Tadalafil Improves Erectile Dysfunction and Quality Of Life in Men with Cirrhosis: A Randomized Placebo Controlled Trial

Abstract Background and Aims: Patients with cirrhosis have high prevalence of erectile dysfunction (ED). The aim of this study was to study the efficacy and safety of tadalafil for ED in patients with cirrhosis. Methods: 140 cirrhotic males with ED were randomized into tadalafil 10 mg daily (n = 70) or placebo (n = 70) for 12 weeks. ED was diagnosed if erectile function (EF) domain score was  5 points in EF domain of the IIEF. Results: At end of 12 weeks, more patients in tadalafil group achieved > 5 points increase in the EF domain of the IIEF as compared to the placebo group [44(62.9%) vs. 21(30%), P < 0.001]. At the end of 12 weeks, patients receiving tadalafil had significantly more change in scores on the erectile function domain, orgasmic function domain, intercourse satisfaction domain, overall satisfaction domain, erection vaginal penetration rates and successful intercourse; significantly more decline in the GAD-7 and PHQ- 9 scores; significantly more improvement in scores of five of the eight domains of SF-36 (general health perception, vitality score, social functioning, role emotional, and mental health), and the mental component summary rates as compared to placebo. The development of side effects and the changes in HVPG were not significantly different between the two groups. Conclusions: Tadalafil therapy significantly enhanced erectile function, improved anxiety, depression and quality of life, and was well tolerated by cirrhotic men with ED. (ClinicalTrials.gov identifier number: NCT03566914; first posted date: June 25, 2018).