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 phosphodiesterase 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 (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF 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 IIEF-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 IIEF 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 mirodeniafl 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.

Mechanisms of Penile Erection and Basis for Pharmacological Treatment of Erectile Dysfunction

“…The optimal doses in terms of efficacy and safety were determined from these studies to be 50 and 100 mg. Mirodenafil was shown to be effective and safe in men with ED concomitantly taking antihypertensive medications (Paick et al, 2010). In 112 Korean men with ED and diabetes, Park et al (2010a) showed in an RCT that mirodenafil was effective and well tolerated. The most common adverse events were facial flushing, headache, nausea, and eye redness.…”

A review of the efficacy and safety of mirodenafil in the management of erectile dysfunction

“…The clinical efficacy and tolerability of mirodenafil in patients with ED of various underlying etiologies and severities have been assessed in several randomized, placebo-controlled clinical studies [Paick et al 2008a[Paick et al , 2008b[Paick et al , 2010Park et al 2010;Chung et al 2013]. Tables 2 and 3 of the Sexual Encounter Profile (SEP3)] in the mirodenafil treatment groups (44.9-63.2%) were significantly greater than 18.6% in the placebo group.…”

“…However, further head-tohead comparative studies between the PDE5Is are needed because it is difficult to directly compare the efficacy between different PDE5Is due to differences in baseline characteristics of patients, inclusion criteria, outcome measures, dosing schedules and treatment periods. Furthermore, four of the five randomized clinical trials of mirodenafil excluded the nonresponders to PDE5Is [Paick et al 2008a[Paick et al , 2008b[Paick et al , 2010Park et al 2010], while only a few sildenafil trials, half of vardenafil trials and only a third of tadalafil trials excluded men with ED that did not respond to previous PDE5Is [Tsertsvadze et al 2009]. Thus, the difference could limit the comparison of treatment outcomes of mirodenafil trials with those of historical trials of vardenafil, tadalafil or sildenafil.…”

“…While the pharmacokinetic profile is similar to that of sildenafil, mirodenafil appears to be 10 times more selective for PDE5 than sildenafil [Shin et al 2006]. Several randomized, controlled trials have reported the favorable clinical efficacy and tolerability of mirodenafil in men with ED of a broad range of etiologies or severity [Paick et al 2008a[Paick et al , 2008b[Paick et al , 2010Park et al 2010;Chung et al 2013]. Thus, the availability of various PDE5Is including mirodenafil can provide multiple treatment regimens from which clinicians and patients may choose to optimize the likelihood of treatment success and improve the patients' satisfaction with few adverse effects.…”

Re: Efficacy and safety of mirodenafil for patients with erectile dysfunction: a meta-analysis of three multicenter, randomized, double-blind, placebo-controlled clinical trials

“…The meta-analysis identified three randomized controlled trials (RCTs) [2][3][4] including 374 participants and concluded that mirodenafil is effective and well-tolerated therapy for ED. However, the main issue needed to be addressed is that whether it is reasonable to simply integrate data from the three RCTs.…”