Efficacy and Safety of Oral Mirodenafil in the Treatment of Erectile Dysfunction in Diabetic Men in Korea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Abstract

Introduction. Mirodenafil is a newly developed selective phosphocliesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED). Aim. To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes. Methods. A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks. Main Outcome Measures. Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (TTEF) questionnaire. Secondary efficacy variables included change in the scores of -REF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the REF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC). Results. After 12 weeks of treatment, mirodenafil group showed significantly greater change in the TIEF-EF domain score from baseline compared with the placebo group (9.3 vs. 1.4, P < 0.0001). The changes from baseline in the mirodenafil group in REF Q3 (1.7 vs. 0.4, P < 0.0001) and Q4 (1.7 vs. 0.3, P < 0.0001) were higher compared with the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P = 0.0003), SEP3 (68.9% vs. 22.3%, P < 0.0001). Difference in GAQ "YES" responses was also significant (76.9% vs. 19.1%, P < 0.0001). Normal EF domain scores (:26) at study end were achieved by 32.7% and 9.4% in the mirocleniafl and placebo groups, respectively (P = 0.0031). As for the LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously. Conclusions. Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea. Park HJ, Choi HK, Alm TY, Park JK, Chung WS, Lee SW, Kim SW, Hyun JS, and Park NC. Efficacy and safety of oral mirodenafil in the treatment of erectile dysfunction in diabetic men in Korea: A multicenter, randomized, double-blind, placebo-controlled clinical trial. J Sex Med 2010;7:2842-2850.