New Obesity Drug May Help Heart, Too
Drug Plus Diet Cut Weight, Metabolism Woes in Study Funded by Drug's Maker
Nov. 16, 2005 -- A new antiobesity drug, Acomplia, may trim some heart risks along with extra pounds.
So says a year-long study published in The New England Journal of Medicine. The study was funded by Sanofi Aventis, Acomplia's maker. Acomplia is not yet on the market.
Weight, waist size, and blood fats (cholesterol and triglyceride) were tracked in 1,036 overweight and obese people for a year. Extra pounds, big waists, and blood fat problems can be heart hazards.
Participants didn't just pop pills. They also ate fewer calories every day for a year. Many quit the study early.
Those who stuck with it lost some weight, slimmed their waists, and improved their blood-fat levels. Those taking Acomplia showed bigger improvements, write the researchers.
They included Jean-Pierre Despres, PhD. Despres works at Canada's Quebec Heart Institute at the Laval Hospital Research Center.
Drug Plus Diet
All patients had high levels of triglycerides or cholesterol problems when the study started.
They were randomly assigned to take either an inactive pill (placebo), 5 milligrams of Acomplia, or 20 milligrams of Acomplia daily. No one knew which pill they were taking.
Less than two-thirds finished the study. Here are their weight and waistline losses:
- Placebo: 5.07 pounds and 1.33 inches lost
- Acomplia (lower dose): 9.26 pounds and 1.92 inches lost
- Acomplia (higher dose): 18.96 pounds and 3.58 inches lost
Weight loss happened during the first nine months and leveled off later, the study shows.
All three groups also showed improvements in HDL "good" cholesterol, with the biggest improvements in those taking the higher dose of Acomplia.
All three groups had roughly the same percentage of participants quit the study (37% to 40%).
Dropping out of the study because of side effects was mainly seen in the people taking the higher 20-milligram dose of Acomplia.
Overall, the researchers note that few patients quit over those problems.
The researchers suggest that Acomplia may go above and beyond drug-free weight loss in improving waist size, triglycerides, and cholesterol. However, they don't present Acomplia as a magic bullet against obesity.
The "moderate" weight loss was similar to that seen with available medications, writes Susan Yanovski, MD, in a journal editorial.
Yanovski didn't work on the Acomplia study. She's on staff at the National Institute of Diabetes and Digestive and Kidney Diseases, a branch of the National Institutes of Health (NIH).
The patients didn't have diabetes or psychiatric problems. That could limit the impact of the results, Yanovski writes.
New obesity treatments are "welcome," Yanovski writes. She notes that most American adults are overweight or obese.
According to the CDC, nearly two-thirds of U.S. adults are overweight and about 30% are obese, based on body mass index (BMI) from 1999 to 2002.
While nondrug approaches - such as diet and exercise -- should be the main method of weight loss, some patients need more help, Yanovski writes.
The risks and benefits of different options should be carefully considered, writes Yanovski. She calls for science to learn more about obesity and its treatment and prevention.