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Non-surgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness

Slide: 38 of 50

Adverse Effects of Pharmacological Interventions for Urgency UI: Placebo Comparisons (1 of 2)

Tolerability of pharmacological interventions is represented as the rate of discontinuation from treatment due to adverse effects when compared with placebo groups. The tolerability findings of the CER for each pharmacotherapy are described below. The strength of evidence for all of these findings is high.

For darifenacin, in 7 studies of 3,138 participants, no statistically significant difference between darifenacin and placebo was found for discontinuation due to adverse effects.

For fesoterodine, in 6 studies of 6,338 patients, the odds of discontinuation with fesoterodine were 2.1 times that of placebo, with a statistically valid range as determined by the 95 percent confidence interval of between 1.5 and 2.9 times the rate with placebo. The number of discontinuations due to adverse effects per 1,000 treated patients that are attributable to fesoterodine is 31, with a statistically valid range of 10 to 56 discontinuations per 1,000 treated patients.

For oxybutynin, in 6 studies of 1,662 patients, the odds of discontinuation were 1.7 times that of placebo, with a statistically valid range as determined by the 95 percent confidence interval of between 1.2 and 2.5 times the placebo rate. The number of discontinuations due to adverse effects per 1,000 treated patients that are attributable to oxybutynin is 63, with a statistically valid range of 12 to 127 discontinuations per 1,000 treated patients.

For solifenacin, in 8 studies of 9,819 patients, the odds of discontinuation were 1.4 times that of placebo, with a statistically valid range as determined by the 95 percent confidence interval of between 1.1 and 1.7 times the placebo rate. The number of discontinuations due to adverse effects per 1,000 treated patients that are attributable to solifenacin is 13, with a statistically valid range of 1 to 26 discontinuations per 1,000 treated patients.

For tolterodine, in 13 studies of 7,801 patients, no statistically difference between tolterodine and placebo was found in the odds of discontinuation due to adverse effects.

For trospium, in 6 studies of 3,936 patients, the odds of discontinuation were 1.5 times that of placebo, with a statistically valid range as determined by the 95 percent confidence interval of between 1.1 and 1.9 times the placebo rate. The number of discontinuations due to adverse effects per 1,000 treated patients that are attributable to solifenacin is 18, with a statistically valid range of 4 to 33 discontinuations per 1,000 treated patients.