analysis of cardiovascular thromboembolic events with etoricoxib n.
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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

Analysis of Cardiovascular Thromboembolic Events With Etoricoxib

Joel Schiffenbauer, M.D.

DAAODP, ODE V

February 17, 2005

etoricoxib
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
etoricoxib1
Etoricoxib
  • Exposure
  • Mortality data
  • CV/TE data
    • NDA
    • EDGE
etoricoxib2

Etoricoxib

Exposure

etoricoxib3

Etoricoxib

Mortality Data

etoricoxib4

Etoricoxib

CV/TE Events in NDA

serious adverse events included in thrombotic cv saes
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
etoricoxib5

Etoricoxib

CV Events in EDGE Study

slide23
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
summary
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