Analysis of cardiovascular thromboembolic events with etoricoxib
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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

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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


Chronic exposure to etoricoxib across the nda

Chronic Exposure to Etoricoxib Across the NDA


Edge study

EDGE Study


Etoricoxib3

Etoricoxib

Mortality Data


Nda deaths rates are per 100 pyr

NDA/Deaths(rates are per 100 PYR)


Edge deaths

EDGE/Deaths


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


Nda absolute rate relative risk

NDA/Absolute Rate & Relative Risk


Nda absolute rate relative risk1

NDA/Absolute Rate & Relative Risk


Nda placebo

NDA/Placebo


Nda km estimates for cv events

NDA (KM Estimates for CV Events)


Nda absolute rate relative risk2

NDA/Absolute Rate & Relative Risk


Nda non naproxen nsaids

NDA/Non-naproxen NSAIDs


Nda km

NDA/KM


Nda absolute rate relative risk3

NDA/Absolute Rate & Relative Risk


Nda naproxen

NDA/Naproxen


Nda km1

NDA/KM


Etoricoxib5

Etoricoxib

CV Events in EDGE Study


Analysis of cardiovascular thromboembolic events with etoricoxib

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


Edge km estimates

EDGE/KM Estimates


Edge confirmed thrombotic cv saes

EDGE/Confirmed Thrombotic CV SAEs


Edge asa users combined

EDGE/ASA Users Combined


Edge non asa users combined

EDGE/Non-ASA Users Combined


Edge hypertension

EDGE/Hypertension


Edge hypertension1

EDGE/Hypertension


Edge chf

EDGE/CHF


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


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