Introduction Pravastatin-Aspirin

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IntroductionPravastatin-Aspirin

• Fred T. Fiedorek, M.D.
• Vice President, Clinical Design Evaluation,
  MetabolicsPharmaceutical Research
  InstituteBristol-Myers Squibb

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Cardiovascular Disease Far and Away the Leading
Cause of Death
TotalCVD
Cancer
Accidents
Pneumonia/Influenza
Pneumonia/Influenza
TotalCVD
Cancer
ChronicObstructivePulmonaryDisease
ChronicObstructivePulmonaryDisease
DiabetesMellitus
US 1998 Source CDC / NCHS and the American Heart
Association
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Deaths and Death Rates for CHDUnited States
1979 98
Source NHLBI Chartbook 2000
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A Pravastatin-Aspirin Combination Will Facilitate

• Accuracy and adherence
• Enhanced implementation of guidelines
  recommending both therapies
• Enhanced assurance for health care providers
• correct product
• correct doses
• Enhanced convenience for patients
• Decreased pill burden

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Aspirin Label

• Aspirin is indicated in patients
• with a previous MI or unstable anginato reduce
  death and non-fatal MI
• with chronic stable angina to reduce MI and
  sudden death
• who have undergone revascularization procedures
  for a pre-existing condition
• with a suspected acute MI to reduce vascular
  mortality
• who have had ischemic stroke or transient
  ischemia of the brain due to fibrin platelet
  embolito reduce death and non-fatal stroke

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Pravastatin Label Secondary Prevention

• In patients with clinically evident coronary
  heart disease, pravastatin is indicated to
• reduce the risk of total mortality by reducing
  coronary death
• reduce the risk of MI
• reduce the risk of undergoing myocardial
  revascularization procedures
• reduce the risk of stroke and stroke/TIA
• slow the progression of coronary atherosclerosis

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Pravastatin-Aspirin Proposed 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

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Pravastatin-Aspirin Patient Population
Aspirin
12.4 Million CHD Patients
GI Hemorrhage Peptic Ulcer Disease ASA
sensitivity
Contraindicated
Pravastatin
Contraindicated Hepatic Disease
Sources ACC/AHA Guidelines 2001, 2001
Pharmametrics Database, Boston MA
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Properties Required of Combination Product

• Different mechanisms of action of components
• No PK or PD interaction between components
• Acceptable safety and tolerability profile
• Appropriate dose combinations available
• Both components contribute independently to
  efficacy
• Addresses a medical need

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BMS Consultant Panel

• Donald A. Berry, Ph.D. Frank T. McGraw
  MemorialChair of Cancer Research, University of
  Texas, M.D. Anderson Cancer Center
• Thomas A. Pearson, M.D., M.P.H., Ph.D. Albert
  D. Kaiser Professor and Chair of Community and
  Preventive Medicine, University of Rochester
  School of Medicine
• Charles H. Hennekens, M.D. Professor of
  Medicine and Epidemiology / Public Health,
  University of Miami School of Medicine
• Andrew Tonkin, M.D. National Heart Foundation
  of Australia Professor of Medicine, University
  of Melbourne Principal Investigator of LIPID
  Trial
• Frank Sacks, M.D. Harvard School of Public
  Health Professor of Cardiovascular Disease
  PreventionAttending Physician, Hyperlipidemia
  Clinic,Brigham Womens Hospital

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Speakers for This Morning

• Dr. René Belder
• Mechanism of action of components
• PK analysis
• Safety and tolerability of combination
• Dose combinations available
• Efficacy based on individual trials
• Dr. Donald Berry
• Efficacy based on meta-analyses
• Efficacy presence of consistent benefit
• Dr. Thomas Pearson
• Medical Need

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