Key result
Nineteen months of sibutramine treatment did not affect heart valve function but regressed stage II diastolic dysfunction in 33.3% of the 10 mg group and 50% of the 15 mg group.
Why the study?
Does sibutramine affect cardiac valve characteristics and adipokine levels in obese women?
RCT (n=60)
randomized
Does sibutramine affect cardiac valve characteristics and adipokine levels in obese women?
Long-term sibutramine treatment in obese women does not cause significant valvular heart disease and is associated with improved diastolic function and favorable changes in inflammatory biomarkers.
Sibutramine may improve diastolic function without valvular risk in obese women; extends RCT evidence on its long-term cardiac effects.
OBJECTIVE: The aims of present study were 1) to evaluate cardiac valve characteristics, 2) to determine the plasma concentrations of fibrinogen, high sensitivity C-reactive protein (hsCRP), adiponectin, and tumor necrosis factor-alpha (TNF-alpha) in the obese women before and after 19 months sibutramine treatment in the obese women. METHODS: Sixty obese women were enrolled in this prospective, randomized study. Thirty women received 10 mg once daily dose of sibutramine for 19 months. The rest of the obese women received 15 mg once daily dose of sibutramine for 19 months. All patients were evaluated with echocardiography. Plasma levels of adiponectin and TNF-alpha were measured by enzyme-linked immunosorbent assay (ELISA) and hsCRP by immunoturbimetric assay. Student paired and unpaired t tests were used to compare the 10 mg or 15 mg dose sibutramine effects either in groups or between the groups. RESULTS: There were no signs of significant regurgitation or thickening of the mitral and aortic valves on echocardiographic evaluation performed after 19 months of treatment. Parameters of systolic function after 10 or 15 mg treatment were not different from pretreatment characteristics. Minimal tricuspid regurgitation was found in one (1/27) patient treated with 10 mg sibutramine after 19 months. Among obese patients treated with 15 mg sibutramine one patient (1/28) had minimal mitral valve regurgitation and 2 patients (2/28) had minimal aortic insufficiency. Stage II diastolic dysfunction in the 15 obese treated with 15 mg regressed to stage I diastolic dysfunction (50%). Stage II diastolic dysfunction in the 10 obese treated with 10 mg regressed to stage I diastolic dysfunction (33.3%). Mean levels of TNF-alpha(p=0.04), fibrinogen (p=0.03) and hsCRP (p=0.04)i decreased and adiponectin (p=0.03) levels increased in the obese treated with 10 mg sibutramine. Likewise, in the patients treated with 15 mg sibutramine, mean levels of TNF- alpha(p=0.01), fibrinogen (p= 0.02), and hsCRP (p= 0.04) decreased and adiponectin (p= 0.02) levels increased. CONCLUSION: Nineteen months of sibutramine treatment does not affect heart valve and systolic functions, however, diastolic dysfunction severity reduced with sibutramine treatment. Also In addition, mean levels of adiponectin, TNF- alpha, fibrinogen and hs- CRP change with 19 months sibutramine treatment.
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Sarac et al. (2010) conducted an RCT in Obesity (n=60). Sibutramine vs. 15 mg once daily was evaluated on Cardiac valve characteristics and plasma concentrations of fibrinogen, hsCRP, adiponectin, and TNF-alpha. Nineteen months of sibutramine treatment did not affect heart valve function but regressed stage II diastolic dysfunction in 33.3% of the 10 mg group and 50% of the 15 mg group.
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