8 1/2 Pounds Lost in 16 Weeks With New Drug
June 17, 2004 — A new drug helped obese people drop up to 8.5 pounds over 16 weeks, researchers report.
Its planned brand name — pending FDA approval — is Acomplia. For now, it’s still going by its generic name rimonabant. But it already has a nickname: the munchies drug. That’s because it works like marijuana in reverse. It blocks cannabinoid receptors in the brain.
Rimonabant curbs appetite. It also cuts the urge to smoke, its manufacturer announced earlier this year. At that February 2004 press conference, researchers and officials from drug maker Sanofi-Synthelabo said they had data on people who took the drug for a full year. They said the drug was safe, that people who stayed on the drug — and on diet with a moderate reduction in calories — lost 17 pounds. Their waists shrank by 3 inches. And they doubled their odds of quitting smoking.
Now the first of these clinical trials is seeing the light of day. In a report to this week’s 86th annual meeting of the Endocrine Society in New Orleans, F. Xavier Pi-Sunyer, MD, MPH, reported on 287 obese people who took rimonabant for 16 weeks. Pi-Sunyer is director of the obesity research center, director of the Joslin center for diabetes, and chief of endocrinology, diabetes, and nutrition at St. Luke’s-Roosevelt Hospital Center.
“Our findings demonstrate that rimonabant is a safe and effective treatment for obesity,” Pi-Sunyer said in a news release. “These findings may help provide an option for the growing number of people who suffer from obesity, but do not respond to traditional weight-loss options such as diet and exercise. Longer and larger studies are needed to confirm these findings.”
The study’s 235 women and 52 adult men had a body mass index (BMI) between 29 and 41. An adult with a BMI of 30 is considered obese. The volunteers randomly got one of four treatments: an inactive placebo, or one of three doses of rimonabant. All subjects also went on a moderate diet: They took in 500 fewer calories each day.
After 16 weeks, those who got the placebo lost about 2 pounds, and dropped a little less than a 1/2 inch from their waistlines. Those who got the lowest dose of rimonabant lost 5.5 pounds, and took an inch off their waistline. Those who got the highest dose of rimonabant lost 8.5 pounds and shrank their waists by 1.5 inches.
Overall, the Pi-Sunyer reported the “safety profile of rimonabant was satisfactory.”
Douglas A. Greene, MD, Sanofi-Synthelabo vice president for regulatory affairs, says that obese people and people with a craving for nicotine have an overactive cannabinoid system. By partially blocking this system, rimonabant helps people lose weight and quit smoking.
So is rimonabant a weight-loss drug or a stop-smoking drug? Greene says it’s both and neither. He prefers to think of it as a heart-health drug.
“This compound is completely novel,” he said at the February press conference. “It is the first in a class of new medications that has effects on two major cardiovascular risk factors. These are probably the two major preventable risk factors for heart disease: smoking and obesity. This represents a major medical advance for patients at risk of heart disease. This is an important medical therapy that will have a major public health impact.”
