JUPITER: Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-reactive Protein

Ridker PM, Danielson E, Fonseca FA, et al; for the JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein.
N Engl J Med. 2008;359(21):2195-2207. 

The Justification for Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) was a randomized, double-blind, placebo-controlled trial which sought to examine whether rosuvastatin treatment compared with placebo would decrease the rate of first cardiovascular (CV) events.  

Subjects enrolled in JUPITER (n=17,802 men aged ≥50 years and women aged ≥60 years) had LDL-C <130 mg/dL and high-sensitivity C-reactive protein levels ≥2.0 mg/L, and were randomized to rosuvastatin 20 mg qd (n=8,901) or placebo (n=8,901). Subjects who had plasma TG >500 mg/dL were excluded from the study. A diverse population was included in the study: 38% of subjects were women, and 25% were African American or Hispanic.  

JUPITER’s primary endpoint was combined incidence of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes. The study’s secondary endpoints were the components of the primary endpoint considered individually and death from any cause.  

JUPITER was stopped after median follow-up of 1.9 years due to “unequivocal benefit” of statin therapy vs placebo.  

Results:
Rates of the primary endpoint (composite of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) were 0.77 and 1.36 per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio for rosuvastatin, 0.56; 95% confidence interval, 0.46–0.69; P<0.00001).  

A 47% risk reduction in the combined endpoint of MI, stroke, or death from CV causes (HR, 0.53; 95% CI, 0.40–0.69; P<0.00001) and a 20% risk reduction in all-cause mortality (HR, 0.80; 95% CI, 0.67–0.97; P=0.02) were also seen.  

The rosuvastatin group had a 50% lower median LDL-C level (55 mg/dL), a 37% lower median hs-CRP level (2.2 mg/L), and a 17% lower median TG level (99 mg/dL) vs those taking placebo at 12 months (P<0.001 for all comparisons). These effects were seen throughout the study’s duration.  

Benefits with rosuvastatin treatment were seen across all subgroups studied, regardless of age, sex, ethnicity, or other baseline characteristics (including high CRP and no other risk factor). Groups typically considered low risk (according to Framingham risk score) also showed benefit with rosuvastatin treatment.  

Adverse events were similar in the rosuvastatin and placebo groups (1,352 vs 1,377, respectively; P=0.60).  

Small increases in A1C and physician-reported diabetes were noted in the rosuvastatin group compared with the placebo group (A1C: 5.9% vs 5.8%, respectively; P=0.001; physician-reported diabetes: 270 reports vs 216 reports, respectively; P=0.01).  

Rosuvastatin is not FDA approved for risk reduction of UA hospital admission, CV death, VTE, all-cause mortality, or diabetes 

 

August 2012 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional/commercial interest.  

Related content: 

JUPITER: Statin Therapy for Primary Prevention of Cardiovascular Disease—Rationale  

JUPITER: Statin Therapy for Primary Prevention of Cardiovascular Disease—Participant Profile  

JUPITER: Study Design  

JUPITER Results: Primary Endpoint  

JUPITER Results: Components of Primary Endpoint  

JUPITER: Lipid and Hs-CRP Levels  

JUPITER Results: Summary  

Last Modified: 11/18/2013