Research Article

Vibegron for the Treatment of Patients with Dry and Wet Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial

Table 1

Demographics and baseline clinical characteristics of patients with OAB dry and wet from the EMPOWUR trial.

CharacteristicDry populationWet populationOverall population (FAS§)
Placebo (N = 115)Vibegron (N = 123)Tolterodine (N = 98)Placebo (N = 405)Vibegron (N = 403)Tolterodine (N = 319)Placebo (N = 520)Vibegron (N = 526)Tolterodine (N = 417)

Mean (SD) age, y59.5 (14.6)59.4 (14.0)60.7 (12.4)60.0 (13.0)61.2 (13.1)59.5 (13.4)59.9 (13.3)60.8 (13.3)59.8 (13.2)
 ≥65, n (%)52 (45.2)50 (40.7)38 (38.8)168 (41.5)192 (47.6)128 (40.1)220 (42.3)242 (46.0)166 (39.8)
 ≥75, n (%)13 (11.3)16 (13.0)11 (11.2)44 (10.9)59 (14.6)36 (11.3)57 (11.0)75 (14.3)47 (11.3)
Gender, n (%)
 Women81 (70.4)88 (71.5)68 (69.4)364 (89.9)361 (89.6)284 (89.0)445 (85.6)449 (85.4)352 (84.4)
 Men34 (29.6)35 (28.5)30 (30.6)41 (10.1)42 (10.4)35 (11.0)75 (14.4)77 (14.6)65 (15.6)
Race, n (%)
 White81 (70.4)100 (81.3)63 (64.3)325 (80.2)322 (79.9)254 (79.6)406 (78.1)422 (80.2)317 (76.0)
 Black or African  American20 (17.4)18 (14.6)21 (21.4)59 (14.6)56 (13.9)48 (15.0)79 (15.2)74 (14.1)69 (16.5)
 Asian12 (10.4)3 (2.4)12 (12.2)17 (4.2)24 (6.0)14 (4.4)29 (5.6)27 (5.1)26 (6.2)
 Others2 (1.7)2 (1.6)2 (2.0)4 (1.0)1 (0.2)3 (0.9)6 (1.2)3 (0.6)5 (1.2)
Region, n (%)
 US114 (99.1)123 (100.0)96 (98.0)349 (86.2)349 (86.6)280 (87.8)463 (89.0)472 (89.7)376 (90.2)
 Non-US1 (0.9)02 (2.0)56 (13.8)54 (13.4)39 (12.2)57 (11.0)54 (10.3)41 (9.8)
Mean (SD) urgency episodes per day8.6 (5.0)8.6 (4.4)8.4 (3.9)8.0 (4.6)8.0 (4.4)7.8 (3.9)8.1 (4.7)8.1 (4.4)7.9 (3.9)
Mean (SD) micturitions per day11.9 (3.8)11.3 (3.5)11.6 (3.0)11.7 (4.1)11.3 (3.4)11.5 (3.2)11.8 (4.0)11.3 (3.4)11.5 (3.2)

FAS, full analysis set; OAB, overactive bladder. All randomized patients with OAB dry at study entry who took ≥1 dose of double-blind study treatment and had ≥1 evaluable change from baseline micturition measurement. All randomized patients with OAB wet at study entry who took ≥1 dose of double-blind study treatment and had ≥1 evaluable change from baseline micturition measurement. §All randomized patients who took ≥1 dose of double-blind study treatment and had ≥1 evaluable change from baseline micturition measurement.