Jupiter Trial
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The JUPITER trial evaluated whether rosuvastatin could reduce cardiovascular events in patients with normal LDL cholesterol but elevated high-sensitivity C-reactive protein (hs-CRP). The trial randomized over 17,000 patients to rosuvastatin 20mg daily or placebo. Patients on rosuvastatin had a 44% reduced risk of myocardial infarction, stroke or cardiovascular death after a median follow-up of 1.9 years. The results suggested that statin treatment based on elevated hs-CRP could benefit those at intermediate cardiovascular risk without hyperlipidemia.
Jupiter Trial
- 1. JUPITER OVMC LANDMARK TRIALS SERIES Ridker PM, et al. "Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein". The New England Journal of Medicine. 2008. 359(21):2195-2207.
- 2. The Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER)
- 3. BACKGROUND It is hypothesized that inflammatory pathways play a role in atherosclerosis CRP is a marker of inflammation, and elevated levels can predict future vascular events Sometimes cardiovascular events can still occur in patients with normal LDL cholesterol Statins lower levels of CRP as well as cholesterol The JUPITER trial seeks to assess if statin (Rosuvastatin) can benefit patients without hyperlipidemia but with elevated CRP levels
- 4. CLINICAL QUESTION In patients with normal LDL and elevated high- sensitivity CRP (HS-CRP), does treatment with Rosuvastatin (20mg qday) reduce the rate of first major CV events?
- 5. DESIGN Analysis: Intention-to-treat Trial Design: Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial N=17,802 patients with normal LDL and elevated HS-CRP Rosuvastatin (n=8,901) Placebo (n=8,901) Powered to detect reduction in primary end point with 90% power Setting: 1315 centers in 26 countries Enrollment: 2003-2006 Median follow-up: 1.9 years Primary outcome: Combined endpoint of first major CV event
- 6. POPULATION Inclusion Criteria Men >50 years, or women >60 years LDL <130 mg/dL HS-CRP >2.0 mg/L Triglycerides <500 mg/dL No history of CV disease Exclusion Criteria Usage of any lipid-lowering Hormone replacement therapy Diabetes SBP >190 mmHg or DBP >100 mmHg Cancer (except skin BCC) in the prior 5 years Alcohol or drug abuse Inflammatory conditions Use of immunosuppressants
- 7. INTERVENTIONS Randomization: Rosuvastatin 20mg qday Placebo Four-week placebo-only run-in phase: those who took more than 80% of their tablets were enrolled in the trial Follow-up visits: to be scheduled at ~3 months then every 6 months after randomization until month 60 Telephone follow-ups and in-person visits Patients followed up in a close-out visit following cessation of the study
- 8. CRITICISMS/LIMITATIONS/FUNDING Many study participants were not on optimal medical therapy (eg, aspirin therapy if high Framingham score) Excluded individuals with low/normal HS-CRP values (<2g/L) Did not include Asian participants, important because this group metabolizes rosuvastatin differently Trial stopped early: only at 2 years, therefore may lead to effect overestimation FUNDING: AstraZeneca (makers of Crestor/Rosuvastatin) Primary Author owns patent for HS-CRP assay
- 9. BOTTOM LINE In patients without hyperlipidemia but elevated high sensitivity CRP, Rosuvastatin as PRIMARY PREVENTIATION significantly reduces the incidence of major CV events (eg death, MI, stroke) at 2 years
- 10. DISCUSSION QUESTIONS What did the JUPITER trial suggest about CRP levels and statin use? According to the JUPITER trial, should patients without hyperlipidemia be treated with statin? When studying rosuvastatin, why is it recommended to have Asian participants? Who funded the JUPITER Trial?
- 11. DISCUSSION QUESTIONS/ANSWERS What did the JUPITER trial suggest about hsCRP levels and statin use? ANSWER: There is a strong linear association with elevated hsCRP and ischemic stroke/vascular mortality. In patients with elevated CRP levels at an increased risk of cardiovascular events, a statin is recommended because statins lower hsCRP level. According to the JUPITER trial, should patients without hyperlipidemia be treated with statin? ANSWER: In a patient with normal LDL level but elevated high sensitivity CRP with increased risk of CV events, a statin is recommended When studying rosuvastatin, why is it recommended to have Asian participants? ANSWER: Asian participants processs Rosuvastatin therapy differently. They are at increased risk of side effects, especially myopathy may be increased. Therefore, half the standard dose may be recommended.
- 12. BOARD-LIKE QUESTION 61 yo man is evaluated for annual exam and asks for advise on cardiac risk assessment. He denies any current chest pain, SOB, PND, orthopnea. He runs 4 miles ever 3 days and has never smoked. He has no medical problems and does not take any medications. Cardiovascular risk calculation using Pooled Cohort question is 7% risk of MI or CV event within 10 years. ADAPTED from MKSAP 17 QUESTION What test should be performed on this patient? A. Cardiac CT angiography B. Cardiac Cath C. Fractionated lipoprotein profile D. High sensitivity CRP E. Stress Echo
- 13. BOARD-LIKE QUESTION Educational Objective: High-sensitivity C-reactive (hsCRP) protein level can guide treatment and cardiac risk stratification in a patient at intermediate risk of cardiovascular disease. Key Point: - Patients with hsCRP>1 are considered high risk - hsCRP<1 is considered low risk - There is no role in evaluating lipid particle size and number for targeting treatment regimen ANSWER What test should be performed on this patient? A. Cardiac CT angiography B. Cardiac Cath C. Fractionated lipoprotein profile D. High sensitivity CRP E. Stress Echo
- 14. BOARD-LIKE QUESTION Results of the tests showed elevated high sensitivity CRP (7.4). QUESTION What is your next step? A. Prescribe Aspirin B. Prescribe Rosuvastatin C. Prescribe Amlodipine D. Perform a baseline EKG E. Perform an ECHO
- 15. BOARD-LIKE QUESTION Educational Objective: In patients with elevated High-sensitivity C- reactive (hsCRP) and normal lipids, Rosuvastatin as primary prevention can reduce CV events at 2 years QUESTION What is your next step? A. Prescribe Aspirin B. Prescribe Rosuvastatin C. Prescribe Amlodipine D. Perform a baseline EKG E. Perform an ECHO
- 16. REFERENCES Ridker PM, et al. "Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein". The New England Journal of Medicine. 2008. 359(21):2195-2207. Brain, P. JUPITER. Retrieved March 5, 2017, from https://www.wikijournalclub.org/wiki/JUPITER MKSAP 17