Observational study on safety and tolerability of duloxetine in the treatment of female stress urinary incontinence in German routine practice

Objective

To evaluate the safety and tolerability of duloxetine during routine clinical care in women with stress urinary incontinence (SUI) in Germany, and in particular, to identify previously unrecognized safety issues as uncommon adverse reactions, and the influence of confounding factors present in clinical practice on the safety profile of duloxetine.

Office‐based urologists, gynecologists and primary care physicians.

Women newly started on treatment for moderate to severe symptoms of SUI; 6,854 patients from urologist/gynecologist practices and 5879 primary care patients.

Two‐armed, observational study with parallel 12‐week (urologists and gynecologists) or 24‐week (primary care physicians) design, during which patients were treated with duloxetine or other conservative treatment.

Occurrence of adverse events (AEs)

Baseline characteristics differed slightly between patient groups and studies. Duloxetine doses in most patients were lower than recommended. Overall, AE‐frequency with duloxetine was lower than in controlled studies (15.9% (95% CI 14.9‐16.9%) and 9.1% (CI 8.2‐10.0%) in the 12‐ and 24‐week treatment groups, respectively), but exhibited a similar qualitative spectrum. In the logistic regression models, the following factors were associated with greater AE‐risk: investigator specialization (gynecologist vs. urologist and primary care physician), initial duloxetine dose (80 vs. 20 mg/d) and use of any concomitant medication. Within the 24 week study, a positive screen for depressive disorder was surprisingly common, but no case of suicide attempt was reported in either study.

Our results from German clinical practice show that women with SUI were often treated with duloxetine doses lower than recommended. This was associated with a low incidence of AEs. Suicide attempts were not reported.