The study recruited over 5,000 patients with heart failure graded as New York Heart Association grade (NYHA) II, III or IV. Patients were randomly assigned to treatment with rosuvastatin 10mg or placebo and followed up for almost 3 years. The primary outcome of the study was a composite of death from cardiovascular causes, nonfatal myocardial infarction or nonfatal stroke.
At the end of the study the was no significant difference in the primary outcome despite levels of low density lipoprotein cholesterol (LDL-C) being 45% lower in the treatment group. In a pre-specified secondary outcome, there was an 8% relative risk reduction (2.1% absolute risk reduction) of a cardiovascular related hospital admission in patients taking the study drug. Overall there were 154 fewer admission per 1,000 patients treated for the median follow up of 2.7 years.
The discussion details that nonfatal MI and nonfatal stroke were uncommon in this study and therefore the primary outcome was driven mainly by the outcome of cardiovascular death. It is therefore a disappointment that treatment with a statin in this group of patients had no significant effect on cardiovascular deaths.
Possible explanations proposed for the lack of effect are that this is a true result and there is no effect, that rosuvstatin does have a benefit but this is counter balanced by harms although this is dismissed as unlikely due to the safety analyses conducted as part of the study, or that the study did not run for a long enough period to detect differences.
Action: This study provides no justification for using rosuvastatin ahead of other statins with lower acquisition costs in patients over 60 years of age with heart failure. Cholesterol management should continue in line with current recommendations.
|« Drug Safety Update, Issue 4||Vildagliptin delayed »|