Rosuvastatin in older patients with systolic heart failure

John Kjekshus, Eduard Apetrei, Vivencio Barrios, Michael Böhm, John G F Cleland, Jan H. Cornel, Peter Dunselman, Cândida Fonseca, Assen Goudev, Peer Grande, Lars Gullestad, Åke Hjalmarson, Jaromir Hradec, András Jánosi, Gabriel Kamenský, Michel Komajda, Jerzy Korewicki, Timo Kuusi, François Mach, Vyacheslav MareevJohn J V McMurray, Naresh Ranjith, Maria Schaufelberger, Johan Vanhaecke, Dirk J. Van Veldhuisen, Finn Waagstein, Hans Wedel, John Wikstrand

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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.)

Original languageEnglish
Pages (from-to)2248-2261
Number of pages14
JournalNew England Journal Of Medicine
Volume357
Issue number22
DOIs
Publication statusPublished - 29 Nov 2007

Keywords

  • MYOCARDIAL-INFARCTION
  • CHOLESTEROL LEVELS
  • MERIT-HF
  • TRIAL
  • STATINS
  • DISEASE
  • PRAVASTATIN
  • SURVIVAL
  • EVENTS
  • DEATH

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    Kjekshus, J., Apetrei, E., Barrios, V., Böhm, M., Cleland, J. G. F., Cornel, J. H., ... Wikstrand, J. (2007). Rosuvastatin in older patients with systolic heart failure. New England Journal Of Medicine, 357(22), 2248-2261. https://doi.org/10.1056/NEJMoa0706201