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

Giuseppe Derosa, Arrigo Francesco Giuseppe Cicero, Anna Carbone, Fabrizio Querci, Elena Fogari, Angela D'Angelo, Pamela Maffioli

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)621-629
Number of pages9
JournalExpert Opinion on Drug Safety
Issue number5
Publication statusPublished - Sep 2013


  • Amlodipine
  • Combination therapy
  • Hypertension
  • Interleukins
  • Olmesartan

ASJC Scopus subject areas

  • Pharmacology (medical)


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