New Treatment for Overactive Bladder
Overactive bladder, or OAB, is an embarrassing, disruptive,
chronic medical condition that affects more than 17 million people in the
U.S., including nearly one of every
five adults over the age of 45. OAB is caused by untimely irregular
contractions of the bladder muscle and its symptoms generally include urinary
frequency or urinating more than eight times in a 24-hour period, including
two or more times a night. Other symptoms include urinary urgency (a
strong and sudden need to urinate) and urge incontinence (the accidental loss
of urine caused by a sudden and unstoppable urge to urinate). Many people
with overactive bladder mistakenly believe that the condition is an unavoidable
part of aging that they must learn to live with. As a result, many patients
suffer in silence without seeking help. The good news is that there
are several treatment options available.
Until recently, the two prescription drug treatment
choices were Ditropan XL®
and Detrol LA®. Just last month (12/04), the U.S. Food and Drug Administration (FDA) approved Enablex® (darifenacin) extended-release tablets (7.5mg and 15mg)
to treat overactive bladder (OAB). Enablex, a once-daily medication, is a unique product which works by blocking the
M3 receptor which is primarily responsible for bladder contractions. It is
expected to be available to consumers in the U.S.
in early 2005.
Enablex treats OAB in several ways. It is a potent
muscarinic receptor antagonist that helps reduce incontinence episodes, increases
the amount of urine the bladder can hold, reduces the frequency of urination
episodes, and decreases the pressure or urgency associated with the urge to
FDA approval of Enablex was based on efficacy data from four pivotal studies
and safety data from studies in which more than 7,000 patients with a mean
age of 58 years were treated with varying doses of Enablex. In these
studies, patients taking Enablex
experienced decreased frequency of incontinence and
urination episodes, increased bladder capacity, and decreased feelings of
urgency. Enablex was shown to reduce weekly incontinence episodes by
up to 83 percent and results were seen within two weeks of beginning treatment.
Efficacy was sustained throughout the 12-week treatment period, and long-term
safety was studied for up to one year.
In total, Enablex has been studied in 98 clinical trials
involving more than 10,000 people. In clinical trials, the most frequently
reported adverse events associated with Enablex were dry mouth and constipation,
however patient discontinuation rates due to these events were low.
The majority of adverse events in Enablex treated subjects were mild or moderate
and mostly occurred during the first two weeks of treatment. As with
other OAB medications, Enablex is contraindicated in patients with urinary
retention, gastric retention or uncontrolled narrow-angle glaucoma and in
patients who are at risk for these conditions. Enablex is also contraindicated
in patients with known hypersensitivity to the drug or its ingredients.
If you have urinary incontinence, it is important
to know that there are new treatment options available, even if previous treatment
was unsuccessful. Discuss this with your doctor.
Created: 1/31/2005  - Donnica Moore, M.D.