Table 2.
Comparison of AUA-SI, Prostate Volumen and Qmax for Patients Who Entered the Open-Label Phase Versus Those Who Did Not
| Placebo | Dutasteride | |||
|---|---|---|---|---|
| Entered | Did Not Enter | Entered | Did Not Enter | |
| Open-Label | Open-Label | Open-Label | Open-Label | |
| (n = 1152) | (n = 1006) | (n = 1188) | (n = 979) | |
| AUA-SI score | 14.5 ± 7.16* | 15.5 ± 7.56* | 12.3 ± 6.68 | 12.1 ± 6.49 |
| Change in AUA-SI Score from baseline | −2.5 ± 6.67* | −1.6 ± 7.30* | −4.4 ± 6.52 | −4.7 ± 6.96 |
| Prostate volume (cc) | 54.4 ± 25.31 | 53.1 ± 24.65 | 41.3 ± 20.19 | 40.8 ± 22.24 |
| Change in prostate volume from baseline (%) | 1.4 ± 26.16 | 2.8 ± 24.74 | −26.0 ± 19.38 | −24.7 ± 21.03 |
| Qmax (mL/sec) | 11.3 ± 4.60* | 10.9 ± 5.48* | 12.5 ± 5.57 | 12.7 ± 5.75 |
| Change in Qmax (mL/sec) | 0.6 ± 4.57 | 0.9 ± 5.12 | 2.2 ± 5.15 | 2.3 ± 5.42 |
Data are derived from the month 24 visit (double-blind ITT population) and are means ± standard deviations.
*
P < .05. AUA-SI, American Urological association-symptom Index; Qmax, maximal flow rate; ITT, Intention to treat. Reprinted from Debruyne F et al20 with permission from European Association of Urology.