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


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.


CONCLUSIONS
Six-week treatment with sibutramine appears to be efficacious, tolerable and safe in this high-risk population for whom sibutramine is usually contraindicated.
Torp-Pedersen
Christian
C
Department of Cardiology, Bispebjerg University Hospital, Bispebjerg Bakke 23, Copenhagen 2400 NV, Denmark. ctp@heart.dk
Caterson
Ian
I
Coutinho
Walmir
W
Finer
Nick
N
Van Gaal
Luc
L
Maggioni
Aldo
A
Sharma
Arya
A
Brisco
Wygenia
W
Deaton
Roger
R
Shepherd
Gillian
G
James
Philip
P
D000368:Aged; D001067:Appetite Depressants / Q000627:therapeutic use*; D003503:Cyclobutanes / Q000627:therapeutic use*; D003925:Diabetic Angiopathies / Q000401:mortality*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000401:mortality; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D015431:Weight Loss
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine