Jupiter Trial

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Information about Jupiter Trial

Published on October 16, 2016

Author: IsabellaLai

Source: slideshare.net

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  High level of inflammatory biomarker C-reactive protein can predict future vascular events  Statins lower levels of CRP as well as cholesterol  Sometimes cardiovascular events can still occur in patients with normal LDL cholesterol  The JUPITER trial seeks to assess if statin 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 rosuvastatin reduce the incidence of major CV events?

5. DESIGN  Analysis: Intention-to-treat  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)  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  Patients who have used any lipid-lowering  Post-menopausal hormone replacement therapy  Diabetes  SBP >190 mmHg or DBP >100 mmHg  Cancer (except basal or squamous cell carcinoma of the skin) in the prior 5 years  Recent alcohol or drug abuse  Inflammatory conditions (including, but not limited to, severe arthritis, lupus, IBD)  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 were scheduled at 13 weeks then every 6 months after randomization until month 60  Some sites performed telephone follow-ups with patient between inperson visits  Patients followed up in a close-out visit following cessation of the study

8. CRITICISMS  Many patients were not on optimal medical therapy for their risk factors (eg, aspirin therapy if high Framingham score)  Trial was truncated at 2 years so possible overestimation of treatment effect  Did not include Asian participants, important because this group has distinct rosuvastatin pharmacokinetics  Individuals with normal HS-CRP values (eg, <2 g/L) were not studied  Did not adequately address increased risk of new-onset DM

9. BOTTOM LINE Rosuvastatin significantly reduces the incidence of major CV events (eg death, MI, stroke) in patients without hyperlipidemia but elevated high sensitivity CRP.

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?

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

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