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Cited 15 time in webofscience Cited 17 time in scopus
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Efficacy and Safety of Mirodenafil in Men Taking Antihypertensive Medications

Authors
Paick, Jae-SeungKim, Je JongKim, Sae ChulMoon, Ki HakMin, Kweon SikPark, KwangsungSuh, Jun-KyuYang, Dae Yul
Issue Date
Sep-2010
Publisher
ELSEVIER SCI LTD
Keywords
Erectile Dysfunction; PDE5 inhibitor; Antihypertensives; Mirodenafil
Citation
JOURNAL OF SEXUAL MEDICINE, v.7, no.9, pp 3143 - 3152
Pages
10
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF SEXUAL MEDICINE
Volume
7
Number
9
Start Page
3143
End Page
3152
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/35367
DOI
10.1111/j.1743-6109.2010.01926.x
ISSN
1743-6095
1743-6109
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.
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