An Agency for Healthcare Research & Quality report recommends behavioral intervention to treat obesity but does not make a recommendation regarding drug therapy.

AHRQ's U.S. Preventive Services Task Force found "the evidence supporting pharmacotherapy of mostly fair quality," the Dec. 1 ¹ report "Screening for Obesity in Adults" states.

As a result, while the report notes clinicians may consider pharmaceuticals for treatment of obesity, no recommendation on their use is made.

The report's "Clinical Considerations" section highlights the efficacy and adverse event profile of Abbott's Meridia (sibutramine) and Roche's Xenical (orlistat).

The task force says the drugs "can produce modest weight loss (2.6-4.8 kg) that can be sustained for at least two years if the medication is continued," but also notes that there is no long-term data on the drugs' benefits or adverse events.

"Experts recommend that pharmacological treatment of obesity be used only as part of a program that also includes lifestyle modification interventions, such as intensive diet and/or exercise counseling and behavioral interventions," the report notes.

The only clinical action the report recommends is that clinicians routinely "screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults."

High-intensity intervention "is more than one person-to-person (individual or group) session per month for at least the first three months of the intervention."

The report found that "high-intensity counseling - about diet, exercise, or both - together with behavioral interventions aimed at skill development, motivation and support strategies produces modest, sustained weight loss (typically 3-5 kg for 1 year or more) in adults who are obese."

The "Scientific Evidence" section of the report also says weight loss with orlistat or sibutramine therapy is "modest," but adds that the effects are "potentially sustained."

"Although average weight loss was consistently modest (weight reduction of 3-5 kg), the percentage of patients achieving clinically significant weight loss (5-10% of body weight) was sometimes substantial," the report states.

However, the report notes that discontinuation of drug therapy is likely to result in the patient regaining the lost weight.

"Weight maintenance trials suggested that prolonged pharmacotherapy confers some benefit but that its discontinuation may lead to rapid weight regain," the report says.

The report notes that there is a lack of outcomes data for drug treatment used in combination with behavioral interventions.

"There are limited data on combined behavioral and pharmacological interventions," the report states.

"One fair-quality trial showed that a combination of intensive behavioral therapy and sibutramine led to greater weight loss (mean of 7.3 kg over 1 year) compared with sibutramine alone, and that a combination of intensive behavioral therapy and diet control with sibutramine led to even greater weight loss (mean of 12.8 kg over 1 year) compared with sibutramine alone."

The Medicare prescription drug legislation expected to be signed into law Dec. 8 adopts Medicaid's definition of a covered drug, meaning obesity drugs such as Xenical and Meridia will not be covered under the Part D drug benefit.

However, the bill includes provisions to encourage diabetes and cholesterol screening, which could lead to more obese patients being diagnosed and receiving prescriptions.

The Medicare bill also gives AHRQ a more prominent role in outcomes research. It sets aside $50 mil. in fiscal year 2004 for AHRQ. This will increase the agency's cost-effectiveness research budget from $6 mil. to $20 mil. (² Also see "AHRQ Stepping Up Cost-Effectiveness Research; Says Key Is Openness" - Pink Sheet, 17 November, 2003., p. 5).

AHRQ Obesity Report Recommends Behavior Therapy, Is Cautious On Drugs

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