The effect of udenafil on the hemodynamics of healthy male volunteers
administered tamsulosin.
Author(s): Kim MG(1), Kim JR, Kim BH, Lim KS, Shin SG, Jang IJ, Yu KS, Cho JY.
Affiliation(s): Author information:
(1)Department of Clinical Pharmacology and Therapeutics, Seoul National University
College of Medicine and Hospital, Seoul, Republic of Korea.
Publication date & source: 2013, Curr Med Res Opin. , 29(6):685-93
OBJECTIVE: The purpose of this study is to evaluate the hemodynamic interactions
between udenafil and tamsulosin.
METHODS: After a placebo lead-in period, 27 healthy volunteers received 200 mg
udenafil + tamsulosin placebo, udenafil placebo +0.4 mg tamsulosin, or 200 mg
udenafil +0.4 mg tamsulosin. Blood pressure and pulse rate (PR) were measured at
15 time points from 0 to 24 hours.
RESULTS: A single dose of udenafil, when administered with multiple tamsulosin
doses, produced statistically significant increases in PR (mean: 10.7; 95%
confidence interval: 5.3, 16.2 bpm; p < 0.001) compared with tamsulosin
administered with an udenafil placebo. Systolic and diastolic blood pressure
measurements remained unchanged. Two subjects who took udenafil with tamsulosin
had a decrease in standing systolic blood pressure (SBP) greater than 30 mmHg in
comparison to their baseline SBP; however, compared with the frequency of a
decrease in standing SBP greater than 30 mmHg in comparison to the baseline,
there was no significant difference in frequency among the four treatments (p =
0.243). There was no difference in the Cmax, AUClast, or AUCinf of udenafil and
its active metabolite DA-8164 between the administration of udenafil and udenafil
with tamsulosin.
CONCLUSION: The coadministration of udenafil and tamsulosin was not associated
with clinically significant hemodynamic changes in healthy volunteers. Although
this study was conducted on a small number of healthy young subjects, the use of
udenafil for the treatment of erectile dysfunction in patients taking tamsulosin
for the treatment of benign prostatic hyperplasia is not expected to cause
significant safety problems.
|