Table 1.
Month 24 Data and Change from Baseline at Month 24 Data for Primary and Secondary Endpoints in the Placebo-Controlled Trials and Values at Month 48 for the Open-Label Extension
| Open-Label Extension Month 48 | ||||||
| Parameter | Time | Placebo (n = 2158) | Dutasteride (n = 2167) | Between-Group Comparison | P/D (n = 1152) | D/D (n = 1188) |
| Serum | Month 24 | 4002 ± 1481 | 4817 ± 1780 | <.001 | 4718 ± 1688 | 4904 ± 2186 |
| testosterone | Change | 36 ± 1226 | 749 ± 1475 | |||
| (pg/mL) | P | NS | <.001 | |||
| Serum DHT | Month 24 | 426 ± 197 | 40 ± 77 | <.001 | 29.7 ± 63.0 | 31.1 ± 60.7 |
| (pg/mL) | Change | 16 ± 150 | −389 ± 228 | |||
| P | <.001 | <.001 | ||||
| Serum PSA | Month 24 | 4.3 ± 2.8 | 1.8 ± 1.8 | <.001 | 2.0 ± 1.8 | 1.7 ± 1.8 |
| (ng/mL) | Change | 0.5 ± 2.1 | −2.2 ± 2.0 | |||
| P | <.001 | <.001 | ||||
| Total prostate | Month 24 | 54.1 ± 25.2 | 41.2 ± 20.6 | <.001 | 42.2 ± 20.2 | 41.3 ± 23.1 |
| volume (cm3) | Change | 0.8 ± 14.3 | −14.6 ± 13.5 | |||
| P | .040 | .04 | ||||
| Transition zone | Month 24 | 28.4 ± 19.1 | 21.1 ± 13.9 | <.001 | 22.8 ± 18.8 | 22.4 ± 16.0 |
| volume (cm3) | Change | 1.9 ± 11.2 | −7.1 ± 9.7 | |||
| P | <.001 | <.001 | ||||
| AUA-SI Score | Month 24 | 14.7 ± 7.2 | 12.2 ± 6.6 | <.001 | 11.3 ± 6.4 | 10.2 ± 6.1 |
| Change | −2.3 ± 6.8 | −4.5 ± 6.6 | ||||
| P | <.001 | <.001 | ||||
| Qmax (mL/s) | Month 24 | 11.2 ± 4.8 | 12.5 ± 5.6 | <.001 | 12.6 ± 5.1 | 12.8 ± 5.5 |
| Change | 0.6 ± 4.7 | 2.2 ± 5.2 | ||||
| P | <.001 | <.001 | ||||
Data presented as mean ± standard deviation. D/D, subjects initially treated with dutasteride continuing with dutasteride; P/D, subjects initially given placebo then switched to dutasteride; NS, not significant; DHT, dihydrotestosterone; PSA, prostate-specific antigen; AUA-SI, American Urological Association Symptom Index; Qmax, peak urinary flow.