Efficacy and Safety of Mirodenafil, A New Oral Phosphodiesterase Type 5 Inhibitor, for Treatment of Erectile Dysfunction

Abstract

Introduction Mirodenafil is a newly developed oral phosphodiesterase type 5 inhibitor, currently under investigation as a treatment for erectile dysfunction (ED). Aim We investigated the efficacy and safety of on demand mirodenafil therapy at fixed doses (50 and 100 mg) in Korean men with a broad range of ED. Methods A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 223 subjects who were randomized to placebo or mirodenafil at fixed doses of 50 or 100 mg for 12 weeks on an “as needed” basis. Main Outcome Measures Primary efficacy measures were scores on the International Index of Erectile Function (IIEF) Question 3 (Q3) and Question 4 (Q4). Secondary efficacy measures included all domain scores of the IIEF, Sexual Encounter Profile Question 2 (SEP2), Sexual Encounter Profile Question 3 (SEP3), the Global Assessment Question (GAQ), and the Life Satisfaction Checklist (LSC). Safety assessments included laboratory tests, vital signs, physical examination, 12-lead electrocardiogram recordings, and patients’ reporting of adverse events. Results Mirodenafil 50 and 100 mg groups showed a significantly greater increase in IIEF Q3 (P = 0.0001, P < 0.0001, respectively) and Q4 scores (both P < 0.0001) at the end point compared with the placebo group. And mirodenafil in both doses significantly improved the scores of all five domains of the IIEF, SEP2, and SEP3 as well as the percentages of patients responding positively to the GAQ compared with the placebo group. As for LSC scores, the two mirodenafil groups showed significantly greater improvements in items regarding life as a whole, sexual life, and partner relationship than the placebo group. Most treatment-associated adverse events were of mild intensity, resolving spontaneously. Conclusions Mirodenafil, in doses of 50 or 100 mg, significantly improved erectile function and were well tolerated in a representative population of Korean men with broad-spectrum ED of various etiologies and severities.

Prevalence and medical management of erectile dysfunction in Asia

“…44 The mirodenafil 50 and 100 mg groups showed a significantly greater increase in the scores for IIEF question 3 regarding the availability of penile penetration to partner (P50.0001 and P,0.0001, respectively) and question 4 (both P,0.0001) at the end point as compared with the placebo group. Mirodenafil in both doses significantly improved the IIEF, SEP2 and SEP3 scores and the GAQ as compared with placebo.…”

“…These included four RCTs of sildenafil, [31][32][33][34] two RCTs of vardenafil, 35,36 four RCTs of tadalafil, [37][38][39][40] two RCTs of udenafil 41,42 and two RCTs of mirodenafil. 43,44 The efficacy and safety of two novel PDE-5 inhibitors, mirodenafil and udenafil, were evaluated only in Korean men. In this review, we did not include clinical trials of PDE-5 inhibitors in men with specific comorbid diseases, such as diabetes, hypertension and other neurovascular diseases.…”

“…36 Treatment with vardenafil produced significant improvement in the main efficacy measures of IIEF-EF score and SEP2 and SEP3 as well as the GAQ. The efficacy [31][32][33][34][35][36][37][38][39][40][41][42][43][44] Prevalence and management of ED in Asia K Park et al 547…”

Oral Pharmacokinetics of Mirodenafil in Mexican Healthy Volunteers

“…Therefore, in order to establish an adequate dosage regimen in Mexicans, it is important to establish if oral pharmacokinetics of Mirodenafil in our population is similar to the reported in Koreans, population in which efficacy and safety of Mirodenafil have been evaluated [1].…”

“…Mirodenafil is a 5-phosphodiesterase (PDE-5) inhibitor that is useful in the treatment of erectile dysfunction [1]. PDE-5 inhibitors produce their effect by increasing cyclic guanosine monophosphate (cGMP), by an augment and long duration of vasodilatory activity of nitric oxide (NO) and prostaglandin I2 [2,3].…”