Efficacy and Safety of Mirodenafil in Men Taking Antihypertensive Medications

Title
Efficacy and Safety of Mirodenafil in Men Taking Antihypertensive Medications
Author(s)
문기학백재승[백재승]김제종[김제종]김세철[김세철]민권식[민권식]박광성[박광성]서준규 [서준규 ]양대열[양대열]
Keywords
ERECTILE DYSFUNCTION; SILDENAFIL CITRATE; HYPERTENSIVE MEN; BLOOD-PRESSURE; PHOSPHODIESTERASE-5 INHIBITOR; ARTERIAL-HYPERTENSION; OPEN-LABEL; TADALAFIL; AGENTS; PREVALENCE
Issue Date
201009
Publisher
WILEY-BLACKWELL
Citation
JOURNAL OF SEXUAL MEDICINE, v.7, no.9, pp.3143 - 3152
Abstract
Introduction. Mirodenafil is a recently developed oral phosphodiesterase type 5 inhibitor, which was observed to significantly improve erectile function and was well tolerated in men with broad-spectrum erectile dysfunction (ED). Aim. To investigate the efficacy and safety of mirodenafil treatment compared with placebo in men taking at least one antihypertensive medication. Methods. A multicenter, double-blind, placebo-controlled, parallel group, fixed-dose study was conducted with 109 subjects who were randomized to placebo or mirodenafil 100 mg for 12 weeks on an "as needed" basis. Main Outcome Measures. The primary efficacy measures were the changes from baseline in sum of scores on International Index of Erectile Function-erectile function domain (IIEF-EF) questions 1 to 5 and 15 with treatment. The secondary efficacy measures included scores on IIEF question 3 and 4 (Q3 and Q4), all domain scores of IIEF, and Sexual Encounter Profile Question 2 and 3 (SEP2 and SEP3) along with responses to Global Assessment Question (GAQ) and Life Satisfaction Checklist (LSC). The safety assessments included laboratory tests, vital signs, 12-lead electrocardiogram recordings, and patients' reporting of adverse events. Results. The mirodenafil group showed significantly greater increase in IIEF-EF scores at 12 weeks compared with the placebo group (9.35 +/- 6.86 vs. 2.66 +/- 6.44, P < 0.001). The mirodenafil group also demonstrated significantly greater improvement in scores of IIEF Q3 and Q4, other four domains of IIEF, SEP2, SEP3, and LSC along with percentages of patients responding positively to GAQ compared with the placebo group. During the study, no clinically significant changes were observed regarding blood pressure, heart rate, electrocardiographic findings, or laboratory values. Facial flushing and headache were the most common treatment-associated adverse events, which were mild or moderate in severity, resolving spontaneously. Conclusions. Mirodenafil was effective and safe in men with ED concomitantly taking antihypertensive medications. Paick J-S, Kim JJ, Kim SC, Moon KH, Min KS, Park K, Suh J-K, and Yang DY. Efficacy and safety of mirodenafil in men taking antihypertensive medications. J Sex Med 2010;7:3143-3152.
URI
http://hdl.handle.net/YU.REPOSITORY/23648http://dx.doi.org/10.1111/j.1743-6109.2010.01926.x
ISSN
1743-6095
Appears in Collections:
의과대학 > 비뇨기과학교실 > Articles
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