The BBC and other media companies have been heavily reporting the outcomes of the ASTEROID Trial. This trial has been made available online by the Journal of the American Medical Association along with the accompanying editorial.
The trial examined the effect of very high dose statin therapy (rosuvastatin 40mg) on the progression of atherosclerosis with the objective of assessing if therapy could regress the atherosclerosis. Athersclerosis was assessed as baseline and after 24 months using intravenous ultrasound.
349 patients completed the study. The average reduction in low-density lipoprotein cholesterol (LDL-C) was 53.2% and there were statistically significant but modest reductions in three pre-specified efficacy parameters of atheroma volume. The parameters and reductions were:
- Percent Atheroma Volume reduced by 0.98%
- Atheroma Volume in most diseased area reduced by a median of 9.1%
- Total Atheroma Volume reduced by a median of 6.8%
Initially, 507 patients were recruited to the study 63 suffered adverse events after at least one dose leading to withdrawal from the study. In total, 127 patients dropped out of the study. Some reporting of the study has reported that "four out of five patients (78%) demonstrated some reduction in the level of atherosclerosis" however correcting this figure to an intention to treat value shows the true level of efficacy to be 49%.
The conclusion of the paper and the editorial raise the need for further studies since this work is not linked to reduced numbers of clinical outcomes such as myocardial infarctions and strokes. Echoing this position, the British Heart Foundation issued a press release calling for further studies to confirm that these changes actually save lives.
Action: This study does not change current practice but does raise possibilities that require further investigation. Simvastatin remains the first line choice as lipid lowering agent.