Rosuvastatin associated with significant stroke risk reduction in patients with high hsCRP

Apparently healthy people with normal cholesterol levels but elevated levels of high-sensitivity C-reactive protein (hsCRP) demonstrated a significant relative reduction in stroke risk if treated with rosuvastatin rather than placebo in the Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, according to data presented at the International Stroke Conference 2009.

Apparently healthy people with normal cholesterol levels but elevated levels of high-sensitivity C-reactive protein (hsCRP) demonstrated a significant relative reduction in stroke risk if treated with rosuvastatin rather than placebo in the Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, according to data presented at the International Stroke Conference 2009.

The effect of rosuvastatin on stroke risk was greater than that achieved with statin therapy in other randomized clinical trials, said Robert J. Glynn, PhD, ScD, associate professor of medicine (biostatistics), Harvard School of Public Health, Boston. In previous trials, the risk of stroke was reduced by 19% to 48% with statin therapy, but patients enrolled in these trials had established vascular disease or diabetes, he noted.

JUPITER was a primary prevention study in which 17,802 adults without cardiovascular disease or diabetes, with low-density lipoprotein (LDL) cholesterol levels
When the study was terminated after a median 1.9 years of follow-up, patients assigned to rosuvastatin demonstrated a 44% reduction (P
The relative risk of any stroke was reduced by 48% among the rosuvastatin recipients compared with the placebo group (P=.002); this reduction included a 51% reduction in the risk of ischemic stroke (P=.004) in rosuvastatin-treated patients. The risk of hemorrhagic stroke was reduced by a nonsignificant 33% (P=.44) in rosuvastatin-treated patients, although only 15 hemorrhagic strokes occurred in the study overall.

The reduction in the occurrence of stroke with rosuvastatin was apparent almost immediately, and the difference in stroke rates between the rosuvastatin and placebo groups expanded over time, noted Dr Glynn.

The absolute difference in the risk of stroke associated with rosuvastatin treatment was approximately 1%, yielding a number needed to treat (NNT) of 100 to prevent 1 stroke over 5 years in patients with elevated hsCRP levels, Dr Glynn said. Questions therefore arose about the high NNT and the cost-effectiveness of using rosuvastatin as primary prevention in patients with normal cholesterol levels.

Dr Glynn stated 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.”

Notably, the benefits of treatment were consistent across all subgroups examined, including high-risk groups such as patients aged >65 years, those with hypertension, and those with a Framingham risk score >10.