MONDAY, Oct. 15 (HealthDay News) -- A prescription medication
originally developed to treat epilepsy may help obese adults shed
weight when combined with routine nutritional counseling,
researchers say.
Patients who took 400 milligrams of the anti-seizure drug
zonisamide daily for a year lost nearly 7.5 pounds more on average
than those assigned to dietary and lifestyle changes alone, the new
study found. But they also suffered more side effects than patients
not taking the medication.
"The question was to see if more weight loss could be achieved if we provided decent quality lifestyle intervention, mostly dietary counseling, along with this medication," said study lead author Dr. Kishore Gadde, director of the Obesity Clinical Trials Program at Duke University Medical Center in Durham, N.C.
"And the answer was yes," Gadde said.
The research, funded by the U.S. National Institutes of Health,
appears online Oct. 15 in the journal
Archives of Internal Medicine.
For obese men and women who can't control their weight through
diet and lifestyle changes, nonsurgical options are limited, the
study authors noted. Just a few prescription medications are
approved in the United States for long-term treatment of obesity,
including orlistat (brand name Xenical) and lorcaserin
hydrochloride (Belviq).
Gadde and colleagues set out to follow up on a 16-week
investigation they conducted in 2003 that had indicated that
zonisamide (Zonegran) at a dosage of 400 milligrams a day might
offer an alternative.
Between 2006 and 2011 the study team randomly assigned more than
200 obese men and women to one of three groups. One group took 200
milligrams of zonisamide daily, another got 400 mg of zonisamide
daily and one received a dummy pill. The participants' average age
was 43, and their average body-mass index (BMI) was nearly 38. BMI
is a calculation of body fat based on height and weight, and a BMI
of more than 30 is considered obese. None had diabetes.
All study participants followed their treatment plan for one
year. During this time, they all also received monthly
individualized nutritional counseling, which Gadde described as
"not intensive," to help them reduce their overall caloric
intake.
Those on the higher-dose zonisamide protocol fared the best in
terms of overall weight loss, while the lower-dose regimen was not
much more effective than the placebo.
Although nearly 55 percent of those on the higher-dose
medication shed 5 percent or more of their pre-study weight, that
figure was 34 percent among the lower-dose group and 31 percent
among the non-medication participants.
But patients in both drug groups faced a higher risk for side
effects, including diarrhea, headache, fatigue, nausea/vomiting,
concentration and memory difficulties, anxiety, and
depression-related symptoms.
The authors said such side effects were typically "mild." They
concluded that the higher-dose zonisamide showed promise as a
weight-loss aid, but advised clinicians to carefully weigh the pros
and cons on a patient-by-patient basis.
"There's no medicine that is a panacea for obesity," cautioned Gadde. "The important thing to keep in mind is that although we diagnose obesity on the basis of a mathematical formula -- a BMI of 30 and up -- the basis for obesity may differ from one individual to another."
Psychological factors or lifestyle factors may play a role, he
said. "But for about a third [of patients], biological issues are
at play, such as not easily experiencing satiety signals from the
gut to the brain, which senses what your energy intake has been,"
he said. "And for those people, medication can help."
Lona Sandon, a registered dietitian and assistant professor of
clinical nutrition at the University of Texas Southwestern Medical
Center at Dallas, agreed.
Caution is vital when using any drug that has been approved for
one condition for another, Sandon said.
"But for many people, this kind of drug might absolutely be of great help, by doing something that helps the regulation of these appetite hormones and the regulatory pathway," she said.
More information
For more on obesity, visit the
U.S.
National Institutes of Health.