The European Medicines Agency is reviewing data from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial that indicated an increased risk of serious cardiovascular events with sibutramine containing medicines (Reductil®, Reduxade® and Zelium®).

The study which included nearly 10,000 patients enrolled for up to six years, aimed to determine how long-term treatment with sibutramine would impact on the risk of developing cardiovascular events in a large group of overweight and obese patients with known or high risk of cardiovascular disease. These patients were actively selected for the study even though treatment with sibutramine would have been contraindicated in the majority of cases.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) is currently assessing the implications of the study findings for the use of sibutramine in clinical practice and will conclude its review at the January 2010 meeting. In the meantime, doctors and patients are reminded of the following:

• Use sibutramine-containing medicines with caution, and only in accordance with the currently approved product information.

• Sibutramine-containing medicines should not be used in patients with coronary artery disease, congestive heart failure, peripheral arterial occlusive disease, arrhythmia and cerebrovascular disease.

• All patients should be regularly monitored for increases in blood pressure and heart rate.

• Patients who do not lose at least 5% of their body weight within 3 months should stop treatment.

• The maximum treatment duration should not exceed one year.