title: Rosuvastatin in older patients with systolic heart failure.
abstract: BACKGROUND
  Patients with systolic heart failure have generally been excluded from statin trials. Acute coronary events are uncommon in this population, and statins have theoretical risks in these patients.
  
  
  METHODS
  A total of 5011 patients at least 60 years of age with New York Heart Association class II, III, or IV ischemic, systolic heart failure were randomly assigned to receive 10 mg of rosuvastatin or placebo per day. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included death from any cause, any coronary event, death from cardiovascular causes, and the number of hospitalizations.
  
  
  RESULTS
  As compared with the placebo group, patients in the rosuvastatin group had decreased levels of low-density lipoprotein cholesterol (difference between groups, 45.0%; P<0.001) and of high-sensitivity C-reactive protein (difference between groups, 37.1%; P<0.001). During a median follow-up of 32.8 months, the primary outcome occurred in 692 patients in the rosuvastatin group and 732 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.83 to 1.02; P=0.12), and 728 patients and 759 patients, respectively, died (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.31). There were no significant differences between the two groups in the coronary outcome or death from cardiovascular causes. In a prespecified secondary analysis, there were fewer hospitalizations for cardiovascular causes in the rosuvastatin group (2193) than in the placebo group (2564) (P<0.001). No excessive episodes of muscle-related or other adverse events occurred in the rosuvastatin group.
  
  
  CONCLUSIONS
  Rosuvastatin did not reduce the primary outcome or the number of deaths from any cause in older patients with systolic heart failure, although the drug did reduce the number of cardiovascular hospitalizations. The drug did not cause safety problems. (ClinicalTrials.gov number, NCT00206310.)
authors.affiliation: Department of Cardiology, University of Oslo, Rikshospitalet University Hospital, Oslo, Norway. john.kjekshus@medisin.uio.no
authors.forename: John
authors.initials: J
authors.lastname: Kjekshus
authors.forename: Eduard
authors.initials: E
authors.lastname: Apetrei
authors.forename: Vivencio
authors.initials: V
authors.lastname: Barrios
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.forename: John G F
authors.initials: JG
authors.lastname: Cleland
authors.forename: Jan H
authors.initials: JH
authors.lastname: Cornel
authors.forename: Peter
authors.initials: P
authors.lastname: Dunselman
authors.forename: Cândida
authors.initials: C
authors.lastname: Fonseca
authors.forename: Assen
authors.initials: A
authors.lastname: Goudev
authors.forename: Peer
authors.initials: P
authors.lastname: Grande
authors.forename: Lars
authors.initials: L
authors.lastname: Gullestad
authors.forename: Ake
authors.initials: A
authors.lastname: Hjalmarson
authors.forename: Jaromir
authors.initials: J
authors.lastname: Hradec
authors.forename: András
authors.initials: A
authors.lastname: Jánosi
authors.forename: Gabriel
authors.initials: G
authors.lastname: Kamenský
authors.forename: Michel
authors.initials: M
authors.lastname: Komajda
authors.forename: Jerzy
authors.initials: J
authors.lastname: Korewicki
authors.forename: Timo
authors.initials: T
authors.lastname: Kuusi
authors.forename: François
authors.initials: F
authors.lastname: Mach
authors.forename: Vyacheslav
authors.initials: V
authors.lastname: Mareev
authors.forename: John J V
authors.initials: JJ
authors.lastname: McMurray
authors.forename: Naresh
authors.initials: N
authors.lastname: Ranjith
authors.forename: Maria
authors.initials: M
authors.lastname: Schaufelberger
authors.forename: Johan
authors.initials: J
authors.lastname: Vanhaecke
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: van Veldhuisen
authors.forename: Finn
authors.initials: F
authors.lastname: Waagstein
authors.forename: Hans
authors.initials: H
authors.lastname: Wedel
authors.forename: John
authors.initials: J
authors.lastname: Wikstrand
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000401:mortality; D005260:Female; D005464:Fluorobenzenes / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000209:etiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000150:complications; D016016:Proportional Hazards Models; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D016037:Single-Blind Method; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013599:Systole; D016896:Treatment Outcome
chemical_list: D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium