title: Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial).
abstract: BACKGROUND
  Statins have been proved to be effective in reduction of mortality and morbidity when started in the early secondary prevention in stabilized patients after acute coronary syndrome (ACS). The safety and efficacy of statin administration directly in the first-line therapy in unstable ACS patients is not clear. The aim of our study was, therefore, to assess the effect of statin treatment initiated immediately at hospital admission of patients with ACS.
  
  
  METHODS
  The trial was stopped prematurely after enrollment of one hundred and fifty-six patients with ACS that were randomized at admission to fluvastatin 80 mg (N = 78) or placebo (N = 78). Study medication was administered immediately after randomization and then once daily for 30 days; all patients were then encouraged to continue in open-label statin therapy and at the end of one-year follow-up 75% in the fluvastatin group and 78% in the placebo group were on statin therapy.
  
  
  RESULTS
  We did not demonstrate any difference between groups in the level of C-reactive protein, interleukin 6, and pregnancy-associated plasma protein A on Day 2 and Day 30 (primary endpoint). Fluvastatin-therapy, however, significantly reduced one-year occurrence of major adverse cardiovascular events (11.5% vs. 24.4%, odds ratio (OR) 0.40, 95% CI 0.17-0.95, P = 0.038). This difference was caused mainly by reduction of recurrent symptomatic ischemia (7.7% vs. 20.5%, OR 0.32, 95% CI 0.12-0.88, P = 0.037).
  
  
  CONCLUSIONS
  This study failed to prove the effect of fluvastatin given as first-line therapy of ACS on serum markers of inflammation and plaque instability. Fluvastatin therapy was, however, safe and it may reduce cardiovascular event rate that supports immediate use of a statin in patients admitted for ACS.
  
  
  BACKGROUND
  NCT00171275.
authors.affiliation: Heart Center, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic. ostadal@yahoo.com
authors.forename: Petr
authors.initials: P
authors.lastname: Ostadal
authors.forename: David
authors.initials: D
authors.lastname: Alan
authors.forename: Jiri
authors.initials: J
authors.lastname: Vejvoda
authors.forename: Jiri
authors.initials: J
authors.lastname: Kukacka
authors.forename: Milan
authors.initials: M
authors.lastname: Macek
authors.forename: Petr
authors.initials: P
authors.lastname: Hajek
authors.forename: Martin
authors.initials: M
authors.lastname: Mates
authors.forename: Milan
authors.initials: M
authors.lastname: Kvapil
authors.forename: Jiri
authors.initials: J
authors.lastname: Kettner
authors.forename: Martin
authors.initials: M
authors.lastname: Wiendl
authors.forename: Ondrej
authors.initials: O
authors.lastname: Aschermann
authors.forename: Josef
authors.initials: J
authors.lastname: Slaby
authors.forename: Frantisek
authors.initials: F
authors.lastname: Holm
authors.forename: Peter
authors.initials: P
authors.lastname: Telekes
authors.forename: David
authors.initials: D
authors.lastname: Horak
authors.forename: Peter
authors.initials: P
authors.lastname: Blasko
authors.forename: David
authors.initials: D
authors.lastname: Zemanek
authors.forename: Josef
authors.initials: J
authors.lastname: Veselka
authors.forename: Jana
authors.initials: J
authors.lastname: Cepova
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D000368:Aged; D002097:C-Reactive Protein / Q000378:metabolism; D016009:Chi-Square Distribution; D018153:Czech Republic; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D057239:Early Termination of Clinical Trials; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000077340:Fluvastatin; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D018836:Inflammation Mediators / Q000097:blood; D015850:Interleukin-6 / Q000097:blood; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010343:Patient Admission; D018579:Patient Selection; D015990:Placebo Effect; D011266:Pregnancy-Associated Plasma Protein-A / Q000378:metabolism; D011446:Prospective Studies; D018570:Risk Assessment; D018401:Sample Size; D055502:Secondary Prevention / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C508600:IL6 protein, human; D007211:Indoles; D018836:Inflammation Mediators; D015850:Interleukin-6; D000077340:Fluvastatin; D002097:C-Reactive Protein; D011266:Pregnancy-Associated Plasma Protein-A