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 (CV) hospitalizations, according to a study in the Nov. 29 issue of the New England Journal of Medicine.
John Kjekshus, MD, from the department of cardiology at the University of Oslo, Rikshospitalet University Hospital in Oslo, Norway, and colleagues examined 5,011 patients at least 60 years of age with N.Y. Heart Association class II, III, or IV ischemic, systolic heart failure. Patients were randomly assigned to receive 10 mg of rosuvastatin (Crestor from AstraZeneca) or placebo per day.
The authors wrote that the primary composite outcome was death from CV causes, nonfatal MI or nonfatal stroke. Secondary outcomes included death from any cause, any coronary event, death from CV causes and the number of hospitalizations.
As compared with the placebo group, the researchers found that the patients in the rosuvastatin group had decreased levels of low-density lipoprotein cholesterol (difference between groups was 45 percent) and of high-sensitivity C-reactive protein (difference between groups, 37.1 percent).
During a median follow-up of 32.8 months, they found that the primary outcome occurred in 692 patients in the rosuvastatin group and 732 in the placebo group, and 728 patients and 759 patients, respectively, died.
Overall, Kjekshus and colleagues said that there were no significant differences between the two groups in the coronary outcome or death from CV causes. In a pre-specified secondary analysis, there were fewer hospitalizations for CV causes in the rosuvastatin group (2,193) than in the placebo group (2,564). No excessive episodes of muscle-related or other adverse events occurred in the rosuvastatin group.
While the authors said that the drug did not cause safety problems, they also noted that they “do not know exactly why rosuvastatin did not reduce the frequency of the primary composite outcome.”
However, Kjekshus and colleagues said that rosuvastatin reduced the number of hospitalizations for cardiovascular causes, in addition to effectively reducing levels of LDL cholesterol and high-sensitivity C-reactive protein.
AstraZeneca funded the study.