International stroke conference, San Diego Thursday, February 19, 2009, 4:00 pm - 5:30 pm
Background: LDL cholesterol is not a major risk factor for stroke, yet statin therapy reduces stroke risk. As increased levels of the inflammatory biomarker high sensitivity C-reactive protein (hsCRP) predict stroke, we sought evidence that statin therapy might reduce stroke rates among individuals with low levels of cholesterol but elevated levels of hsCRP.
Methods: 17,802 apparently healthy men and women with low density lipoprotein cholesterol levels (LDLC) <130mg/dl and hsCRP levels >2.0mg/L were randomly allocated to rosuvastatin 20mg daily or placebo and then followed for occurrence of a first major cardiovascular event (nonfatal myocardial infarction, nonfatal stroke, arterial revascularization, hospitalization for unstable angina, or cardiovascular death). All endpoints, including stroke, were adjudicated by an independent committee of physicians unaware of treatemnt status.
Results: The trial was stopped after a median follow-up of 1.9 years (maximum 5.0 years) because, compared to placebo, rosuvastatin resulted in a 44 percent reduction in the hazard of the primary trial endpoint (cumulative incidence 3.0 vs 6.2 percent at 4 years, hazard ratio [HR] 0.56, 95% confidence interval 0.46-0.69, P<0.00001).With regard to stroke events, there were 33 among those allocated to rosuvastatin and 64 among those allocated to placebo, a 48 percent reduction in hazard (HR 0.52, 95%CI 0.34-0.79, P=0.002) almost all of which were thromboembolic. In contrast to a prior study of high-dose statin therapy, there was no increase in risk of hemorrhagic stroke (6 vs 9 events in the rosuvastatin and placebo groups,respectively, P=0.44). Details of the stroke data according to gender, ethnicity, and baseline risk factor status will be presented for the first time.
Conclusions: Rosuvastatin reduces by almost half the incidence of thromboembolic stroke among men and women with elevated levels of hsCRP.