The Sibutramine Cardiovascular OUTcomes (SCOUT) trial involved approximately 10,000 patients who were overweight or obese and had risk factors for cardiovascular disease for example diabetes or dyslipidaemia. The study aimed to assess the efficacy of drug assisted weight loss using sibutramine on cardiovascular outcomes in this higher risk population.
The EMEA are reviewing data that indicate an increased risk of serious cardiovascular events, such as stroke or heart attack. In the meantime clinicians and patients are reminded to use sibutramine-containing medicines with caution, and only in accordance with the currently approved product information. It is noted that the patients recruited to the SCOUT study would have been contraindicated in the majority of cases.
Clinicians should refer to the Summary of Product Characteristics and be aware of the following:
- Sibutramine is contraindicated in patients with a history of coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or TIA)
- All patients taking sibutramine 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
Action: Clinicians should be aware of this review and use sibutramine cautiously until it is completed. Preferential use of orlistat, for the time being at least, would seem sensible.