Long-term data show benefit of DETROL LA as first-line therapy for overactive bladder

12/13/04

New York, December 13, 2004 – Pfizer Inc today announced results of a comprehensive six-year review of efficacy and safety data for DETROL® LA (tolterodine tartrate extended release capsules) indicating that DETROL LA significantly reduces symptoms of overactive bladder (OAB) with a low occurrence of side effects, and should be considered first-line therapy. The results were recently published in the journal Drug Safety.

An estimated 33 million Americans over the age of 18 suffer from OAB, a medical condition which studies have found disrupts daily activities and sleep, and can negatively impact patients' mental health.

"We know that OAB is an important medical condition that can dramatically impact quality of life for some sufferers. Yet many are resigned to coping with their symptoms or concerned about bothersome treatment side effects," said lead study author Dr. Alan D. Garely, Winthrop University Hospital, Mineola, New York. "This six year review is good news for people with OAB because it shows that DETROL LA can significantly reduce symptoms with a low frequency of side effects. This may contribute to greater patient satisfaction with treatment, resulting in patients staying on treatment longer."

The meta-analysis summarized worldwide clinical trial and postmarketing surveillance data collected during a six-year period, from January 1,1997 to March 2003, in the 100 countries where DETROL LA is approved for use. In 26 clinical studies, DETROL LA was found to significantly reduce OAB symptoms, including frequency, urgency and number of episodes of urge incontinence. In the two largest trials, the number of incontinence episodes was approximately halved and incontinence pad usage was decreased by more than a third. Disruption of daily activities was also shown to improve with DETROL LA across several health-related quality of life measures, including physical limitations, sleep and energy. Dry mouth was the most commonly reported adverse event associated with DETROL LA, and most cases were mild to moderate.

The safety profile of DETROL LA in adults aged 65 and older is similar to that in younger adults. Unlike other OAB medications, DETROL LA is not associated with a high incidence of constipation, which can significantly impact patients' quality of life and develop into more serious bowel conditions. The incidence of constipation with DETROL LA was reported by 2 percent to 7 percent of patients versus 4 percent reported by those receiving placebo. Serious adverse events (affecting the gastrointestinal tract, nervous system and cardiovascular system) are reported infrequently in patients treated with DETROL LA.

About OAB OAB a medical condition associated with involuntary contractions of the bladder muscle. A person with OAB 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 OAB is diagnosed, muscarinic receptor antagonists, the mainstay of medical treatment for OAB, 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 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 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).

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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