Phase III Study Results For Transdermal Oxybutynin Patch Reported.(Brief Article)

2001 SEP 13 - (NewsRx.com & NewsRx.net) -- In a large-scale, randomized, placebo-controlled clinical trial, patients treated with transdermal oxybutynin achieved statistically significant reductions in symptoms of overactive bladder, and an incidence of anticholinergic side effects comparable to those observed in the placebo group.

The study, involving patients at 40 medical centers in the United States, was conducted by the Transdermal Oxybutynin Study Group, and is to be reported by G. Willy Davila, MD, at the 31st Annual Meeting of the International Continence Society to be held in Seoul, Korea, on September 19, 2001. Meeting abstracts are published in the September 2001 issue of Neurourology and Urodynamics.

In this study, 520 patients were randomized to receive a placebo patch or patches delivering either 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day of the active drug. The patches were applied twice weekly for 12 weeks, followed by a 12-week open-label, dose-titration phase. More than 90% of the patients were female and more than 90% were Caucasian; the average age was about 61 years.

The 3.9 mg/day transdermal oxybutynin group had significantly greater improvements compared with placebo (p

According to Davila, "The most notable outcome was the demonstration of comparable rates of anticholinergic side effects in the 3.9 mg/day transdermal oxybutynin group and the placebo group - since the severity of side effects is commonly the limiting factor in the ability of patients to tolerate the oral formulation of oxybutynin."

Dry mouth occurred in 9.6% of patients in the 3.9 mg/day transdermal oxybutynin group and in 8.3% of those receiving placebo. Pruritus at the patch site was the most common adverse ...