Table 1.
Baseline, 24- and 48-Month Parameters for the Open-Label ITT Population
| Baseline | 24 Months | 48 Months | ||||
|---|---|---|---|---|---|---|
| Parameter | P/D | D/D | P/D | D/D | P/D | D/D |
| Serum DHT (pcg/mL) | 407.0 ± 201.9 | 427.9 ± 232.1 | 424.9 ± 194.2 | 39.1 ± 75.7 | 29.7 ± 63.0 | 31.1 ± 60.7 |
| Serum testosterone (pcg/mL) | 3959 ± 1595 | 4042 ± 1707 | 3990 ± 1472 | 4797 ± 1792 | 4718 ± 1688 | 4904 ± 2186 |
| Total prostate volume (cc) | 53.9 ± 20.9 | 56.1 ± 24.2 | 54.4 ± 25.3 | 41.3 ± 20.2 | 42.2 ± 20.2 | 41.3 ± 23.1 |
| Transition zone volume (cc) | 26.9 ± 16.0 | 28.6 ± 18.0 | 28.6 ± 19.2 | 21.5 ± 14.2 | 22.8 ± 18.8 | 22.4 ± 16.0 |
| AUA-SI | 16.9 ± 5.9 | 16.6 ± 5.7 | 14.5 ± 7.2 | 12.3 ± 6.7 | 11.3 ± 6.4 | 10.2 ± 6.1 |
| Qmax (mL/sec) | 10.7 ± 3.7 | 10.2 ± 3.6 | 11.3 ± 4.6 | 12.5 ± 5.6 | 12.6 ± 5.1 | 12.8 ± 5.5 |
| Serum PSA (ng/mL) | 3.9 ± 2.1 | 4.1 ± 2.2 | 4.3 ± 2.8 | 1.9 ± 1.9 | 2.0 ± 1.8 | 1.7 ± 1.8 |
Data presented as means ± standard deviations. ITT, intention to treat; P/D, placebo/dutasteride-treated subjects; D/D, dutasteride/dutasteride-treated rate; subjects; DHT, dihydrotestosterone; AUA-SI, American Urological Association-Symptom Index; Qmax, maximal flow rate; PSA, prostate-specific antigen. Reprinted from Debruyne F et al20 with permission from European Association of Urology.