title: Observational study on safety and tolerability of duloxetine in the treatment of female stress urinary incontinence in German routine practice.
abstract: 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.
  
  
  METHODS
  Office-based urologists, gynaecologists and primary care physicians were asked to document women newly started on treatment for moderate to severe symptoms of SUI. Six thousand eight hundred and fifty-four patients from urologist/gynaecologist practices and 5879 primary care patients were assessed. In a two-armed, observational study with parallel 12 week (urologists and gynaecologists) or 24 week (primary care physicians) design, patients were treated with duloxetine or other conservative treatment. The main outcome measure was the occurrence of adverse events (AEs).
  
  
  RESULTS
  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% (95% 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 (gynaecologist vs. urologist and primary care physician), initial duloxetine dose (80 vs. 20 mg day(-1) ) and use of any concomitant medication. Within the 24 week study, a positive screen for depressive disorder was surprisingly common, but no case of attempted suicide was reported in either study.
  
  
  CONCLUSIONS
  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.
authors: Department of Pharmacology, Johannes Gutenberg University, Mainz, Germany. martin.michel@boehringer-ingelheim.com
authors: Martin C
authors: MC
authors: Michel
authors: Anette
authors: A
authors: Minarzyk
authors: Inka
authors: I
authors: Schwerdtner
authors: Deborah
authors: D
authors: Quail
authors: Hans D
authors: HD
authors: Methfessel
authors: Hans-Joachim
authors: HJ
authors: Weber
mesh_terms: D000928:Antidepressive Agents / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D000068736:Duloxetine Hydrochloride; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D011331:Private Practice; D012307:Risk Factors; D013876:Thiophenes / Q000009:adverse effects*; D014550:Urinary Incontinence, Stress / Q000188:drug therapy*
chemical_list: D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride