Efficacy and safety of mirodenafil, a new oral phosphodiesterase type 5 inhibitor, for treatment of erectile dysfunction.

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.

Sexual behaviour and dysfunction and help-seeking patterns in adults aged 40-80 years in the urban population of Asian countries.

OBJECTIVE: To study sexual activity, the prevalence of sexual dysfunction and related help-seeking behaviour among middle-aged and elderly people in Asia. SUBJECTS AND METHODS: A random population survey was carried out in 2001-2002 among urban residents aged 40-80 years in China, Taiwan, South Korea, Japan, Thailand, Singapore, Malaysia, Indonesia and The Philippines, with interviews based on a standardized questionnaire covering demographic details, health, relationships, and sexual behaviours, attitudes and beliefs. An intercept method of sampling was used in all countries except Japan, where questionnaires were mailed to a sample drawn from telephone directories. Sexual dysfunction was defined as persistent sexual problems. RESULTS: The questionnaire was completed by 6700 people (3350 men and 3350 women), giving a response rate of 27%. Across all countries, 82% of men and 64% of women had engaged in sexual intercourse during the year preceding the interview. Most of the respondents considered satisfactory sex an essential means of maintaining a relationship. More than 20% of men and 30% of women complained of having at least one sexual dysfunction, although there were marked variations among the countries. The sexual dysfunctions most frequently reported were early ejaculation (20%; 95% confidence interval, CI, 18-21) and erectile dysfunction (15%, 14-17) among men; and a lack of sexual interest (27%, 25-29), lubrication difficulties (24%, 22-25), and an inability to reach orgasm (23%, 22-25) among women. Of the 948 men and 992 women who were sexually active and reported sexual dysfunctions, 45% did sought no help or advice and only 21% sought medical care. CONCLUSION: Men and women in Asian countries continue to show sexual interest and activity into middle age and beyond. Although sexual dysfunction is prevalent in this age group, several sociocultural and economic factors appear to be preventing individuals from seeking medical help for these problems.