Safety and efficacy of once daily administration of 50 mg mirodenafil in patients with erectile dysfunction: a multicenter, double-blind, placebo controlled trial.

Abstract

PURPOSE:

We evaluated the improvement in erectile dysfunction and lower urinary tract symptoms as well as the safety of once daily administration of 50 mg mirodenafil in men with erectile dysfunction.

MATERIALS AND METHODS:

A total of 226 patients visited for treatment of erectile dysfunction and were recruited for the study. Of these men 180 met the study inclusion criteria after completing a 2-week screening period (visit [V]1). The patients were randomly allocated into 2 groups. Group 1 (90 patients) received 50 mg mirodenafil once daily and group 2 (90 patients) received a placebo daily. Blood pressure, heart rate, IIEF-5 (5-item version of the International Index of Erectile Function), and SEP (Sexual Encounter Profile) questions 2 and 3 were assessed at 4 (V2), 8 (V3) and 12 weeks after the start of treatment (V4). I-PSS (International Prostate Symptom Score), maximal flow rate and post-void residual volume were also assessed for the evaluation of lower urinary tract symptoms.

RESULTS:

Of the 180 patients 71 in group 1 and 63 in group 2 completed the 12-week clinical trial. IIEF-5 and I-PSS significantly improved in group 1 (p <0.001 for both). Facial flushing was the most common adverse effect, followed by headaches. Notably there were no statistically significant differences in either of the variables related to the cardiovascular system.

CONCLUSIONS:

Once daily administration of 50 mg mirodenafil was efficacious and safe for the treatment of erectile dysfunction and lower urinary tract symptoms.

• Authors: Jae Hoon Chung, Dong Hyuk Kang, Cheol Young Oh, Jae Min Chung, Ki Soo Lee, Tae Hyo Kim, Kyung Hyun Moon, Wan Lee, Jeong Man Cho, Seung Wook Lee
• Journal: The Journal of urology (J Urol) Vol. 189 Issue 3 Pg. 1006-13 (Mar 2013) ISSN: 1527-3792 [Electronic] United States
• PMID: 23017527 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Phosphodiesterase 5 Inhibitors
• Pyrimidinones
• Sulfonamides
• mirodenafil

Topics

• Administration, Oral
• Adult
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Erectile Dysfunction (drug therapy, physiopathology)
• Humans
• Male
• Middle Aged
• Penile Erection (drug effects)
• Phosphodiesterase 5 Inhibitors (administration & dosage)
• Pyrimidinones (administration & dosage)
• Sulfonamides (administration & dosage)
• Treatment Outcome
• Young Adult