The efficacy and safety of tadalafil for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.
In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took tadalafil.
The efficacy results for patients with both ED and BPH, who received either tadalafil 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.
Tadalafil 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. tadalafil 5 mg for once daily use also resulted in statistically significant improvement in SEP3. tadalafil 2.5 mg did not result in statistically significant improvement in the total IPSS.
|Placebo||Tadalafil 5 mg||p – value|
|Total Symptom Score ( IPSS )|
|( N = 193 )||( N = 206 )|
|Change from Baseline to Week 12||-3.8||-6.1||<.001|
|EF Domain Score ( IIEF EF )|
|( N = 188 )||( N = 202 )|
|Change from Baseline to Week 12||1.9||6.5||<.001|
|Placebo||Tadalafil 5 mg|
|( N = 187 )||( N = 199 )||p – value|
|Maintenance of Erection ( SEP3 )|
|Change from Baseline to Week 12||12%||32%||<.001|
In this study, the effect of tadalafil 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.