No abstract

In contrast to the PROVE IT trial and the A to Z trial, MIRACL compared statin treatment with placebo, rather than an active comparator or different dose of statin treatment, and MIRACL relied on soft end points. The PROVE IT trial and the A to Z trial differed in the acuteness of the intervention setting, the magnitude of the difference in lowdensity lipoprotein cholesterol (LDL-C) levels among patients in the 2 treatment groups, and the LDL-C levels in the less aggressively treated group. The PROVE IT trial has been used to justify an LDL-C level of 70 mg/dL (1.81 mmol/L) for highrisk individuals. 5 However, in the PROVE IT trial, only half of the participants taking pravastatin achieved an LDL-C level lower than 100 mg/dL (Ͻ2.59 mmol/L), and there was no difference in events between the aggressively and less aggressively treated groups for the subset with LDL-C levels at baseline lower than 125 mg/dL (Ͻ3.24 mmol/L), a subgroup in which pravastatin would likely achieve an LDL-C level lower than 100 mg/dL (Ͻ2.59 mmol/L). In the low-dose group in the A to Z trial, the 25th percentile LDL-C level was 66 mg/dL (1.71 mmol/L) and the 75th percentile was 96 mg/dL (2.49 mmol/L), suggesting that this group achieved its LDL-C level goal.Additionally, the clinical advisory board of the American College of Cardiology, the American Heart Association, and the National Heart, Lung, and Blood Institute 6 defines rhabdomyolysis as an elevation in creatine phosphokinase with myalgia and evidence of renal failure. It would be of interest to know how many patients in the A to Z trial fulfilled this renal failure criterion for rhabdomyolysis.