Company to test obesity/smoking pill for heart disease
Tuesday, November 9th 2004, 12:01 pm
By: News On 6
LAS VEGAS (AP) _ Not content with having a drug that might merely fight obesity and smoking, the company developing this eagerly anticipated pill will soon launch studies to see if it can treat and prevent clogged arteries and heart disease.
The reason the drug looks promising is that even the one-third of people who didn't lose weight on rimonabant, or Acomplia, still had improvements in cholesterol and other heart-disease risk factors, said Dr. Douglas Greene, vice president for corporate and regulatory affairs for Sanofi-Aventis, the French company developing the drug.
He also gave the first details on its safety and side effects, including the one major concern to emerge so far: a doubled risk of depression.
``We're trying to get the information forward without hyping or frightening people,'' Greene said. But he said the company considers the drug one of those ``once-in-a-decade'' developments that offer a radically new way to treat a variety of diseases.
Greene discussed the drug Sunday at a meeting of the North American Association for the Study of Obesity and in an interview afterward.
Acomplia has generated unusual excitement because it attacks obesity and possibly other addictive behavior in a novel way _ by blocking a pleasure center in the brain. People on the drug eat less.
At a meeting of heart specialists last week, doctors reported that the drug helped obese people lose an average of 19 pounds and keep it off for two years, longer than any other diet drug has been able to do. A previous study showed it could help smokers kick the habit.
The company is aiming to seek Food and Drug Administration approval in April to sell Acomplia for dieters and smokers. But Greene said Sanofi also might seek labeling saying it can be used to prevent metabolic syndrome _ a collection of problems including big waistlines, high cholesterol and high blood sugar that are known to put people at high risk of heart disease.
If so, it would be the first drug marketed that way.
Studies involving 5,560 obese people found that those on the optimal dose of Acomplia had improvements in cholesterol, the type and amount of fat particles in their blood, and levels of key proteins involved in inflammation, which can cause artery blockages.
Sanofi soon plans to start two studies of the drug in obese smokers with blood-fat abnormalities to see if Acomplia can slow or prevent the buildup of blockages. One will involve people getting an angiogram to open a clogged artery. Researchers will choose a smaller artery that is not being treated and measure changes in the amount of blockage over time on the drug.
As for side effects, Greene repeated what doctors said at the heart meeting last week _ that patients on the drug had scored no different on three separate and widely used measures of anxiety and depression than people getting fake pills.
However, 2.9 percent (63 out of 2,164) on the optimal dose of the drug had to drop out of the study because they developed depression, compared with only 1.5 percent (19 out of 1,254) of those given fake pills.
``Perhaps we've uncovered some latent cases of depression. Perhaps people who are depressed treat their depression by eating. We're in the process of figuring all that out,'' Greene said.
However, a host of other measures of mood actually improved on the drug, according to quality-of-life information from one study involving about 1,000 obese people. They reported better self-esteem, happiness with their sex lives, ability to work and ability to resist food cravings, and less distress when out in public.
Overall, 5.6 percent of people who took the optimal dose of Acomplia developed side effects serious enough to make them drop out of the study compared with 4.1 percent of those on fake pills.
Four deaths occurred _ one on the optimal dose, two on a low dose now considered ineffective, and one in the group who took fake pills. One death was due to a car accident and another to a gunshot wound, Greene said. He could not recall the reasons for the other two.
None were considered treatment-related, in that the FDA did not request any more information or modification of the study based on their occurrence, he said.