Munich, Germany, Sunday 31 August 2008: The GISSI-HF trial found rosuvastatin (10 mg daily) did not affect clinical outcomes in patients with chronic heart failure of any cause, in whom the drug seemed to be safe.
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 randomised controlled trials have been methodologically weak. We investigated the efficacy and safety of the statin rosuvastatin in patients with heart failure.
Up to 4,574 patients (mean age 68±11 yr) with chronic heart failure of New York Heart Association class II-–IV, irrespective of cause and left ventricular ejection fraction, were included in a double-blind randomised trial testing rosuvastatin 10 mg daily (n=2,285) against placebo (n=2,289). Patients were followed- up for a median of 3·9 years. Primary endpoints were time to death, and time to death or admission to hospital for cardiovascular reasons. This study is registered with ClinicalTrials.gov, number NCT00336336.
According to the intention to treat analysis, 657 (29%) patients died from any cause in the rosuvastatin group (28·8%) and 644 (28%) in the placebo group (adjusted hazard ratio [HR] 1·00, [95·5% CI 0·898-–1·122], p=0·943). No differences were found also with respect to the other primary end-point: 1305 (57%) patients in the rosuvastatin group died or were admitted to hospital for cardiovascular reasons and 1283 (56%) in the placebo group (adjusted HR 1·01, [99% CI [0·908-–1·112], p=0·903).
Our conclusion is that rosuvastatin, in doses of 10 mg daily, did not affect clinical outcomes in patients with chronic heart failure of any cause, in whom the drug seemed to be safe.
The GISSI study is endorsed by the Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO), Firenze, Italy; Ist.Ricerche Farmacologiche Mario Negri, Milan, Italy and the Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy.
The GISSI-HF trial was planned, conducted and analyzed by the GISSI group which has full ownership of the data.