November 2004
Rebecca Hamm [email protected] 212-733-8811 Pfizer Inc.
Detrol LA combined with standard treatment for enlarged prostate is twice as effectiveIn relieving overactive bladder as standard treatment aloneNew York, November 4, 2004 � Combination therapy with Pfizer Inc's DETROL� LA (tolterodine tartrate extended release capsules) and an alpha blocker, a standard treatment for enlarged prostate, was twice as effective in relieving overactive bladder (OAB) symptoms as the alpha blocker alone in men with both bladder obstruction and OAB, according to a study published in the October issue of the British Journal of Urology. Six million American men suffer from a combination of a common complication of enlarged prostate called bladder outlet obstruction, which reduces or prevents urine flow, and OAB, a medical condition associated with involuntary contractions of the bladder muscle.
"There is overlap in the symptoms of bladder outlet obstruction and overactive bladder, so current clinical practice entails treating bladder obstruction first, and adding a therapy like DETROL LA only if the man continues to suffer for several months from urgency, frequency and excessive urination at night," said study author Dr. Michael Chancellor, professor of urology at the University of Pittsburgh. "These findings suggest that combination therapy is well tolerated and can be considered for men with or without bladder obstruction."
The prospective study divided 144 men into two groups, those with bladder obstruction only (n=76) and those with bladder obstruction plus OAB (n=68). All patients were treated with alpha blocker doxazosin for three months. In patients with no symptomatic improvement, DETROL LA was added for an additional three months. Seventy-three percent of men with bladder obstruction and OAB reported an improvement during the combination therapy phase of the study compared to 35 percent reporting improvement in the initial doxazosin alone phase.
The most common side effects of doxazosin were dizziness, postural hypotension and abnormal ejaculation. The most common side effect of DETROL LA was dry mouth. There was a low incidence (3.3 percent) of transient urinary retention in men who received combination therapy. The transient urinary retention was resolved within 24 hours after stopping treatment.
About Overactive Bladder
An estimated 33 million Americans over the age of 18 suffer from OAB. A person with overactive bladder will feel a sudden and sometimes overwhelming urge to urinate (urgency). This is because the bladder muscle squeezes or contracts at a small volume and without the normal warning signals that capacity is being reached. This usually results in more frequent urination (frequency), and sometimes, wetting accidents (urge incontinence).
Treatment
Once overactive bladder is diagnosed, muscarinic receptor antagonists, the mainstay of medical treatment for overactive bladder, may be prescribed. One such medication, DETROL LA works by helping to control involuntary contractions of the bladder muscle. Behavioral techniques such as pelvic floor muscle exercises, or bladder training may provide additional benefit to the medication by helping the patient reassert control over his or her bladder.
About DETROL LA
DETROL LA is a once-daily medication with proven efficacy for 24 hours to help control bladder contractions and reduce wetting accidents and voiding accidents. DETROL LA reduces the number and intensity of involuntary bladder muscle contractions, and also reduces the strong urinary urgency 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 seven 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 percent vs. placebo 8 percent); others (> 4 percent) included headache (DETROL LA 6 percent vs. placebo 4 percent), constipation (DETROL LA 6 percent vs. placebo 4 percent), and abdominal pain (DETROL LA 4 percent vs. placebo 2 percent).
*While bladder obstruction is a precaution to the use of DETROL LA, in this study all men received doxazosin for treatment of the obstruction prior to adding DETROL LA and only two men (3.3%) on combination therapy developed transient urinary retention, which resolved within 24 hours after stopping treatment.
Please see www.detrolLA.com for full Prescribing Information.
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