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JUPITER Trial Design

Tailoring Intervention – Effectively Targeting the High-risk Population Cardiovascular Event Reduction in the Higher-Risk Primary Prevention Population.

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JUPITER Trial Design

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  1. Tailoring Intervention – Effectively Targeting the High-risk PopulationCardiovascular Event Reduction in theHigher-Risk Primary Prevention Population

  2. The information contained in this slide set is based on data contained in the European SmPC and is therefore intended for EU markets only. Other markets should refer to their local Prescribing Information.

  3. JUPITER Trial Design Multi-national Randomized Double Blind, Placebo Controlled Trial of Rosuvastatin in the Prevention of Cardiovascular Events Among Individuals With Low LDL and Elevated hsCRP MIStrokeUnstableAnginaCVD DeathCABG/PTCA CRESTORTM 20 mg (N=8901) 4-week run-in No Prior CVD or DM Men >50, Women >60 LDL-C <130 mg/dL hsCRP ≥2 mg/L Placebo (N=8901) Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Denmark, El Salvador, Estonia, Germany, Israel, Mexico, Netherlands, Norway, Panama, Poland, Romania, Russia, South Africa, Switzerland, United Kingdom, Uruguay, United States, Venezuela CRESTOR is a trademark of the AstraZeneca group of companies Ridker PM et al, New Eng J Med 2008; 359: 2195–2207

  4. JUPITER High Risk Population • These data were post-hoc analyses performed at the request of the European health authorities • All of the JUPITER study participants were classified according to 10-year global risk estimates using the Framingham risk score and the European SCORE risk algorithm • The SCORE model is limited to ages 45–64 years, so toaccount for the large proportion of subjects enrolled in JUPITER >65 years, a modification of the SCORE model was used in which the risk conferred by age was extrapolated for patients aged 65 or older (extrapolated model) • The extrapolated model is the model cited in the European CRESTORSummary of the Product Characteristics Koenig W, RCRESTOR is a trademark of the AstraZeneca group of companies (1): 75-83

  5. JUPITER High Risk Population • 9% (n=1558) of the JUPITER population were considered to be high risk in having a Framingham 10-year risk >20% • 52% (n=9302) of the JUPITER population were considered to be high risk in having a 10-year SCORE risk ≥5% using the extrapolated model Koenig W, Ridker PM. Eur Heart J 2011; 32(1): 75-83

  6. JUPITER High Risk Population Efficacy Endpoints • Time to the first occurrence of non-fatal MI, non-fatal stroke or death from cardiovascular causes, in each of the two high risk populations • Individual components of this composite endpoint in each of these high risk patient populations Koenig W, Ridker PM. Eur Heart J 2011; 32(1): 75-83

  7. Baseline Characteristics Koenig W, Ridker CRESTOR is a trademark of the AstraZeneca group of companies 3

  8. JUPITER Results: Post-hoc Analysis in High Risk Patients (10-year Framingham Risk >20%) Incidence of CV Death, MI or Stroke 10 9 Placebo Hazard Ratio 0.50 (95% CI: 0.27-0.93) P=0.028 8 7 6 CRESTOR 20 mg Cumulative incidence (%) 5 4 NNT for 4y = 26 3 2 1 0 0 1 2 3 4 5 Follow-up (years) Number at RiskCRESTORPlacebo 749717 359335 131110 6343 2414 Koenig W, Ridker PM. Eur Heart J 2011; 32(1): 75-83 CRESTOR is a trademark of the AstraZeneca group of companies

  9. JUPITER Results: Post-hoc Analysis in High Risk Patients (SCORE ≥ 5%; Extrapolated Model) Incidence of CV Death, MI or Stroke 7 Placebo Hazard Ratio 0.57 (95% CI: 0.43-0.78) P=0.0003 6 5 CRESTOR 20 mg 4 Cumulative incidence (%) 3 NNT for 4y = 41 2 1 0 0 1 2 3 4 5 Follow-up (years) Number at RiskCRESTORPlacebo 43554351 22152223 670702 280284 102105 Koenig W, Ridker PM. Eur Heart J 2011; 32(1): 75-83 CRESTOR is a trademark of the AstraZeneca group of companies

  10. JUPITER High Risk Population: Safety Adverse Events and Laboratory Abnormalities in High-risk Subgroups Koenig W, Ridker PM. Eur Heart J 2011; 32(1): 75-83

  11. JUPITER High Risk Population: Safety Adverse Events and Laboratory Abnormalities in High-risk Subgroups Koenig W, Ridker PM. Eur Heart J 2011; 32(1): 75-83

  12. Conclusion • CRESTOR 20 mg significantly reduced major cardiovascular events in primary prevention patients with elevated hsCRP with high global cardiovascular risk (10-year Framingham risk score >20% or SCORE risk ≥5%), but LDL-C levels not requiring pharmacologic treatment • On the basis of these post-hoc analyses, European health authorities approved the use of CRESTOR to reduce first major cardiovascular events among ‘high’ global risk primary prevention patients defined either by Framingham risk score >20% or European systematic coronary risk evaluation (SCORE) ≥5% Koenig W, Ridker PM. Eur Heart J 2011; 32(1): 75-83 CRESTOR is a trademark of the AstraZeneca group of companies

  13. CRESTOR™ (rosuvastatin) Summary of Product CharacteristicsApril 2012 Click on the icon below to access the Summary of Product Characteristics. Consult full prescribing information for CRESTOR before prescribing. Koenig W, Ridker PM. Eur Heart J 2011; 32(1): 75-83 CRESTOR is a trademark of the AstraZeneca group of companies CRESTOR exhibition JUPITER slides 2012

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