Table 2.
Efficacy Results for Use of Daily-Dosed Tadalafil 5 mg, Tadalafil 5/20 mg, and Placebo at 6 and 12 Weeks
| Tadalafil | Tadalafil | |||||
|---|---|---|---|---|---|---|
| Placebo | 5 mg | Placebo | 5/20 mg | |||
| 6 wk | 6 wk | P Value | 12 wk | 12 wk | P Value | |
| n | 143 | 138 | 143 | 138 | ||
| IPSS* | − 1.2 ± 0.47 | − 2.8 ± 0.48 | .003 | − 1.7 ± 0.49 | − 3.8 ± 0.50 | < .001 |
| IPSS QOL* | − 0.2 ± 0.11 | − 0.5 ± 0.11 | .017 | − 0.3 ± 0.12 | − 0.7 ± 0.12 | .008 |
| BII* | − 0.4 ± 0.21 | − 0.7 ± 0.22 | .107 | − 0.6 ± 0.23 | − 1.3 ± 0.23 | .008 |
| LUTS GAQ, | 32.6 | 55.9 | < .001 | 37.7 | 57.4 | < .001 |
| endpoint (% yes) |
*
Change from baseline, least-squares mean ± standard error.
IPSS, International Prostate Symptom Score; QOL, quality of life; BII, Benign prostatic hyperplasia Impact Index; LUTS GAQ, lower urinary tract symptoms global assessment question. Reproduced from Roehrborn C et al.20 with permission from the American Urological Association.