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After 10 years and 26 cvots, where do we stand on cv ...

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Over 130,000 subjects with diabetes are entered into placebo- controlled clinical trials to prove the absence of a problem.
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After 10 Years and 26 CVOTs,Where do We Stand on CVSafety in Diabetes?Robert E. Ratner, MDGeorgetown University School of MedicineWashington, DC1Financial DisclosureConsultant: Adocia, Novo Nordisk, VirtaStock Holdings: J & J, Abbott, Abbvie2“...sponsors should demonstratethat the therapy will not result inan unacceptable increase in CVrisk.”• Meta-analysis strategy using Phase 2/3 data• Blinded central adjudication of CVD eventsin Phase 2/3• Inclusion of high-risk subjects: advancedCVD, elderly, CKD• Minimum exposure of 2 years in large CVOT• Approximately 15,000 pt-yrs1.0Hazard Ratio1.81.3Pre-marketing AnalysesUpper CL of 95% CI <1.8For a HR=1.0  ≈122 eventsPost-marketing AnalysesUpper CL of 95% CI <1.3For a HR=1.0  ≈611 events3• Over 130,000 subjects with diabetes are entered into placebo-controlled clinical trials to prove the absence of a problem.• These patients must be at very high risk for cardiovascular outcomesso that the trial can be undertaken in a reasonable period of ti...
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