Level 1: Likely reliable evidence
The Gruppo Italiano per lo Studio della Sopravvivenza nell’Insufficienza Cardiaca (GISSI-HF) randomized placebo-controlled trial evaluated rosuvastatin (Crestor) in 357 cardiology or internal medicine centers in Italy (Lancet. 2008;372:1231-1239). Patients who had chronic heart failure (New York Heart Association [NYHA] class II-IV) and were not taking statins (N=4,631, mean age 68 years) were randomized to rosuvastatin 10 mg vs. placebo once daily. Median follow-up was 3.9 years. Mean baseline LDL levels were 121-122 mg/dL (3.13-3.16 mmol/L). Fifty-seven patients (1%) from one site were not analyzed because of inadequate data.
There were no significant differences in death (all-cause or cardiovascular), sudden cardiac death, cancer death, hospital admission for cardiovascular reasons, fatal or nonfatal MI, fatal or nonfatal stroke, or admission for heart failure. By the end of the trial, the percentages of patients who were no longer taking the study drug or placebo were similar (35% with treatment vs. 36% with placebo). GI disorders were the most frequently reported adverse reaction in both groups. The study (funded by the drug’s manufacturer) is the first large randomized trial of a statin medication in heart failure.