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).
Please see www.detrolLA for full Prescribing Information.
Contact: Rebecca Hamm
rebecca.hammpfizer
212-733-8811
Pfizer Inc
View drug information on Detrol LA.