News Release

Overactive bladder episodes completely controlled in 40 percent of elderly patients treated with once-a-day Oxybutynin

Peer-Reviewed Publication

Porter Novelli

Elderly patients suffering from overactive bladder can significantly and safely reduce the symptoms of their condition by taking a once-a-day, extended-release formulation of oxybutynin chloride (Ditropan XL®), according to a study conducted by the Cleveland Clinic Foundation scheduled for presentation at the 2000 Annual Scientific Meeting of the American Geriatrics Society.

In the study, 40 percent of patients age 65 and older taking extended-release oxybutynin reported no incontinence episodes, while the average reduction in the weekly number of incontinence episodes for the elderly patients in the study was 82 percent.

"We found that elderly patients not only benefit by significantly reducing or eliminating their incontinence episodes when taking the extended-release formulation of oxybutynin, they also can do so safely and tolerate the drug very well. This is good news for this patient population, which frequently must deal with taking multiple medications and experiencing worrisome side effects," said Rodney Appell, M.D., study author and head, Section of Voiding Dysfunction and Female Urology at the Cleveland Clinic Urological Institute.

Overactive bladder is a common and chronic condition that affects an estimated 17 million Americans. The condition is characterized by urge urinary incontinence (sudden and involuntary loss of bladder control resulting in wetting accidents), urgency (the urgent need to empty the bladder) and frequency (frequent urination). Ditropan XL is the first and only once-a-day treatment for overactive bladder approved by the FDA and is marketed by ALZA Corporation and UCB Pharma.

For the study, investigators analyzed three clinical trials comparing different doses of extended-release and immediate-release oxybutynin in 159 patients older than 65 and in 261 patients age 18 to 65. All of the 420 patients suffered from overactive bladder.

During the clinical trials, researchers adjusted the patients' doses of extended-release oxybutynin within the range of 5 to 30 mg/day and immediate-release oxybutynin within the range of 5 to 20 mg/day for a balance of efficacy and tolerability. Most patients, regardless of age, received lower doses of 5 to 15 mg, rather than higher doses of 20 to 30 mg. Symptom improvement was measured using patient-completed voiding diaries.

In the analysis, the younger patients experienced an 84 percent reduction in the average number of incontinence episodes, and the older patients experienced a reduction of 82 percent while taking the extended-release formulation. The mean reduction in incontinence episodes for all patients, regardless of age, was 82.7 percent, from an average of 20.7 to 3.9 episodes per week. In addition, by the end of the study, 40.1 percent of the older patients and 44.6 percent of the younger patients taking extended-release oxybutynin reported no incontinence episodes.

The rates of adverse effects did not differ statistically in older and younger patients treated with the extended-release formulation. Patients on the extended-release formulation experienced significantly less dry mouth than patients on immediate-release oxybutynin. Overall, 3.8 percent of older patients and 1.9 percent of younger patients treated with extended-release oxybutynin experienced severe dry mouth.

"Based on our analysis, extended-release oxybutynin, which allows a steady concentration of the drug to be absorbed throughout the day, means that patients no longer need to suffer the side effects of the fluctuations in drug concentrations caused by having to take multiple doses of the immediate-release formulation during the day. Also, we have found that having to take only one pill a day greatly improves patients' compliance to therapy, which further improves their condition," says Appell.

Ditropan XL was introduced by ALZA in February 1999. The efficacy and safety of the product was demonstrated in 429 adult overactive bladder patients with incontinence episodes in three controlled studies and one open-label study.

In the placebo-controlled study, Ditropan XL demonstrated efficacy superior to placebo in the reduction of urge incontinence episodes. Patients treated with Ditropan XL experienced a decrease in incontinence episodes from 18.6 episodes per week to 1.5 episodes per week. Patients taking placebo went from 20.9 episodes per week to 10.3 incontinence episodes per week (p=0.004). In additional clinical trials, Ditropan XL generally was well tolerated by patients.

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The Cleveland Clinic has the largest full-time clinical and basic science urology staff in the United States. The Urological Institute houses 37 full-time clinicians and basic scientists. It is well-represented in all subspecialties of urology, including urologic oncology and transplantation, pediatric urology, urodynamics, renovascular surgery, laparoscopic surgery, prostate disease, adrenal surgery, male infertility, erectile dysfunction, prosthetic surgery, microsurgery, endourology, stone disease, genital reconstructive surgery, and corrective vaginal surgery for incontinence and pelvic prolapse.

The Cleveland Clinic Foundation, founded in 1921, integrates clinical and hospital care with research and education in a private, non-profit group practice. At the Cleveland Clinic in 1999, nearly 1,000 full-time salaried physicians representing more than 100 medical specialities and subspecialties provided more than 1.7 million outpatient visits and nearly 50,000 hospital admissions for patients from throughout the United States and more than 80 countries. The Cleveland Clinic Health System was formed in 1996. It now includes The Cleveland Clinic Foundation, Cleveland Clinic Florida (a multi-specialty group practice and hospital) and the Cleveland Children Children's Hospital for Rehabilitation, in addition to Euclid, Fairview, Hillcrest, Huron, Lakewood, Lutheran, Marymount and South Pointe hospitals. With more than 3,000 available beds, the Cleveland Clinic Health System provides broad geographic coverage, a full continuum of care, high quality and low-cost health care to the populations we serve.

This study was supported by a grant from ALZA Corporation.

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