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Detrol LA Significantly Reduced Daytime and Nighttime Urinary Frequency In Men Who Had Previously Tried Alpha Blocker Therapy

NEW YORK, NY -- November 28, 2005 -- Pfizer Inc's Detrol® LA (tolterodine tartrate extended release capsules) significantly improved lower urinary tract storage symptoms from baseline in men following unsuccessful treatment with alpha blocker therapy, according to a study published in the December issue of the Journal of Urology.

More than 17 million men over the age of 40 experience lower urinary tract symptoms.

Lower urinary tract symptoms (LUTS) include overactive bladder symptoms such as frequency, urgency and incontinence, and voiding symptoms such as dribbling, hesitancy, weak stream and incomplete emptying.

"Men with lower urinary tract symptoms are often diagnosed as having benign prostatic hyperplasia, or BPH, and are initially treated with alpha blockers," said study lead author Dr. Steven Kaplan, professor of urology at the Institute for Bladder and Prostate Health at Cornell University in New York. "However, many patients treated with alpha blockers report persistent frequency and urgency of urination. This study is the latest evidence to suggest that tolterodine may be a reasonable therapeutic option in these men with LUTS."

This open-label prospective study assessed the efficacy and safety of Detrol LA in men with lower urinary tract symptoms who discontinued alpha blocker therapy either due to lack of symptom relief or because of side effects. Researchers treated 43 men aged 50 or older with Detrol LA (4 mg) for 6 months. Patients reported their lower urinary tract symptoms including daytime and nighttime urination using a bladder diary and the American Urological Association symptom score questionnaire.

In the study, mean lower urinary tract symptoms measured by American Urological Association symptom score improved over 6 months with Detrol LA treatment. Furthermore, the mean daytime urination frequency decreased from 9.8 episodes to 6.3 episodes per day and the mean nighttime urination frequency decreased from 4.1 episodes to 2.9 episodes a night. There was no occurrence of urinary retention (inability to empty the bladder) in Detrol LA-treated men.

Detrol LA is a once-daily medication with proven efficacy for 24 hours to help control involuntary bladder contractions and reduce wetting accidents. By reducing the number and intensity of involuntary bladder muscle contractions, Detrol LA also reduces the strong sensation of urinary urgency and the number of voiding episodes associated with overactive bladder.

Since its introduction in January 2001, Detrol LA has become the number one prescribed treatment for overactive bladder in the United States and has been prescribed for more than 10 million patients worldwide.

Detrol LA is indicated for the treatment of overactive bladder with symptoms of urge incontinence, urgency and frequency.

Detrol LA is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who have demonstrated hypersensitivity to the drug or its ingredients.

Patients with the following conditions should be treated with caution: renal impairment, bladder outflow obstruction, gastrointestinal obstructive disorders, controlled narrow-angle glaucoma, and significantly reduced hepatic function. Dry mouth was the most frequently reported adverse event (Detrol LA 23% versus placebo 8%); others (greater than or equal to 4%) included headache (Detrol LA 6% versus placebo 4%), constipation (Detrol LA 6% versus placebo 4%), and abdominal pain (Detrol LA 4% versus placebo 2%).


SOURCE: Pfizer Inc.

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