title: Effects of amlodipine fosinopril combination on microalbuminuria in hypertensive type 2 diabetic patients.
abstract: BACKGROUND
  The aim of this study is to compare the long-term effect of amlodipine and fosinopril in monotherapy or in combination on urinary albumin excretion (UAE) in hypertensive diabetic patients.
  
  
  METHODS
  We selected 453 hypertensive patients with type 2 diabetes and microalbuminuria and randomized them to amlodipine (5 to 15 mg/day), fosinopril (10 to 30 mg/day), or amlodipine plus fosinopril (5/10 to 15/30 mg/day) for a 3-month titration period. The nonresponder patients or those complaining of side effects during the titration period were discontinued (n = 144); the remaining 309 patients were enrolled in the trial and treated with the same therapy for 4 years. Every 6 months, blood pressure (BP), heart rate (HR), UAE, creatinine clearance, and glycosylated hemoglobin (HbA1c) were evaluated.
  
  
  RESULTS
  The combination therapy was more effective in reducing BP than either drug alone at any time of the study without affecting glucose homeostasis. All three treatments provided a significant decrease in UAE during the 48-month study period. However, this effect was more pronounced and became evident earlier with fosinopril than with amlodipine monotherapy (after 3 v 18 months of therapy). In addition, the combination therapy provided a greater antialbuminuric effect than the single drugs. This could be due to the greater antihypertensive effects, although other drug-specific effects cannot be excluded. The cardiovascular outcomes were similar in the amlodipine and in the fosinopril group, but they were lower in the combination group.
  
  
  CONCLUSIONS
  These results strengthen the rationale to use a calcium-antagonist/angiotensin converting enzyme inhibitor combination in the treatment of hypertensive patients with type 2 diabetes.
authors.affiliation: Department of Internal Medicine and Therapeutics, Clinica Medica IRCCS Policlinico S. Matteo, University of Pavia, Pavia, Italy. r.fogari@smatteo.pv.it
authors.forename: Roberto
authors.initials: R
authors.lastname: Fogari
authors.forename: Paola
authors.initials: P
authors.lastname: Preti
authors.forename: Annalisa
authors.initials: A
authors.lastname: Zoppi
authors.forename: Andrea
authors.initials: A
authors.lastname: Rinaldi
authors.forename: Luca
authors.initials: L
authors.lastname: Corradi
authors.forename: Carlo
authors.initials: C
authors.lastname: Pasotti
authors.forename: Luigi
authors.initials: L
authors.lastname: Poletti
authors.forename: GianLuigi
authors.initials: G
authors.lastname: Marasi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Derosa
authors.forename: Amedeo
authors.initials: A
authors.lastname: Mugellini
authors.forename: Carlo
authors.initials: C
authors.lastname: Voglini
authors.forename: Pierangelo
authors.initials: P
authors.lastname: Lazzari
mesh_terms: D000368:Aged; D000419:Albuminuria / Q000188:drug therapy* / Q000209:etiology; D017311:Amlodipine / Q000627:therapeutic use*; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D004338:Drug Combinations; D005260:Female; D017328:Fosinopril / Q000627:therapeutic use*; D006442:Glycated Hemoglobin; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D017311:Amlodipine; D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D017328:Fosinopril; D006442:Glycated Hemoglobin