2nd Study OKs French Diet Pill
ORLANDO, Fla. — A second study confirms that an experimental diet pill can help people lose weight and keep it off for up to two years, setting the stage for its maker to seek approval to sell it in the United States.
The drug, rimonabant, which the French company Sanofi-Aventis hopes to sell under the brand name Acomplia, trimmed nearly 16 pounds on average from people taking the optimal dose for two years, compared with 5.5 pounds for those who took dummy pills, doctors reported.
"The majority of the weight that was lost at one year is still maintained after two years. There is only a slight increase over that second year," said Dr. Luc Van Gaal of University Hospital in Antwerp, Belgium, who led the study involving 1,507 severely obese people in Europe.
About two-thirds of American adults are overweight or obese; in European countries, one-third to half are. Diet drugs sold now are only for short-term use or have unpleasant side effects that make it tough to stay on them.
Acomplia works by blocking a brain "pleasure center," leading people to eat less and acting directly on fat cells to prevent weight gain. Studies suggest it may help people quit smoking.
In a North American study of 3,040 obese people reported last fall, those given the higher of two doses of the drug lost about 19 pounds and kept it off for up to two years, compared with only 5 pounds for those given fake pills.
In the new study, those on the higher dose regained some weight in the second year but fared far better than those on placebo. Waistlines in the drug group were 3.4 inches smaller after one year and 3 inches after two.
The proportion of people with metabolic syndrome — a collection of conditions such as high blood sugar and blood pressure and low amounts of "good" cholesterol — went from 42 percent at the start of the study to 21 percent at two years for those on the higher dose of the drug. About 47 million Americans have metabolic syndrome.
However, the drug has side effects: 13.7 percent on the optimal dose reported nausea compared with 5.5 percent taking dummy pills, though researchers said it tended to be mild and short-lived. Rates of dizziness and diarrhea were almost twice as common on the drug.
About 19 percent on the higher dose quit the test because a problem occurred, but so did 13 percent in the placebo group. Depression was the reason for discontinuing for 2.8 percent on the higher dose of the drug and 1.6 percent in the placebo group.
Dr. Julius Gaardin, a cardiologist at Wayne State University, called it and similar ones on the drug "truly landmark studies in the field of obesity."
He said "the safety profile was quite good" and obesity is such a serious problem that there ought to be higher tolerability of side effects than for drugs for other conditions.