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David Henry and Tom Hogan

David Henry and Tom Hogan

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David Henry and Tom Hogan

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  1. David Henry and Tom Hogan Cardiovascular and Renal Drugs Advisory Committee U.S. Food and Drug Administration Adelphi, MD March19, 2009 Stop the Clot ™ www.stoptheclot.org

  2. NATT • Community-based, patient led, science driven volunteer organization • Committed to prevention and quality treatment of blood clots and clotting disorders Stop the Clot ™ www.stoptheclot.org

  3. NATT’s Mission. . . To prevent, diagnose and treat thrombosis and thrombophilia through research, education, support and advocacy Stop the Clot ™ www.stoptheclot.org

  4. NATT-CDC COOPERATIVE AGREEMENT 2007-2009 • Patient Education and Support • Health Professional Education • Website Development • Development of Nationwide Chapter Network Stop the Clot ™ www.stoptheclot.org

  5. SURGEON GENERAL’S CALL TO ACTION TO PREVENT DVT/PE • Issued September 2008 • Spotlights public health urgency posed by DVT/PE Stop the Clot ™ www.stoptheclot.org

  6. CALL TO ACTION PUBLIC HEALTH THREAT Surgeon General’s Report • 350,000-600,000 Americans have blood clots every year • 100,000 deaths Blood clots are a leading cause of death! Stop the Clot ™ www.stoptheclot.org

  7. MAYO CLINIC DATA (Heit et al) • 900,000 Americans have blood clots every year • 300,000 deaths Blood clots are a leading cause of death! Stop the Clot ™ www.stoptheclot.org

  8. PRIORITY - REINFORCE EVIDENCE-BASED PREVENTION • Majority of at-risk patients with confirmed DVT were not prophylaxed, despite risk, and availability of evidence-based guidelines Stop the Clot ™ www.stoptheclot.org

  9. SURGEON GENERAL RECOMMENDATIONS • Encourage development of new pharmaceutical agents with fewer adverse effects of existing agents: • Faster onset • Wider therapeutic range • Fewer food or drug interactions Stop the Clot ™ www.stoptheclot.org

  10. SURGEON GENERAL RECOMMENDATIONS • Conduct further research on anticoagulants: • Best or optimal choice for designated populations • Safest dosing Stop the Clot ™ www.stoptheclot.org

  11. HIP/KNEE REPLACEMENT TRENDS • 2005 < 1 Million • 2009 Nearly 1.2 Million • Future Aging Baby Boomers Stop the Clot ™

  12. NEED TO REINFORCE ESTABLISHED GUIDELINES • Reluctance of orthopedists to implement prophylaxis on patients with knee and hip replacement • Major Concern: BLEEDING • A clot is an act of God, whereas bleeding is surgical error Stop the Clot ™ www.stoptheclot.org

  13. Tom Hogan Stop the Clot ™

  14. POTENTIAL BENEFITS OF NEW ORAL MEDICATION • No INR monitoring • Pill instead of injection • Minimal diet concerns (e.g. vitamin K) • Minimal worry about interaction with other medication • Quick action and rapid elimination • (onset-offset) Stop the Clot ™ www.stoptheclot.org

  15. If potential benefits are realized… Close to optimal care + Reduced risks for complications = Increased acceptance/use for TKR/THR + Reduced morbidity and mortality Stop the Clot ™ www.stoptheclot.org

  16. NATT SUMMARY • Supports Surgeon General Call to Action • Appreciates the safety and efficacy review that will be done by committee • If approval is recommended, urges expeditious consideration by FDA Stop the Clot ™ www.stoptheclot.org