Korean J Urol.  2010 Sep;51(9):647-652.

Efficacy and Safety of Tadalafil 5 mg Administered Once Daily in Korean Men with Erectile Dysfunction: A Prospective, Multicenter Study

• Kang DH
• Lee JY
• Park SY
• Moon HS
• Jeong TY
• Yoo TK
• Choi HY
• Park HY
• Lee TY
• Lee SW

Abstract

PURPOSE
The aim of this study was to evaluate the efficacy of a daily dose of tadalafil 5 mg as well as its safety for the cardiovascular system in men with erectile dysfunction.
MATERIALS AND METHODS
This study included a total of 162 men who were administered a daily dose of tadalafil 5 mg between April and December of 2009. A total of 127 men completed the 8-week clinical trial. The International Index of Erectile Function (IIEF)-5, blood pressure, and heart rate were measured before treatment with tadalafil (V1) and 4 (V2) and 8 weeks (V3) after treatment with tadalafil. Adverse effects were assessed at V1, V2, and V3. In cases in which the International Prostate Symptom Score (IPSS) was > or =8 at V1, maximal flow rate (Qmax) and postvoid residual volume (PVR) were measured.
RESULTS
The IIEF-5 values were 11.25+/-3.18, 14.56+/-3.79, and 16.91+/-3.56 at V1, V2, and V3, respectively, with significant improvement (V1 vs. V2, p<0.001; V1 vs. V3, p<0.001). The IPSS values were 10.59+/-5.56, 9.07+/-6.06, and 8.15+/-6.10 at V1, V2, and V3, respectively, and the differences were statistically significant (V1 vs. V2, p<0.001; V1 vs. V3, p<0.001). There were no significant differences in blood pressure or heart rate. Adverse effects were observed in 7 men (5.51%) at V2 and in 5 men (3.94%) at V3.
CONCLUSIONS
Tadalafil 5 mg administered once-a-day may be effective in improving erectile function. Adverse effects on the cardiovascular system may be minimal. In addition, it is believed that this may also be effective in improving voiding symptoms.

Keyword

Erectile dysfunction; Safety; Tadalafil; Treatment outcome

MeSH Terms

Blood Pressure
Carbolines
Cardiovascular System
Erectile Dysfunction
Heart Rate
Humans
Male
Prospective Studies
Prostate
Residual Volume
Treatment Outcome
Tadalafil
Carbolines

Figure

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  FIG. 1 There was a significant domain score increase in all questions (Q1 to Q5) of the International Index of Erectile Function (IIEF)-5.

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  FIG. 2 In the group with maximal flow rate (Qmax) less than 12 ml/sec (n=30, 32.97%), there was a significant increase in Qmax compared with that in the group with Qmax of 12 or more than 12 ml/sec (n=61, 67.03%).

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