Does rosuvastatin improve outcomes in patients with congestive heart failure?

Rosuvastatin (Crestor) was no better than placebo in decreasing death or cardiovascular hospitalizations in patients with congestive heart failure. (LOE = 1b)

Gissi-Hf Investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet 2008;372:1231-1239.  [PMID:18757089]

Randomized controlled trial (double-blinded)

Industry

Concealed

Outpatient (specialty)

Adults with New York Heart Association class II or worse congestive heart failure were randomly assigned to receive rosuvastatin 10 mg daily (n = 2285) or placebo (n = 2289). Patients were evaluated at 1, 3, 6, and 12 months, and then every 6 months thereafter. The researchers used intention-to-treat analysis to evaluate the outcomes that were assessed by members of the research team who were unaware of which treatment the patient received. The main outcomes of interest were death and hospital admission for cardiovascular reasons. After a median follow-up of 3.9 years, there was no significant difference in all-cause mortality (29% in patients treated with rosuvastatin, 28% in patients receiving placebo). There was also no difference in hospitalizations (56% in each group). After slicing and dicing the data, the authors were unable to find any differences in any other outcomes or in any subgroups. The study was powerful enough to detect small differences in event rates.