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Title: Tolterodine ER Decreases Patients' Most Bothersome Overactive Bladder Symptoms: Presented at EAU
URL: http://www.pslgroup.com/dg/259986.htm
Doctor's Guide
April 6, 2006


By Jill Stein

PARIS, FRANCE -- April 6, 2006 -- The extended-release (ER) formulation of tolterodine (Detrol LAŽ/Detrusitol SRŽ) provides symptom-specific efficacy in primary care patients with overactive bladder (OAB), investigators reported here on April 6th at the 21st Congress of the European Association of Urology (EAU).

The findings, from the IMprovement in Patients: Assessing symptomatic Control with Tolterodine ER (IMPACT) trial, also showed that patients treated with tolterodine ER had a decrease in symptom bother score of 63% and a 52% increase in health-related quality of life score.

"Symptoms of OAB may be bothersome, and the level of bother associated with individual symptoms may vary," said co-investigator Victor Elinoff, MD, research director, Regional Clinical Research, Inc., Endwell, New York, United States. "Furthermore, OAB patients may not experience all symptoms, with some describing only a single symptom and others reporting multiple symptoms. Outcomes related to specific OAB symptoms are thus extremely important."

The 12-week single-arm open label trial is the first to evaluate OAB treatment outcomes in patients in primary care practices.

Dr. Elinoff and colleagues tested the efficacy of 12 weeks' treatment with tolterodine ER, 4 mg/day for treating patients' most bothersome OAB symptom.

The 896 patients enrolled in the trial had OAB symptoms for at least 3 months and reported being at least "moderately bothered" by their most bothersome OAB symptom, as indicated on the patient-completed OAB Bother Rating Scale.

At baseline and after 4 and 12 weeks of treatment participants completed a 3-day bladder diary, the Patient Perception of Bladder Condition Questionnaire (PPBC), the OAB questionnaire (OAB-q).

Results showed that tolterodine ER significantly reduced patients' most bothersome OAB symptom, Dr. Elinoff said. Urgency urinary incontinence episodes were decreased by 80%, urgency by 78%, daytime frequency by 30%, and nocturnal frequency by 40%.

At the 12th week, some improvement in overall bladder condition as measured by the PPBC was experienced by 86% of the urgency group, 79% of patients most bothered by nocturnal frequency, 78% of patients most bothered by daytime frequency, and 75% of patients most bothered by urgency urinary incontinence.

In addition, changes from baseline in OAB symptoms at week 12 significantly correlated with changes in PPBC (r= 0.26 to 0.36, P <.001) and symptom bother and health-related quality of life (r=0.24 to 0.51, P <.001).

Tolterodine ER was associated with a low rate of adverse events. The most commonly reported treatment-emergent adverse events were dry mouth in 10% of patients, constipation in 4%, and headache in 3%.

"Our results reflect what primary care patients might achieve when using tolterodine ER to treat patients with bothersome OAB symptoms," Dr. Elinoff said.

Elsewhere at the meeting, researchers announced the launch of a study that is evaluating the efficacy and safety of tolterodine ER versus placebo as add-on therapy in men with persistent OAB symptoms of urgency and frequency, with or without urgency incontinence, while on treatment with alpha blockers.

Although OAB affects about 20% of adults in the US and Europe, it remains underdiagnosed in primary in primary care practice.

The IMPACT study was sponsored by Pfizer Inc, in New York, New York.


[Presentation title: Symptom-Specific Efficacy of Tolterodine Extended Release in Primary Care Patients with Overactive Bladder: The IMPACT Trial. Abstract 376]

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