Olmesartan/amlodipine combination versus olmesartan or amlodipine monotherapies on blood pressure and insulin resistance in a sample of hypertensive patients.

Despite the wide range of antihypertensive medications, about 45.5% of treated patients fail to achieve the desired blood pressure (BP) target. This study evaluated the effects of an olmesartan/amlodipine single pill combination compared to olmesartan or amlodipine monotherapies on BP, lipid profile, insulin resistance, and insulin sensitivity parameters. Two hundred and seventy-six patients were randomly assigned to olmesartan (20 mg), amlodipine (10 mg), or a single pill containing olmesartan/amlodipine (5/20 mg) for 12 months. We evaluated the following parameters at the baseline, and after 6 and 12 months: body weight, body mass index (BMI), systolic and diastolic blood pressure (SBP and DBP), fasting plasma glucose (FPG), fasting plasma insulin (FPI), and lipid profile. At the baseline, and after 6 and 12 months, patients underwent an euglycemic, hyperinsulinemic clamp to assess M value. Olmesartan/amlodipine gave a greater decrease in SBP and DPB compared to amlodipine and olmesartan at 6 (P < .05) and 12 months (P < .01). There was a decrease in FPG with olmesartan/amlodipine after 12 months compared to amlodipine (P < .05). Olmesartan/amlodipine decreased FPI and homeostasis model assessment index compared to both baseline (P < .05) and olmesartan and amlodipine (P < .05). Olmesartan/amlodipine gave an increase in M value, compared to baseline (P < .01) and to olmesartan monotherapy (P < .05) and amlodipine monotherapy (P < .01). In this randomized, double-blind clinical trial, olmesartan/amlodipine combination resulted more effective than olmesartan and amlodipine monotherapies in reducing BP, in improving insulin resistance, and insulin sensitivity parameters in patients with stage I essential hypertension. The combination also resulted in less peripheral edema.

RCT Entities:   Population Interventions Outcomes