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A novel drug that dampens the brain's craving for flavorful foods andnicotine helps people lose weight—and keep it off over the long term,according to research presented at the November American Heart AssociationScientific Sessions in NewOrleans.
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Unlike other medications that often lose effectiveness after a few monthsof treatment, rimonabant (Acomplia, Sanofi-Aventis) helped patients maintainweight loss during a 2-year follow-up period, according to Xavier Pi-Sunyer,MD, chief of endocrinology at St. Luke's-Roosevelt Medical Center in New YorkCity and lead investigator of the Rimonabant in Obesity (RIO)-North Americatrial.
"This is a very interesting drug that works in a very differentsystem," says Pi-Sunyer. "It's very promising."
NEW DISCOVERIES
Rimonabant is the first of a novel category of drugs known as selectivecannabinoid (CB) receptor blockers. The recently discovered endocannabinoidsare a system of receptors and chemical messengers believed to play a role inweight regulation and lipid metabolism.
CB receptors in the brain stimulate the ingestion of palatable foods, amechanism thought responsible for the "munchies." Activation ofthe CB system in peripheral tissues has been shown to stimulate fataccumulation.
CLINICAL STUDY
RIO-North America is a multicenter trial of 3,040 subjects from throughoutthe U.S. and Canada. Participants were randomized to receive either 5 mg or 20mg of the drug in a daily dose. For comparison, at the end of 1 year, subjectson rimonabant were re-randomized to receive either a placebo or the same doseof the drug.
In addition to the medication, subjects were instructed to reduce theirfood intake by 600 calories per day.
At the end of two years, more than 60% of those on the higher dose ofrimonabant lost more than 5% of their body weight, and 33% of subjects lostmore than 10%. Subjects taking the drug lost an average of 19 pounds, comparedwith 5.1 pounds in the placebo group, and 3.1 inches on their waistlines.
Aside from the weight loss, those on the higher dose of rimonabant hadtheir high-density lipoprotein (HDL) level increase by 24.5%, compared with a13.8% rise in the placebo group. Triglycerides were reduced by 9.9% amongthose taking the higher dose of rimonabant, compared with 1.6% among thosereceiving placebo.
About 13% of participants stopped taking rimonabant, compared with 7% amongthose who were given a placebo. Side effects of the higher dose of druginclude a slightly increased incidence of depression, anxiety, irritability,and nausea.
Other experts greeted the findings of RIO-North America with guardedoptimism. Rimonabant is "almost too good to be true," says GeorgeBakris, MD, of Rush University Medical Center, Chicago.
However, more study is required to determine how rimonabant works and thelong-term effects it may have on the body. The drug "blocks pleasurecenters in the brain," says Bakris. "It works at a very deeplevel, and we need to understand what other effects it mayhave."
SMOKING CESSATION
Clinical trials with rimonabant also appear to help people quit smokingcigarettes and avoid the excess weight gain that often plagues ex-smokers. Thedrug nearly doubles a person's chance of successful smoking abstinence whileavoiding weight gain, according to a phase III trial reported at November'sNorth American Association for the Study of Obesity (NAASO) Annual Meeting inLas Vegas.
In a study presented as part of a joint effort by NAASO and the AmericanDiabetes Association, 787 subjects were randomized to receive placebo orrimonabant in either a 5-mg or 20-mg once-daily oral dose. At the end of the10-week treatment phase, almost 28% of those who took the 20-mg daily dosestopped smoking for at least a month, compared with 16% of those in theplacebo group. Those who quit smoking gained an average of 1 pound, comparedwith 6 pounds noted in the placebo-treated subjects who quit smoking.
Results of two other phase III clinical trials of rimonabant in smokingcessation are still pending, according to the company. Aside from RIO-NorthAmerica, rimonabant is being studied in a second phase III trial for thetreatment of obesity and two phase III trials for the treatment of highlipids.
Pi-Sunyer says that data from the RIO-North America trial are beingprepared for publication.
Sanofi-Aventis is expected to file a new drug application for rimonabantduring 2005, and the drug could be on the market the following year.
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