PMID- 22921287
OWN - NLM
STAT- MEDLINE
DCOM- 20130205
LR  - 20181201
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 34
IP  - 9
DP  - 2012 Sep
TI  - Assessment of the effect of mirodenafil on the hemodynamics of healthy male 
      Korean volunteers administered tamsulosin: a randomized, double-blind, 
      placebo-controlled, 2-period crossover study.
PG  - 1929-39
LID - S0149-2918(12)00483-3 [pii]
LID - 10.1016/j.clinthera.2012.08.002 [doi]
AB  - BACKGROUND: Both mirodenafil, a phosphodiesterase type 5 inhibitor for the 
      treatment of erectile dysfunction, and tamsulosin, a selective alpha(1A)-adrenergic 
      receptor antagonist for the treatment of benign prostatic hyperplasia, have mild 
      vasodilational effects. OBJECTIVE: The aim of this study was to investigate the 
      effect of mirodenafil on the hemodynamics of healthy volunteers who were 
      administered tamsulosin. METHODS: Healthy, Korean normotensive male volunteers 
      were enrolled in a randomized, placebo-controlled, double-blind, 2-sequence, 
      2-period crossover study. Mirodenafil 100 mg or placebo was administered orally 
      after pretreatment with tamsulosin 0.2 mg once daily for 7 days in each period, 
      with a 1-week washout period. Blood pressure (BP) and pulse rate (PR) in supine 
      and standing positions were measured repeatedly before and until 24 hours after 
      the administration of mirodenafil or placebo. The mean differences from the 
      baseline values of the maximum changes of BP and PR, which were measured at 4 and 
      24 hours, were analyzed by using a mixed-effects model. RESULTS: Eighteen 
      subjects (mean [SD] age, 26.8 [3.9] years; weight, 65.5 [7.0] kg) were 
      administered any trial medication, and 16 of them completed the study. For 4 
      hours/24 hours after mirodenafil administration, the mean maximal changes from 
      baseline versus placebo in supine systolic BP, diastolic BP, and PR were -1.0 mm 
      Hg (95% CI, -4.2 to 2.2) (P = 0.53)/-1.2 mm Hg (95% CI, -5.3 to 2.9) (P = 0.56), 
      -2.1 mm Hg (95% CI, -4.6 to 0.4) (P = 0.10)/-1.1 mm Hg (95% CI, -3.9 to 1.6) (P = 
      0.39), and 7.2 beats/min (95% CI, 4.7 to 9.6) (P < 0.05)/4.8 beats/min (95% CI, 
      1.4 to 8.1) (P < 0.05), respectively. Those changes in a standing position were 
      -4.0 mm Hg (95% CI, -8.9 to 0.9) (P = 0.10)/-4.3 mm Hg (95% CI, -10.0 to 1.5) (P 
      = 0.13), -1.1 mm Hg (95% CI, -4.9 to 2.7) (P = 0.54)/-1.9 mm Hg (95% CI, -5.5 to 
      1.7) (P = 0.27), and 10.7 beats/min (95% CI, 4.4 to 16.9) (P < 0.05)/6.0 
      beats/min (95% CI, 0.7 to 11.3) (P < 0.05), respectively. A total of 33 adverse 
      events (AEs) were reported in 9 of 18 subjects. The number of subjects with AEs 
      (P = 0.13) and the number of AEs (P = 0.26) were not significantly different 
      between the 2 groups. The most common AEs were vasodilational symptoms, such as 
      nasal congestion, headache, and flushing. CONCLUSIONS: The coadministration of 
      mirodenafil 100 mg did not induce a significant decrease in BP when associated 
      with an increase in PR in these healthy male Korean volunteers administered 
      tamsulosin 0.2 mg compared with placebo. (Clinical Trial Registry, 
      http://cris.cdc.go.kr/cris/en/: KCT0000117).
CI  - Copyright (c) 2012 Elsevier HS Journals, Inc. All rights reserved.
FAU - Gu, Namyi
AU  - Gu N
AD  - Department of Clinical Pharmacology and Therapeutics, Seoul National University 
      College of Medicine and Hospital, Jongno-gu, Seoul, Republic of Korea.
FAU - Kim, JaeWoo
AU  - Kim J
FAU - Lim, Kyoung Soo
AU  - Lim KS
FAU - Shin, Kwang-Hee
AU  - Shin KH
FAU - Kim, Tae-Eun
AU  - Kim TE
FAU - Lee, Bongyong
AU  - Lee B
FAU - Shin, Sang-Goo
AU  - Shin SG
FAU - Jang, In-Jin
AU  - Jang IJ
FAU - Yu, Kyung-Sang
AU  - Yu KS
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120824
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Adrenergic alpha-1 Receptor Antagonists)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 0 (Pyrimidinones)
RN  - 0 (Sulfonamides)
RN  - 0 (Vasodilator Agents)
RN  - 504G362H0H (mirodenafil)
RN  - G3P28OML5I (Tamsulosin)
SB  - IM
MH  - Administration, Oral
MH  - Adrenergic alpha-1 Receptor Antagonists/adverse effects/*pharmacology
MH  - Adult
MH  - Blood Pressure/*drug effects
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Drug Interactions
MH  - Heart Rate/drug effects
MH  - Hemodynamics/drug effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phosphodiesterase 5 Inhibitors/adverse effects/*pharmacology
MH  - Pyrimidinones/adverse effects/*pharmacology
MH  - Republic of Korea
MH  - Sulfonamides/adverse effects/*pharmacology
MH  - Tamsulosin
MH  - Vasodilator Agents/adverse effects/pharmacology
MH  - Young Adult
EDAT- 2012/08/28 06:00
MHDA- 2013/02/06 06:00
CRDT- 2012/08/28 06:00
PHST- 2012/08/06 00:00 [accepted]
PHST- 2012/08/28 06:00 [entrez]
PHST- 2012/08/28 06:00 [pubmed]
PHST- 2013/02/06 06:00 [medline]
AID - S0149-2918(12)00483-3 [pii]
AID - 10.1016/j.clinthera.2012.08.002 [doi]
PST - ppublish
SO  - Clin Ther. 2012 Sep;34(9):1929-39. doi: 10.1016/j.clinthera.2012.08.002. Epub 
      2012 Aug 24.