title: Results from a 12 months, randomized, clinical trial comparing an olmesartan/amlodipine single pill combination to olmesartan and amlodipine monotherapies on blood pressure and inflammation.
abstract: OBJECTIVE
  Hypertension affects nearly 1 in 3 adults in the United States, and it is an important modifiable risk factor for coronary artery disease, heart failure, renal failure, and stroke. The aim of this study was to evaluate the effects of a fixed-dose olmesartan/amlodipine combination on blood pressure control, lipid profile, insulin sensitivity, and inflammation compared to singles monotherapies.
  
  
  METHODS
  We randomized 276 hypertensive patients to olmesartan 20 mg, amlodipine 10mg or a single pill containing a fixed-dose olmesartan/amlodipine combination 20/5mg for 12 months. We evaluated: body weight, body mass index (BMI), systolic and diastolic blood pressure (SBP and DBP), fasting plasma glucose (FPG), fasting plasma insulin (FPI), lipid profile, omentin, chemerin, high sensitivity C-reactive protein (Hs-CRP). At baseline, and after 6 and 12 months, patients underwent an euglycemic, hyperinsulinemic clamp to assess insulin sensitivity (M value).
  
  
  RESULTS
  Olmesartan/amlodipine combination was more effective than amlodipine or olmesartan in reducing blood pressure. Olmesartan/amlodipine combination, but not amlodipine, decreased FPG after 12 months. Olmesartan/amlodipine combination better decreased FPI and HOMA index and increased M value compared to olmesartan and amlodipine monotherapies. Olmesartan/amlodipine significantly decreased chemerin and omentin compared to olmesartan and amlodipine.
  
  
  CONCLUSIONS
  Other than to be more effective in reducing blood pressure, olmesartan/amlodipine single pill combination gave also a major increase of insulin sensitivity and a decrease of inflammatory markers compared to single monotherapies.
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Pavia, Italy. Electronic address: 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 / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001786:Blood Glucose / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects*; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D007093:Imidazoles / Q000008:administration & dosage*; D007249:Inflammation / Q000188:drug therapy*; D007333:Insulin Resistance / Q000502:physiology; D008055:Lipids; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000008:administration & dosage*
chemical_list: D000959:Antihypertensive Agents; D001786:Blood Glucose; D004338:Drug Combinations; D007093:Imidazoles; D008055:Lipids; D013777:Tetrazoles; D017311:Amlodipine; C437965:olmesartan
keywords: Amlodipine; Amlodipine besylate; Amlodipine besylate/olmesartan medoxomil; Combination therapy; High sensitivity C-reactive protein; Olmesartan; Olmesartan medoxomil; Omentin