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No New Adverse Events Observed With Use of Duloxetine for Urinary Incontinence in Real World Setting: Presented at ICS

By Sandra Ripley Distelhorst

SAN FRANCISCO -- October 3, 2009 -- A clinical practice study in Germany found no previously unknown or uncommon adverse event (AE) with the use of duloxetine in a subset of patients with stress urinary incontinence (SUI), researchers reported here October 2 at the 39th Annual Meeting of the International Continence Society (ICS).

This study population represents a higher mean age and higher prevalence for cardiovascular risks than published clinical trials.

The Duloxetine Routine Safety (DUROSA) study evaluated the safety and tolerability of duloxetine for SUI in a large sample of women treated in routine clinical practice, according to Andreas Gross, Asklepios Klinik Barmbek, Hamburg, Germany.

Women aged 18 years or older with symptoms of SUI were initiated to conservative treatment either with duloxetine or any other conservative SUI therapy when seen in primary healthcare practices. In all, 5,879 patients were included (4,010 in the duloxetine group and 1,869 in the OTHER group). Baseline characteristics were similar between groups.

The primary care practice population, compared with previous clinical trials, was older (mean age, 63.1 years), and more than half of the study patients were overweight, and a substantial percentage had cardiovascular risk factors such as hypertension, lipid metabolism disorder, diabetes, and manifest heart disease.

Data on AEs and early discontinuation were collected at 4, 12, and 24 weeks of treatment. In addition, a short baseline screening for depressive core symptoms and suicidality was included.

Results from the screening for depression and suicidality indicated a potential underlying depressive disorder of 15.6% in the duloxetine group and 13.2% in the OTHER group; suicidal ideation in 9.8% and 8.5%, respectively; tendencies towards self harm in 4.4% and 5.0%, respectively; and a history of suicide attempts in 1.7% and 1.6%, respectively. In both groups about 11% received concomitant antidepressant medication, <0.3% had duloxetine as an antidepressant.

"Depression as an adverse event was rare," Dr. Gross reported. "And overall adverse events, 9% duloxetine and 5.7% for the OTHER group were lower than in seen in previous clinical trials."

AEs reported for the duloxetine group included nausea (2.2%), dry mouth (1.1%), dizziness (0.8%), fatigue (0.8%), sleep disorder (0.7%), and headache (0.5%). In the OTHER group, all AEs reported were less than 0.5%. Depression as an AE was reported in 0.1% for both groups.

Funding for this study was provided by Lilly Deutschland GmbH.

[Presentation title: Safety And Tolerability of Duloxetine in the Treatment of Female Stress Urinary Incontinence (SUI) in General Practice in Germany - Results From a Large Observational Study. Abstract 162]

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