Cardiovascular responses to weight management and sibutramine in high-risk subjects: an analysis from the SCOUT trial.

Abstract

AIMS:

The Sibutramine Cardiovascular OUTcomes (SCOUT) trial is a randomized, double-blind comparison of sibutramine vs. placebo, in addition to standard care for weight management, in overweight/obese subjects with an increased risk of cardiovascular disease. The study had an initial single-blind, 6-week lead-in period with sibutramine plus weight management. We report the cardiovascular responses and weight loss during this period.

METHODS AND RESULTS:

A total of 10,742 subjects received treatment in the lead-in period; 97% had cardiovascular disease, 88% hypertension and 84% type 2 diabetes. Body weight decreased (median 2.2 kg [5th, 95th percentile changes -6.2, 0.5]); waist circumference was reduced by 2.0 cm (men: -8.5, 2.9; women: -9.0, 3.0), systolic blood pressure fell by 3.0 mmHg (-23.5, 12.5) and diastolic by 1.0 mmHg (-13.5, 10.0). Pulse rate increased by 1.5 b.p.m. (-11.0, 13.5). All changes were statistically significant (P < 0.001). Two consecutive increases in blood pressure or pulse rate of >10 mmHg/b.p.m. were observed in 4.7 and 3.5% of subjects, respectively. Fifteen subjects (0.1%) died; 10 deaths were attributed to a cardiovascular cause, equivalent to 1.2 and 0.8 deaths per 100 years of exposure, respectively.

CONCLUSION:

Six-week treatment with sibutramine appears to be efficacious, tolerable and safe in this high-risk population for whom sibutramine is usually contraindicated.

• Authors: Christian Torp-Pedersen, Ian Caterson, Walmir Coutinho, Nick Finer, Luc Van Gaal, Aldo Maggioni, Arya Sharma, Wygenia Brisco, Roger Deaton, Gillian Shepherd, Philip James, SCOUT Investigators
• Journal: European heart journal (Eur Heart J) Vol. 28 Issue 23 Pg. 2915-23 (Dec 2007) ISSN: 0195-668X [Print] England
• PMID: 17595194 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Appetite Depressants
• Cyclobutanes
• sibutramine

Topics

• Aged
• Appetite Depressants (therapeutic use)
• Cyclobutanes (therapeutic use)
• Diabetic Angiopathies (mortality)
• Double-Blind Method
• Female
• Humans
• Hypertension (mortality)
• Male
• Middle Aged
• Obesity (drug therapy, mortality)
• Reproducibility of Results
• Risk Assessment
• Risk Factors
• Weight Loss