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A New 'Wonder' Drug for Weight Loss?
Study Shows Losing Pounds and Inches Is Easier With Experimental Diet Drug

By Peggy Peck


Reviewed By Brunilda Nazario, MD
on Monday, August 30, 2004
WebMD Medical News

Aug. 30, 2004 (Munich) -- An experimental diet drug continues to show promise in the battle against obesity, and may benefit those with multiple risk factors for health-related complications stemming from obesity.

In the latest study of the drug rimonabant, overweight volunteers who took 20 milligrams of the drug daily for a year lost an average of 20 pounds and reduced their waist size by an average of over 3 inches.

Rimonabant works by inhibiting the CB1 receptor, which works on a newly described network system called the endocannabinoid system (EC System). This system plays a critical role in the regulation of food intake and metabolism.

This is the same drug that has shown promise as a smoking-cessation aid, helping smokers quit smoking, while losing rather than gaining weight.

The newest study, which was presented at the European Society of Cardiology meeting, reports on 1,500 overweight volunteers who were randomized to one year of either 20 milligrams or 5 milligrams of rimonabant or to a dummy pill.

All of the volunteers had a BMI (a indirect measure of body fat) of 27 or higher, which would classify them as overweight or obese. They also had at least one risk factor for obesity related complications such as high cholesterol or high blood pressure.

In addition, all the volunteers were told to reduce their daily calorie intake by 600. This may explain why even persons taking dummy pills lost an average of 8 pounds, says researcher, Luc Van Gaal, MD, a professor of medicine at Antwerp University. In the study, those who took the low-dose rimonabant lost an average of 10.5 pounds.

The drug works by blocking endocannabinoid receptors, which are found in the brain and in fat tissue. These receptors play a role in cravings, so the drug appears to work by turning off the "urge" center in the brain. It "breaks the vicious circle by cutting the desire to eat," Van Gaal tells WebMD.

Seventy percent of people taking 20 milligrams a day of rimonabant lost more than 5% of their initial body weight, compared with 44% of those taking 5 milligrams of rimonabant daily. Only 31% in those taking the dummy pill lost 5% of their weight.

Drug Helps 'Good' HDL Cholesterol

Van Gaal says that an unexpected result of rimonabant treatment was a 27% increase in HDL -- "good" cholesterol -- among those taking the higher dose of the drug. One of the most reliable ways to increase HDL is through exercise but Van Gaal says that increase seen in people taking rimonabant was better than the HDL increase associated with physical training.

However, patients in the placebo arm also had a 10% increase in HDL. Van Gaal says the increase is most likely attributable to the decreased-calorie diet "but the extra 10% in the rimonabant arm appears to be a drug effect."

The drug was well tolerated, although 13% of those taking higher doses of the drug experienced gastrointestinal symptoms including nausea and diarrhea, he says.

While the rimonabant results continue to be positive, not everyone is pleased to see a new diet drug. Asked about the rimonabant in obesity treatment studies, Richard Horton, MD, editor of The Lancet, tells WebMD that he has reservations about the use of a drug to treat obesity. "This isn't rheumatoid arthritis and the idea of giving a drug to people for years to treat obesity is troublesome," says Horton. "Moreover, we don't really know if the weight loss in this study will translate into reduced risk of cardiovascular disease."

Horton was not involved in the study.

Van Gaal says that Sanofi-Aventis, the maker of the drug, plans to file for FDA approval during the second quarter of 2005. He says the company will probably ask the FDA to approve the drug for both weight loss and smoking cessation.


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SOURCES: European Society of Cardiology, Munich, Germany, Aug. 28-Sept. 1, 2004. Hotline Prevention and Medical Treatment I Session "RIO-EUROPE: a randomized double-blind study of weight reducing effect and safety of rimonabant in obese patients with or without comorbidities. Luc Van Gaal, MD, professor of medicine, Antwerp University, Antwerp, Belguim. Richard Horton, MD, editor, The Lancet, London, presented Aug. 29, 2004.


 

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