ROCKVILLE, Md -- November 23, 2009 -- The US Food and Drug Administration (FDA) is reviewing preliminary data from a recent study suggesting that patients using sibutramine (Meridia) have a higher number of cardiovascular events than patients using a placebo.
The analysis of these data is ongoing and the FDA is making no conclusions about the preliminary findings at this time.
These findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease, congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling.
The Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study began in 2002. The analysis of the study results is ongoing by the manufacturer. The FDA was made aware of the preliminary results for the study primary endpoint (combination of myocardial infarction [MI], stroke, resuscitated cardiac arrest, or death) in mid November 2009. Part of a post-approval commitment between the European Medicines Agency (EMEA) and the manufacturer, the study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared with weight loss from a placebo and standard care.
Patients included in the study were aged 55 years and older, overweight or obese, and had a history of heart disease or type 2 diabetes plus 1 additional cardiovascular risk factor. Patients who recently had a MI or stroke, or had poorly controlled CHF were not included in the study. Approximately 10,000 patients enrolled in the study.
The preliminary analysis of the primary endpoint suggests that patients using sibutramine experienced a higher number of cardiovascular events compared with those using a placebo. The preliminary data shows that cardiovascular events were reported in 11.4% of patients using sibutramine compared with 10% of patients using a placebo. This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population.
Healthcare professionals should continue to evaluate the benefits and risks of sibutramine, taking into account individual patient medical histories.
The FDA urges both healthcare professionals and consumers to report side effects from the use of sibutramine to FDA's MedWatch Adverse Event Reporting program.
SOURCE: US Food and Drug Administration
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