title: Olmesartan Combined With Amlodipine on Oxidative Stress Parameters in Type 2 Diabetics, Compared With Single Therapies: A Randomized, Controlled, Clinical Trial.
abstract: To evaluate the effects of a fixed combination of olmesartan/amlodipine compared with olmesartan or amlodipine alone on some parameters of endothelial damage in diabetic, hypertensive patients.We enrolled 221 patients; 74 were randomized to olmesartan 20 mg, 72 to amlodipine 10 mg, and 75 to olmesartan/amlodipine fixed combination 20/5 mg for 12 months. We assessed blood pressure monthly; in addition, we also assessed at baseline, and after 6 and 12 months, the following parameters: lipoprotein (a), myeloperoxidase (MPO), isoprostanes, and paraoxonase-1 (PON-1). Blood pressure values obtained with fixed olmesartan/amlodipine combination were significantly lower than those reached with single monotherapies. There was a reduction of lipoprotein (a), and isoprostanes levels with olmesartan/amlodipine fixed combination, both compared with baseline, and with single monotherapies. On the other hand, there was an increase of PON-1 with fixed olmesartan/amlodipine combination, both compared with baseline, and with single drugs. All treatments reduced MPO compared with baseline; however, in group-to-group comparison, MPO reduction was greater with olmesartan/amlodipine fixed combination. Fixed combination of olmesartan/amlodipine was more effective than single monotherapies in reducing oxidative stress, especially in increasing PON-1, and reducing isoprostanes levels in diabetic and hypertensive patients.
authors.affiliation: From the Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico San Matteo (GD, AM, RMP, ADA, PM); Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research (GD); Laboratory of Molecular Medicine (GD, ADA); and PhD School in Experimental Medicine (PM), University of Pavia, Pavia, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Derosa
authors.forename: Amedeo
authors.initials: A
authors.lastname: Mugellini
authors.forename: Rosa Maria
authors.initials: RM
authors.lastname: Pesce
authors.forename: Angela
authors.initials: A
authors.lastname: D'Angelo
authors.forename: Pamela
authors.initials: P
authors.lastname: Maffioli
mesh_terms: D000328:Adult; D017311:Amlodipine / Q000008:administration & dosage / Q000494:pharmacology; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000494:pharmacology*; D043303:Aryldialkylphosphatase / Q000097:blood; D001794:Blood Pressure; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology*; D007093:Imidazoles / Q000008:administration & dosage / Q000494:pharmacology; D028421:Isoprostanes / Q000097:blood; D008297:Male; D018384:Oxidative Stress / Q000187:drug effects*; D009195:Peroxidase / Q000097:blood; D013777:Tetrazoles / Q000008:administration & dosage / Q000494:pharmacology
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D007093:Imidazoles; D028421:Isoprostanes; D013777:Tetrazoles; D017311:Amlodipine; C437965:olmesartan; D009195:Peroxidase; D043303:Aryldialkylphosphatase