Does rosuvastatin improve outcomes for heart failure patients without hyperlipidemia?

Rosuvastatin (Crestor) does not improve clinical outcomes in patients with heart failure and average cholesterol levels (low-density lipoprotein [LDL] = 137 mg/dl). (LOE = 1b)

Kjekshus J, Apetrei E, Barrios V, et al, for the CORONA Group. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007;357(22):2248-2261.  [PMID:17984166]

Randomized controlled trial (double-blinded)

Industry

Concealed

Outpatient (any)

Statins are thought to have benefits for patients with heart disease that extend beyond their ability to lower serum lipid levels. In this study, 5011 patients older than 60 years with an ejection fraction of less than 40% whose physician had not recommended a statin were randomized to receive rosuvastatin 10 mg daily or matching placebo. The authors excluded patients with elevated serum creatinine, hepatic transaminases, or creatine kinase values; valvular disease; liver disease; or recent unstable coronary disease. A run-in period assured that only compliant patients were included, which may introduce a bias in favor of treatment. Groups were balanced at the start of the study, 24% were women, with a mean age of 73 years, a mean total cholesterol of 207 mg/dl (5.35 mmol/L), and a mean LDL cholesterol of 137 mg/dl (3.55 mmol/L). Comorbidities such as hypertension, diabetes, and chronic renal disease were common. Groups were balanced at baseline, analysis was by intention to treat, and patients were followed up for a median of 33 months. Not surprisingly, patients in the rosuvastatin group had a drop in their mean LDL cholesterol to 76 mg/dl (1.96 mmol/L), while LDL levels did not change in the placebo group. There was no significant difference in deaths, nonfatal myocardial infarction, nonfatal stroke, or the composite of all 3. There was also no difference in death from any cause, any coronary event, sudden death, or worsening of heart failure. There were slightly fewer hospitalizations for a cardiovascular cause (25 vs 22.9 per 100 patient years of follow-up). However, given the very large number of comparisons, this could be a chance finding; it is also of questionable clinical significance, since you would have to treat 50 patients for 1 year to prevent 1 hospitalization.