Apparently healthy people with average levels of cholesterol but elevated levels of high-sensitivity C-reactive protein who were randomized to rosuvastatin had half the risk of stroke compared with those randomized to placebo.
Apparently healthy people with average levels of cholesterol but elevated levels of highsensitivity C-reactive protein (hsCRP) who were randomized to rosuvastatin (Crestor) had half the risk of stroke compared with those randomized to placebo, reported Robert J. Glynn, PhD, ScD, associate professor of medicine (biostatistics), Harvard School of Public Health, Boston. This finding was part of JUPITER (Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin), a primary prevention study designed to assess the potential benefit of rosuvastatin on cardiovascular outcomes in adults without cardiovascular disease or diabetes who had low-density lipoprotein cholesterol levels less than 130 mg/dL and hsCRP levels of 2 mg/dL or greater. The trial included 17,802 men aged 50 or older and women aged 60 or older.
“The relative benefit on stroke observed in JUPITER was greater than in almost all prior statin trials,” said Dr. Glynn. In previous trials, the risk of stroke was reduced by 19% to 48% with statin therapy in patients with established vascular disease or diabetes. These populations have a higher risk of events; thus, significant benefits of treatment would be easier to identify in these patients, he noted.
The main finding of JUPITER was that rosuvastatin was associated with a 44% reduction (P <.001) in the primary end point, which was a composite of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes after a mean follow-up of 1.9 years.
Patients randomized to rosuvastatin experienced a 48% relative reduction in the risk of any stroke (P = .002), including a 51% reduction in the risk of ischemic stroke (P = .004) and a nonsignificant 33% reduction in the risk of hemorrhagic stroke (P = .44). The reduction in stroke in the group randomized to rosuvastatin occurred almost immediately, and the difference in stroke rates between the rosuvastatin and placebo groups expanded over time, noted Dr. Glynn.
Notably, the benefits of treatment were consistent across all subgroups examined, including high-risk groups, such as individuals older than 65 years, those with hypertension, and those with a Framingham risk score in excess of 10.
The absolute reduction in the risk of stroke with rosuvastatin treatment was about 1%; therefore, the number needed to treat (NNT) for 2 years to prevent 1 stroke among persons with elevated hsCRP levels but unremarkable cholesterol levels is approximately 100, said Dr. Glynn. Although some questioned that this NNT would make rosuvastatin cost prohibitive in the population studied, Dr. Glynn indicated that the benefits of the drug in the trial extended beyond stroke prevention. “The benefit on stroke was virtually spot on as the benefit on MI,” he said. “The NNT for the overall population was 25 to prevent a primary vascular event, so I don’t think you can use stroke in isolation when making a treatment decision.”