Efficacy and safety of mirodenafil in men taking antihypertensive medications.
BACKGROUND
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).


OBJECTIVE
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.


METHODS
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
Jae-Seung
JS
Department of Urology, Seoul National University Hospital, Seoul, Korea. jspaick@snu.ac.kr
Kim
Je Jong
JJ
Kim
Sae Chul
SC
Moon
Ki Hak
KH
Min
Kweon Sik
KS
Park
Kwangsung
K
Suh
Jun-Kyu
JK
Yang
Dae Yul
DY
D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure; D004311:Double-Blind Method; D004562:Electrocardiography; D007172:Erectile Dysfunction / Q000150:complications / Q000188:drug therapy*; D005483:Flushing / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006339:Heart Rate; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D011744:Pyrimidinones / Q000627:therapeutic use*; D013449:Sulfonamides / Q000627:therapeutic use*
D000959:Antihypertensive Agents; D058986:Phosphodiesterase 5 Inhibitors; D011744:Pyrimidinones; D013449:Sulfonamides; C528396:mirodenafil