title: Efficacy and safety of mirodenafil in men taking antihypertensive medications.
abstract: 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.
authors.affiliation: Department of Urology, Seoul National University Hospital, Seoul, Korea. jspaick@snu.ac.kr
authors.forename: Jae-Seung
authors.initials: JS
authors.lastname: Paick
authors.forename: Je Jong
authors.initials: JJ
authors.lastname: Kim
authors.forename: Sae Chul
authors.initials: SC
authors.lastname: Kim
authors.forename: Ki Hak
authors.initials: KH
authors.lastname: Moon
authors.forename: Kweon Sik
authors.initials: KS
authors.lastname: Min
authors.forename: Kwangsung
authors.initials: K
authors.lastname: Park
authors.forename: Jun-Kyu
authors.initials: JK
authors.lastname: Suh
authors.forename: Dae Yul
authors.initials: DY
authors.lastname: Yang
mesh_terms: 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*
chemical_list: D000959:Antihypertensive Agents; D058986:Phosphodiesterase 5 Inhibitors; D011744:Pyrimidinones; D013449:Sulfonamides; C528396:mirodenafil