Statin Found Effective in Reducing Cardiovascular Events in Persons with Elevated C-Reactive Protein

A study of 17,802 persons with low levels of cholesterol but elevated levels of C-reactive protein (CRP) who were given rosuvastatin (Crestor) resulted in a reduction of 44% in the incidence of major cardiovascular events. The study, published in The New England Journal of Medicine, was halted early due to the significance of the results. The study, which was designed to last five years, was stopped after 1.9 years.

CRP, which is made in the liver, is a marker for acute inflammation and infection and is considered a predictor of cardiovascular events. CRP levels above 2 milligrams per liter (mg/l) are associated with a risk for such events. Study participants had CRP levels of at least 2.0 mg/l and LDL levels of 130 mg per deciliter or lower.

Rosuvastatin treatment reduced CRP by 37% and low-density lipoprotein (LDL) cholesterol levels by 50%. The primary outcome--nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, arterial revascularization, or death from a cardiovascular event--was significantly lower in the treatment group than the treated group. Individual risk reductions ranged from 65% for nonfatal myocardial infarction to 41% for hospitalization for unstable angina.

Statins can increase the risk of muscle weakness; however, during this study no differences were found between the control and treatment groups. One nonfatal case of rhabdomyolysis occurred after the study was halted. A significant difference in intracranial hemorrhage was not found between the two groups.

Physician-reported diabetes was significantly more frequent in the treatment group (270 reports) compared to the control group (216 reports). The study itself, however, did not find increased levels of fasting glucose or glycosuria in the treatment group compared to the control group. The researchers indicated that further review of study records is warranted to resolve this issue.

Given that the study was halted after less than two years, it is possible that greater numbers of adverse events in the treatment group might have become evident had the study lasted longer. Also, because the study reduced LDL as well as CRP, it is possible that the cardiovascular benefits may be related to reduced LDL rather than CRP reduction. CRP is believed to have a role atherothrombosis; therefore, it is plausible that the cardiovascular benefits seen in the study were due to some extent to the reduction of CRP.

This study is being hailed as a significant contribution to the understanding and treatment of cardiovascular disease. Further study is awaited to confirm the results and assess appropriate treatment practices. AstraZeneca, the maker of Crestor, funded the study.