Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects

The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established.

Obesity and excess weight are escalating public health concerns because they increase the prevalence of associated conditions such as diabetes mellitus and the risk of premature death.1,2 More than 80% of even highly motivated patients are unable to achieve weight loss with dietary and lifestyle modifications alone.3

Sibutramine is a norepinephrine and serotonin reuptake inhibitor that was approved for weight management in patients who are unable to lose weight by means of diet and exercise alone. Sibutramine induces satiety (resulting in reduced food intake) and an increase in energy expenditure.4,5 In some patients, sibutramine increases blood pressure, pulse rate, or both, owing to its sympathomimetic effects.6 Sibutramine is not indicated for patients with a history of cardiovascular disease; otherwise, treatment with sibutramine is recommended for no more than 1 to 2 years in patients who achieve a 5% weight loss. The Sibutramine Cardiovascular Outcomes (SCOUT) trial evaluated the long-term effects of sibutramine treatment combined with diet and exercise on the rates of cardiovascular events and cardiovascular death among subjects who were at high cardiovascular risk.

Conclusions

Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.)