title: L-arginine therapy in acute myocardial infarction: the Vascular Interaction With Age in Myocardial Infarction (VINTAGE MI) randomized clinical trial.
abstract: BACKGROUND
  The amino acid L-arginine is a substrate for nitric oxide synthase and is increasingly used as a health supplement. Prior studies suggest that L-arginine has the potential to reduce vascular stiffness.
  
  
  OBJECTIVE
  To determine whether the addition of L-arginine to standard postinfarction therapy reduces vascular stiffness and improves ejection fraction over 6-month follow-up in patients following acute ST-segment elevation myocardial infarction.
  
  
  METHODS
  Single-center, randomized, double-blind, placebo-controlled trial with enrollment from February 2002 to June 2004.
  
  
  METHODS
  A total of 153 patients following a first ST-segment elevation myocardial infarction were enrolled; 77 patients were 60 years or older.
  
  
  METHODS
  Patients were randomly assigned to receive L-arginine (goal dose of 3 g 3 times a day) or matching placebo for 6 months.
  
  
  METHODS
  Change in gated blood pool-derived ejection fraction over 6 months in patients 60 years or older randomized to receive L-arginine compared with those assigned to receive placebo. Secondary outcomes included change in ejection fraction in all patients enrolled, change in noninvasive measures of vascular stiffness, and clinical events.
  
  
  RESULTS
  Baseline characteristics, vascular stiffness measurements, and left ventricular function were similar between participants randomized to receive placebo or L-arginine. The mean (SD) age was 60 (13.6) years; of the participants, 104 (68%) were men. There was no significant change from baseline to 6 months in the vascular stiffness measurements or left ventricular ejection fraction in either of the 2 groups, including those 60 years or older and the entire study group. However, 6 participants (8.6%) in the L-arginine group died during the 6-month study period vs none in the placebo group (P = .01). Because of the safety concerns, the data and safety monitoring committee closed enrollment.
  
  
  CONCLUSIONS
  L-arginine, when added to standard postinfarction therapies, does not improve vascular stiffness measurements or ejection fraction and may be associated with higher postinfarction mortality. L-arginine should not be recommended following acute myocardial infarction. Clinical Trial Registration ClinicalTrials.gov, NCT00051376.
authors.affiliation: Division of Cardiology, Johns Hopkins Medical Institutions, Baltimore, USA. sschulma@jhmi.edu
authors.forename: Steven P
authors.initials: SP
authors.lastname: Schulman
authors.forename: Lewis C
authors.initials: LC
authors.lastname: Becker
authors.forename: David A
authors.initials: DA
authors.lastname: Kass
authors.forename: Hunter C
authors.initials: HC
authors.lastname: Champion
authors.forename: Michael L
authors.initials: ML
authors.lastname: Terrin
authors.forename: Sandra
authors.initials: S
authors.lastname: Forman
authors.forename: Kavita V
authors.initials: KV
authors.lastname: Ernst
authors.forename: Mark D
authors.initials: MD
authors.lastname: Kelemen
authors.forename: Susan N
authors.initials: SN
authors.lastname: Townsend
authors.forename: Anne
authors.initials: A
authors.lastname: Capriotti
authors.forename: Joshua M
authors.initials: JM
authors.lastname: Hare
authors.forename: Gary
authors.initials: G
authors.lastname: Gerstenblith
mesh_terms: D000368:Aged; D001120:Arginine / Q000009:adverse effects / Q000627:therapeutic use*; D050197:Atherosclerosis; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000503:physiopathology / Q000628:therapy*; D013318:Stroke Volume / Q000187:drug effects; D016277:Ventricular Function, Left / Q000187:drug effects*
chemical_list: D001120:Arginine