Table 2.
Comparing the Baseline Entry Characteristics
| Pivotal | Pivotal | PLESS | PLESS | |
|---|---|---|---|---|
| 2-Year | 2-Year | 4-Year | 4-Year | |
| Double-Blind | Double-Blind | Double-Blind | Double-Blind | |
| Placebo | Dutasteride | Placebo | Finasteride | |
| Baseline Data | n = 2158 | n = 2167 | n = 1516 | n = 1524 |
| Age (years) | 66.1 ± 7.4 | 66.5 ± 7.6 | 64 ± 7 | 64 ± 6 |
| AUA-SI | 17.1 ± 6.1 | 17.0 ± 6.0 | 15 ± 6* | 15 ± 6* |
| Qmax (mL/sec) | 10.4 ± 3.6 | 10.1 ± 3.5 | 11 ± 4 | 11 ± 4 |
| PSA (ng/mL) | 4.0 ± 2.1 | 4.0 ± 2.1 | 2.8 ± 2.1 | 2.8 ± 2.1 |
| Prostate volume (cc) | 54.0 ± 21.9 | 54.9 ± 23.9 | 55 ± 26 | 54 ± 25 |
| Transition zone (cc) | 26.8 ± 17.4 | 26.8 ± 17.1 | N/A | N/A |
Pivotal — ARIA 3001 (USA), ARIA 3002 (USA), ARIA 3003 (19 countries); PLESS (USA).
*
PLESS used a quasi-AUA symptom score, adapted from the AUA-SI and described in the trial’s method section.
PLESS, Proscar Long-Term Efficacy and Safety Study; AUA-SI, American Urological Association-Symptom Index; Qmax, maximum flow rate; PSA, prostate-specific antigen; N/A, not available.