By LEE BOWMAN
Scripps Howard News Service
February 15, 2006
The drug, awaiting government approval to be sold by prescription under the brand name Acomplia, works by blocking receptors of a brain chemical called cannabinoid 1, which stimulates hunger and other cravings in the brain and is also present in fat tissue. The receptors are the same ones that create the sensation of hunger - "the munchies" - in people after smoking marijuana.
Although the drug was initially announced in 2004 as an anti-obesity drug, it's developer, Sanofi-Aventis, has since sponsored a number of clinical trials, including this study, aimed at demonstrating that rimonabant could reduce the risk of obesity-related illnesses including heart disease and diabetes. Still other studies have showed the drug could help some people stop smoking.
Company officials appear to be seeking broader medical indications for the drug, if approved by the Food and Drug Administration, than simply a weigh-loss pill, which many health insurance plans still reject covering as "lifestyle" drugs rather than medical necessities.
According to the latest study, published in The Journal of the American Medical Association, after a year of taking 20 mg a day of rimonabant and exercising, 48.6 of those subjects who remained in the study achieved a 5 percent or greater loss of body weight, compared to 20 percent of patients getting an inactive drug, and 26.1 percent who took a 5 mg daily dose.
The high-dose group also saw greater average reductions in weight, waist circumference and levels of triglycerides in the blood and an increase in the level of high-density lipoprotein (HDL), or beneficial cholesterol.
All the 3,045 adults in the study were either obese (body mass index of 30 or greater) or overweight (BMI of 27 or greater) and were either being treated or untreated for high blood pressure or abnormal lipid and lipoprotein levels in the blood.
Only 45 percent of the patients getting the higher dose of the drug remained in the study for one year, as did 49 percent of the low-dose and placebo group.
Those still taking rimonabant were randomly reassigned for the second year of the study to either switch to placebo or continue taking the same dose, while the original placebo group continued to get inactive pills.
The patients who went from the high dose to placebo regained much of the weight they'd lost, but those who stayed on the 20 mg dose sustained their weight loss and other favorable changes to heart disease risk factors.
The researchers, led by Dr. F. Xavier Pi-Sunyer of St. Luke's-Roosevelt Hospital Center, Columbia University College of Physicians and Surgeons, New York, conceded that their study was limited by the high dropout rate, noting that it may have been affected by "patients who derived less benefit and dropped out more frequently."
"Still, our observations collectively suggest that rimonabant may well represent an innovative approach to the management of multiple cardiometabolic risk factors."
There have been some reports of depression suffered in patients taking the drug, although the more common side effects have been nausea, dizziness, diarrhea and joint pain. But because it's expected that patients would continue to take the drug for many years, researchers and regulators are expected to be particularly watchful for adverse effects.
"While it does look hopeful, one has to be somewhat skeptical due to the lack of information on long-term effects," said Barrie Wolfe, a registered dietician with New York University Medical Center's Program for Surgical Weight Loss, recalling the fen-phen diet drug combination that had to be withdrawn several years ago after it was found to cause irreversible heart valve damage.
"I still don't think rimonabant is the 'magic bullet' we are all searching for, but it does seem to have a synergistic effect when diet and exercise is in the picture," Wolfe added.
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