The U.S. Food and Drug Administrationapproved a new drug Wednesday to help people battle chronic obesity.
The drug was approved for obese adults with a BMI of 30 or greater and overweight adults with a BMI of 27 or greater. People must also have at one least one weight-related condition - high blood pressure, high cholesterol, type 2 diabetes - to qualify to use the drug.
Belviq was tested in three trials that included 8,000 obese and overweight patients with and without Type 2 diabetes. The patients were treated for 52 to 104 weeks and some were given a placebo. Those on Belviq had an average weight loss of 3 percent to 3.7 percent when compared to those on a placebo.
About 47 percent of patients without type 2 diabetes lost at least 5 percent of their body weight compared to 23 percent of patients on the placebo. About 38 percent of patients with Type 2 diabetes lost 5 percent of their body weight when treated with Belviq. That was compared to 16 percent treated with the placebo.
Arena Pharmaceuticals, manufacturer of the drug, will have to conduct six follow-up studies once the drug goes to market. They will have to test for long-term cardiovascular affects such as heart attack and stroke.
Two other weight loss drugs were removed from the market in the 90s because they were found to cause heart valve damage. There was no significant damage found in patients who used Belviq in the trials. Still, FDA officials said Belviq should be used with caution by people with congesstive heart failure because they may have increased serotonin 2B receptors. The drug hasn't been studied in patients with serious valvular disease.