The SCOUT study: risk-benefit profile of sibutramine in overweight high-risk cardiovascular patients

Moderate weight loss improves metabolic and cardiovascular risk factors and prevents the progression to Type 2 diabetes. Furthermore, a healthy lifestyle is associated with lower cardiovascular mortality, whereas sustained weight loss and increased fitness are both associated with reduced cardiovascular mortality. Currently available antiobesity drugs have been shown to deliver moderate weight loss in more patients and for longer than diet and exercise alone. In addition, these anti-obesity agents impact positively on multiple cardiovascular risk factors. The question of whether the use of weight loss agents can prevent cardiovascular morbidity and mortality has not been studied so far. The Sibutramine Cardiovascular Outcome Trial (SCOUT) has been designed to determine whether weight management in cardiovascular high-risk overweight and obese patients can impact upon cardiovascular endpoints. Patient enrolment for the SCOUT trial began in December 2002 with the first patient randomized in February 2003. The study will involve 9000 patients in 16 countries. They will be treated with a novel lifestyle intervention programme and randomized in a double-blind fashion to receive either sibutramine or placebo.