Half of the participants took sibutramine along with standard medical care for five years, while the other half received a sugar pill (placebo) and got standard medical care. During that time, serious cardiovascular events occurred in 11.4 percent of those taking sibutramine, compared to 10 percent of patients taking the placebo. These results suggest that instead of reducing cardiovascular risk, sibutramine is associated with an increased risk. However, additional data from the SCOUT study indicates that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of heart disease.
Abbott spokesman Kurt Ebenhoch says Meridia is safe when used as prescribed in the appropriate group of people. He argues that the SCOUT study not only included high-risk patients, but that participants took the drug much longer than the one-year maximum use recommended. “Sibutramine is not recommended or approved for use in more than 90 percent of the patients in the SCOUT study,” Ebenhoch said. Approved by the FDA in 1997, Meridia is intended for use by obese people with a body mass index (BMI) of 30 or higher in conjunction with a reduced calorie diet and regular exercise. It is also prescribed for some people with BMIs as low as 27 when they have weight-related conditions such as diabetes, high cholesterol, controlled hypertension or sleep apnea.
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