1 / 9

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

pink
Download Presentation

Pravastatin-Aspirin Introduction

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related