Tolterodine Extended-Release Does Not Impair Memory In Patients With Overactive Bladder

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Main Category: Urology / Nephrology
Also Included In: Clinical Trials / Drug Trials
Article Date: 01 Dec 2006 - 8:00 PDT

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CHRISTCHURCH, NEW ZEALAND - Tolterodine tartrate extended-release or ER (Detrol LAR), 4 mg per day, does not affect recent memory in healthy older patients with overactive bladder, according to data reported today at the 36th Annual Meeting of the International Continence Society (ICS).

The results also showed, however, that oxybutynin chloride ER (Ditropan-XL®), 20 mg per day, reduced memory to the same degree as might be expected with 20 years of aging.

"Our study is the first to demonstrate the cognitive safety of tolerodine ER," Gary Kay, PhD, associate professor of neurology at Georgetown University School of Medicine in Washington DC, said. "While earlier studies that examined the central nervous system (CNS) safety of tolterodine have found the drug to be comparable to placebo on measures of quantitative electroencephalography, self-reported sleepiness, and sleep architecture, none of these studies investigated memory changes."

Tolterodine ER and oxybutynin ER are muscarinic receptor antagonists that are approved for the treatment of overactive bladder in association with urinary incontinence, urgency, and frequency.

Because the chronic use of anti-cholinergic drugs by older adults can cause mild cognitive impairment, it's important to identify which medication has the least CNS side effects in this age group, Dr. Kay said.

Dr. Kay and colleagues randomized 22 patients to three weeks' double-blind treatment with tolterodine ER, 4 mg per day, which was sham-titrated after the first and second week AND three weeks' treatment with oxybutynin ER titrated at weekly intervals from 10 mg to 15 mg to 20 mg.

Following each treatment period (four to seven days of dosing), subjects were administered computerized cognitive function tests.

At the end of the first three-week treatment period, patients underwent a seven-day minimum washout before starting the second three-week treatment period.

Trial participants were highly educated, healthy adults with a mean age of 63.4 years.

Results in 17evaluable patients showed that tolterodine ER (4 mg) had no effect on the primary outcome measure of delayed recall on the Name-Face Association Test or on other measures in the cognitive function test battery at any time point. In fact, there was no decline from baseline in cognitive test performance when subjects were being treated with tolterodine ER.

Oxybutynin ER 20 mg was associated with a significant decrease in delayed recall on the Name-Face Association Test. Participants were able to recall correctly 7.9 names at baseline versus 4.8 names at week three.

There were no significant differences between tolterodine ER and oxybutynin ER on cognitive functioning after their first and second weeks (i.e., oxybutynin ER at doses of 10 mg and 15 mg).

On a self-rating memory questionnaire, subjects reported no awareness of changes in their memory functioning at any time point.

"Our findings thus indicate that at baseline prior to treatment with oxybutynin ER 20 mg, patients were functioning at a 50 to 59 year age level according to published norms," Dr. Kay commented. "In contrast, they were functioning at the level of 70-year old individuals after one week of oxybutynin ER 20 mg."

He also noted that the subjects' lack of awareness of changes in their memory, even when their performance decline was comparable to 20 years of additional aging, may explain the lack of complaints by patients regarding changes in their memory when being treated with this medication.

Jill Stein is a Paris-based freelance medical writer.
Jillstein03 at cs.com


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