Sanofi-Aventis Drug Effectively Aids and Maintains Weight Loss, Study Finds
Patients who took a high dose of rimonabant, a weight-loss medication manufactured by Sanofi-Aventis, lost an average of 19 pounds and maintained the weight loss, provided that they continued to take the treatment, according to a study presented on Tuesday at the American Heart Association annual conference, USA Today reports (Sternberg, USA Today, 11/10).
The study, led by Xavier Pi-Sunyer, chief of endocrinology at St. Luke-Roosevelt Hospital Center in New York, involved 3,045 patients (Winslow, Wall Street Journal, 11/10). In the study, participants received either a 20-milligram dose of rimonabant, a two-milligram dose -- which is marketed as Acomplia -- or a placebo (USA Today, 11/10). Researchers also instructed participants to reduce their daily caloric consumption by 600 (Fauber, Milwaukee Journal Sentinel, 11/9). The study found that more than 60% of participants who took the high dose of rimonabant lost more than 5% of their body weight and that 33% lost more than 10%. Among participants who took the low dose of rimonabant, about 33% lost 5% of their body weight, and about 20% lost more than 10%, the study found. Pi-Sunyer said that participants who took the high dose of rimonabant "achieved and maintained a weight loss of 19 pounds as compared to 5.1 pounds in the placebo group."
In addition, participants who took the high dose of rimonabant lost an average of three inches from their waistlines, compared with 1.9 inches among participants who took the low dose of the medication and 1.5 inches among those who took a placebo, the study found. However, participants who ended treatment with rimonabant regained weight, the study found (USA Today, 11/10). According to the study, participants who took the high dose of rimonabant also experienced a 24.5% increase in HDL, or "good" cholesterol levels, compared with 13.8% among those who took a placebo, and a 9.9% decrease in triglyceride levels, compared with 1.6% among those who took a placebo.
The study also found that participants who took the high dose of rimonabant experienced significant improvement in their ability to use insulin and that the medication might help in smoking cessation (Milwaukee Journal Sentinel, 11/9). According to Pi-Sunyer, about 50% of study participants withdrew in the first year. Among study participants who withdrew, 13% of those who had taken the high dose of rimonabant reported depression, anxiety, irritability and nausea, compared with 7.2% of those who had taken a placebo (Wall Street Journal, 11/10).
Researchers at St. Luke's Medical Center in Milwaukee plan to conduct a second study in December that will involve about 10 patients who are overweight, diabetic or smokers and have coronary artery blockage. In the study, participants will take rimonabant for 18 months to determine whether the medication could reduce their coronary artery blockage.
Rimonabant represents the first medication in a new class of treatments that block receptors in the endocannabinoid system, which helps to regulate food intake and energy expenditure (Milwaukee Journal Sentinel, 11/9). Some researchers have said that the receptors also are located in fat and nerve cells in the stomach and might help regulate appetite. Other studies have indicated that abdominal fat leads to a higher risk for heart disease than other body fats (Wall Street Journal, 11/10).
According to Douglas Greene, a physician and vice president of corporate and medical affairs for Sanofi, although other pharmaceutical companies have developed medications that target the same receptors, rimonabant is the first to reach clinical trials. The company plans to seek FDA approval for rimonabant in the second quarter of 2005 (Milwaukee Journal Sentinel, 11/9).
Pi-Sunyer said, "The sustained weight loss is a nice effect, which is unusual." Sidney Smith, past president of AHA and a cardiologist at University of North Carolina at Chapel Hill, said, "The pill is a good partner to get the ball rolling. But willingness to change behavior and diet will be essential to achieving goals" (Wall Street Journal, 11/10). George Bakris, vice chair of the department of preventive medicine at Rush University Medical Center in Chicago, said, "What worries me is this may be an excuse to not go out and do what you are supposed to be doing in terms of lifestyle." He also raised concerns about the potential of rimonabant to cause depression, adding, "When you start interfering in that part of the brain, things can happen" (Milwaukee Journal Sentinel, 11/9).
Tufts University nutrition researcher Ernst Schaefer said, "None of these drugs in development are going to be the magic bullet. In a 300-pound person who loses 10%, that person still weighs 270 pounds" (Smith, Boston Globe, 11/10).
Several broadcast programs reported on the rimonabant study:
- ABCNews' "World News Tonight": The segment includes comments from Dr. Louis Aronne of New York Presbyterian Hospital/Cornell Medical School, Dr. Christopher Cannon from Brigham and Women's Hospital and study participants (McKenzie, "World News Tonight," ABCNews, 11/9).
- CBS' "Evening News": CBS' medical correspondent Elizabeth Kaledin reports on the study (Kaledin, "Evening News," CBS, 11/9). The complete segment is available online in RealPlayer.
- NBC's "Nightly News": The segment includes comments from Dr. Robert Anthenelli from the University of Cincinnati College of Medicine, Aronne and study participants (Bazell, "Nightly News," NBC, 11/9). The complete segment is available online in Windows Media.