E016: Anti-obesity therapy with sibutramine has no clinically significant effect on cardiovascular variables, ventricular dimensions and heart valves in obese patients

Abstract

Background:

Anorexigens have been associated with cardiovascular side effects including heart rate (HR), blood pressure (BP) and valvular changes. We assessed the effect of sibutramine (sib), a monoamine reuptake inhibitor, on HR, BP, LV geometry and function and heart valves.

Methods:

non complicated obese patients (n = 184, 30 ≤ BMI < 40 kg/m2) were randomized double blind to 6 months o.d. sib 10 mg (n = 64) or 20 mg (n = 60) or placebo (n = 60). 2D-Echos were obtained using an ATL Peak 800+ machine, LV mass index (LVMI) was calculated according to Devereux and Reichek and adjusted for height. Heart valves were examined in various axes. Echo data were obtained for 173 patients (10 mg = 61, 20 mg = 56 or placebo = 56). Echo were performed at baseline (twice − poor quality and/or reproducibility echo were excluded) and at 6 months by a single operator.

Results:

Baseline patients’ characteristics, comparable between the 3 treatment groups, were as follows: age = 38.7 ± 10.8 yrs, 85% female, BMI = 33.8 ± 2.8 kg/m², SBP/DBP = 121.4 ± 11.7/75.3 ± 8.6 mmHg, LVMI = 60.8 ± 15.9 g/m, LVEF = 65.0 ± 5.4%; grade 1 or 2 valve regurgitation was found in 11% (mitral), 8% (aortic), and 3% (tricuspid) of patients. At 6 months sib decreased BMI (ANOVA) (10 mg: −3.5 ± 2.1 vs 20 mg: −4.4 ± 2.5 vs placebo −1.7 ± 1.6, p < 0.001) and slightly increased HR (+5.7 vs +5.8 vs +0.1bpm, p = 0.001). SBP and DBP and ECG variables, including QT and QTc, were unchanged. Statistically significant differences for LVMI reductions were seen in the sib groups from baseline (p < 0.01) but pairwise comparisons with placebo were not significant (−4.4, −4.3 vs −3.0). Valvular changes were not significant.

Conclusion:

Obese patients treated with sib 10 mg or 20 mg or placebo for 6 ••• falls in LVM associated with weight loss; these falls were significantly greater for the sib groups from baseline. Also, apart from a slight rise in HR, sib did not affect BP, ECG variables and heart valves.

© American Journal of Hypertension, Ltd. 2000