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New Study Suggests That Men Who Experienced Symptoms of Both Overactive Bladder and Prostate Enlargement Benefited From Combined Use of Tolterodine and Tamsulosin

First Large-Scale Placebo-Controlled Study of Men with Both Bladder and Prostate Symptoms Published in the Journal of the American Medical Association (JAMA)

NEW YORK, NY -- November 15, 2006 -- Men who experienced bothersome symptoms of both overactive bladder (OAB) and prostate enlargement benefited from concurrent treatment with Detrol® LA (tolterodine tartrate extended release capsules) and Flomax® (tamsulosin), according to a study published in the November 15th issue of the Journal of the American Medical Association (JAMA).

This is the first large-scale placebo-controlled study of men with both OAB and prostate symptoms. This study shows that treating these men for both conditions simultaneously, rather than treating one condition alone, resulted in better clinical outcomes.

This double-blind study found that a significantly greater percentage of patients treated with Detrol LA plus Flomax reported treatment benefit compared to placebo, Detrol LA alone or Flomax alone. Specifically, the study found that 80% of patients taking Detrol LA plus Flomax reported treatment benefit versus 62% in patients taking placebo. Patient perception of treatment benefit was assessed using a single-question self-reporting tool reflecting the patient's own assessment of his global response to treatment. Neither group treated with Detrol LA or Flomax alone showed significant differences versus placebo on this measure.

Additionally, patients who took Detrol LA plus Flomax showed improvement in OAB symptoms including frequency, urgency and urgency incontinence, as well as prostate symptoms as measured by International Prostate Symptom Score (IPSS).

Men with OAB and symptoms of prostate enlargement are part of a larger population of men with lower urinary tract symptoms (LUTS), a condition that is common in men as they age. LUTS includes OAB symptoms such as frequency, urgency and urgency incontinence as well as prostate symptoms such as dribbling, hesitancy, weak stream and incomplete emptying. It is often assumed that LUTS is due only to an enlarged prostate. Therefore, the current standard of care for male LUTS is an alpha blocker, such as Flomax, to relax the prostate and allow urine to flow more freely. However, recent literature suggests that men with LUTS may have a bladder condition and a prostate condition at the same time. Both conditions may cause bothersome LUTS symptoms in men.

"The large number of men bothered by LUTS including OAB can be challenging to treat because they have two conditions that contribute to their symptoms, those being an enlarged prostate and overactive bladder," said study lead investigator Dr. Steven Kaplan, Chief, Institute for Bladder and Prostate Health at Weill Cornell Medical College in New York. "This is the first study that does not assume that prostate enlargement is the sole cause of LUTS in men and evaluates the efficacy and safety of simultaneously using two medications to treat both conditions – an antimuscarinic and an alpha blocker. The data suggest that treatment with Detrol LA in addition to Flomax is effective and well tolerated in this patient population."

About the Study
This 12-week, randomized, double-blind, placebo-controlled study assessed the efficacy and safety of Detrol LA and/or Flomax in men bothered by OAB as well as symptoms of prostate enlargement. Researchers treated 851 men age 40 and older with once-daily Detrol LA (4 mg), Flomax (0.4 mg), Detrol LA plus Flomax or placebo. The primary efficacy measure was a patient perception of treatment benefit question: "Have you had any benefit from your treatment?" and if so, "Have you had little or much benefit?" Secondary efficacy measures included bladder diary variables, such as episodes of urination during the day and night, urgency and urgency incontinence, and IPSS (patients' assessment of urgency, straining, hesitancy, weak stream, dribbling, and daytime and nocturnal urinary frequency).

In the study, 80% of men treated with Detrol LA plus Flomax reported treatment benefit by week 12 versus placebo (62%; P <.0001), Flomax alone (71%; P <.05), or Detrol LA alone (65%; P <.01). The Detrol LA plus Flomax group demonstrated significant reductions in all bladder diary variables at week 12 versus placebo: urgency incontinence (-.88 vs. -.31), urgency without incontinence (-3.33 vs. -2.54), frequency (-2.54 vs. -1.41) and nocturnal frequency (-.59 vs. -.39) as well as total IPSS by 8.02 points versus placebo (6.19).

In the Detrol LA group, urgency incontinence episodes per 24 hours were significantly reduced compared to placebo at week 12 (-.83 vs. -.38). In the Flomax group, there were significant reductions in IPSS score compared to placebo (-7.89 points vs. -6.19) at week 12.

Detrol LA, administered with or without Flomax, was well tolerated, and reported urinary retention adverse events were similar to placebo. The most common side effects observed in patients taking Detrol LA plus Flomax were dry mouth (21%), headache (6%), nasal congestion (4%) and constipation (4%). The effect of treatment with Detrol LA on flow rate and postvoid residual was similar to placebo. Symptoms suggestive of urinary retention were reported by two men in the Detrol LA plus Flomax arm, three men in the Detrol LA alone arm, four men in the placebo arm and no one in the Flomax alone arm. Two men required catheterization: one in the Detrol LA plus Flomax arm and one in the Detrol LA alone arm.

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

Detrol LA should be used with caution in patients with clinically significant bladder outflow obstruction, gastrointestinal obstructive disorders, controlled narrow-angle glaucoma, and significantly reduced hepatic or renal function.

Flomax is indicated for the treatment of male urinary symptoms due to benign prostatic hyperplasia (BPH) – enlargement of the prostate. Please see www.4flomax.com for full Prescribing Information.

Detrol LA is a registered trademark of Pfizer Inc. Flomax is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc.


SOURCE: Pfizer

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