Table 3.
Key Patient Baseline Demographics and Clinical Characteristics of Patients ≥65 Years Old (a Subpopulation Analysis from the EMPOWUR Trial)
| Characteristic | Placebo | Vibegron 75 mg | Tolterodine 4 mg ER | Overall |
|---|---|---|---|---|
| Full Analysis Set, N | 220 | 242 | 166 | 628 |
| Women, n (%) | 178 (80.9) | 204 (84.3) | 132 (79.5) | 514 (81.8) |
| Men, n (%) | 42 (19.1) | 38 (15.7) | 34 (20.5) | 114 (18.2) |
| Mean (SD) age, y | 71.8 (5.39) | 71.8 (5.59) | 72.0 (5.43) | 71.9 (5.47) |
| Age ≥75 y, n (%) | 57 (25.9) | 75 (31.0) | 47 (28.3) | 179 (28.5) |
| Race, n (%) | ||||
| White | 176 (80.0) | 197 (81.4) | 129 (77.7) | 502 (79.9) |
| Black or African American | 19 (8.6) | 26 (10.7) | 19 (11.4) | 64 (10.2) |
| Asian | 23 (10.5) | 19 (7.9) | 17 (10.2) | 59 (9.4) |
| Other | 2 (0.9) | 0 | 1 (0.6) | 3 (0.5) |
| Region, n (%) | ||||
| US | 190 (86.4) | 218 (90.1) | 150 (90.4) | 558 (88.9) |
| Non-US | 30 (13.6) | 24 (9.9) | 16 (9.6) | 70 (11.1) |
| Safety Set,* N | 228 | 246 | 171 | 645 |
| Medical history (conditions of interest), n (%) | ||||
| Hypertension† | 134 (58.8) | 155 (63.0) | 120 (70.2) | 409 (63.4) |
| Osteoarthritis | 64 (28.1) | 76 (30.9) | 59 (34.5) | 199 (30.9) |
| Gastroesophageal reflux | 59 (25.9) | 65 (26.4) | 48 (28.1) | 172 (26.7) |
| Diabetes mellitus | 12 (5.3) | 15 (6.1) | 10 (5.8) | 37 (5.7) |
| Concomitant non-OAB medications,‡ n (%) | ||||
| Agents acting on the renin-angiotensin system | 99 (43.4) | 112 (45.5) | 81 (47.4) | 292 (45.3) |
| Lipid-modifying agents | 96 (42.1) | 101 (41.1) | 80 (46.8) | 277 (42.9) |
| Vitamins | 87 (38.2) | 89 (36.2) | 59 (34.5) | 235 (36.4) |
Notes: *Patients in the safety set were excluded from the full analysis set for one or more reasons (ie, they did not have a baseline or ≥1 post-baseline micturition assessment or they did not receive double-blind study medication). †Pre-existing hypertension was based on baseline vitals and medical history. ‡Within the past 12 months.
Abbreviations: ER, extended release; OAB, overactive bladder.