JUPITER is a randomized, double-blind, placebo-controlled trial involving 1315 sites in 26 countries. Nearly 18,000 JUPITER study participants with an LDL level of 130mg/dL or lower and an hsCRP level of 2.0mg/L or higher and no history of cardiovascular disease or diabetes were randomly assigned 20mg of rosuvastatin or placebo daily. The participants were followed for an average of nearly two years, and some were followed for up to five years.
During the course of the study the researchers observed an overall total of 97 strokes among the participants, with 33 seen in the rosuvastatin group compared to 64 in the placebo group, for a 48 percent reduction in the risk of stroke for those randomly assigned to rosuvastatin. The vast majority of the strokes were ischemic (70 out of 97 total), and the researchers observed 23 ischemic strokes in the rosuvastatin group and 47 in the placebo group, for a 51 percent reduction in stroke risk for participants taking active therapy. A similar 48 percent risk reduction with rosuvastatin therapy was seen for non-fatal strokes. The researchers did not observe any differences in hemorrhagic stroke between the two treatment arms.
“The results are striking: for the first time in a population of patients without established cardiovascular disease, randomized treatment with statin therapy led to a statistically significant reduction in the risk of stroke. That risk reduction was large and clinically relevant; participants taking rosuvastatin had a 50 percent reduction in the risk of ischemic stroke, the most common type of stroke. Even more remarkable is the fact that these results were seen in a population with acceptable levels of LDL cholesterol, but elevated levels of hsCRP. Depending on a patient’s other cardiovascular risk factors, many physicians would not treat levels of LDL cholesterol this low, and yet statin therapy cut the risk of any kind of stroke, including non-fatal and ischemic strokes, approximately in half,” said Brendan Everett, MD, MPH, cardiologist and researcher in the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital. “The benefits were consistent in all the patients groups we examined, including men and women, Caucasians, Blacks, and Hispanics, and those without and without a family history of cardiovascular disease. All groups seemed to derive the same benefit from rosuvastatin therapy.
The research was funded by a grant from AstraZeneca.
Led by Dr. Paul Ridker of BWH, JUPITER was a randomized, double-blind, placebo-controlled trial conducted by investigators in 26 countries and overseen by an academic statistician (Robert Glynn, PhD, Harvard University, USA) and an independent Data and Safety Monitoring Board (chaired by Professor Rory Collins, Oxford University, UK). The study was funded by AstraZeneca, US who had no access to unblinded trial data and played no role in analysis or interpretation of the study data nor in manuscript preparation. Dr. Ridker is listed as a co-inventor on patents held by BWH that relate to the use of inflammatory biomarkers in cardiovascular disease that have been licensed to AstraZeneca and Siemens Healthcare Diagnostics in the therapeutic and diagnostics field respectively.