Archief Roodbont

The role of statin therapy in primary prevention is uncertain for patients whose cholesterol levels are not markedly elevated. Among such patients, elevated levels of high-sensitivity C-reactive protein (hsCRP) are associated with excess cardiovascular risk. In this international industry-sponsored study, 17,802 people (men’s age, 50; women’s age, 60) without known cardiovascular disease and with LDL cholesterol levels <130 src="http://general-medicine.jwatch.org/math/ge.gif" alt="≥" _base_href="http://general-medicine.jwatch.org" border="0">2 mg/L were randomized to receive daily rosuvastatin (Crestor; 20 mg) or placebo. Exclusion criteria were numerous and included diabetes, uncontrolled hypertension, and various other chronic diseases.

The trial was stopped early, after a median follow-up of 1.9 years. Rosuvastatin lowered mean LDL cholesterol level by 50% and hsCRP level by 37%. The incidence of the primary endpoint (first major adverse cardiovascular event, including unstable angina, myocardial infarction, stroke, arterial revascularization, or death from cardiovascular causes) was significantly lower in the rosuvastatin group than in the placebo group (0.77 vs. 1.36 per 100 person-years; hazard ratio, 0.56); occurrence of all components of the composite endpoint was lower in the rosuvastatin group, as was the overall mortality rate (HR, 0.8). Physician-reported new-onset diabetes was significantly more common in the rosuvastatin group; median glycosylated hemoglobin (HbA_1c) level at 24 months also was higher with rosuvastatin.

Comment: In this study of apparently healthy subjects with elevated hsCRP levels, statins lowered the incidence of adverse cardiovascular events; this result supports expanded use of statins in primary prevention. An editorialist sounds several cautionary notes, however, mentioning the high proportion of patients who were excluded from enrollment, the relatively modest absolute effect size (about 100 people need to be treated for almost 2 years to prevent 1 event), the higher incidence of diabetes, and the lack of long-term data on hazards of statin therapy. He also reminds us that this is a randomized trial of statin therapy, not of hsCRP testing, and he advocates selective, rather than routine, use of hsCRP testing.

— Kirsten E. Fleischmann, MD, MPH

Published in Journal Watch General Medicine November 18, 2008