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Abstract
Large observational studies, small prospective studies and post-hoc analyses of randomised
clinical trials have suggested that statins could be beneficial in patients with chronic
heart failure. However, previous studies have been methodologically weak. We investigated
the efficacy and safety of the statin rosuvastatin in patients with heart failure.
We undertook a randomised, double-blind, placebo-controlled trial in 326 cardiology
and 31 internal medicine centres in Italy. We enrolled patients aged 18 years or older
with chronic heart failure of New York Heart Association class II-IV, irrespective
of cause and left ventricular ejection fraction, and randomly assigned them to rosuvastatin
10 mg daily (n=2285) or placebo (n=2289) by a concealed, computerised telephone randomisation
system. Patients were followed up for a median of 3.9 years (IQR 3.0-4.4). Primary
endpoints were time to death, and time to death or admission to hospital for cardiovascular
reasons. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov,
number NCT00336336.
We analysed all randomised patients. 657 (29%) patients died from any cause in the
rosuvastatin group and 644 (28%) in the placebo group (adjusted hazard ratio [HR]
1.00 [95.5% CI 0.898-1.122], p=0.943). 1305 (57%) patients in the rosuvastatin group
and 1283 (56%) in the placebo group died or were admitted to hospital for cardiovascular
reasons (adjusted HR 1.01 [99% CI 0.908-1.112], p=0.903). In both groups, gastrointestinal
disorders were the most frequent adverse reaction (34 [1%] rosuvastatin group vs 44
[2%] placebo group).
Rosuvastatin 10 mg daily did not affect clinical outcomes in patients with chronic
heart failure of any cause, in whom the drug was safe.