Weight loss is fundamental for the prevention of cardiovascular events, so trials to find effective solutions to overweight and obesity are more and more frequently performed. In this trial, sponsored by pharmaceutical industry, over 10,000 subjects with an excess of weight and with known cardiovascular risk factors or with type 2 diabetes and at least another risk factor have been collected. After 6 weeks of treatment with sibutramine, participants tolerating it have been further treated with sibutramine or placebo for over 3 years, receiving, at the same time, a counseling concerning diet and physical exercise, too. Weight loss at the end resulted of 2 kg more in the group treated with sibutramine, but in this group the incidence of the primary endpoint (infarction, stroke, death for cardiovascular cause) has been significantly higher: 11.4% vs. 10.0%; P=0.02. The greater presence of side effects has been caused by an excess in infarctions and non-fatal strokes, while the data on cardiovascular mortality have been the same in the two groups.
In the USA there is a contraindication to the use of sibutramine in non-controlled patients with heart diseases or with hypertension. The results from this trial confirm this restriction and, to be sincere, the little gain obtained as to weight loss is not balanced by side effects, which are certainly heavy. Probably, the best choice is to use the drug in no patients, as the European Authority has recently recommended.
