A046: Well-controlled hypertension in obese patients remains well-controlled during weight reduction on sibutramine treatment

The beneficial effect of weight reduction on risk factors for CHD, including hypertension and serum lipids, is known. The prevalence of obesity has increased in the US, and although many attempt weight reduction, long-term success has been disappointing. Sibutramine (Sib), a serotonin noradrenaline reuptake inhibitor (SNRI) taken once daily, is an effective adjunct to a weight reduction program (reduced calorie diet and behavioral changes). However, changes in BP have been a concern with Sib. Three multicenter, double-blind, placebo-controlled, randomized trials in obese (BMI ≤ 30 kg/m2), hypertensive patients were designed to assess the effects of Sib on BP in patients with well-controlled hypertension at entry. Hypertension was controlled with either ACEIs, CCBs, or β-blockers, with or without concomitant thiazide diuretics. Both mean SBP and DBP increased slightly from entry to study end, but mean BP values remained within the general target ranges shown to confer maximal protection against combined major CV endpoints (Table above). This occurred even with a Sib dose of 20 mg, higher than currently recommended. Generally, beneficial changes in some serum lipid risk factors for CHD (HDL-C, VLDL-C, and triglycerides) were significantly greater in the Sib group compared with placebo (P ≤ 0.05), as was weight reduction and reduced BMI (P ≤ 0.05 for the comparison). Significantly greater weight reduction on Sib resulted in greater improvements in serum lipid risk factors for CHD. In all 3 studies, hypertension well controlled at entry remained well controlled at the end of the study.BP (mean, mm Hg, supine) in obese patients during weight loss on Sib treatment (20 mg once daily; LOCF) Blood Pressure at entry at endpoint Antihypertensive (n, wk) SBP DBP SBP DBP Weight change (kg) ACEIs (145, 52) 129.3 82.5 133.1* 85.5* −4.5* CCBs (142, 52) 133.8 84.1 136.5 86.1* −4.4* β-blockers (29, 12) 130.8 82.0 132.4 84.4 −4.2* *P ≤ 0.05; change in Sib treatment compared with change in placebo.