Oral agents for OAB do not affect sleep, cognition, studies show

March 18, 2005

Trospium chloride (Sanctura) does not affect sleep patterns in patients aged 51 to 65 years, according to a study published in the British Journal of Urology (2005; 95:346-9).

Trospium chloride (Sanctura) does not affect sleep patterns in patients aged 51 to 65 years, according to a study published in the British Journal of Urology (2005; 95:346-9). Also, another anticholinergic agent, darifenacin (Enablex), does not impair cognition in elderly patients, according to a study in the Journal of Urology (2005; 173:493-8).

In the first study, a randomized, double-blind, placebo-controlled trial, researchers followed 12 men and 12 women with healthy sleeping habits. The patients (aged 51 to 65 years) underwent polysomnographic recordings and cognitive tests in the sleep laboratory. Oxybutynin, tolterodine, and trospium were given as a single dose containing the total recommended daily dose.

Rapid-eye movement duration and latency in patients taking trospium were the same as those taking placebo, reported the researchers, from the Institute for Clinical Pharmacology in Berlin. Patients taking oxybutynin and tolterodine had significant reduction in REM sleep of 15% and slightly greater REM latency than placebo.

New research also shows that darifenacin does not impair cognition in older patients, according to researchers from Albert Einstein College of Medicine in New York.

The double-blind, three-period crossover study randomized 129 volunteers (aged =65 years or older) with no or mild cognitive impairment to receive three of five treatments--darifenacin controlled release (3.75, 7.5 or 15 mg, once daily), darifenacin immediate release (5 mg, three times daily), or matching placebo for 14 days. Cognitive tests were done at baseline and at the end of treatment.

Investigators found darifenacin had no effect on the three primary cognitive endpoints (ie, memory scanning sensitivity, speed of choice reaction time, and word recognition sensitivity) at any dose. There were no statistically significant differences in secondary variables (ie, simple reaction time, digit vigilance speed or accuracy, or word recognition speed) compared with placebo. Memory scanning speed increased in all groups relative to baseline and was greater with placebo than with darifenacin, 3.75 mg.

In other news about OAB, Odyssey Pharmaceuticals said it will launch a phase IV study of the effectiveness and safety of trospium in patients with OAB symptoms. The company said SECURE (Sanctura Study to Evaluate Control of Urinary Symptoms Resulting From Overactive Bladder) trial will be the largest OAB study ever conducted, enrolling about 4,000 patients. It will be a multicenter, prospective study conducted in the United States.