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Pravastatin-Aspirin Introduction

Pravastatin-Aspirin Introduction. Todd Baumgartner, MD, MPH Vice President Regulatory Sciences Pharmaceutical Research Institute Bristol-Myers Squibb. Pravastatin-Aspirin Chronology. June 2001 Original application filed January 18 Initial Cardio-Renal Drugs Advisory Committee Meeting

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Pravastatin-Aspirin Introduction

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  1. Pravastatin-AspirinIntroduction Todd Baumgartner, MD, MPH Vice President Regulatory Sciences Pharmaceutical Research InstituteBristol-Myers Squibb

  2. Pravastatin-Aspirin Chronology • June 2001 Original application filed • January 18 Initial Cardio-Renal Drugs Advisory Committee Meeting • February - May Discussions with FDA on remaining issues • May 8 Revised application filed

  3. Contents of Original Pravastatin-Aspirin NDA • Meta-analysis of 5 secondary prevention trials demonstrating efficacy, safety and independent contribution of individual components • Pharmacokinetic study demonstrating no PK interactions

  4. Pravastatin-Aspirin Advisory Committee – Jan 18, 2002 General agreement • …a population could be identified for which the combination product would be indicated • …meta-analysis demonstrated individual contribution to the beneficial cardiovascular outcomes in the secondary prevention population • …choice of the two doses of aspirin (81mg and 325mg)

  5. Issues To Be Discussed Today • Choice of pravastatin doses to be offered • Potential for excessive bleeding should pravastatin-aspirin not be discontinued prior to surgery • Potential for inappropriate discontinuation of pravastatin • Concern over inappropriate use in a non-indicated population

  6. Pravastatin-Aspirin Proposed Secondary Prevention Indication • Long-term management to reduce the risk of the following cardiovascular events in patients with clinically evident coronary heart disease: • Death • Non-fatal myocardial infarction • Myocardial revascularization procedures • Ischemic stroke

  7. Experts Available to Committee • Jerome L. Avorn, MD • Associate Professor of Pharmacoepidemiology, Harvard Medical School • Donald A. Berry, PhD • Professor and Chair of Biostatistics, University of Texas, M.D. Anderson Cancer Center • Bernard R. Chaitman, MD • Professor of Medicine, St. Louis University • Lawrence J. Dacey, MD • Associate Professor of Surgery, Dartmouth – Hitchcock Medical Center, NH

  8. Experts Available to Committee • Charles H. Hennekens, MD, DrPH • Professor of Medicine, Epidemiology and Public Health, University of Miami School of Medicine, FL • Thomas A. Pearson, MD, PhD, MPH • Professor and Chair of Community Medicine, University of Rochester, NY • Marc A. Pfeffer, MD, PhD • Professor of Medicine, Brigham & Women’s, Boston • Eric J. Topol, MD • Chair of Cardiovascular Medicine, Cleveland Clinic

  9. Agenda • Todd Baumgartner, MD, MPH • Introductory remarks • Rene Belder, MD • Pravastatin doses and rationale • Aspirin safety considerations • Temporary discontinuation of statin therapy • Fred Fiedorek, MD • Pravastatin-aspirin: Context and rationale

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