The combination of sibutramine therapy, basic counseling, and a low-calorie diet structured to include meal replacements forms an effective three-pronged approach to weight loss and maintenance. "No single technique has been very successful in the primary care setting at helping people lose weight and keep it off — even the use of medications by themselves has not had dramatic results," according to James L. Early, MD, lead investigator "We combined three simple changes — basic counseling, medication, and meal replacement — for an additive effect in treating obesity."
According to Dr. Early, a clinical associate professor at the University of Kansas School of Medicine in Wichita, the approach is similar to that used for smoking cessation, in which patients receive counseling, nicotine replacement therapy, and a drug to decrease nicotine cravings.
In the study, investigators evaluated the efficacy of sibutramine (Meridia, made by Abbott Laboratories, Inc.) in combination with a structured low-calorie diet that included a daily meal replacement (Slim-Fast shakes, made by Unilever PLC/LV), and simple behavioral counseling. Patients were treated in a setting similar to that of a community clinic.
In the first phase of the study, 148 patients aged 18 to 50 years (body mass index, 29 – 43 kg/m2) received open-label, 10 mg of sibutramine/low-calorie diet/meal replacement combination therapy for three months.
Results showed that 85.1% of patients achieved a weight loss of 5% or more for the three-month period, relative to baseline and a mean change in waist circumference [WC], of -9.8 cm.
Of these patients, 104 continued into the nine-month, single-blind portion of the study and were randomized to receive treatment with either 15-mg of sibutramine/low-calorie diet/meal replacement (n = 55) or placebo plus low-calorie diet (n = 49). All patients were counseled as before regarding diet and exercise on at least a monthly basis.
Results at one year showed that treatment with sibutramine/low-calorie diet/meal replacement yielded a mean 5.3-kg greater weight loss and 4.5-cm greater reduction in WC from baseline relative to placebo/low-calorie diet.
A significantly greater proportion of patients treated with sibutramine/low-calorie diet/meal replacement maintained 80% or more of their initial weight loss from the first phase of the trial (85.5% vs 36.7%)
"We found that patients who continued on the active treatment with sibutramine and a low-calorie diet with a daily meal replacement actually had an additional 2- to 3-kg weight loss for the next nine months, while those who received placebo had a gradual rise [in weight] and in fact gained in the neighborhood of five additional pounds [2.3 kg]," Dr. Early pointed out.
Overall, the three-pronged approach to the treatment of obesity proved effective for weight loss and maintenance; 89.1%, 54.5%, and 32.7% of patients randomized to receive sibutramine/low-calorie diet/meal replacement through both phases of the study achieved weight reductions of 5-, 10-, and 15-kg or more at one year, respectively.
"By the end of the study, we saw a slow but steady trend of continued weight loss in those who continued receiving sibutramine and one meal replacement a day," noted Dr. Early.
ENDO 2005: Abstract P1-710. Presented June 6, 2005.
DID YOU KNOW: On May 2, the FDA approved revisions to the safety labeling for rosuvastatin calcium (Crestor tablets, made by AstraZeneca Pharmaceuticals, LP) to warn of the increased risk of serious muscle toxicity (myopathy/rhabdomyolysis) associated with its use, especially at the highest approved dose of 40 mg.
In clinical trials, rosuvastatin has been associated with an increased incidence of myopathy and rhabdomyolysis when administered at doses exceeding 40 mg. Adverse effects on skeletal muscle (uncomplicated myalgia, myopathy, and rhabdomyolysis) also have been reported during marketed use of rosuvastatin and other 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ("statins").
Concurrent administration of other lipid-lowering therapies or cyclosporine may also increase the risk of myopathy. The FDA advises that the benefit of further alterations in lipid levels be carefully weighed against potential risks when considering combination therapy with fibrates or niacin. Combination therapy with rosuvastatin and gemfibrozil generally should be avoided.