PMID- 22816871
OWN - NLM
STAT- MEDLINE
DCOM- 20130920
LR  - 20240322
IS  - 1365-2125 (Electronic)
IS  - 0306-5251 (Print)
IS  - 0306-5251 (Linking)
VI  - 75
IP  - 4
DP  - 2013 Apr
TI  - Observational study on safety and tolerability of duloxetine in the treatment of 
      female stress urinary incontinence in German routine practice.
PG  - 1098-108
LID - 10.1111/j.1365-2125.2012.04389.x [doi]
AB  - AIMS: 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.
CI  - (c) 2012 The Authors. British Journal of Clinical Pharmacology (c) 2012 The British 
      Pharmacological Society.
FAU - Michel, Martin C
AU  - Michel MC
AD  - Department of Pharmacology, Johannes Gutenberg University, Mainz, Germany. 
      martin.michel@boehringer-ingelheim.com
FAU - Minarzyk, Anette
AU  - Minarzyk A
FAU - Schwerdtner, Inka
AU  - Schwerdtner I
FAU - Quail, Deborah
AU  - Quail D
FAU - Methfessel, Hans D
AU  - Methfessel HD
FAU - Weber, Hans-Joachim
AU  - Weber HJ
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Br J Clin Pharmacol
JT  - British journal of clinical pharmacology
JID - 7503323
RN  - 0 (Antidepressive Agents)
RN  - 0 (Thiophenes)
RN  - 9044SC542W (Duloxetine Hydrochloride)
SB  - IM
MH  - Antidepressive Agents/*adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Duloxetine Hydrochloride
MH  - Female
MH  - Germany/epidemiology
MH  - Humans
MH  - Incidence
MH  - Middle Aged
MH  - Private Practice
MH  - Risk Factors
MH  - Thiophenes/*adverse effects
MH  - Urinary Incontinence, Stress/*drug therapy
PMC - PMC3612728
EDAT- 2012/07/24 06:00
MHDA- 2013/09/21 06:00
PMCR- 2014/04/01
CRDT- 2012/07/24 06:00
PHST- 2012/02/09 00:00 [received]
PHST- 2012/07/17 00:00 [accepted]
PHST- 2012/07/24 06:00 [entrez]
PHST- 2012/07/24 06:00 [pubmed]
PHST- 2013/09/21 06:00 [medline]
PHST- 2014/04/01 00:00 [pmc-release]
AID - 10.1111/j.1365-2125.2012.04389.x [doi]
PST - ppublish
SO  - Br J Clin Pharmacol. 2013 Apr;75(4):1098-108. doi: 
      10.1111/j.1365-2125.2012.04389.x.