Comparison of the effects of valsartan and felodipine on plasma leptin and insulin sensitivity in hypertensive obese patients.

Aim of this study was to compare the effect of valsartan and felodipine on blood pressure (BP), plasma leptin (L), insulin sensitivity and plasma norepinephrine (NE) in obese hypertensive patients. Ninty-six obese patients (body mass index [BMI] > or = 30 kg/m2) with mild to moderate essential hypertension (diastolic blood pressure [DBP] > 90 and < 110 mmHg, as evaluated with an appropriately sized cuff) aged 31-60 years, were randomized to a valsartan (80 mg/day for 16 weeks; n = 48) or felodipine (5 mg/day for 16 weeks; n = 48) treatment group after a 2-week wash-out period. After the first 4 weeks of treatment there was a titration with dose-doubling in non responder patients (DBP > 90 mmHg). At the end of the placebo period and of active treatment period, BP and BMI were evaluated and a venous sample was drawn at the same hour in the morning to evaluate plasma L and NE. Insulin resistance index (HOMA-IR) was calculated. No dietary advice was prescribed. Both valsartan and felodipine significantly decreased BP values (-19.3/15 mmHg and -18.9/13.6 mmHg, respectively p < 0.001 vs. placebo), with no difference between treatments. However, felodipine increased plasma NE (+124 pg/ml, +38.2%, p < 0.05 vs. placebo and < 0.01 vs. valsartan) and had no effect on L, body weight and HOMA-IR index, while valsartan did not modify NE and produced a significant reduction in L (-3.7 ng/ml, -10.1%, p < 0.05 vs. placebo), BMI (-1.7 kg/m2, -4.7%, p < 0.01 vs. placebo) and HOMA-IR index (-1.6, -20%, p < 0.05 vs. placebo). These results suggest that in hypertensive obese subjects, treatment with valsartan might offer an advantage over treatment with felodipine, since valsartan may help to improve obesity-related disorders in addition to lowering BP.

RCT Entities:   Population Interventions Outcomes