Abstract
Background
Both mirodenafil, a phosphodiesterase type 5 inhibitor for the treatment of erectile
dysfunction, and tamsulosin, a selective α1A-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).
Key words
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Article info
Publication history
Published online: August 27, 2012
Accepted:
August 6,
2012
Identification
Copyright
© 2012 Elsevier HS Journals, Inc. Published by Elsevier Inc. All rights reserved.
