A study presented by Eli Lilly shows that women who transitioned from placebo to duloxetine in an open-label study reported similar improvement to that of women who took duloxetine during the preceding 12 weeks in a double-blind study. Duloxetine hydrochloride is an investigational agent being developed under the trade name Yentreve for the treatment of stress urinary incontinence (SUI), the accidental urine leakage during physical activities such as sneezing, coughing, laughing, lifting or exercising.
The post-hoc analysis evaluated whether women in a randomized, double- blind study who transitioned from a placebo to duloxetine therapy in the open- label extension would perceive similar improvement when compared to women who took duloxetine throughout both periods. An open-label extension is not a controlled study, and patients knew they were taking duloxetine, the release said.
"The study results show that duloxetine can significantly improve SUI
symptoms in women," said David Muram, medical advisor for Eli Lilly and Company, discussing the poster presentation of the data at the AUGS/SGS meeting. He added, "What was most exciting about this study is that women who took placebo in the first phase of the study and then transitioned to duloxetine in the open-label phase perceived similar improvements in their condition to those who took duloxetine in both phases."
The post-hoc analysis of a phase III North American study evaluated the improvement in 493 women with SUI who continued to an open-label treatment with duloxetine. Following a two-week lead-in period with a single-blind placebo, the subjects were randomized to either 40 mg duloxetine twice a day or placebo. After 12 weeks of blinded therapy, women who were taking duloxetine or placebo had the option of entering an open-label extension phase in which all subjects received 40 mg duloxetine twice a day.
SUI is an embarrassing and bothersome medical condition that affects nearly 15 million adult women in the United States and can have a significant impact on quality of life. With nearly twice the prevalence of urge incontinence, SUI is the most common form of urinary incontinence among women.
Clinical studies of duloxetine for the treatment of SUI have shown the most commonly reported adverse events (incidence of >/= 5 percent and at least twice the placebo rate) reported by patients receiving duloxetine have been nausea, dry mouth, fatigue, insomnia, constipation, headache, dizziness, somnolence (drowsiness) and diarrhoea.
Study results were presented at a scientific meeting organized by the American Urogynecological Society (AUGS) and the Society of Gynecological Surgeons (SGS).