Clinical Study

Comparative Evaluation of the Safety and Efficacy of Long-Term Use of Imidafenacin and Solifenacin in Patients with Overactive Bladder: A Prospective, Open, Randomized, Parallel-Group Trial (the LIST Study)

Table 3

Distribution of major anticholinergic adverse events in each group over 52 weeks.

Variable, n (%)ImidafenacinSolifenacinP-value

N (safety population)2120
Dry mouth15 (71.4%)18 (90.0%) 0 . 2 3 7 9 b
 Mild8 (38.1%)4 (20.0%)
 Moderate7 (33.3%)10 (50.0%) 0 . 0 0 9 2 a
 Severe0 (0%)4 (20.0%)
Constipation3 (14.3%)13 (65.0%) 0 . 0 0 1 3 b
Blurred vision2 (9.5 %)7 (35.0%) 0 . 0 6 7 0 b

The severity of dry mouth was evaluated on a 3-point scale: mild, barely noticeable; moderate, tolerable after drinking water; severe, intolerable after drinking water, leading to discontinuation of the investigational drug;
a: Mann-Whitney U test, b: Fisher exact test, two-sided.