Study: Weight-loss drug ups risk of heart attack, stroke in some September 01, 2010 2:38PM

The study confirms longstanding concerns about the safety of Meridia in people with heart disease and other heart problems, who are already warned against taking the drug.

A Food and Drug Administration (FDA) advisory committee is scheduled to meet later this month to discuss the possibility of increased regulation for Meridia. The meeting was prompted by the preliminary results from the study, known as SCOUT, which were released by the agency in November 2009.

In the study -- which was sponsored by the drug's maker, Abbott Laboratories -- researchers followed 10,744 overweight and obese people who had heart disease or type 2 diabetes and a risk factor for heart disease (such as high blood pressure) for about 3.5 years.

During that time, 4.1 percent and 2.6 percent of the people taking Meridia had a nonfatal heart attack or stroke, respectively, compared with 3.2 percent and 1.9 percent of the people taking a placebo pill. That translates into a 28 percent increased risk of heart attack and a 36 percent increased risk of stroke, according to the study.

However, Meridia did not appear to increase the risk of heart attack or stroke in diabetics with no history of heart disease. Nor did the researchers find any differences in the death rates from heart attack, stroke, or other causes in people taking Meridia versus placebo.

Lead researcher W. Philip T. James, M.D., an obesity expert at the London School of Hygiene and Tropical Medicine, in the U.K., says that the study underscores that Meridia should not be prescribed to people with existing heart problems.

But, he adds, "it does not prove that you should extrapolate the data to the normal population for which the drug is intended."

The active ingredient in Meridia, sibutramine, suppresses appetite by affecting levels of the brain chemicals serotonin and norepinephrine. The drug is designed to be used by overweight and obese people, not by people who are a bit chubby and are trying to slim down.

Meridia has been shown to slightly raise blood pressure and heart rate, and the cardiovascular risk associated with the drug has been known for years.

Since being approved by the FDA in 1997, Meridia has carried a warning on its label that says the drug should not be used in people with a history of heart disease, heart failure, heart-rhythm problems, or stroke.

In January 2010, after reviewing the preliminary data from the SCOUT study, the FDA asked Abbott to strengthen the warning. The European Medicines Agency -- the European equivalent of the FDA -- chose to suspend sales of the drug in the European Union.

In an editorial accompanying the study, three New England Journal of Medicine editors suggest that the heart risk associated with Meridia is not justified by the weight loss seen in the study -- about 9.5 pounds (or 4.5 percent of initial body weight) after one year, on average.

"[I]t is difficult to discern a credible rationale for keeping this medication on the market," the editors write.

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- Anne Harding

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