title: Olmesartan/amlodipine combination versus olmesartan or amlodipine monotherapies on blood pressure and insulin resistance in a sample of hypertensive patients.
abstract: 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.
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, Piazzale C. Golgi 2, Pavia, Italy. giuseppe.derosa@unipv.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Derosa
authors.forename: Arrigo F G
authors.initials: AF
authors.lastname: Cicero
authors.forename: Anna
authors.initials: A
authors.lastname: Carbone
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Querci
authors.forename: Elena
authors.initials: E
authors.lastname: Fogari
authors.forename: Angela
authors.initials: A
authors.lastname: D'Angelo
authors.forename: Pamela
authors.initials: P
authors.lastname: Maffioli
mesh_terms: D017311:Amlodipine / Q000494:pharmacology* / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000494:pharmacology* / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects* / Q000502:physiology; D015992:Body Mass Index; D001835:Body Weight / Q000502:physiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000188:drug therapy / Q000503:physiopathology*; D007093:Imidazoles / Q000494:pharmacology* / Q000627:therapeutic use; D007333:Insulin Resistance / Q000502:physiology*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000494:pharmacology* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D007093:Imidazoles; D008055:Lipids; D013777:Tetrazoles; D017311:Amlodipine; C437965:olmesartan