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Experimental weight-loss pill clears hurdle

Posted - Nov. 10, 2004 at 6:20 a.m.



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NEW ORLEANS -- The closest thing to an antidote for unhealthy living has cleared its biggest test yet: A study released Tuesday shows that people who took an experimental pill lost weight and kept it off for an unprecedented two years.

The study of more than 3,000 people in the USA and Canada found that more than 60% of those given the greater of two doses of the drug rimonabant lost more than 5% of their body weight, and 33% of them lost more than 10%.

''They achieved and maintained a weight loss of 19 pounds as compared to 5.1 pounds in the placebo group,'' study leader F-Xavier Pi-Sunyer of Columbia University said at the annual meeting of the American Heart Association.

The drug matched its performance in two previous studies showing it can restore a healthier balance of blood fats and cholesterol. Research also suggests rimonabant can help people stop smoking.

People given a lower dose of the drug, sold under the trade name Acomplia, did only slightly better than those given a placebo. About one-third of the people in the low-dose group lost 5% of their weight, and about one-fifth lost 10%.

Rimonabant also shrank participants' waistlines. Those on the high dose (20 milligrams) bid goodbye to 3 inches around their waists, compared with 1.9 inches for those on the low dose (5 milligrams) and 1.5 inches for those on a placebo. But the study also showed that patients who stopped taking the drug regained weight.

''At a time when obesity and smoking are major concerns, this shows major promise,'' says Sidney Smith of the University of North Carolina-Chapel Hill. ''But we have to be careful not to substitute any drug for lifestyle change.''

Doctors regard waistlines as a critical risk factor for heart disease because abdominal fat has been linked to high cholesterol and pre-diabetic insulin abnormalities. Recent findings suggest abdominal fat is a better predictor of heart attacks than a person's weight or body mass. Forty-four percent of Americans have waistlines that betray such risk: 40 inches for men and 35 inches for women.

The drug affects the same biological network, the endocannabinoid system, that is activated by marijuana. It mutes appetite alarms in the brain, stomach and fatty tissue that promote smoking and eating. Side effects included anxiety, irritability and depression.

''We need more safety data, especially among young people,'' said Robert Bonow of Northwestern University, noting that many young people are obese and that use of antidepressants by this group has been linked to suicidal behavior.

The drug's maker, Sanofi-Aventis, plans to seek government approval next year.

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© Copyright 2004 USA TODAY, a division of Gannett Co. Inc.

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