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Analysis of Cardiovascular Thromboembolic Events With Etoricoxib

Analysis of Cardiovascular Thromboembolic Events With Etoricoxib. Joel Schiffenbauer, M.D. DAAODP, ODE V February 17, 2005. Etoricoxib. NDA indications include: OA, CLBP, RA, AS, acute gout, acute pain, dysmenorrhea Proposed doses: 60 and 90 mg chronically and 120 mg acutely

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Analysis of Cardiovascular Thromboembolic Events With Etoricoxib

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  1. Analysis of Cardiovascular Thromboembolic Events With Etoricoxib Joel Schiffenbauer, M.D. DAAODP, ODE V February 17, 2005

  2. Etoricoxib • NDA indications include: OA, CLBP, RA, AS, acute gout, acute pain, dysmenorrhea • Proposed doses: 60 and 90 mg chronically and 120 mg acutely • EDGE study: Etoricoxib vs. Diclofenac Sodium Gastrointestinal Tolerability and Effectiveness

  3. Etoricoxib • Exposure • Mortality data • CV/TE data • NDA • EDGE

  4. Etoricoxib Exposure

  5. Chronic Exposure to Etoricoxib Across the NDA

  6. EDGE Study

  7. Etoricoxib Mortality Data

  8. NDA/Deaths(rates are per 100 PYR)

  9. EDGE/Deaths

  10. Etoricoxib CV/TE Events in NDA

  11. Serious Adverse Events Included in Thrombotic CV SAEs • Cardiac • Acute MI • Fatal MI • Unstable angina • Sudden death • Peripheral • Pulmonary embolism • Fatal PE • Peripheral arterial or venous thrombosis • Cerebrovascular • Ischemic cerebrovascular stroke • Fatal stroke • TIA

  12. NDA/Absolute Rate & Relative Risk

  13. NDA/Absolute Rate & Relative Risk

  14. NDA/Placebo

  15. NDA (KM Estimates for CV Events)

  16. NDA/Absolute Rate & Relative Risk

  17. NDA/Non-naproxen NSAIDs

  18. NDA/KM

  19. NDA/Absolute Rate & Relative Risk

  20. NDA/Naproxen

  21. NDA/KM

  22. Etoricoxib CV Events in EDGE Study

  23. EDGE • 7000 patient GI tolerability study; collect CV data; non-inferiority to diclofenac (upper limit of 95% CI for hazard ratio is 1.3) • Issues: • Non-inferiority trial (no placebo) • diclofenac only comparator • only OA, no RA • ASA use (30%) • previous Cox-2 use allowed (15% rofecoxib; 13% celecoxib; 5% valdecoxib) • 2600 with >2 CV risk factors

  24. EDGE/KM Estimates

  25. EDGE/Confirmed Thrombotic CV SAEs

  26. EDGE/ASA Users Combined

  27. EDGE/Non-ASA Users Combined

  28. EDGE/Hypertension

  29. EDGE/Hypertension

  30. EDGE/CHF

  31. Summary • In NDA, etoricoxib trends worse in terms of CV/TE particularly cardiac/MI • Comparisons of etoricoxib to naproxen for CV/TE events are similar to rofecoxib/naproxen comparisons • Trial design concerns in EDGE (2 ongoing trials of similar design) • Trends in EDGE for cardiac events worse for etoricoxib, mainly in non-ASA users

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