Rosuvastatin in older patients with systolic heart failure.


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. ( number, NCT00206310.)

DOI: 10.1056/NEJMc073536
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@article{Kjekshus2007RosuvastatinIO, title={Rosuvastatin in older patients with systolic heart failure.}, author={John Kjekshus Kjekshus and Eduard Apetrei and Vivencio Barrios and Michael B{\"{o}hm and John Gf Cleland and Jan Hein Cornel and Peter H. J. M. Dunselman and C{\^a}ndida Fonseca and Assen Rachev Goudev and Peer Grande and Lars Gullestad and A Ke Hjalmarson and Jarom{\'i}r Hradec and Andr{\'a}s J{\'a}nosi and Gabriel Kamensk{\'y} and Michel Komajda and Jerzy Korewicki and Timo Kuusi and François Mach and Vyacheslav Mareev and John J V McMurray and Naresh Ranjith and Maria Schaufelberger and Johan Vanhaecke and Dirk Jan van Veldhuisen and Finn Waagstein and Hans Wedel and John Wikstrand}, journal={International journal of clinical practice}, year={2007}, volume={62 1}, pages={1} }