Table 1.
Patient characteristics at baseline; overall sample and by treatment regimen (ITT analysis)
| Variable | Overall sample (n = 1713) | Watchful waiting (n = 153) | Monotherapy | Combination therapy | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| AB (n = 398) | 5ARI (n = 94) | HESr (n = 678) | P. africanum (n = 34) | AB + 5ARI (n = 93) | AB + HESr (n = 219) | 5ARI + HESr (n = 28) | Other (n = 16) | |||
| Age, mean (SD) years | 64.0 (9.1) | 63.1 (9.6) | 64.7 (8.3) | 69.3 (8.8) | 61.7 (9.1) | 63.7 (7.7) | 69.4 (7.3) | 64.6 (8.2) | 71.0 (8.4) | 67.5 (6.0) |
| BMI (kg/m2), mean (SD) | 26.7 (2.9) | 26.4 (2.4) | 26.8 (2.8) | 27.0 (2.6) | 26.5 (2.9) | 27.2 (2.7) | 26.7 (2.8) | 26.8 (3.0) | 26.7 (2.3) | 28.6 (3.1) |
| IPSS, mean (SD) | 16.8 (5.4) | 14.9 (5.2) | 17.4 (4.8) | 19.7 (5.6) | 15.1 (4.9) | 16.3 (5.6) | 21.4 (5.8) | 18.7 (5.4) | 18.3 (5.9) | |
| BII, mean (SD) | 6.8 (2.6) | 5.9 (3.1) | 7.3 (2.2) | 7.8 (2.5) | 6.0 (2.6) | 6.3 (1.5) | 8.3 (2.6) | 7.9 (2.3) | 7.2 (2.5) | |
| Qmax (mL/s), mean (SD) | 12.9 (3.8) | 13.5 (3.5) | 11.7 (3.5) | 12.6 (3.9) | 14.0 (3.9) | 12.5 (2.0) | 10.8 (4.7) | 12.8 (3.3) | 11.1 (2.5) | 13.7 (3.4) |
| Prostate volume (cm3), mean (SD) | 51.1 (20.1) | 46.7 (17.5) | 52.2 (19.8) | 68.9 (21.8) | 43.3 (15.9) | 55.5 (12.5) | 72.7 (22.6) | 53.2 (17.2) | 69.9 (21.5) | 59.9 (21.9) |
| Total PSA (ng/mL), mean (SD) | 2.4 (1.3) | 2.1 (1.2) | 2.5 (1.3) | 3.1 (1.5) | 2.2 (1.3) | 2.2 (1.0) | 3.2 (1.3) | 2.4 (1.4) | 3.3 (1.5) | 2.4 (1.1) |
AB α- blockers, 5ARI 5α-reductase inhibitors, P. africanum Pygeum africanum, HESr hexanic extract of Serenoa repens, BMI body mass index, IPSS International Prostate Symptom Score, BII Benign Prostatic Hyperplasia Impact Index, PSA prostate-specific antigen, ITT Intention to treat