Reduction in C-Reactive Protein and Low-Density Lipoprotein Cholesterol and Cardiovascular Event Rates After Initiation of Rosuvastatin: A Prospective Study of the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin Trial

Two previous trials have reported that the best clinical outcomes in treatment of acute coronary ischemia among patients receiving statins occurred in those who achieved low-density lipoprotein (LDL) cholesterol <1.8 mmol/L (<70 mg/dL) and high-sensitivity C-reactive protein (hsCRP) <2 mg/L. Despite these findings, the added benefits of reduced hsCRP concentrations remain controversial. The Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin trial was a randomized, double-blind, placebo-controlled trial designed to assess the effects of rosuvastatin 20 mg versus placebo on several prespecified cardiovascular end points according to on-treatment concentrations of LDL cholesterol (≥1.8 mmol/L or <1.8 mmol/L) and hsCRP (≥2 mg/L or <2 mg/L). The study population was comprised of 15,548 initially healthy men and women. Prespecified end points were rates of nonfatal myocardial infarction, nonfatal stroke, admission for unstable angina, arterial revascularization, or cardiovascular death. The maximum follow-up period was 5 years (median: 1.9 years). All events arising after randomization were included. The data were adjusted for baseline LDL cholesterol and other risk factors at study entry. Compared with placebo, there was a 55% reduction in vascular events among patients treated with rosuvastatin who achieved LDL cholesterol <1.8 mmol/L (event rate: 1.11 vs. 0.51 per 100 person-years; adjusted hazard ratio [HR]: 0.45; 95% CI: 0.33–0.59, P < 0.0001) and a 62% reduction in those achieving hsCRP <2 mg/L (event rate: 0.42 per 100 person-years; adjusted HR: 0.36; 95% CI: 0.24–0.54, P < 0.0001). Despite a weak correlation between LDL cholesterol and hsCRP reductions in individual patients (r values: <0.15), there was a 65% reduction in vascular events among participants receiving rosuvastatin who achieved both LDL cholesterol <1.8 mmol/L and hsCRP <2 mg/L (event rate: 0.38 per 100 person-years); adjusted HR: 0.35; 95% CI: 0.23–0.54), compared with a 33% reduction in those who achieved one or neither target (event rate: 0.74 per 100 person-years; adjusted HR: 0.64; 95% CI: 0.49–0.84) (P across treatment groups <0.0001). At a target of LDL cholesterol <1.8 mmol/L and hsCRP <1 mg/L, there was a 79% reduction in cardiac events (event rate: 0.24 per 100 person-years; adjusted HR: 0.21; 95% CI: 0.09–0.51). Irrespective of the lipid end point used, there was a similar pattern of risk reduction with achieved hsCRP concentrations. These findings indicate that reduction in both LDL cholesterol and hsCRP to targeted levels is predictive of improved event-free survival in a population of healthy adults.

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