Cardiovascular responses to weight management and sibutramine in high-risk subjects: an analysis from the SCOUT trial.
نویسندگان
چکیده
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.
منابع مشابه
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 ...
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1. Florentin M, Liberopoulos EN, Elisaf MS. Sibutramineassociated adverse effects: a practical quide for its safe use. Obes Rev. 2008;9:378-87. 2. Torp-Pedersen C, Caterson I, Coutinho W, Finer N, van Gaal L, Maggioni A, et al; on the behalf of the SCOUT Investigators. Cardiovascular responses to weight management and sibutramine in high-risk subjects: an análisis from the SCOUT trial. Eur Hear...
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BACKGROUND Obesity, type 2 diabetes mellitus (T2D) and unhealthy blood lipid profile are strongly associated with the risk of developing cardiovascular disease (CVD). We examined whether blood lipid changes with short term administration of the weight lowering drug, sibutramine and lifestyle modification in obese and overweight high-risk patients was associated with T2D status at screening. M...
متن کاملAuthor's response to reviews Title: The weight lowering effect of sibutramine and its impact on serum lipids in cardiovascular high risk patients with and without type 2 diabetes mellitus - an analysis from the SCOUT lead-in period Authors:
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Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial
BACKGROUND AND AIMS Elevated levels of serum uric acid are associated with an increased risk of cardiovascular morbidity and mortality. The response of uric acid to weight loss therapy (lifestyle plus sibutramine) in an overweight and obese cardiovascular high risk population was studied. METHODS AND RESULTS Data from a four week single-blind lead-in period of the Sibutramine Cardiovascular O...
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عنوان ژورنال:
- European heart journal
دوره 28 23 شماره
صفحات -
تاریخ انتشار 2007