How are women with SUI-symptoms treated with duloxetine in real life practice? - Preliminary results from a large observational study in Germany

Martina Manning (1) , Ursula Gotsch (1) , Anette Minarzyk (2) , Deborah Quail (3) , Gross Andreas (4) , Ines Pages (5) , Hans D Methfessel (6) , M C Michel (7)

1 Medical
2 Medical
3 Medical Information Sciences
4 AK Barmbek
5 Klinikum Ludwigshafen
6 Universitätsklinikum Halle
7 Dept. Pharmacology & Pharmacotherapy

Background: Duloxetine was found safe and effective in the treatment of moderate to severe female stress urinary incontinence (SUI) in controlled clinical trials; complementary data from routine clinical practice are still wanted. Objectives: To explore use of various initial duloxetine doses by physicians in the treatment of female SUI in routine clinical practice and its implications on drug safety and patients' subjective impression of effectiveness. Methods: Adult women treated with duloxetine for SUI symptoms were documented as part of an ongoing large-scale observational study in Germany. Data collected at baseline, after 4 and after 12 weeks were evaluated by initial doses. Statistics were descriptive, 95% confidence intervals were calculated for adverse event (AE) rates. Results: 7,888 adult women were treated with duloxetine; their mean age was 61.4 years, BMI 27 kg/m2, incontinence episode frequency (IEF) 14.0/week. Previous SUI treatments were observed in 52.2%, comorbidities in 60.4% of the patients. 90.7% reported reduced frequency of SUI-episodes, 12.1 % any AE; nausea (5.7%) and vertigo (1.6%) were reported most frequently. 52.2% of patients were initiated on a duloxetine dose of 40 mg /day. Only minor differences in patient characteristics, effectiveness and tolerability were associated with varying initial duloxetine doses. Conclusions: Many women received lower duloxetine doses than expected based on evidence-based dosing recommendations. Though SUI patients in this study had a higher health risk because of old age and multiple comorbidities than in previous controlled clinical trials, AE rates were lower, possibly due to the observational character of the study and/or the use of rather low doses. Similar AE rates for varying initial doses possibly reflect sensible dose-adjustment to individual needs.

Mots clés: Medicine

Martina Manning, Ursula Gotsch, Anette Minarzyk, Deborah Quail, Gross Andreas, et al.. How are women with SUI-symptoms treated with duloxetine in real life practice? - Preliminary results from a large observational study in Germany. International Journal of Clinical Practice, 2009, 63 (12), pp.1724. ⟨10.1111/j.1742-1241.2009.02186.x⟩. ⟨hal-00532545⟩