The American Heart Association (AHA) and the National Heart, Lung and Blood Institute (NHLBI) on Sept. 13 issued a new scientific statement taking issue with two major diabetes organizations that a month ago questioned the validity of diagnosing patients with "metabolic syndrome."

The debate could well impact efforts of Sanofi-Aventis to get regulators to approve Acomplia (rimonabant) not just as an anti-obesity drug but as a comprehensive approach to treating "metabolic syndrome," a cluster of conditions that raise the risk of heart disease and diabetes.

According to new statement, published in the Sept. 13 issue of Circulation, Journal of the American Heart Association, metabolic syndrome is a real and growing health problem that affects more than 50 million Americans.

"Metabolic syndrome is an important issue both for physicians and the general public," said Dr. Scott Grundy, chairman of the panel that wrote the joint statement.

The criteria for metabolic syndrome include:

• Elevated waist circumference;
• Elevated triglycerides (150 mg/dL or higher);
• Reduced HDL-cholesterol (40 mg/dL or lower in men and 50 mg/dL or lower in women);
• Elevated blood pressure (130/85 mm Hg or higher) and
• Elevated fasting glucose (100 mg/dL or higher).

The AHA/NHLBI statement said metabolic syndrome increases the risk for atherosclerotic cardiovascular disease by 1.5- to threefold, and more than triples the risk for type 2 diabetes.

The statement would appear to reinforce efforts of Sanofi, which already promotes rimonabant on its web site as "a comprehensive management approach" to metabolic syndrome.

Clinical trials of Acomplia have shown that the new drug is capable of producing not just weight loss, but improvement in all of the "metabolic syndrome" risk factors.

The new statement comes a month after the American Diabetes Association and the European Association for the Study of Diabetes publicly declared that doctors should not diagnose people with metabolic syndrome or prescribe drugs for it because it may not independently affect the likelihood of developing heart disease.

The diabetes organizations, in a paper published on the Web sites of both groups in August, argued that each of the conditions that make up metabolic syndrome is potentially life threatening, and said doctors should treat each risk factor individually.

The debate is likely to continue as U.S. and European regulators weigh approval of Acomplia.