Duloxetine may alleviate stress incontinence: drug under FDA review.
This is the first study to evaluate duloxetine for severe urodynamic stress incontinence, defined as at least 14 episodes of incontinence per week, Dr. Linda Cardozo said at the annual meeting of the American Urogynecologic Society.
Duloxetine is currently under Food and Drug Administration review; approval is expected in late 2004 or early 2005, according to Eli LiLly & Co.
Investigators assessed 109 women from 14 centers in Australia, Canada, the Netherlands, and the United Kingdom--countries where women typically wait for surgery. Participants were randomly assigned to receive placebo (54) or duloxetine at 40 mg twice a day for 4 weeks, followed by 60 mg twice a day for another 4 weeks (55 women).
Outcome measures included changes in incontinence episode frequency, number of continence pads used, and patient assessments using the Incontinence Quality of Life (I-QOL) questionnaire, Patient Global Impression of Improvement (PGI-I) and Severity (PGI-S) ratings, and Willingness to Consider Surgery (WCS).
The subjects' mean age was 53 and their mean BMI was 28; 94% were white. The two groups were well matched demographically, reported Dr. Cardozo, who is professor of urogynecology at King's College Hospital, London, and a researcher, consultant, and speaker for Eli Lilly. The study was cosponsored by Eli Lilly and Boehringer Ingelheim.
The mean incontinence episode frequency at baseline was 23 for the duloxetine group and 22 for the placebo group. There was a 60% improvement in this measure with duloxetine, compared with a 27% improvement with placebo. There were also improvements in I-QOL with duloxetine, compared with placebo (11% vs. 2%), particularly in the domains of social embarrassment and psychosocial impact.
Women taking duloxetine used 35% fewer pads, compared with 5% fewer for women taking placebo. Onethird of the duloxetine group rated themselves as "much better" or "very much better" after 8 weeks, compared with 8% of the placebo group.
"Women may reconsider undergoing surgery after a trial with duloxetine," Dr. Cardozo said. All of the women in the placebo group wanted to proceed with surgery at the end of the study; 11 (20%) of the women in the duloxetine group were no longer interested in surgery.
Adverse events were more common in the duloxetine group and included nausea, headache, constipation, and dry mouth. There was no significant clinical improvement or increase in adverse events at the higher dosage of duloxetine.
The study is ongoing in an open-label format, Dr. Cardozo said. "We want to see how long they will take medication chronically for a benign condition."
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|Publication:||Internal Medicine News|
|Date:||Nov 1, 2003|
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