Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder

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Objective To evaluate the effect of mirabegron on lipid profile (serum cholesterol and triglyceride) and BMI in patients with OAB. Materials and Methods In the medical city complex (Ghazi AL-Hariri Hospital) urology outpatient clinic, a prospective study of 40 patients diagnosed with OAB. These patients took a single dose of mirabegron 50 mg for 4 months and assessed its effect during this period on weight and fasting serum (s.) cholesterol and triglycerides. Results Investigation showed that there is a statistically significant reduction from baseline after 2 and 4 months of treatment with mirabegron (P-value = 0.001) in fasting s. Triglyceride, while fasting s. cholesterol level showed an increase in level after 2 and 4 months of treatment. However, this increment not statically significant after 2 months (P-value = 0.227) and after 4 months (P-value = 0.261) BMI showed slightly reduction after 2 and 4 months’ treatment with mirabegron but also this reduction not statically significant after 2 months (P-value = 0.114) and after 4 months (P-value = 0.562). Conclusion Mirabegron causes an interesting and useful decline in the level of triglyceride, which is responsible for cardiovascular disease. 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F1000Research 2025, 13 :1534 ( https://doi.org/10.12688/f1000research.158961.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Research Article Revised Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] Hiba Hameed https://orcid.org/0009-0001-2987-0136 1 , Mohammed Ismail https://orcid.org/0000-0003-3310-0000 2 Hiba Hameed https://orcid.org/0009-0001-2987-0136 1 , Mohammed Ismail https://orcid.org/0000-0003-3310-0000 2 PUBLISHED 30 Jul 2025 Author details Author details 1 College of Medicine, University of Baghdad, Baghdad, Baghdad Governorate, 10011, Iraq 2 College of Medicine, University of Baghdad, Baghdad, Baghdad Governorate, 10011, Iraq Hiba Hameed Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Mohammed Ismail Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background Mirabegron is a β3-adrenergic receptor (β3-AR) agonist indicated for the treatment of overactive bladder. β3-AR agonists are located in the urinary bladder and adipose tissue, where they are involved in the regulation of thermogenesis and lipolysis. Objective To evaluate the effect of mirabegron on lipid profile (serum cholesterol and triglyceride) and BMI in patients with OAB. Materials and Methods In the medical city complex (Ghazi AL-Hariri Hospital) urology outpatient clinic, a prospective study of 40 patients diagnosed with OAB. These patients took a single dose of mirabegron 50 mg for 4 months and assessed its effect during this period on weight and fasting serum (s.) cholesterol and triglycerides. Results Investigation showed that there is a statistically significant reduction from baseline after 2 and 4 months of treatment with mirabegron (P-value = 0.001) in fasting s. Triglyceride, while fasting s. cholesterol level showed an increase in level after 2 and 4 months of treatment. However, this increment not statically significant after 2 months (P-value = 0.227) and after 4 months (P-value = 0.261) BMI showed slightly reduction after 2 and 4 months’ treatment with mirabegron but also this reduction not statically significant after 2 months (P-value = 0.114) and after 4 months (P-value = 0.562). Conclusion Mirabegron causes an interesting and useful decline in the level of triglyceride, which is responsible for cardiovascular disease. READ ALL READ LESS Keywords Mirabegron, serum cholesterol, serum triglyceride, body mass index, Beta-3 adrenergic receptors Corresponding Author(s) Hiba Hameed ( [email protected] ) Close Corresponding author: Hiba Hameed Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2025 Hameed H and Ismail M. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Hameed H and Ismail M. Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.12688/f1000research.158961.3 ) First published: 19 Dec 2024, 13 :1534 ( https://doi.org/10.12688/f1000research.158961.1 ) Latest published: 30 Jul 2025, 13 :1534 ( https://doi.org/10.12688/f1000research.158961.3 ) Revised Amendments from Version 2 Background Rephrasing to make it easier to understand the meaning as peer reviewer noted. Introduction Changing jargons in to simple English words with grammars and linguistic corrections. Removing unnecessary non relevant information. Method Adding inclusion and exclusion criteria as peer reviewer note. Result Changing in secondary tittle from significant of therapy to the effect of treatment with mirabegron Discussion Several sentences rephrased for better linguistic understanding. Conclusion Rephrasing to simple and shorter paragraph. Background Rephrasing to make it easier to understand the meaning as peer reviewer noted. Introduction Changing jargons in to simple English words with grammars and linguistic corrections. Removing unnecessary non relevant information. Method Adding inclusion and exclusion criteria as peer reviewer note. Result Changing in secondary tittle from significant of therapy to the effect of treatment with mirabegron Discussion Several sentences rephrased for better linguistic understanding. Conclusion Rephrasing to simple and shorter paragraph. To read any peer review reports and author responses for this article, follow the "read" links in the Open Peer Review table. READ REVIEWER RESPONSES Introduction Overactive bladder (OAB, Urgency) syndrome Symptom, defined by ICS as: Urinary urgency, usually accompanied by increased daytime frequency and/or nocturia, with urinary incontinence (OAB-wet) or without (OAB-dry), in the absence of urinary tract infection or other detectable disease. OAB affects quality of life significantly and affects both men and women. 1 Symptoms of OAB may be attributed to involuntary contractions of the bladder muscle. 2 Behavior therapy fluid management, can be started tried initially to overcome the fluid burden, additionally, averting or decreasing excess liquor intake, avoiding juicy meals with high percentage of fluid rich vegetables and fruits. Furthermore, avoiding excessive caffeine ingestion, as they can irritate the bladder. Antimuscarinic drugs, which are thought to be the first line of pharmaceutical treatment, can be initiated as a treatment if these approaches are unsuccessful. 3 Although it is common worldwide, hyperlipidemia is a medical condition characterized by an increase in one or more of the plasma lipids, including triglycerides, cholesterol, cholesterol esters, phospholipids and or plasma lipoproteins including very low-density lipoprotein and low-density lipoprotein along with reduced high-density lipoprotein levels. Cholesterol levels, lipoproteins, chylomicrons, very low-density lipoproteins (VLDL), LDL, Apo lipoproteins, and HDL are all lipid components. 4 , 5 For several decades, the β3-adrenergic receptor (β3-AR) has been a focus of interest, as its activation in rodents leads to increased energy expenditure and improved metabolic profiles. 6 These facts raised the concern about its usefulness to be used in humans with same useful effects. Even though TGs are not really atherogenic, they are a main biomarker of cardiovascular disease risk due to their association with atherogenic remnant particles. Independent of LDL, atherogenesis is eased by many class of triglyceride-rich lipoproteins (TRLs), such as VLDL and VLDL fragments. 7 In comparison to beta1- and beta2 (β1/2)-adrenergic receptors, Beta3-receptors (β3-AR) are members of the G protein-coupled receptor superfamily and exhibit a more extensive dispersion across the body. 8 Three particular differences among the various adipose tissue (AT) types. A reduced level of mitochondrial presence is evident in white adipose tissue (WAT). It is also characterized by its conformation as a singlelipid droplet and is associated with the storage of energy. Brown adipose tissue (BAT), which is made up of multilocular lipid droplets, has a lot of mitochondria, which promote thermogenesis and energy expenditure. 9 Interestingly, the mitochondrial concentration of a WAT is elevated and the characteristics of its lipid droplets are changed in response to an external stimulus, such as cold, exercise, or sympathetic activation. 10 The sympathetic nervous system is a meaningful inducer of two together lipolysis and thermogenesis. From the molecular standpoint, noradrenaline (NA) triggers a complicated cascade on adipocytes via binding to β3-adrenergic receptors (β3-AR). Gs-proteins’ α-subunit is activated by this interaction, which results in the synthesis of cyclic adenosine monophosphate (cAMP). The ultimate target for this cascade which is the Lipid droplet- proteins, most notably hormone-sensitive lipase (HSL), are important participants in this pathway as they initiate the process of lipolysis in white adipocytes. Free fatty acids (FFAs) are consequently liberated from hydrolyzed triglycerides that are kept in lipid droplets. FFAs induce the production of Uncoupling Protein 1 (UCP1) in mitochondria, which in turn stimulates thermogenesis in brown adipocytes. Subsequently, FFAs undergo β-oxidation, resulting in the production of heat and water as byproducts inside the mitochondria. This process builds stable quantities substantial in the form of ATP, which is generated through β-oxidation and citric acid cycle. As a result, FFAs are used by different tissues as an energy source. Free fatty acids (FFAs) are produced by triglycerides that are stored in adipose tissue or consumed as fat in food. Cells need FFAs to assist energy synthesis and metabolic control. 11 , 12 Mirabegron, that is authorized for use in the treatment of over active bladder with its favorable low drop out effect in comparison to this category preceding one, namely the Anticholinergic, marked its position among the first line treatment 13 adding to that, Mirabegron effect in the breakdown of white adipose tissue (WAT) and the activity of brown adipose tissue (BAT) are also facilitated by the activation of the β3-adrenergic receptor: thus, making this line of even more interest. 14 Mirabegron has been shown in a human research to increase WAT metabolism and BAT activity. 15 This study will test the effect of mirabegron on lipid profile (fasting serum cholesterol and triglyceride) and BMI in patient suffering from OAB and being treated with this drug. Methods Inclusion criteria: Adult patients diagnosed with OAB by urologist through proper history, examination and investigation: ultrasound and urodynamic study. No gender discrimination was made. Exclusion criteria 1. Patients with renal impairment (eGFR < 15 mL/min/1.73 m 2 or patient requiring dialysis). 2. Patients with untreated urinary tract infections. 3. Patients with urinary outlet obstruction. 4. Pregnant and lactating women. 5. Patients with severe hepatic impairment. 6. Patients who were lost to follow-up. 7. Patients with severe uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg, or both). The study included total of 50 Iraqi adult patients diagnosed with clinical OAB in medical city complex (Ghazi Al-Hariri hospital) urology clinic according to International Continence society and American urological association criteria. Patient’s consent was obtained after explaining to the patient the purpose, procedures, and rights involved in participating in the study. All patients involved in this research acknowledged and consented the form to be included in this study protocol. The study design did not impose any gender and diet restrictions. Ten patients who did not attend follow-up visits were excluded, resulting in a final sample of 40 patients. These 40 patients were prescribed Mirabegron at a dose of 50 mg per day, a standard treatment for OAB. Weight and height to calculate body mass index by equation 16 BMI = Weight in kg / ( height in m ) 2 During the baseline assessment of the patients: The weight in kilograms divided by the square of the height in meters yielded the body mass index, or BMI (kg/m 2 ). In accompanying study, women accompanying a BMI of ≤18.5 were classified as thin, those accompanying a BMI of 18.5-24.9 were deliberate to have normal weight, women accompanying a BMI of 25-29.9 were classification as obese, and women accompanying a BMI of ≥30 were marked as corpulent. 17 The lipid profile included the measurement of fasting serum cholesterol and triglyceride levels Venous blood samples were collected from 6 hour fasting patients using plastic tubes with gel barriers. These gel barriers, being a pure substance, are highly stable in terms of their physical and chemical properties. After centrifugation, the collected samples were separated into serum or plasma from blood cells. Both serum and plasma were deemed acceptable specimens. The gel barrier effectively separated the serum from fibrin and cells post-centrifugation, thereby preventing the exchange of substances between blood cells and serum. This process maintained the biochemical characteristics and chemical components of the serum for an extended period. The levels of serum cholesterol and triglycerides were analyzed using the Architect c4000 analyzer (Abbott Diagnostics ® , USA). This system is a high-throughput clinical chemistry analyzer capable of performing up to 800 tests per hour. For more information, visit Abbott Diagnostics at [ https://www.corelaboratory.abbott/int/en/home.html ]. During the first follow-up visit (2 months after the baseline assessment), the patients’ weight and subsequent changes in body mass index, as well as fasting serum cholesterol and triglyceride levels, were measured. In the second follow-up visit (2 months after the first visit), the same parameters were assessed as in the initial visit. Out of the total 40 patients, only a subset completed the follow-up assessments. Statistical analysis The data were analyzed using statistical package for social sciences (SPSS) version 22. The data were presented as mean ± standard deviation. paired t-test was used for compare the mean of continuous variable in the study. Level of P-value less than 0.05 was considered significant. Results Baseline characteristic The total sample included in this study was 40 patients, of whom 60% were female and 40% were male, and the mean age of participants were 50.7±18.12 years. Regarding the height and weight of the sample, the results showed that the mean of height and weight were (163.65±8.393 m and 77.25±12.09 kg respectively) as shown in Table 1 . Table 1. Distribution of study sample according demographic and baseline characteristic data of participants. N=40. Baseline time Mean Std. Deviation Age (year) 50.7 18.125 Height (m) 163.65 8.393 Weight (kg) 77.25 12.9 BMI (kg/m 2 ) 29.0246 5.21624 Sr cholesterol (mg/dl) 192.33 33.300 Sr triglyceride (mg/dl) 142.62 29.127 At baseline time, the result of study showed the mean of BMI were (29.02±5.216 kg/m 2 ), while the mean of s. cholesterol and s. triglyceride were (192.33±33.300 mg/dl and 142.62±29.127 mg/dl respectively) as shown in Table 1 . Parameter after 2 months of treatment Two months later, we reevaluate the same parameters from our sample and discover that the mean BMI has dropped to 28.82±64.926 kg/m 2 . Moreover, the results showed that the mean serum cholesterol level (196.45±30.932 mg/dl) was higher than the baseline level, whereas the mean triglyceride level (130.2±27.936 mg/dl) was lower. Considering Table 2 . Table 2. Summary of changes in patient’s data after 2 months. 2 months N Mean Std. Deviation BMI (kg/m 2 ) 40 28.8212 4.92666 Sr cholesterol (mg/dl) 40 196.45 30.932 Sr triglyceride (mg/dl) 40 130.2 27.936 Parameter after 4 months of treatment four months later, when we reevaluate the same characteristics from our sample, discover that the mean BMI has slightly fallen to (28.62 ±4.859 kg/m 2 ). As show in Figure 1 and Table 3 . Figure 1. BMI, cholesterol and triglyceride mean of study sample after the use of mirabegron. Table 3. Summary of changes in patient’s data after 4 months. 4 months N Mean Std. Deviation BMI (kg/m 2 ) 40 28.6225 4.85935 Sr cholesterol (mg/dl) 40 199.90 24.746 Sr triglyceride (mg/dl) 40 121.25 27.554 Additionally, the mean triglyceride level (121.25±27.554 mg/dl) decreased while the mean cholesterol (199.90±24.746 mg/dl) marginally increased. As shown in Figure 1 and Table 3 . The effect of treatment with mirabegron After 2 months According to the study’s findings, there is no a statistically significant correlation between the mean BMI and S. cholesterol after two months (p=0.114,0.227 respectively). However, the results, as indicated in Table 4 , reveal a statistically significant difference among mean of S. triglycerides after 2 months (p=0.001). Table 4. The difference in the effect of Mirabegron between the study variables after2 months. Variables No Zero time Mean ±SD 2 months Mean ±SD T test (DF=39) P value BMI (kg/m 2 ) 40 29.02±5.21 28.82±4.92 1.617 0.114 S. cholesterol (mg/dl) 40 192.33±33.3 196.45±30.93 -1.229 0.227 S. triglyceride (mg/dl) 40 142.63±29.12 130.2±27.93 10.346 0.001* After 4 months The outcomes of the study demonstrate that after four months, there is a statistically significant link (p=0.001) between the mean triglyceride, but not between BMI and S. cholesterol (p=0.562, 0.261 respectively). According to Table 5 . Table 5. The difference in the effect of Mirabegron between the study variables after 4 months. Variables No 2 months Mean ±SD 4 months Mean ±SD T test (DF=39) P value BMI (kg/m 2 ) 40 28.82±4.92 28.62±4.85 4.546 0.562 S. cholesterol (mg/dl) 40 196.45±30.93 199.90±24.74 -6.543 0.261 S. triglyceride (mg/dl) 40 130.2±27.93 121.25±27.55 9.593 0.001* Discussion The β3-adrenergic receptor (β3-ARs) plays an important act in managing various physical functions, containing including thermogenesis in brown adipose tissue and lipolysis in white adipose tissue. The metabolic and cardiovascular impacts of β3-AR incitement by its agonists in animal models focal point the potential of β3-AR as a therapeutic target for various human diseases. 18 This research aims to judge the impact of Mirabegron on the lipid profile in patients with overactive bladder. The judgments concerning this current study, attended over a period of 8-12 weeks, disclose a notable change in the mean triglyceride levels (p=0.001), while no significant differences were seen in BMI or serum cholesterol (p=0.114, 0.227, individually). Therapy effect on TG and BMI After a period of two to four months under the mirabegron presidency, the study sample displayed a decrease in both mean BMI and plasma triglyceride levels. This finding is in line with a review conducted by Dąbrowska AM and colleagues, which highlights the importance of two distinct types of adipose tissue, each with its own unique physiological function. The activation of the thermogenic tissue-specific uncoupling protein 1 (UCP1) plays a crucial role in the metabolism of glucose, fatty acids, and other substances to generate heat in brown adipose tissue (BAT), including the associated “beige”/“brite” adipocytes derived from white adipose tissue (WAT). In situations where energy intake exceeds expenditure, WAT is responsible for storing excess triglycerides. 19 There is emerging evidence suggesting that BAT may have potential therapeutic applications in adult humans. β3-adrenergic receptors (ARs) are expressed not only in brown and white adipocytes but also in the urinary bladder. Adipocytes in both white and brown adipose tissue may be stimulated to undergo thermogenesis by a β3-adrenergic agonist such as mirabegron that is currently being studied. These adipose tissue types hold thermogenic fat containers, and their incitement holds promise as a creative policy for combating corpulence by growing strength energy expenditure. 20 , 21 Numerous clinical troubles and exploratory research have illustrated the impact of mirabegron on two together body mass and BAT activity. The authors noticed that mirabegron increased BAT exercise and resting energy expenditure. 22 Preliminary data desires that mirabegron may have comparable effects to light exercise on the metabolism of triglycerides, bile acids, HDL, and glucose. 23 Ying Z and others found that later four and twelve weeks of situation, the levels of plasma lipids were judged following a four-time fasting period. Mirabegron usually diminished plasma triglyceride levels. Despite the plasma HDL-cholesterol waited unaltered at either time points, there was a leaning towards diminished plasma triglycerides following in position or time 12 weeks of mirabegron treatment. 24 Body mass index (BMI) was included in this particular study to assess the effect of the treatment on body weight. However, proficient was no statistically significant change in BMI (p=4.546), regardless of few decrease in the figures. In contrast, Cypess and others executed a study place 12 healthy men were performed 200 mg of oral mirabegron often for 12 weeks. The group receiving mirabegron demonstrated a 203±40 kcal per day rise in basal metabolic rate and an increase in BAT activity, which was known to those who took a placebo. According to the researchers’ calculations, weight reduction through energy expenditure might be as much as 5 kg in the first year and 10 kg in the next three years. Despite the fact that mirabegron was prescribed off-label to treat overactive bladder syndrome in the majority of trial participants, it was generally well tolerated. The most frequent side effects that have been authorized seen was tachycardia. 25 Another study by Loh and so forth established indicates there was a notable rise in energy expenditure following the management of 100 mg and 200 mg doses of mirabegron, but skilled was no significant unlikeness from direction following the 50 mg of mirabegron. 26 Zhao and others throwed a complex remedy approach promoting metformin and mirabegron for the preventation and treatment of obesity. Through this approach, the summed and spent energy are dealt with at the same time, which does not have any negative impact on cardiac and vascular system. In the prevention model, the association of metformin and mirabegron grown in additional reductions of 12 percent and 14 percent in raised body weight inferred by an extreme-fat diet, separately, distinguished to handling metformin or mirabegron singular. In the treatment model, the alliance of metformin and mirabegron managed to a 17% decrease in body weight in fat rodent convinced by a diet, that was 13 portion and 6 portion more having movement than exploiting metformin or mirabegron distinctively, independently. 27 Animal studies have demonstrated that the administration of mirabegron reduces obesity; however, there is no trustworthy proof that patients with obesity who have received mirabegron medication have significantly lost weight. The brief trial time period and confined participant volume may be the reasons for this. Especially, extreme doses of mirabegron were the most effective treatment for adipose tissue stimulation in humans, and a long-term safety assessment is still necessary. 28 Therapy effect on fasting plasma cholesterol The study found no evidence of statistically significant variations in serum cholesterol levels amongst participants treated with mirabegron with respect to the medication’s impact on fasting plasma cholesterol (p=0.227). Nevertheless, further trial is authorized to sufficiently acknowledge the impact of mirabegron on cholesterol and lipid levels. This finding of this study are inconsistent with those of Finlin BS et al., who observed statistically significant decrease in cholesterol following the administration of mirabegron for 12 weeks. 29 Certain studies have recorded that the incitement of the β3-adrenoreceptor, furthered by mirabegron, leads to a significant increase in ApoA-1, a critical protein component of HDL in plasma. HDL plays a awake act in mobile cholesterol from tissues to the liver for evacuation. 30 In a study executed by Sui and so forth., it was seen that adult rodent incomplete in Apo lipoprotein E (Apo-E) and LDL-receptor shown raised plasma levels of total cholesterol and LDL-C after being treated with mirabegron (8mg/kg/term) for 6 weeks. 31 Also, another study demonstrated that rats enhance an extreme-fat diet experienced an outdoing in their lipid description following in position or time 12 weeks of situation accompanying two differing doses of mirabegron (5 mg/kg/age and 10 mg/kg/day). This bettering was from a decrease in total cholesterol, triglycerides, and LDL-C levels, in addition to an increase in HDL-C serum levels, recognized to non-treated rats. To completely understand the impact of mirabegron on cholesterol in humans, supplementary research is necessary. Various factors, such as diet and mutations in ApoA-1, Apo-E, or LDL-receptor action, can influence serum cholesterol levels. 32 Conclusion This study found that Mirabegron has favorable health effect by reducing fasting serum triglyceride which responsible for cardiovascular disease,although it leads to slightly increase in serum cholesterol. In addation; this therapy has minimum weight reduction effect. Ethics and consent Ethics and research participation consent form This study was carried out according to the tenets of the Declaration of Helsinki. It was also approved by the Research Ethics Committee of University of Baghdad’s College of Medicine, Registration number: 03-28 date: 21/12/2023. In the first part, forty Iraqis suffering from OAB in Medical City Complex from January 2024 to June 2024 were collected. All patients gave their written informed consent to participate in the study. These patients were treated with 50 mg/day mirabegron for four months, and the results of such treatment were observed. The following consent form is designed to explain the purpose, procedures, and rights involved in participating in the study, Effect of Mirabegron on Lipid Profile (Serum Cholesterol and Triglyceride) in Iraqi Patients with Overactive Bladder. “I hereby give my consent to participate in the study and to allow the use of my medical records in the research. The researcher has committed not to share my personal information, and I reserve the right to withdraw my participation at any time. I have been informed that the study may require several blood draws (phlebotomies) and body weight measurements”. Data availability Underlying data Zenodo: betmiga and betmiga pulse rate datasheet, https://doi.org/10.5281/zenodo.14057595 . 33 This project contains following files: 1. betmiga pulse rate.xlsx 2. betmiga datasheet.xlsx Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). References 1. Ismail MB, Abdullhussein WQ: Efficacy and safety of sacral neuromodulation in treatment of refractory overactive bladder. Indian J Forensic Med Toxicol. 2021; 15 (1): 1315–1321. 2. Abbas IK, Rajab NA, Hussein AA: Formulation and in-vitro evaluation of darifenacin hydrobromide as buccal films. Iraqi J Pharm Sci. 2019; 28 (2): 83–94. Publisher Full Text 3. Scarneciu I, Lupu S, Bratu O, et al. : Overactive bladder: A review and update. Exp Ther Med. 2021; 22 (6): 1–8. 4. Onwe P, Folawiyo M, Ogah A, et al. : Hyperlipidemia: Etiology and Possible Control. IOSR J Dent Med Sci. 2015; 14 (10): 2279–2861. 5. Guo J, Chen S, Zhang Y, et al. : Cholesterol metabolism: physiological regulation and diseases. MedComm. 2024; 5 (2): 1–24. Publisher Full Text 6. Yang LK, Tao YX: Physiology and pathophysiology of the β3-adrenergic receptor. Prog Mol Biol Transl Sci. 2019; 161 : 91–112. Publisher Full Text 7. Talayero BG, Sacks FM: The role of triglycerides in atherosclerosis. Curr Cardiol Rep. 2011; 13 (6): 544–552. PubMed Abstract | Publisher Full Text | Free Full Text 8. Bachus E, Ponikowski P: Beta-3 Receptor Agonists. Int Cardiovasc Forum J. 2019; 18 : 15–18. Publisher Full Text 9. Parra-Peralbo E, Talamillo A, Barrio R: Origin and Development of the Adipose Tissue, a Key Organ in Physiology and Disease. Front Cell Dev Biol. 2021; 9 (December): 1–22. Publisher Full Text 10. Antunes GC, Macêdo APA, Conceição LR, et al. : Mirabegron and physical exercise as a potential strategy for BAT activation in obesity. Obesities. 2022; 2 (4): 380–388. Publisher Full Text 11. McAdams RP: Everything You Always Wanted To Know About the Superintendency, But Were Afraid To Ask. NASSP Bull. 2019; 79 (570): 86–90. Publisher Full Text 12. Kimura I, Ichimura A, Ohue-Kitano R, et al. : Free fatty acid receptors in health and disease. Physiol Rev. 2020; 100 (1): 171–210. PubMed Abstract | Publisher Full Text 13. O’Kane M, Robinson D, Cardozo L, et al. : Mirabegron in the management of overactive bladder syndrome. Int J Women’s Health. 2022; 14 : 1337–1350. PubMed Abstract | Publisher Full Text | Free Full Text 14. Machado SA, Pasquarelli-do-Nascimento G, da Silva DSS , et al. : Browning of the white adipose tissue regulation: new insights into nutritional and metabolic relevance in health and diseases. Nutr Metab. 2022; 19 (1): 1–27. 15. Allison SJ, Gibson W: Mirabegron, alone and in combination, in the treatment of overactive bladder: real-world evidence and experience. Ther Adv Urol. 2018 Sep 26; 10 (12): 411–419. PubMed Abstract | Publisher Full Text | Free Full Text 16. Ali ZAM, Jasim WK, Hussein DZ, et al. : Tamoxifen effects on the lipid profile in premenopausal women with breast cancer: a follow-up study. J Fac Med Baghdad. 2018; 60 (3): 141–144. Publisher Full Text 17. Klatsky AL, Zhang J, Udaltsova N, et al. : Body mass index and mortality in a very large cohort: Is it really healthier to be overweight? Perm J. 2017; 21 : 16–142. PubMed Abstract | Publisher Full Text 18. Yang LK, Tao YX: Physiology and pathophysiology of the β3-adrenergic receptor. Prog Mol Biol Transl Sci. 2019; 161 : 91–112. Publisher Full Text 19. Dąbrowska AM, Dudka J: Mirabegron, a selective β3-adrenergic receptor agonist, as a potential anti-obesity drug. J Clin Med. 2023 Nov 2; 12 (21): 6897. PubMed Abstract | Publisher Full Text | Free Full Text 20. Finlin BS, Memetimin H, Zhu B, et al. : Pioglitazone does not synergize with mirabegron to increase beige fat or further improve glucose metabolism. JCI Insight. 2021; 6 (6). PubMed Abstract | Publisher Full Text | Free Full Text 21. Cero C, Lea HJ, Zhu KY, et al. : β3-Adrenergic receptors regulate human brown/beige adipocyte lipolysis and thermogenesis. JCI Insight. 2021; 6 (11). PubMed Abstract | Publisher Full Text | Free Full Text 22. Dehvari N, da Silva Junior ED , Bengtsson T, et al. : Mirabegron: potential off-target effects and uses beyond the bladder. Br J Pharmacol. 2018; 175 (21): 4072–4082. PubMed Abstract | Publisher Full Text | Free Full Text 23. O’Mara AE, Johnson JW, Linderman JD, et al. : Chronic mirabegron treatment increases human brown fat, HDL cholesterol, and insulin sensitivity. J Clin Invest. 2020; 130 (5): 2209–2219. PubMed Abstract | Publisher Full Text | Free Full Text 24. Ying Z, van Eenige R , Beerepoot R, et al. : Mirabegron-induced brown fat activation does not exacerbate atherosclerosis in mice with a functional hepatic ApoE-LDLR pathway. Pharmacol Res. 2023 Jan 1; 187 : 106634. Publisher Full Text 25. Cypess AM, Weiner LS, Roberts-Toler C, et al. : Activation of Human Brown Adipose Tissue by a β3-Adrenergic Receptor Agonist. NIH Public Access. 2016; 21 (1): 33–38. Publisher Full Text 26. Loh RKC, Formosa MF, La Gerche A, et al. : Acute metabolic and cardiovascular effects of mirabegron in healthy individuals. Diabetes Obes Metab. 2019; 21 : 276–284. PubMed Abstract | Publisher Full Text 27. Zhao XY, Liu Y, Zhang X, et al. : The combined effect of metformin and mirabegron on diet-induced obesity. MedComm. 2023; 4 (2): 1–18. Publisher Full Text 28. Dąbrowska AM, Dudka J: Mirabegron, a selective β3-adrenergic receptor agonist, as a potential anti-obesity drug. J Clin Med. 2023 Nov 2; 12 (21): 6897. PubMed Abstract | Publisher Full Text | Free Full Text 29. Finlin BS, Memetimin H, Zhu B, et al. : The β3-adrenergic receptor agonist mirabegron improves glucose homeostasis in obese humans. J Clin Invest. 2020; 130 (5): 2319–2331. PubMed Abstract | Publisher Full Text | Free Full Text 30. Cao X, Li Y: β3-Adrenergic receptor regulates hepatic apolipoprotein A-I gene expression. J Clin Lipidol. 2017; 11 : 1168–1176. PubMed Abstract | Publisher Full Text 31. Sui W, Li H, Yang Y, et al. : Bladder drug mirabegron exacerbates atherosclerosis through activation of brown fat-mediated lipolysis. Proc Natl Acad Sci USA. 2019; 116 (22): 10937–10942. Publisher Full Text 32. Makar N, Abdullah O, Abu-Raia N, et al. : Possible protective effects of mirabegron on experimentally induced non-alcoholic steatohepatitis in rats. Benha Med J. 2022; (academic issue): 277–293. Publisher Full Text 33. Razaq H: betmiga and betmiga pulse rate datasheet. [Dataset]. Zenodo. 2024. Publisher Full Text Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 19 Dec 2024 ADD YOUR COMMENT Comment Author details Author details 1 College of Medicine, University of Baghdad, Baghdad, Baghdad Governorate, 10011, Iraq 2 College of Medicine, University of Baghdad, Baghdad, Baghdad Governorate, 10011, Iraq Hiba Hameed Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Mohammed Ismail Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (3) version 3 Revised Published: 30 Jul 2025, 13:1534 https://doi.org/10.12688/f1000research.158961.3 version 2 Revised Published: 24 Feb 2025, 13:1534 https://doi.org/10.12688/f1000research.158961.2 version 1 Published: 19 Dec 2024, 13:1534 https://doi.org/10.12688/f1000research.158961.1 Copyright © 2025 Hameed H and Ismail M. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Hameed H and Ismail M. Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.12688/f1000research.158961.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 3 VERSION 3 PUBLISHED 30 Jul 2025 Revised Views 0 Cite How to cite this report: Michel MC. Reviewer Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.180602.r401586 ) The direct URL for this report is: https://f1000research.com/articles/13-1534/v3#referee-response-401586 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 22 Aug 2025 Martin C Michel , Department of Pharmacology, Johannes Gutenberg University, Mainz, Germany Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.180602.r401586 I have the following comments to the authors : I have looked at the revised manuscript and found that almost none of my previous comments has been considered. A meaningful point-by-point rebuttal letter is also missing. Thus, I cannot endorse ... Continue reading READ ALL I have the following comments to the authors : I have looked at the revised manuscript and found that almost none of my previous comments has been considered. A meaningful point-by-point rebuttal letter is also missing. Thus, I cannot endorse indexing of this manuscript. Competing Interests: No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Michel MC. Reviewer Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.180602.r401586 ) The direct URL for this report is: https://f1000research.com/articles/13-1534/v3#referee-response-401586 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 2 VERSION 2 PUBLISHED 24 Feb 2025 Revised Views 0 Cite How to cite this report: Michel MC. Reviewer Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.177812.r366818 ) The direct URL for this report is: https://f1000research.com/articles/13-1534/v2#referee-response-366818 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 13 Mar 2025 Martin C Michel , Department of Pharmacology, Johannes Gutenberg University, Mainz, Germany Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.177812.r366818 Main comments: Study design: It is my impression that the manuscript reports on a non-interventional/observational study. This must be clearly reflected in the manuscript title, Abstract, and main manuscript. Anti-obesity effects of b3-AR agonists ... Continue reading READ ALL Main comments: Study design: It is my impression that the manuscript reports on a non-interventional/observational study. This must be clearly reflected in the manuscript title, Abstract, and main manuscript. Anti-obesity effects of b3-AR agonists exist in rodents, whereas their existence in humans is largely a myth. For example, see a recent comprehensive review [1]. One key difference being that adult humans exhibit little if any brown adipose tissue. Of note, mirabegron was originally developed for an obesity/type 2 diabetes indication, whereas the OAB indication only was pursued when effects in obesity were of insufficient magnitude to be of clinical relevance. B3-AR agonists have been in clinical use for more than a decade and have been subjected to more than 100 clinical trials. The Introduction is based on a lot of animal data whereas an assessment of what is known based on the numerous clinical trials is missing. Did you look at previous clinical trials on b3-AR agonists? Thus, there should be a clear statement that the more than 100 trials either failed to assess BMI, cholesterol or triglycerides, or found no effects, or found effects. Such rigorous assessment of the pre-study evidence must form the basis for a meaningful Introduction. Of note, the Discussion mentions some pre-study evidence from earlier studies, but those should have been mentioned already in the Introduction. I encourage the authors to access the FDA site to look at the clinical reports the respective companies have filed for mirabegron and vibegron to see whether changes in body weight and/or serum triglycerides and cholesterol were observed (this information is not in the published papers on the phase III studies of either drug). Leading statisticians generally advise not to focus on p-values but on effect sizes with their confidence intervals. Moreover, p-values should not be reported in the absence of a corresponding effect size indicator. The Methods section lacks an overall description of study design. Important elements would include a list of in- and exclusion criteria, information on time of blood sampling relative to last food intake; it is stated that “only a subset completed the follow-up assessment”, but no information for the reasons for dropouts is provided. A patient flow chart is missing. Further details: A) No table with overall demographic data is provided. B) There is no information on sample size justification. C) The first subsection of Methods only talks about women whereas later subsections include both genders. Which is true? D) We also need a table on comedications. This should be by drug class for those with potential pharmacodynamic interactions and by compound for those with potential pharmacokinetic interactions. Many guidelines on data robustness ask to explicitly separate a study designed to test a specific statistical null hypothesis from exploratory studies (all others) [2, 3]. Based on those guidelines, the present study at best appears to be exploratory. This must be stated explicitly. It follows from the exploratory nature of the study that reported p-values cannot be interpreted as hypothesis-testing but only as descriptive. This must be stated explicitly. The tables and figures repeat information already given in the main text, which is redundant. More relevant than reporting group means for a parameter at different time points would be reporting means ± SD of intra-individual changes. Thus, the current table 6 is the only display item that makes sense. The overall interpretation of the data is inappropriate. There is no such thing as a trend for significance etc. [4, 5]. The only thing that can be stated is that there was insufficient evidence to reject the null hypothesis (if there has ever been one) [6]. Given the fundamentally different role of b3-AR in rodents and humans, the Discussion is flawed by an uncritical mix of rodent and human data. The Discussion sourly lacks a critical discussion of the limitations in the data interpretation based on this being apparently neither a randomized, nor a controlled, nor a blinded study. There is no section on tolerability, which I find ethically unacceptable. When I look at one of the two supplementary online files, I see that heart rate by average is higher on treatment than before. Another supplementary file provides blood pressure data, Given the cardiovascular warnings in the prescribing information, this cardiovascular data must be presented in the main manuscript and discussed. Apparently, also bladder capacity data were recorded; however, there is no information on how this data was derived nor are the findings reported and discussed. Bladder capacity data can be used as a proxy for drug efficacy. The overall conclusions markedly exceed what is supported by the data and lacks a critical appreciation of their relevance. Other comments: The are numerous issues with the overall use of the English language. Just a couple of examples from the Abstract: A) drugs are not “notified” but approved by the regulatory authorities. B) Preclinical data may be promising (but note the above species differences between rodents and humans) but are not “bright”. C) “corpulence-affiliated” probably should read “obesity-associated”. D) “patient” should be “patients”. E) “single dose” probably should read “daily dose”. The subject of this sentence is “The patients”, which makes it illogical to continue the sentence with “and asses” (the latter should be assess”). F) The conclusion part has multiple competing verbs and cannot be understood in its present form. Similar problems exist throughout the entire manuscript, even if my specific examples relate to the Abstract only. Thus, the entire manuscript urgently needs language checking. The person doing this should be identified and acknowledged. The Abstract and main manuscript partly use unexplained abbreviations such as “Sr.” (I assume it stands for serum; however, serum apparently is abbreviated as “s.” in other places and not abbreviated at all in yet other places. All abbreviations must be explained upon first mentioning and should be applied consistently thereafter. The 1 st sentence of the Introduction is factually wrong as the formal definition of OAB by the International Continence Society explicitly excludes those with a UTI (not only occasionally as stated here) [7]. Leading statisticians recommend avoidance of the word “significant” because it has different meanings in plain language (i.e., relevant or similar) as compared to a statistical context (observed p-value smaller than prespecified statistical alpha), which can cause confusion. Please replace by whatever is meant throughout the manuscript. Introduction: The “involuntary contraction of the bladder muscle” is a urodynamic finding, not a symptom. Introduction: The definition of hyperlipidemia provided here does not make sense. If it is defined as exceeding the 90 th percentile in the general population, hyperlipidemia would be present, by definition, in 10% of any group. Please consult and reference relevant international guidelines. The manuscript is inconsistent regarding the use of spelled out beta as compared to beta. Either is potentially fine, but it should be handled consistently. Introduction: The statement on the presence of b3-AR may apply to rodents but is largely wrong for humans. Introduction: The statement on BAT is irrelevant because little if any exists in the adult human body. Introduction: “A main focus of pharmacological mediations …” is wrong. At least nine b3-AR agonists have been tested clinically for the obesity/type 2 diabetes indication, but all programs were discontinued due to insufficient clinical responses [1]. The subsequent wording on improvement of thermogenesis and energy expenditure also is true only for rodents, and not for humans. Results: Many parameters are given with a number of decimals that does not make sense because they imply an unrealistic precision. Just as examples: Could you really measure height with a precision of 100 mm or body weight with a precision of 10 g? References 1. Dwaib HS, Michel MC. Is the ß 3 -adrenoceptor a valid target for the treatment of obesity and/or type 2 diabetes? Biomolecules. 2023;13:1714. 2. Vollert J, Schenker E, Macleod M, Bespalov A, Wuerbel H, Michel M, et al. Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals. BMJ Open Science. 2020;4(1):e100046. 3. Vollert J, Macleod M, Dirnagl U, Kas MJ, Michel MC, Potschka H, et al. The EQIPD framework for rigor in the design, conduct, analysis and documentation of animal experiments. Nat Methods. 2022;19(1):1334-7. 4. Diong J, Butler AA, Gandevia SC, Héroux ME. Poor statistical reporting, inadequate data presentation and spin persist despite editorial advice. PLoS One. 2018;13(8):e0202121. 5. Gibbs NM, Gibbs SV. Misuse of 'trend' to describe 'almost significant' differences in anaesthesia research. Br J Anaesth. 2015;115(3):337-9. 6. Amrhein V, Greenland S, McShane B. Scientists rise up against statistical significance. Nature. 2019;567(7748):305-7. 7. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. The standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. Is the work clearly and accurately presented and does it cite the current literature? No Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? No If applicable, is the statistical analysis and its interpretation appropriate? No Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? No References 1. Dwaib HS, Michel MC: Is the β3-Adrenoceptor a Valid Target for the Treatment of Obesity and/or Type 2 Diabetes?. Biomolecules . 2023; 13 (12). PubMed Abstract | Publisher Full Text 2. Vollert J, Schenker E, Macleod M, Bespalov A, et al.: Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals. BMJ Open Sci . 2020; 4 (1): e100046 PubMed Abstract | Publisher Full Text 3. Vollert J, Macleod M, Dirnagl U, Kas MJ, et al.: The EQIPD framework for rigor in the design, conduct, analysis and documentation of animal experiments. Nat Methods . 2022; 19 (11): 1334-1337 PubMed Abstract | Publisher Full Text 4. Diong J, Butler AA, Gandevia SC, Héroux ME: Poor statistical reporting, inadequate data presentation and spin persist despite editorial advice. PLoS One . 2018; 13 (8): e0202121 PubMed Abstract | Publisher Full Text 5. Gibbs NM, Gibbs SV: Misuse of 'trend' to describe 'almost significant' differences in anaesthesia research. Br J Anaesth . 2015; 115 (3): 337-9 PubMed Abstract | Publisher Full Text 6. Amrhein V, Greenland S, McShane B: Scientists rise up against statistical significance. Nature . 2019; 567 (7748): 305-307 PubMed Abstract | Publisher Full Text 7. Abrams P, Cardozo L, Fall M, Griffiths D, et al.: The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn . 2002; 21 (2): 167-78 PubMed Abstract | Publisher Full Text Competing Interests: I have been an expert witness in patent litigation for Astellas, the company marketing mirabegron. Reviewer Expertise: Beta-3 agonists, obesity, type 2 diabetes I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Michel MC. Reviewer Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.177812.r366818 ) The direct URL for this report is: https://f1000research.com/articles/13-1534/v2#referee-response-366818 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Wagg A. Reviewer Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.177812.r368162 ) The direct URL for this report is: https://f1000research.com/articles/13-1534/v2#referee-response-368162 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 25 Feb 2025 Adrian Wagg , University of Alberta, Edmonton, Canada Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.177812.r368162 The use of English still needs considerable revision for grammar, syntax and spelling throughout the paper. The first sentence of the conclusion cannot be supported - the authors did not assess OAB treatment efficacy. Introduction ... Continue reading READ ALL The use of English still needs considerable revision for grammar, syntax and spelling throughout the paper. The first sentence of the conclusion cannot be supported - the authors did not assess OAB treatment efficacy. Introduction The text " Case focuses on behavior therapy originally, obstructing that burden required, fluid management, averting or menacing vehement liquor avoiding meals, alcohol, and caffeine, as they can irritate the bladder. Antimuscarinic are thought to be the first line of pharmaceutical treatment if these approaches are unsuccessful.", really needs rewriting to make sense. There is over detailed discussion of lipid metabolism in the introduction - this could be edited down for focus and brevity The study's objective had little to do with OAB - the fact that patients here had OAB justifying the use of mirabegron in accordance with its indication, is merely a convenience. The research question also needs a rewrite: "This study will test mirabegron in the composition and review allure pharmacokinetics, conflicting accouterments, and influence in acting OAB and to judge the effect of mirabegron on lipid profile (fasting serum cholesterol and triglyceride) and BMI in patient following OAB." perhaps " this study aimed to assess the effect of mirabegron, used in accordance with its current licensed indication, on lipid profile and BMI in a cohort of patients with OAB"? Competing Interests: No competing interests were disclosed. Reviewer Expertise: incontinence, pharmacotherapy I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Wagg A. Reviewer Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.177812.r368162 ) The direct URL for this report is: https://f1000research.com/articles/13-1534/v2#referee-response-368162 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 19 Dec 2024 Views 0 Cite How to cite this report: Wagg A. Reviewer Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.174622.r354503 ) The direct URL for this report is: https://f1000research.com/articles/13-1534/v1#referee-response-354503 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 20 Jan 2025 Adrian Wagg , University of Alberta, Edmonton, Canada Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.174622.r354503 This quasi experimental, pre-post study aimed to assess the effect of mirabegron on lipid profile and BMI in patients with OAB There are some typographical errors which need correction. Abstract: The background sentences need some editing to make it ... Continue reading READ ALL This quasi experimental, pre-post study aimed to assess the effect of mirabegron on lipid profile and BMI in patients with OAB There are some typographical errors which need correction. Abstract: The background sentences need some editing to make it more understandable, for example "indicated", rather than "notified only". and the second sentence needs considerable rethinking. The conclusion in the abstract cant be supported here - there are no OAB data. The use of language needs considerable revision here too. Introduction: Again, revision for the use of language is required throughout , and the usual term is urgency incontinence, rather than urge. The references need considerable revision. The authors need to use the terminology report of the ICS for ref 1 and the statement qualified by ref 2 is simply not true. I suspect that avoiding meals - as noted by the authors, if adhered to, and followed by the participants in this study, would lead to the changes reported in the study! Re: "A main focus of pharmacological mediations projected at fighting corpulence is the β3-adrenergic receptor (β3-AR)" - clearly this isnt the case - there are no human data which resulted in weight loss. (ref 19) the reference supporting the association between Ach use and an increase in dementia risk needs revision. The research question requires editing for clarity. Methods Was a sample size /power calculation performed? How was the size of the sample selected? Table 1 and figure 1 are overly simple and could be simply included in the text. Alternatively, tables 1 & 2 could be combined - ideally SI units should be used. for such a small sample size - only 1 sf is really justified. What advice regarding weight maintenance was given - did any of the participants alter their diet? Could the error bars be placed on figure 2 and 3 graphs? discussion the dabrowska paper (ref 19) is a review, not a study the discussion is otherwise reasonable but needs considerable editing. Essentially state the findings of your study and note where these agree or disagree with the findings of others the lack of a control group means that the results here need to be taken with caution. No attribution of a causal relationship can be made here Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? No Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? No Are the conclusions drawn adequately supported by the results? No Competing Interests: No competing interests were disclosed. Reviewer Expertise: incontinence, pharmacotherapy I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Wagg A. Reviewer Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.174622.r354503 ) The direct URL for this report is: https://f1000research.com/articles/13-1534/v1#referee-response-354503 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 19 Dec 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 3 (revision) 30 Jul 25 read Version 2 (revision) 24 Feb 25 read read Version 1 19 Dec 24 read Adrian Wagg , University of Alberta, Edmonton, Canada Martin C Michel , Johannes Gutenberg University, Mainz, Germany Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Michel M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 22 Aug 2025 | for Version 3 Martin C Michel , Department of Pharmacology, Johannes Gutenberg University, Mainz, Germany 0 Views copyright © 2025 Michel M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions I have the following comments to the authors : I have looked at the revised manuscript and found that almost none of my previous comments has been considered. A meaningful point-by-point rebuttal letter is also missing. Thus, I cannot endorse indexing of this manuscript. Competing Interests No competing interests were disclosed. I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Michel MC. Peer Review Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.180602.r401586) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-1534/v3#referee-response-401586 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Michel M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 13 Mar 2025 | for Version 2 Martin C Michel , Department of Pharmacology, Johannes Gutenberg University, Mainz, Germany 0 Views copyright © 2025 Michel M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Main comments: Study design: It is my impression that the manuscript reports on a non-interventional/observational study. This must be clearly reflected in the manuscript title, Abstract, and main manuscript. Anti-obesity effects of b3-AR agonists exist in rodents, whereas their existence in humans is largely a myth. For example, see a recent comprehensive review [1]. One key difference being that adult humans exhibit little if any brown adipose tissue. Of note, mirabegron was originally developed for an obesity/type 2 diabetes indication, whereas the OAB indication only was pursued when effects in obesity were of insufficient magnitude to be of clinical relevance. B3-AR agonists have been in clinical use for more than a decade and have been subjected to more than 100 clinical trials. The Introduction is based on a lot of animal data whereas an assessment of what is known based on the numerous clinical trials is missing. Did you look at previous clinical trials on b3-AR agonists? Thus, there should be a clear statement that the more than 100 trials either failed to assess BMI, cholesterol or triglycerides, or found no effects, or found effects. Such rigorous assessment of the pre-study evidence must form the basis for a meaningful Introduction. Of note, the Discussion mentions some pre-study evidence from earlier studies, but those should have been mentioned already in the Introduction. I encourage the authors to access the FDA site to look at the clinical reports the respective companies have filed for mirabegron and vibegron to see whether changes in body weight and/or serum triglycerides and cholesterol were observed (this information is not in the published papers on the phase III studies of either drug). Leading statisticians generally advise not to focus on p-values but on effect sizes with their confidence intervals. Moreover, p-values should not be reported in the absence of a corresponding effect size indicator. The Methods section lacks an overall description of study design. Important elements would include a list of in- and exclusion criteria, information on time of blood sampling relative to last food intake; it is stated that “only a subset completed the follow-up assessment”, but no information for the reasons for dropouts is provided. A patient flow chart is missing. Further details: A) No table with overall demographic data is provided. B) There is no information on sample size justification. C) The first subsection of Methods only talks about women whereas later subsections include both genders. Which is true? D) We also need a table on comedications. This should be by drug class for those with potential pharmacodynamic interactions and by compound for those with potential pharmacokinetic interactions. Many guidelines on data robustness ask to explicitly separate a study designed to test a specific statistical null hypothesis from exploratory studies (all others) [2, 3]. Based on those guidelines, the present study at best appears to be exploratory. This must be stated explicitly. It follows from the exploratory nature of the study that reported p-values cannot be interpreted as hypothesis-testing but only as descriptive. This must be stated explicitly. The tables and figures repeat information already given in the main text, which is redundant. More relevant than reporting group means for a parameter at different time points would be reporting means ± SD of intra-individual changes. Thus, the current table 6 is the only display item that makes sense. The overall interpretation of the data is inappropriate. There is no such thing as a trend for significance etc. [4, 5]. The only thing that can be stated is that there was insufficient evidence to reject the null hypothesis (if there has ever been one) [6]. Given the fundamentally different role of b3-AR in rodents and humans, the Discussion is flawed by an uncritical mix of rodent and human data. The Discussion sourly lacks a critical discussion of the limitations in the data interpretation based on this being apparently neither a randomized, nor a controlled, nor a blinded study. There is no section on tolerability, which I find ethically unacceptable. When I look at one of the two supplementary online files, I see that heart rate by average is higher on treatment than before. Another supplementary file provides blood pressure data, Given the cardiovascular warnings in the prescribing information, this cardiovascular data must be presented in the main manuscript and discussed. Apparently, also bladder capacity data were recorded; however, there is no information on how this data was derived nor are the findings reported and discussed. Bladder capacity data can be used as a proxy for drug efficacy. The overall conclusions markedly exceed what is supported by the data and lacks a critical appreciation of their relevance. Other comments: The are numerous issues with the overall use of the English language. Just a couple of examples from the Abstract: A) drugs are not “notified” but approved by the regulatory authorities. B) Preclinical data may be promising (but note the above species differences between rodents and humans) but are not “bright”. C) “corpulence-affiliated” probably should read “obesity-associated”. D) “patient” should be “patients”. E) “single dose” probably should read “daily dose”. The subject of this sentence is “The patients”, which makes it illogical to continue the sentence with “and asses” (the latter should be assess”). F) The conclusion part has multiple competing verbs and cannot be understood in its present form. Similar problems exist throughout the entire manuscript, even if my specific examples relate to the Abstract only. Thus, the entire manuscript urgently needs language checking. The person doing this should be identified and acknowledged. The Abstract and main manuscript partly use unexplained abbreviations such as “Sr.” (I assume it stands for serum; however, serum apparently is abbreviated as “s.” in other places and not abbreviated at all in yet other places. All abbreviations must be explained upon first mentioning and should be applied consistently thereafter. The 1 st sentence of the Introduction is factually wrong as the formal definition of OAB by the International Continence Society explicitly excludes those with a UTI (not only occasionally as stated here) [7]. Leading statisticians recommend avoidance of the word “significant” because it has different meanings in plain language (i.e., relevant or similar) as compared to a statistical context (observed p-value smaller than prespecified statistical alpha), which can cause confusion. Please replace by whatever is meant throughout the manuscript. Introduction: The “involuntary contraction of the bladder muscle” is a urodynamic finding, not a symptom. Introduction: The definition of hyperlipidemia provided here does not make sense. If it is defined as exceeding the 90 th percentile in the general population, hyperlipidemia would be present, by definition, in 10% of any group. Please consult and reference relevant international guidelines. The manuscript is inconsistent regarding the use of spelled out beta as compared to beta. Either is potentially fine, but it should be handled consistently. Introduction: The statement on the presence of b3-AR may apply to rodents but is largely wrong for humans. Introduction: The statement on BAT is irrelevant because little if any exists in the adult human body. Introduction: “A main focus of pharmacological mediations …” is wrong. At least nine b3-AR agonists have been tested clinically for the obesity/type 2 diabetes indication, but all programs were discontinued due to insufficient clinical responses [1]. The subsequent wording on improvement of thermogenesis and energy expenditure also is true only for rodents, and not for humans. Results: Many parameters are given with a number of decimals that does not make sense because they imply an unrealistic precision. Just as examples: Could you really measure height with a precision of 100 mm or body weight with a precision of 10 g? References 1. Dwaib HS, Michel MC. Is the ß 3 -adrenoceptor a valid target for the treatment of obesity and/or type 2 diabetes? Biomolecules. 2023;13:1714. 2. Vollert J, Schenker E, Macleod M, Bespalov A, Wuerbel H, Michel M, et al. Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals. BMJ Open Science. 2020;4(1):e100046. 3. Vollert J, Macleod M, Dirnagl U, Kas MJ, Michel MC, Potschka H, et al. The EQIPD framework for rigor in the design, conduct, analysis and documentation of animal experiments. Nat Methods. 2022;19(1):1334-7. 4. Diong J, Butler AA, Gandevia SC, Héroux ME. Poor statistical reporting, inadequate data presentation and spin persist despite editorial advice. PLoS One. 2018;13(8):e0202121. 5. Gibbs NM, Gibbs SV. Misuse of 'trend' to describe 'almost significant' differences in anaesthesia research. Br J Anaesth. 2015;115(3):337-9. 6. Amrhein V, Greenland S, McShane B. Scientists rise up against statistical significance. Nature. 2019;567(7748):305-7. 7. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. The standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. Is the work clearly and accurately presented and does it cite the current literature? No Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? No If applicable, is the statistical analysis and its interpretation appropriate? No Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? No References 1. Dwaib HS, Michel MC: Is the β3-Adrenoceptor a Valid Target for the Treatment of Obesity and/or Type 2 Diabetes?. Biomolecules . 2023; 13 (12). PubMed Abstract | Publisher Full Text 2. Vollert J, Schenker E, Macleod M, Bespalov A, et al.: Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals. BMJ Open Sci . 2020; 4 (1): e100046 PubMed Abstract | Publisher Full Text 3. Vollert J, Macleod M, Dirnagl U, Kas MJ, et al.: The EQIPD framework for rigor in the design, conduct, analysis and documentation of animal experiments. Nat Methods . 2022; 19 (11): 1334-1337 PubMed Abstract | Publisher Full Text 4. Diong J, Butler AA, Gandevia SC, Héroux ME: Poor statistical reporting, inadequate data presentation and spin persist despite editorial advice. PLoS One . 2018; 13 (8): e0202121 PubMed Abstract | Publisher Full Text 5. Gibbs NM, Gibbs SV: Misuse of 'trend' to describe 'almost significant' differences in anaesthesia research. Br J Anaesth . 2015; 115 (3): 337-9 PubMed Abstract | Publisher Full Text 6. Amrhein V, Greenland S, McShane B: Scientists rise up against statistical significance. Nature . 2019; 567 (7748): 305-307 PubMed Abstract | Publisher Full Text 7. Abrams P, Cardozo L, Fall M, Griffiths D, et al.: The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn . 2002; 21 (2): 167-78 PubMed Abstract | Publisher Full Text Competing Interests I have been an expert witness in patent litigation for Astellas, the company marketing mirabegron. Reviewer Expertise Beta-3 agonists, obesity, type 2 diabetes I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Michel MC. Peer Review Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.177812.r366818) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-1534/v2#referee-response-366818 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Wagg A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 25 Feb 2025 | for Version 2 Adrian Wagg , University of Alberta, Edmonton, Canada 0 Views copyright © 2025 Wagg A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The use of English still needs considerable revision for grammar, syntax and spelling throughout the paper. The first sentence of the conclusion cannot be supported - the authors did not assess OAB treatment efficacy. Introduction The text " Case focuses on behavior therapy originally, obstructing that burden required, fluid management, averting or menacing vehement liquor avoiding meals, alcohol, and caffeine, as they can irritate the bladder. Antimuscarinic are thought to be the first line of pharmaceutical treatment if these approaches are unsuccessful.", really needs rewriting to make sense. There is over detailed discussion of lipid metabolism in the introduction - this could be edited down for focus and brevity The study's objective had little to do with OAB - the fact that patients here had OAB justifying the use of mirabegron in accordance with its indication, is merely a convenience. The research question also needs a rewrite: "This study will test mirabegron in the composition and review allure pharmacokinetics, conflicting accouterments, and influence in acting OAB and to judge the effect of mirabegron on lipid profile (fasting serum cholesterol and triglyceride) and BMI in patient following OAB." perhaps " this study aimed to assess the effect of mirabegron, used in accordance with its current licensed indication, on lipid profile and BMI in a cohort of patients with OAB"? Competing Interests No competing interests were disclosed. Reviewer Expertise incontinence, pharmacotherapy I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Wagg A. Peer Review Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.177812.r368162) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-1534/v2#referee-response-368162 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Wagg A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 20 Jan 2025 | for Version 1 Adrian Wagg , University of Alberta, Edmonton, Canada 0 Views copyright © 2025 Wagg A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This quasi experimental, pre-post study aimed to assess the effect of mirabegron on lipid profile and BMI in patients with OAB There are some typographical errors which need correction. Abstract: The background sentences need some editing to make it more understandable, for example "indicated", rather than "notified only". and the second sentence needs considerable rethinking. The conclusion in the abstract cant be supported here - there are no OAB data. The use of language needs considerable revision here too. Introduction: Again, revision for the use of language is required throughout , and the usual term is urgency incontinence, rather than urge. The references need considerable revision. The authors need to use the terminology report of the ICS for ref 1 and the statement qualified by ref 2 is simply not true. I suspect that avoiding meals - as noted by the authors, if adhered to, and followed by the participants in this study, would lead to the changes reported in the study! Re: "A main focus of pharmacological mediations projected at fighting corpulence is the β3-adrenergic receptor (β3-AR)" - clearly this isnt the case - there are no human data which resulted in weight loss. (ref 19) the reference supporting the association between Ach use and an increase in dementia risk needs revision. The research question requires editing for clarity. Methods Was a sample size /power calculation performed? How was the size of the sample selected? Table 1 and figure 1 are overly simple and could be simply included in the text. Alternatively, tables 1 & 2 could be combined - ideally SI units should be used. for such a small sample size - only 1 sf is really justified. What advice regarding weight maintenance was given - did any of the participants alter their diet? Could the error bars be placed on figure 2 and 3 graphs? discussion the dabrowska paper (ref 19) is a review, not a study the discussion is otherwise reasonable but needs considerable editing. Essentially state the findings of your study and note where these agree or disagree with the findings of others the lack of a control group means that the results here need to be taken with caution. No attribution of a causal relationship can be made here Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? No Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? No Are the conclusions drawn adequately supported by the results? No Competing Interests No competing interests were disclosed. Reviewer Expertise incontinence, pharmacotherapy I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Wagg A. Peer Review Report For: Effect of mirabegron on lipid profile (serum cholesterol and triglyceride) in Iraqi patients with overactive bladder [version 3; peer review: 2 not approved] . F1000Research 2025, 13 :1534 ( https://doi.org/10.5256/f1000research.174622.r354503) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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