Sibutramine: a safety profile

Sibutramine is one of two anti-obesity agents approved by the National Institute of Clinical Excellence. It inhibits the re-uptake of noradrenaline and serotonin in the brain. By enhancing the sensation of satiety after a meal and reducing the fall in basal metabolic rate which usually occurs during weight loss, sibutramine is a useful aid to achieving weight loss and weight maintenance. Randomised controlled trials have shown that sibutramine 10 mg/day, in combination with diet and exercise, produces and maintains a dose-related weight loss of 5–10% in the majority of obese patients studied. This is accompanied by a range of important health benefits, including improvements in cholesterol and triglyceride levels.
Adverse publicity led to the European Commission’s Committee for Proprietary Medicinal Products recently carrying out an in-depth investigation into the use of sibutramine in over 12,000 patients across Europe. Its findings support the use of sibutramine in obesity management, with no causal link found between the use of the drug and mortality. No change has been made to the Summary Product of Characteristics regarding the cardiovascular safety of sibutramine and the drug has been re-instated for use in Italy.
Prescribers should be aware of the cautions surrounding sibutramine use. While it is not advisable for those with a history of coronary heart disease or cardiac arrhythmias, published data reveal that most patients on sibutramine experience a drop in blood pressure and it may be used safely in patients with controlled hypertension. A small number of patients treated may show increases in blood pressure, particularly those who appear to be non-responders. Regular blood pressure monitoring is therefore advised.