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Jupiter Trial

  1. 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. 2. The Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER)
  3. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

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