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Drug sheds pounds and light on obesity

| Wednesday, Nov. 10, 2004

NEW ORLEANS -- An experimental pill that offers the fairy-tale promise of helping people lose weight and quit smoking has gathered even more stardust.

The biggest test yet of the drug found that it helps people not only drop pounds but also keep them off for two years -- longer than any other diet drug has been able to achieve. Cholesterol and other health measures improved, too.

The impressive results from a study of more than 3,000 obese people were presented at a medical conference Tuesday -- capping months of anticipation about the new drug Acomplia, made by the French pharmaceutical firm Sanofi-Aventis.

Doctors call the research exciting. The company that funded the study said it believes the drug could have blockbuster potential similar to cholesterol-lowering statin drugs.

In a study of 3,040 obese people throughout the United States and Canada, those given the higher of two doses of Acomplia lost more than 5 percent of their initial body weight. One-third of them lost more than 10 percent.

"They achieved and maintained a weight loss of 19 pounds, as compared to 5.1 pounds in the placebo group," said Dr. F-Xavier Pi-Sunyer of Columbia University in New York, who led the research and presented results at the American Heart Association conference yesterday.

Those who quit taking Acomplia in the second year of the study regained most of what they had lost -- suggesting that people might have to take the drug indefinitely to maintain a lower weight.

"We consider this to be a chronic problem. You don't cure obesity; you just improve it," Pi-Sunyer said.

About two-thirds of American adults are overweight or obese, raising their risk of ailments -- from cancer and cardiovascular disease to sore joints and snoring. About one-fourth of American adults smoke, which brings many of the same woes.

It's been devilishly difficult to develop effective treatments for obesity and smoking. Diet drugs, in particular, have a checkered history -- most notably the withdrawal from the market in 1997 of the popular "fen-phen" drug combination after users developed heart-valve problems.

Drugs now on the market either are designed for short-term use or have distasteful side effects, such as bowel problems that make many shy away from them.

Sanofi-Aventis, the maker of Acomplia, said it believes such side effects are unlikely with its pill because Acomplia attacks obesity in a novel way. The pharmaceutical firm plans to seek federal approval for the pill next year.

Acomplia is the first diet drug aimed at blocking the "pleasure center" of the brain and interfering with the cycle of craving and satisfaction that drives many compulsive behaviors and addictions. The same circuitry is activated when people smoke pot.

"Weight regulation is really kind of an addictive behavior," said Dr. Robert Eckel, an expert on metabolism from the University of Colorado Health Sciences Center who had no role in the study.

The study involved people who either were severely obese or were moderately obese and also had another heart-related health problem, such as low "good" cholesterol, high blood pressure or high blood sugar.

Participants were given nutrition advice and urged to cut 600 calories a day from their diet. They randomly were assigned to get either a 5- or 20-milligram dose of Acomplia or fake pills. Neither they nor their doctors knew who had received which.

After one year, those on the higher dose of Acomplia had lost an average of 19 pounds -- the same result found in two smaller studies of the drug reported earlier this year.

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