":"","firstName":"Sarumathy","middleName":"","lastName":"S","suffix":""}],"badges":[],"createdAt":"2026-03-01 06:54:21","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8999676/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8999676/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":106533465,"identity":"26bfbef0-d27e-44f2-8510-7e8fb4f8e11f","added_by":"auto","created_at":"2026-04-09 14:57:32","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":82886,"visible":true,"origin":"","legend":"\u003cp\u003eCONSORT 2010 flow diagram showing participant enrollment, randomization, follow-up, and analysis in the randomized controlled trial comparing atorvastatin monotherapy with atorvastatin plus ezetimibe in post-PCI patients. Analysis boxes show the number included in the intention-to-treat (ITT) population (equal to all randomized in each group), and below, the number included in the per-protocol (PP) set.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8999676/v1/6fbc17d99fa04335430106d6.png"},{"id":106533421,"identity":"7e96c1fe-af6d-49a8-b8e6-3423cf99b161","added_by":"auto","created_at":"2026-04-09 14:57:25","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":65411,"visible":true,"origin":"","legend":"\u003cp\u003eComparison of lipid profile parameters between Group A and Group B at baseline and follow-up. Data are expressed as mean ± standard deviation. Between-group comparisons were performed using Welch’s t-test, with Bonferroni correction applied\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8999676/v1/8488ef2eff58826b7994cae5.png"},{"id":106533683,"identity":"17a1354d-25e3-4765-8f51-b29ef5ecc2ba","added_by":"auto","created_at":"2026-04-09 14:57:56","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1155489,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8999676/v1/5555278c-5f16-48c5-97f1-a66299e9376b.pdf"},{"id":106533467,"identity":"4308b020-a260-49bf-81da-7a445d9e1783","added_by":"auto","created_at":"2026-04-09 14:57:33","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":48928,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementarymaterialezetamibeatorvastatin.docx","url":"https://assets-eu.researchsquare.com/files/rs-8999676/v1/ed4c7d2281cba7c225d1a7ef.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Clinical Efficacy of Ezetimibe as an Add-on to Atorvastatin: Effects on HDL Cholesterol and Triglycerides in Post-PCI Patients from a South Indian Population","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eCoronary artery disease (CAD), a major form of cardiovascular diseases (CVDs), include maladies such as stable angina, unstable angina, myocardial infarction (MI), acute coronary Syndrome and arrythmias remain the leading cause of death globally with a 68% increase in the number of deaths from 1990\u0026ndash;2021, whereas in South Asia, 181% increase\u003csup\u003e1\u003c/sup\u003e. In India, from 2000\u0026ndash;2017, total IHD mortality increased from 851,000 to 1,540,000 deaths (+\u0026thinsp;81.1%) which indicates an increasing burden\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. Acute coronary syndrome (ACS), a severe clinical presentation of coronary artery disease (CAD), remains a major global cause of morbidity and mortality. Plaque rupture inside coronary arteries triggers events such as platelet activation, thrombosis, and arterial obstruction, often necessitating immediate revascularization. Since its inception, percutaneous coronary intervention (PCI), a highly evolved, minimally invasive modality, has been the primary approach for restoring blood flow. Treatment involves expanding the constricted area, often by inserting a stent, to reestablish coronary blood flow. PCI is a standard procedure in the treatment of angina or IHD and is used for myocardial ischemia or myocardial infarction. Atherogenic lipids and vascular inflammation drive residual risk after PCI, despite guideline-directed therapy. Effective lipid management and a reduction in inflammation are therefore key components of post-PCI care\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e. Despite the effects of statins on LDL-C levels, statins are also very effective in lowering HDL-C levels and lowering TG. Drugs that lower cholesterol mostly target low-density lipoprotein cholesterol (LDL-C), which initiates vascular inflammation. High cholesterol levels are considered an indirect indicator of increased inflammation in CVD patients, as cholesterol contributes to thrombus formation, leading to the release of inflammatory biomarkers such as CRP. Compared with statin monotherapy (34.7%), statin plus ezetimibe therapy can decrease cholesterol levels by 32.7%, demonstrating its antiatherosclerotic effect\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. Statin medication or combination cholesterol-lowering therapy may be necessary for patients with increased CRP levels, who are at high risk for cardiovascular disease, to reach appropriate lipid levels and reduce inflammation\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e. Statins are the first drug of choice for reducing lipids, but ezetimibe is often needed to further increase cholesterol reduction. Ezetimibe is a cholesterol absorption inhibitor that reduces blood cholesterol levels by preventing the intestinal absorption of cholesterol. Ezetimibe with statin medication has been shown in studies to be effective in increasing HDL and reducing TG levels. Despite the known benefits of combination therapy in reducing LDL and the importance of managing lipids and inflammation post-PCI, few studies have specifically evaluated the therapeutic efficacy of atorvastatin combined with ezetimibe in post-PCI patients. There is lack of studies emphsising on the HDL and Triglycerides level after the procedure for ensuring the improved quality of life especially in south Indian cohort. The primary goals of this study were to ascertain the safety and therapeutic effectiveness of ezetimibe when used in conjunction with atorvastatin as a post-PCI treatment in terms of HDL and triglycerides. This study compared the impact of combining ezetimibe with atorvastatin versus atorvastatin in patients after percutaneous coronary intervention (PCI) was evaluated over a period of 12 weeks.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStudy design\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSingle-center, prospective, randomized, two-arm parallel design, open-label study included patients referred to the Department of Cardiology for a period of six months at the SRM Medical College Hospital \u0026amp; Research Centre, Kattankulathur. The ethics committee of SRM Medical College Hospital and Research Center (Ethics approval number: SRMIEC-ST0922-170) approved the study. This study was conducted in accordance with the principles of the Declaration of Helsinki.\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003cstrong\u003eInclusion criteria\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis study included patients aged over 20 years who underwent percutaneous coronary intervention (PCI) within 30 days of the procedure. The patients had a history of acute coronary syndrome (ACS) or stable coronary disease and consistently high LDL cholesterol levels (\u0026ge;70 mg/dL) and were also receiving atorvastatin monotherapy daily for at least two weeks before the procedure. All participants had to be clinically stable, without any ongoing ischemic symptoms, and have a preserved left ventricular ejection fraction (LVEF \u0026ge;40%).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eExclusion criteria\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients with a prior history of hypersensitivity or intolerance to statins or ezetimibe, active liver disease or markedly elevated hepatic enzymes (AST or ALT \u0026gt;3 times the upper normal limit), patients with severe renal impairment (eGFR \u0026lt;30 mL/min/1.73 m\u0026sup2;) or those on long-term dialysis were excluded from the study. To minimize the risk of cardiovascular instability, patients with severe heart failure (NYHA class III or IV), a reduced ejection fraction (LVEF \u0026lt;40%), uncontrolled hypertension (systolic \u0026ge;180 mmHg or diastolic \u0026ge;110 mmHg) or those recovering from a significant cardiovascular event or operation in the past 30 days were prohibited. The use of other lipid-lowering therapies, including fibrates or proprotein convertase subtilisin/Kexin type 9 (PCSK9) inhibitors, within the four weeks preceding enrollment was excluded. Patients with target vessel revascularization and with a current malignancy diagnosed in the preceding two years, known substance abuse, or life expectancy of less than one year because of any noncardiac disease were also excluded. The progression of participants through each phase of the study\u0026mdash;from enrollment to analysis\u0026mdash;is depicted in the CONSORT flow diagram.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSample size determination\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA prior power analysis for parallel-group clinical trials with two parallel groups was used for determining the sample size where the calculation was performed via G*power software (version 3.1). After Bonferroni adjustment (two-tailed \u0026alpha; = 0.01) and assuming 80% power, a sample size of 40 participants per group would allow detection of a standardized effect size of approximately 0.5, indicating that only large treatment effects could be reliably identified under this correction. Due to dropouts, final analyzed sample size was lower than planned, reducing statistical power.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eProcedure of the study\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAt a tertiary care hospital, routine post-PCI follow-up visits were used to screen consecutive patients who had recently undergone successful PCI for either acute coronary syndrome or stable coronary artery disease. Eighty patients were evaluated for eligibility. After applying the study\u0026rsquo;s inclusion and exclusion criteria, 80 patients met all the requirements and were enrolled following the provision of written informed consent. Randomization was performed via computer-generated sequence with block randomization to ensure balanced allocation. The randomization was performed by an impartial third party that was not engaged in patient recruitment or clinical management, ensuring allocation concealment. The participants were randomly assigned at a 1:1 ratio into two treatment groups: Group A was given atorvastatin 40 mg once daily and Group B was given atorvastatin 40 mg plus ezetimibe 10 once daily. Baseline demographics, cardiovascular history, and lipid profiles (LDL-C, HDL-C, total cholesterol, triglycerides) were noted. Moreover, CRP reduction was also measured to determine systemic inflammation. Patient Questionnaires were also completed to evaluate medication compliance, which was assessed via the Medication Adherence Rating Scale (MARS) and health-related quality of life (HRQoL) was assessed, via the SF-36 Questionnaire. Follow-up visits were scheduled at 6 weeks and 12 weeks. Throughout the study, patients were monitored for adverse drug reactions, clinical stability, and adherence to therapy. A total of 80 patients were screened and randomized. At 12 weeks, 72 patients completed the study (Group A: n = 37; Group B: n = 35). Eight participants were lost to follow-up or excluded after randomization. The participant flow is illustrated in Figure 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBiochemical assessments\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBiochemical assessments were conducted at the institution laboratory to evaluate the lipid-lowering efficacy and systemic inflammatory response associated with the intervention. Basal measurements were obtained and repeated after the 6\u003csup\u003eth\u003c/sup\u003e week and 12\u003csup\u003eth\u003c/sup\u003e week of treatment, and the measurements were recorded again. Approximately 5 ml of venous blood was drawn from each subject after an overnight fast period of at least 8 hours under sterile precautions. The samples were drawn in plain vacutainers, left to clot, and then centrifuged at 3,500 rpm for 10 minutes. The obtained serum was aliquoted and tested on the same day to preserve sample integrity. The lipid parameters such as, total cholesterol, HDL and triglyceride levels were determined via an automated enzymatic colorimetric assay. In addition, C-reactive protein (CRP) was assessed by a turbidimetric immunoassay as a nonspecific but clinically useful marker of systemic inflammation, most notably for cardiovascular risk.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBlinding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn order ensure the safety of post-surgical patients both participants and care provider was not blinded but the laboratory personnel and the data analyst was blinded to group assignments.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll statistical analyses were performed using SPSS version 31.0.1.0 (IBM Corp., Armonk, NY, USA). Analysis followed both ITT and PPP. Data distributions had tested for normality using the Shapiro-Wilk test. Heteroscedasticity was assessed using Levene\u0026apos;s test. In order to control for type 1 error due to multiple comparisons of five lipid parameters (total cholesterol, HDL-C, LDL-C, VLDL-C, and triglycerides), a Bonferroni correction was applied in which the p -value for statistical significance was set at p \u0026lt; 0.01 (0.05/5) and for SF-36, a p-value of \u0026lt; 0.00625 (0.05/8) is considered statistically significant. For within-group comparisons paired t-tests, while between-group comparisons of atorvastatin (A) and atorvastatin plus ezetimibe (B) were made using Welch\u0026apos;s t-test due to unequal variance. For categorical variable comparison and to compare treatment group distributions with respect to categorical variables, the \u0026chi;\u0026sup2; test was used. A thorough statistical analysis provided a sound basis for the interpretation of lipid parameter changes as adjacently related to the effects of efficacy and safety outcomes. Analysis was performed on participants who completed the 12-week, final 72 participants and intention to treat (ITT) analysis was performed with LOCF as calculated in supplementary.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBaseline clinical characteristics:\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe 72 patients demonstrated a balanced distribution between groups with comparable baseline characteristics, 37 patients (51.38%) in the atorvastatin only group (Group A) with a mean age of 51 \u0026plusmn; 8.79 years and 35 patients (48.61%) in the atorvastatin plus ezetimibe group (Group B) with a mean age of 55 \u0026plusmn; 10.79 years. The sex distribution revealed a male predominance in both groups, with 72.97% males in Group-A and 77.14% in Group-B, as represented in Table 1. The average body mass index (BMI) showed that most patients were overweight (25\u0026ndash;29.9 kg/m\u0026sup2;), comprising 59.45% of Group-A patients and 48.57% of Group-B patients. The study participants were categorized as follows: ST-elevated myocardial infarction (STEMI, 33.33%), non-ST-elevated myocardial infarction (NSTEMI, 30.55%), coronary artery disease with double vessel disease (CAD-DVD, 15.27%), CAD with single vessel disease (CAD-SVD, 12.5%), and unstable angina (8.33%).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eChanges in blood lipid parameters\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLipid profiles improved substantially in both groups. In both groups, lipid profiles improved from baseline. The significance level was set at p \u0026lt; 0.01 via a Bonferroni correction to account for multiple comparisons across the five-lipid metrics.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTable\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e1\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eThere were no statistically significant differences in baseline characteristics between groups (p \u0026gt; 0.05 for all variables).\u003c/em\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cdiv align=\"\"\u003e\n \u003ctable style=\"width: 5.2e+2pt;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003ePARAMETERS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eGROUP - A \u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(N = 37)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eGROUP \u0026ndash; B\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(N = 35)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep \u0026ndash;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;VALUE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eAGE \u0026nbsp; \u0026nbsp; DISTRIBUTION\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.991\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e30-40\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e07\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e05\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e40-50\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e10\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e10\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e50-60\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e15\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e14\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026gt;60\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e05\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e06\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003ePAST \u0026nbsp; \u0026nbsp; MEDICAL \u0026nbsp;HISTORY\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.998\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eSHTN\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;08\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e06\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eT2DM\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e10\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e09\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eBOTH\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e14\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e15\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eOTHERS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e02\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e03\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eNONE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e03\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e02\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eGENDER\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.68\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eMALE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e27\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eFEMALE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e08\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cem\u003ePrimary endpoint:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAfter this correction, HDL, LDL, triglyceride levels were statistically significant where the VLDL and total cholesterol levels not significant after the correction as indicated in Figure 2 and Table 2. Health-related quality of life assessments favor Group-B, After Bonferroni adjustment for eight SF-36 domains (adjusted \u0026alpha; = 0.00625), statistically significant between-group differences were retained for Energy/Fatigue (p = 0.001), Physical Functioning (p = 0.004), Emotional Well-being (p = 0.003), and Pain (p = 0.006). The remaining domains did not meet the corrected threshold for statistical significance as presented in Table 5. These findings are revealed at \u003cstrong\u003econfidence intervals (95%) and\u0026nbsp;\u003c/strong\u003ehighlight the broader benefits of combination therapy in enhancing patients\u0026rsquo; functional and emotional well-being.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSecondary endpoint:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eInflammatory markers revealed CRP reduction in Group- B which are highly significant (8\u0026plusmn;1.9 vs 18\u0026plusmn;1.9 mg/L), as mentioned previously Table 3. Medication adherence improved similarly with the statistical significance (MARS scores: 7\u0026plusmn;1.4 vs 7\u0026plusmn;1.7) as depicted in Table 4,\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003cstrong\u003e:\u003c/strong\u003e Lipid profile comparisons at follow- up and baseline among Group A and Group B.\u003c/p\u003e\n\u003ctable style=\"width: 5.1e+2pt;border: none;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eClinical Parameters (mg/dl)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eBaseline (A)\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e(N = 37)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(Mean\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026plusmn; \u003cstrong\u003eSD)\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eFollow-up (A)\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;(N = 37)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(Mean\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026plusmn; \u003cstrong\u003eSD)\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eBaseline (B)\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;(N = 35)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(Mean\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026plusmn; \u003cstrong\u003eSD)\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eFollow-up (B)\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;(N = 35)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(Mean\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026plusmn; \u003cstrong\u003eSD)\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep-value\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(Follow-up (A)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ev/s Follow-up (B)\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eTotal Cholesterol\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e245.2 \u0026plusmn; 9.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e196.4 \u0026plusmn; 6.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e244.1 \u0026plusmn; 8.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e181.6 \u0026plusmn; 7.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.031\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eHDL\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e31.0 \u0026plusmn; 2.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e37.5 \u0026plusmn; 1.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e31.2 \u0026plusmn; 2.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e44.2 \u0026plusmn; 2.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.004\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eLDL\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e139.3 \u0026plusmn; 3.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e84.6 \u0026plusmn; 3.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e139.0 \u0026plusmn; 3.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e70.3 \u0026plusmn; 2.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.009\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eVLDL\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e51.0 \u0026plusmn; 4.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e36.8 \u0026plusmn; 3.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e51.1 \u0026plusmn; 4.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e34.7 \u0026plusmn; 2.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.021\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eTriglycerides (TG)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e142.0 \u0026plusmn; 8.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e101.4 \u0026plusmn; 5.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e142.2 \u0026plusmn; 7.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e85.6 \u0026plusmn; 3.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.003\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTable\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e3\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e:\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026nbsp;Comparison of C- reactive protein reduction between Group A and Group B.\u003c/em\u003e\u003c/p\u003e\n\u003ctable style=\"width: 5.2e+2pt;border: none;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eCRP (mg/L)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eGroup-A (N = 37)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(Mean\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026plusmn; \u003cstrong\u003eSD)\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eGroup-B (N = 35)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(Mean\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003e\u0026plusmn; \u003cstrong\u003eSD)\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep-value (Group-A v/s Group-B)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cem\u003eBaseline\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e37 \u0026plusmn; 3.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e37 \u0026plusmn; 2.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e0.748\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cem\u003eFollow-up\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e18 \u0026plusmn; 1.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e8 \u0026plusmn; 1.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u0026lt; 0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cem\u003ep-value (Baseline v/s Follow-up)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\" colspan=\"3\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026lt; 0.0001 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026lt; 0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e4\u003c/strong\u003e: Comparison of medication adherence between Group-A and Group-B.\u003c/p\u003e\n\u003ctable style=\"float: ;width: 5.1e+2pt;border: none;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eMARS\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eGroup-A\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(N = 37)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eGroup-B \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;(N = 35)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep- \u0026nbsp;value \u0026nbsp; \u0026nbsp; (Group-A \u0026nbsp;v/s \u0026nbsp;Group-B)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eBaseline\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e4 \u0026nbsp;\u0026plusmn; \u0026nbsp; \u0026nbsp; 1.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e4 \u0026nbsp;\u0026plusmn; \u0026nbsp; \u0026nbsp; 1.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e0.900\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eFollow-up\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e7 \u0026nbsp;\u0026plusmn; \u0026nbsp;1.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e7 \u0026nbsp;\u0026plusmn; \u0026nbsp;1.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e0.785\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd nowrap=\"\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep-value \u0026nbsp;(Baseline \u0026nbsp; \u0026nbsp; v/s \u0026nbsp;Follow-up)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd nowrap=\"\" colspan=\"3\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026lt; \u0026nbsp; \u0026nbsp; 0.0001 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026lt; \u0026nbsp;0.0001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e5\u003c/strong\u003e\u003cstrong\u003e:\u0026nbsp;\u003c/strong\u003eAssessment of HRQoL by comparing follow-up in Group- A and Group- B.\u003c/p\u003e\n\u003ctable style=\"width: 5.0e+2pt;border: none;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eDomains / Parameters\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eFollow-up (Group A)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(N = 37)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eFollow-up (Group B)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e(N = 35)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep-value\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ePhysical Functioning\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e42.1 \u0026plusmn; 3.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e49.0 \u0026plusmn; 4.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.004\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eRole Limitations \u0026ndash; Physical\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e54.2 \u0026plusmn; 4.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e60.0 \u0026plusmn; 4.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.012\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eRole Limitations \u0026ndash; Emotional\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e57.2 \u0026plusmn; 4.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e63.0 \u0026plusmn; 4.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.015\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eEnergy / Fatigue\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e50.3 \u0026plusmn; 2.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e56.5 \u0026plusmn; 3.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eEmotional Well-Being\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e48.5 \u0026plusmn; 3.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e53.5 \u0026plusmn; 2.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.003\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSocial Functioning\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e55.4 \u0026plusmn; 2.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e61.0 \u0026plusmn; 3.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.008\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ePain\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e59.0 \u0026plusmn; 3.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e64.0 \u0026plusmn; 3.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.006\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eGeneral Health\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e45.3 \u0026plusmn; 1.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e52.0 \u0026plusmn; 2.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eHealth Change\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e47.8 \u0026plusmn; 2.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e52.5 \u0026plusmn; 3.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e0.021\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis interventional randomized control study was conducted in a tertiary care hospital. This finding advocates for the integration of ezetimibe into standard lipid-lowering regimens for post-PCI patients, particularly those with suboptimal lipid control on statin monotherapy, involving the investigation of the use of atorvastatin 40 mg alone to that of atorvastatin 40 mg\u0026thinsp;+\u0026thinsp;ezetimibe 10 mg in post PCI patients, This study compares the efficacy and safety of treatment using parameters like lipid profile, C-reactive protein, MARS and SF- 36. The results highlight not only the potential advantages of this combined therapeutic strategy in optimizing LDL control and alleviating the inflammatory burden in patients following PCI, as in previous studies.\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e However, there was also a significant decrease in triglyceride levels and an increase in HDL cholesterol levels. This is among the few Indian prospective trials evaluating atorvastatin\u0026ndash;ezetimibe post-PCI with HRQoL outcomes.\u003c/p\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eHDL and TG levels\u003c/h2\u003e \u003cp\u003eThe reduction in LDL and TG levels and increase in HDL after combination therapy aligns with the results of previous studies.\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e The combination of a moderate dosage of ezetimibe with statins had a positive effect\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. The results of Tsujita et al.'s investigation, which also examined the combined effects of ezetimibe and atorvastatin, showed a regression of atherosclerotic plaques and a considerable decrease in LDL and TG and increase in HDL levels. It is possible that their 9- and 12-month follow-up periods were very important to their results\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e. The decrease in TG and increase in HDL cholesterol are consistent with studies involving different elective cholesteryl ester transfer protein (CETP) inhibitors when given with statins.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eClinicians should consider combination therapy in patients with persistent dyslipidemia as it offers a more comprehensive lipid profile optimization without compromising adherence\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. The pronounced reduction in CRP may play a role in mitigating inflammation-driven atherosclerosis progression, a key consideration for post-PCI patients prone to recurrent events. From a public health perspective, this study underscores the potential of ezetimibe as a cost-effective adjunct to improve cardiovascular outcomes in post-PCI patients, a group with significant morbidity and healthcare burdens. The enhanced lipid control and anti-inflammatory effects of combination therapy could reduce the incidence of recurrent cardiovascular events, thereby decreasing hospitalizations and associated costs. The findings of this study also highlight the need for public health research to explore equitable access to advanced lipid-lowering therapies, ensuring that underserved populations benefit from these advancements. While this study provides compelling evidence for the role of ezetimibe in post-PCI care, several limitations warrant consideration. Differences between PP and ITT analyses may reflect imputation effects inherent to LOCF methodology, which may attenuate variance and influence significance estimates.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eStudy limitations\u003c/h2\u003e \u003cp\u003eThe small sample size (n\u0026thinsp;=\u0026thinsp;72 completers) of the single-center design with a short follow-up period (12 weeks) limits the generalizability of the data however, the observed significant and rapid reductions in LDL-C and the accompanying decrease in the inflammatory marker C-reactive protein (CRP), although surrogate endpoints, provide strong biological and pharmacological justification for a long-term clinical outcome. This finding is rigorously supported by definitive, large-scale clinical evidence. The IMPROVE-IT trial demonstrated that the strategy of adding ezetimibe to statin therapy to achieve lower LDL-C levels directly translates into a reduced incidence of major adverse cardiovascular events (MACE) in high-risk post-acute coronary syndrome patients\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. Therefore, the potent lipid-lowering and anti-inflammatory effects demonstrated over the 12 weeks of our study serve as crucial early indicators (or proofs of concept), suggesting that this intensive regimen is may translate into improved long-term cardiovascular outcomes, as suggested by large-scale trials such as IMPROVE-IT, in line with the established \u0026lsquo;lower is better\u0026rsquo; paradigm for LDL-C reduction. Moreover, insights into long-term outcomes, such as recurrent events or mortality, are lacking. Additionally, while we applied Bonferroni correction for multiple comparisons of lipid parameters, the numerous secondary endpoints tested, particularly across the eight SF-36 domains, raise concerns about potential type I errors. The 7.5% dropout rate, may introduce bias, and the lack of Group- A safety data hinders comprehensive risk- benefit assessment, which raises concerns about type I errors, given the numerous endpoints tested.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eFuture Scope\u003c/h2\u003e \u003cp\u003eFuture research should involve larger, multicenter trials with extended follow-up to confirm these findings and assess clinical endpoints as myocardial infarction or revascularization rates. Stratified analyses by age, sex, BMI, or comorbidities could identify subgroups with optimal benefit, informing personalized medicine approaches in Indian populations. Additionally, cost-effectiveness studies are needed to evaluate the public health feasibility of widespread ezetimibe use, particularly in low resource settings. Incorporating broader safety assessments, including liver function and creatine kinase levels, would provide a more complete risk profile for both treatment arms. The findings of this study have broader implications for cardiovascular disease management and health policy. Health policy makers should prioritize integrating of such therapies into national cardiovascular disease prevention programs, ensuring that diagnostic and monitoring infrastructure supports their implementation. Collaborative efforts between governments, healthcare systems and pharmaceutical stakeholders are essential to address access barriers, ensuring the benefits of ezetimibe reach diverse populations. Ultimately, this study contributes to the growing evidence base for intensified lipid-lowering strategies, paving the way for improved outcomes in one of the most vulnerable cardiovascular patient groups.\u003c/p\u003e \u003c/div\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eOverall, the combination of ezetimibe with atorvastatin in post-PCI patients improves lipid profile optimization, inflammation reduction, and HRQoL over atorvastatin therapy alone, and long-term trials are needed to confirm these findings and assess the impact on clinical events. These observations highlight the clinical and public health value of combination therapy for secondary prevention and provide a strategy to decrease cardiovascular risk and enhance patient quality of life. The incorporation of these findings into practice and public health policy can promote coronary artery disease management, eventually reducing its burden worldwide.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eACS Acute coronary syndrome\u003c/p\u003e\n\u003cp\u003eALT Alanine aminotransferase\u003c/p\u003e\n\u003cp\u003eAST Aspartate aminotransferase\u003c/p\u003e\n\u003cp\u003eBMI Body mass index\u003c/p\u003e\n\u003cp\u003eBP Blood pressure\u003c/p\u003e\n\u003cp\u003eCAD Coronary artery disease\u003c/p\u003e\n\u003cp\u003eCAD-DVD Coronary artery disease - double vessel disease\u003c/p\u003e\n\u003cp\u003eCAD-SVD Coronary artery disease \u0026ndash; single vessel disease\u003c/p\u003e\n\u003cp\u003eCETP Cholesteryl ester transfer protein\u003c/p\u003e\n\u003cp\u003eCRP C-Reactive protein\u003c/p\u003e\n\u003cp\u003eCTRI Clinical trials registry - India\u003c/p\u003e\n\u003cp\u003eCVD Cardiovascular disease\u003c/p\u003e\n\u003cp\u003eeGFR estimated glomerular filtration rate\u003c/p\u003e\n\u003cp\u003eHDL High-density lipoprotein\u003c/p\u003e\n\u003cp\u003eHDL-C High-density lipoprotein cholesterol\u003c/p\u003e\n\u003cp\u003eHRQoL Health-Related Quality of Life\u003c/p\u003e\n\u003cp\u003eIHD Ischemic Heart Disease\u003c/p\u003e\n\u003cp\u003eITT Intention-to-treat\u003c/p\u003e\n\u003cp\u003eLDL Low-density lipoprotein\u003c/p\u003e\n\u003cp\u003eLDL-C Low-density lipoprotein cholesterol\u003c/p\u003e\n\u003cp\u003eLVEF Left ventricular ejection fraction\u003c/p\u003e\n\u003cp\u003eLOCF Last Observation Carried Forward\u003c/p\u003e\n\u003cp\u003eMARS Medication Adherence Rating Scale\u003c/p\u003e\n\u003cp\u003eNSTEMI Non-ST-Segment Elevation Myocardial Infarction\u003c/p\u003e\n\u003cp\u003eNYHA New York Heart Association\u003c/p\u003e\n\u003cp\u003ePAD Peripheral artery disease\u003c/p\u003e\n\u003cp\u003ePCI Percutaneous Coronary Intervention\u003c/p\u003e\n\u003cp\u003ePCSK9 Proprotein Convertase Subtilisin/Kexin type 9\u003c/p\u003e\n\u003cp\u003eSHTN Systemic hypertension\u003c/p\u003e\n\u003cp\u003eSF-36 Short Form 36\u003c/p\u003e\n\u003cp\u003eSTEMI ST-Segment elevation myocardial infarction\u003c/p\u003e\n\u003cp\u003eT2DM Type 2 Diabetes Mellitus\u003c/p\u003e\n\u003cp\u003eTG Triglycerides\u003c/p\u003e\n\u003cp\u003eVLDL Very-low-density lipoprotein\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Institutional Ethics Committee of\u0026nbsp;SRM Medical College Hospital \u0026amp; Research Centre, with reference number SRMIEC-ST0922-170 provided approval. \u0026nbsp;\u0026nbsp;Informed consent was obtained from every participant in the study. After an exhaustive explanation of the purposes of the study, procedures, potential risks and benefits, and confidentiality of the data, each participant signed written informed consent. All participants were clearly informed that participation in the study was entirely at their own discretion and that they were free to withdraw at any point without adverse effects on their medical care or penalty. All the information collected was anonymized and solely for use within this research.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors affirm that signed informed consent was obtained from the participants for the publishing of their data presented in this manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study are available from Aosta BackBone Hospital Management System (HMS) but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Aosta BackBone HMS.\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting Interests:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eNot Applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eNot Applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthors\u0026apos; contributions:\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eS. Srividya, Abisha Judie K, and Nishanthi M.G. were responsible for getting approval from ethical committee and conducting the research project, patient recruitment, and data collection. Pravin Selvi Saravanan and Aishwaryaa Anand performed the data analysis and prepared the manuscript. Dr. Sarumathy S and Dr. Nanda Kumar R contributed to the clinical assessment of the patients, provided critical guidance during the study, and reviewed the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgements:\u0026nbsp; \u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to express their sincere gratitude to Dr. Sarumathy S and Dr. Nanda Kumar R for their valuable guidance and support in the clinical assessment and overall supervision of the study. The authors also thank the staff of SRM Medical College Hospital and Research Centre for their assistance during patient recruitment and data collection.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMartin SS, Aday AW, Allen NB, et al. 2025 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. \u003cem\u003eCirculation\u003c/em\u003e. 2025;151(8). doi:10.1161/CIR.0000000000001303\u003c/li\u003e\n\u003cli\u003eKiran G, Mohan I, Kaur M, Ahuja S, Gupta S, Gupta R. Escalating ischemic heart disease burden among women in India: Insights from GBD, NCDRisC and NFHS reports. \u003cem\u003eAm J Prev Cardiol\u003c/em\u003e. 2020;2:100035. doi:10.1016/j.ajpc.2020.100035\u003c/li\u003e\n\u003cli\u003eForzano I, Florimonte D, Narciso V, et al. Optimal Medical Therapy Targeting Lipids and Inflammation for Secondary Prevention in Patients Undergoing Percutaneous Coronary Intervention. \u003cem\u003eJ Clin Med\u003c/em\u003e. 2025;14(23):8334. doi:10.3390/jcm14238334\u003c/li\u003e\n\u003cli\u003eZhang YJ, Xu M, Duan JQ, Wang DJ, Han SL. Effect of ezetimibe\u0026ndash;statin combination therapy vs. statin monotherapy on coronary atheroma phenotype and lumen stenosis in patients with coronary artery disease: a meta-analysis and trial sequential analysis. \u003cem\u003eFront Pharmacol\u003c/em\u003e. 2024;15. doi:10.3389/fphar.2024.1343582\u003c/li\u003e\n\u003cli\u003eMalakar AKr, Choudhury D, Halder B, Paul P, Uddin A, Chakraborty S. A review on coronary artery disease, its risk factors, and therapeutics. \u003cem\u003eJ Cell Physiol\u003c/em\u003e. 2019;234(10):16812-16823. doi:10.1002/jcp.28350\u003c/li\u003e\n\u003cli\u003eFarshidi H, Bijani B, Sobhani SA, Dastsouz F, Abbaszadeh S. Comparison of ezetimibe and atorvastatin versus atorvastatin alone on short-term major adverse cardiac events after percutaneous coronary intervention, a double-blind placebo-controlled randomized clinical trial. \u003cem\u003eTrials\u003c/em\u003e. 2025;26(1):108. doi:10.1186/s13063-025-08817-7\u003c/li\u003e\n\u003cli\u003eKi YJ, Kim W, Lee KH, et al. Lipid-Lowering Effect and Safety of Ezetimibe and Atorvastatin 5\u0026thinsp;mg in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: A Randomized, Double-Blind, Parallel, Multicenter, Phase 3 Clinical Trial. \u003cem\u003eClin Cardiol\u003c/em\u003e. 2025;48(5):e70138. doi:10.1002/clc.70138\u003c/li\u003e\n\u003cli\u003eEriksson M. The combination of statin and ezetimibe is safe, effective, and preferable. \u003cem\u003eJ Intern Med\u003c/em\u003e. 2025;297(4):350-351. doi:10.1111/joim.20070\u003c/li\u003e\n\u003cli\u003eAi C, Zhang S, He Q, Shi J. Comparing the combination therapy of ezetimibe and atorvastatin with atorvastatin monotherapy for regulating blood lipids: a systematic review and meta-analyse. \u003cem\u003eLipids Health Dis\u003c/em\u003e. 2018;17(1):239. doi:10.1186/s12944-018-0880-8\u003c/li\u003e\n\u003cli\u003eHarada-Shiba M, Davdison MH, Ditmarsch M, et al. Obicetrapib as an Adjunct to Stable Statin Therapy in Japanese Subjects: Results from a Randomized Phase 2 Trial. \u003cem\u003eJ Atheroscler Thromb\u003c/em\u003e. 2024;31(10):1386-1397. doi:10.5551/jat.64828\u003c/li\u003e\n\u003cli\u003eNelson AJ, Sniderman AD, Ditmarsch M, et al. Cholesteryl Ester Transfer Protein Inhibition Reduces Major Adverse Cardiovascular Events by Lowering Apolipoprotein B Levels. \u003cem\u003eInt J Mol Sci\u003c/em\u003e. 2022;23(16):9417. doi:10.3390/ijms23169417\u003c/li\u003e\n\u003cli\u003eRubino J, MacDougall DE, Sterling LR, Hanselman JC, Nicholls SJ. Combination of bempedoic acid, ezetimibe, and atorvastatin in patients with hypercholesterolemia: A randomized clinical trial. \u003cem\u003eAtherosclerosis\u003c/em\u003e. 2021;320:122-128. doi:10.1016/j.atherosclerosis.2020.12.023\u003c/li\u003e\n\u003cli\u003eCannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. \u003cem\u003eNew England Journal of Medicine\u003c/em\u003e. 2015;372(25):2387-2397. doi:10.1056/NEJMoa1410489\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-cardiovascular-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bcar","sideBox":"Learn more about [BMC Cardiovascular Disorders](http://bmccardiovascdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bcar/default.aspx","title":"BMC Cardiovascular Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"percutaneous coronary intervention, ezetimibe, atorvastatin, triglycerides, HDL cholesterol","lastPublishedDoi":"10.21203/rs.3.rs-8999676/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8999676/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eCardiovascular diseases often cause severe ischemic block or narrowing of coronary arteries, obstructing blood flow to the myocardium. Percutaneous coronary intervention (PCI) is a nonsurgical, invasive procedure for treating these conditions. Statins are the standard secondary preventive measure due to their pleiotropic effects. Research on therapeutic efficacy of the Atorvastatin\u0026ndash;ezetimibe combination in improving the quality of life of post-PCI patients, especially in the south Indian population, is limited. This study aimed to compare the safety and effectiveness ezetimibe when it is added to atorvastatin in patients with a history of PCI in terms of HDL and Triglycerides levels.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAmong 80 randomized patients 72 patients\u0026rsquo; data lasted for the final analysis. Compared the atorvastatin monotherapy (Group A) with the atorvastatin\u0026ndash;ezetimibe group (Group B). Only HDL (High-density lipoprotein), LDL (Low-density lipoprotein), TG (Triglycerides) remained significant after Bonferroni correction whereas total cholesterol and VLDL did not meet adjusted threshold; between-group differences were significant with the improvement of HDL (44.2\u0026thinsp;\u0026plusmn;\u0026thinsp;2.3 vs 37.5\u0026thinsp;\u0026plusmn;\u0026thinsp;1.9 mg/dL) and lowering TG (70.3\u0026thinsp;\u0026plusmn;\u0026thinsp;2.8 vs 84.6\u0026thinsp;\u0026plusmn;\u0026thinsp;3.1 mg/dL). Analyses were intention-to-treat (ITT) with LOCF and pre-protocol principles (PPP). CRP level is highly significant (18\u0026thinsp;\u0026plusmn;\u0026thinsp;1.9 vs 8\u0026thinsp;\u0026plusmn;\u0026thinsp;1.9).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eCompared with atorvastatin alone, ezetimibe, when used as an add-on therapy to atorvastatin improved the lipid profile and CRP levels, specifically in decreasing triglycerides and an increasing HDL cholesterol level in post-PCI patients. This combination therapy was associated with improved quality of life, and long-term trials are needed to confirm these findings and assess the impact on clinical events.\u003c/p\u003e","manuscriptTitle":"Clinical Efficacy of Ezetimibe as an Add-on to Atorvastatin: Effects on HDL Cholesterol and Triglycerides in Post-PCI Patients from a South Indian Population","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-09 14:56:26","doi":"10.21203/rs.3.rs-8999676/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision 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