Sibutramine
FDA Approves Sibutramine to Treat Obesity
FDA has approved sibutramine (Meridia)
for the management of obesity, a widespread, chronic disease that,
combined with other risk factors contributes to the deaths of an
estimated 300,000 Americans each year. Marketing is pending scheduling
by the U.S.
Drug Enforcement Administration. The following can be used to
answer questions:
- Sibutramine helps reduce food intake and is indicated for weight
loss and maintenance of weight loss when used in conjunction with
a reduced calorie diet. It is indicated for people whose initial
body mass index (BMI) is at least 30 – that is, someone who
is 5'6" and weighs 185 lbs. or more. Patients with other
risk factors, such as hypertension or diabetes, can be treated
with the drug if their BMI is 27 or higher, for example someone
who is 5'6" and weighs 167 lbs. or more.
- Sibutramine works to suppress the appetite primarily by inhibiting
the reuptake of the neurotransmitters norepinephrine and serotonin.
The anti-obesity drug dexfenfluramine also inhibits the reuptake
of serotonin. However, dexfenfluramine, unlike sibutramine, also
causes an increase in release of serotonin from the nerve cell.
In clinical trials, patients treated with sibutramine while on
a reduced-calorie diet, showed a significant weight loss during
the first six months of treatment, and significant weight loss was
maintained for one year. In one 12-month study, the average weight
loss in patients taking sibutramine, 10 mg daily, was about 10 lbs.,
and in those taking 15 mg daily was about 14 lbs. The average weight
loss in persons on only a reduced calorie diet was 3.5 lbs.
The most common
side effects associated with sibutramine include:
- dry mouth
- headache
- constipation
- insomnia.
Sibutramine causes a small increase in average blood pressure, and
causes a higher increase in some patients. FDA recommends patients
taking sibutramine have regular blood pressure evaluations. People
with uncontrolled high blood pressure should not take sibutramine.
No cases of primary pulmonary hypertension, a rare but serious side
effect associated with the anti-obesity drugs fenfluramine and dexfenfluramine,
have been reported in clinical trials of sibutramine. Echocardiograms
on patients taking sibutramine did not show more valvular disease
than those on placebo.
Sibutramine is manufactured and distributed by Knoll Pharmaceutical
Company, Mount Olive, NJ, under the brand name Meridia.
-From the FDA Talk Paper, Nov. 24, 1997
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