Study Adds to Favorable Research for Experimental Diet Drug
By Peggy Peck
WebMD Medical News
Latest MedicineNet News
Reviewed By Michael Smith, MD
on Tuesday, March 08, 2005
March 8, 2005 (Orlando) - The experimental diet drug Acomplia helps keep off unwanted pounds for up to two years, new research shows.
After two years of treatment, patients in the study maintained a 16-pound weight loss. More than a third of patients taking the drug lost 10% of their body weight.
The drug targets a pleasure center in the brain that researchers believe is linked to overeating and other behaviors such as smoking. This new research is the fourth positive study of the drug, showing that Acomplia can take off pounds and help people stop smoking.
Luc Van Gaal, MD, studied more than 1,500 overweight adults in a two-year study. He reported the findings at the American College of Cardiology 2005 Scientific Session. The study was funded by Sanofi-Aventis, a Paris-based pharmaceutical company that has been developing the drug for clinical use.
In November 2004, Douglas Greene, MD, vice president of corporate medical and regulatory affairs for Sanofi-Aventis, told WebMD that the company planned to file for approval with the FDA in the second quarter of 2005.
"We can now say that we have robust data that can be replicated that shows [Acomplia] helps people lose weight and maintain that weight loss," says Van Gaal, who is a professor of diabetology, metabolism, and clinical nutrition at the University of Antwerp in Belgium.Inches Dropped From Waistline
Participants in the study were randomly selected to take either low-dose Acomplia (5 mg), high-dose Acomplia (20 mg), or a placebo. Additionally, all patients were told to reduce their daily caloric intake by 600 calories. They were not given any specific dietary guidelines, nor were they given exercise recommendations.
After two years, the patients taking 20 mg lost an average of 16 pounds and kept the weight off. The patients taking lower dose Acomplia lost an average of 10 pounds. Patients taking a placebo lost an average of 5.5 pounds.
Perhaps even more encouraging, says Van Gaal, is that the patients taking Acomplia dropped inches from their waist, which is especially significant since expanding waistlines are associated with increased risk of heart disease and diabetes.
Van Gaal says that it looks like each 2.2 pounds of weight lost takes an inch off the waist. The average waist reduction was 3 inches for patients taking 20 mg and 1.3 inches for those on the lower dose.
After the first year of treatment, 39% of patients taking high-dose Acomplia were able to reach a goal of losing 10% of their weight. After two years, 32% of the high-dose patients maintained that level of weight loss.
This is very encouraging, says Van Gaal, because "people always say they want to lose 40 pounds, but you can achieve real health benefits by losing 10% of your body weight. This is a realistic and sustainable goal." He says other studies have reported that patients who hit the 10% goal cut their risk of developing diabetes in half.
Julius Gardin, MD, chief of cardiology at St. John Hospital in Detroit, says, "The question is that we know that the battle against obesity is more than just a two-year fight. We would like to see if this weight reduction is maintained long term." Gardin was not involved in the Acomplia study.
SOURCE: American College of Cardiology 2005 Scientific Session, Orlando, Fla., March 6-9, 2005. Luc Van Gaal, MD, University of Antwerp, Belgium. Julius Gardin, MD, St. John Hospital, Detroit.
© 2005 WebMD Inc. All rights reserved.