Evaluation of safety and efficacy of a fixed olmesartan/amlodipine combination therapy compared to single monotherapies

Autor: Angela D'Angelo, Elena Fogari, Fabrizio Querci, Arrigo F G Cicero, Pamela Maffioli, Anna Carbone, Giuseppe Derosa
Přispěvatelé: Derosa G, Cicero AF, Carbone A, Querci F, Fogari E, D'Angelo A, Maffioli P.
Rok vydání: 2013
Předmět:
Zdroj: Expert Opinion on Drug Safety. 12:621-629
ISSN: 1744-764X
1474-0338
DOI: 10.1517/14740338.2013.816674
Popis: BACKGROUND: Hypertension is known to be one of the main risk factors for cardiovascular disease. OBJECTIVES: To evaluate the safety and efficacy of a fixed olmesartan/amlodipine (Olme/Amlo) combination in improving blood pressure control, lipid profile, insulin sensitivity and some inflammatory and insulin resistance markers. Two hundred and seventy-six hypertensive patients were randomly assigned to olmesartan 20 mg, amlodipine 10 mg or a single pill containing an Olme/Amlo combination 20/5 mg for 12 months. We evaluated after 6 and 12 months: body weight, body mass index (BMI), systolic and diastolic blood pressure (SBP and DBP, respectively), fasting plasma glucose (FPG), fasting plasma insulin (FPI), lipid profile, vaspin, visfatin, interleukins 8 and 10 (IL-8 and IL-10, respectively). Patients also underwent an euglycemic, hyperinsulinemic clamp. RESULTS: Olme/Amlo combination was more effective in decreasing SBP, and DPB compared to single monotherapies after 12 months. Olme/Amlo combination, but not amlodipine, decreased FPG after 12 months. FPI and HOMA index were decreased, and M value increased by Olme/Amlo combination compared to olmesartan monotherapy, and to amlodipine monotherapy. Olme/Amlo significantly decreased IL-8 and IL-10 better than each monotherapy. CONCLUSIONS: Olme/Amlo single pill combination can be a safe and effective option to reduce blood pressure, improve insulin sensitivity and decrease inflammatory markers.
Databáze: OpenAIRE