stop the clot ™ david henry and tom hogan cardiovascular and renal drugs advisory committee u.s....
TRANSCRIPT
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Stop the Clot ™ www.stoptheclot.org
David Henry and Tom Hogan
Cardiovascular and Renal Drugs Advisory Committee
U.S. Food and Drug Administration
Adelphi, MD
March19, 2009
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Stop the Clot ™ www.stoptheclot.org
NATT
Community-based, patient led, science driven volunteer organization
Committed to prevention and quality treatment of blood clots and clotting disorders
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Stop the Clot ™ www.stoptheclot.org
NATT’s Mission. . .
To prevent, diagnose and treat thrombosis and thrombophilia through research, education, support and advocacy
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Stop the Clot ™ www.stoptheclot.org
NATT-CDC COOPERATIVE AGREEMENT 2007-2009
Patient Education and Support Health Professional Education Website Development Development of Nationwide Chapter Network
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Stop the Clot ™ www.stoptheclot.org
SURGEON GENERAL’S CALL TO ACTION TO PREVENT DVT/PE
Issued September 2008
Spotlights public health urgency posed by DVT/PE
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Stop the Clot ™ www.stoptheclot.org
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!
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Stop the Clot ™ www.stoptheclot.org
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!
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Stop the Clot ™ www.stoptheclot.org
PRIORITY - REINFORCE EVIDENCE-BASED PREVENTION
Majority of at-risk patients with confirmed DVT were not prophylaxed, despite risk, and availability of evidence-based guidelines
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Stop the Clot ™ www.stoptheclot.org
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
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Stop the Clot ™ www.stoptheclot.org
SURGEON GENERAL RECOMMENDATIONS
Conduct further research on anticoagulants:
• Best or optimal choice for designated populations
• Safest dosing
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HIP/KNEE REPLACEMENT TRENDS
2005 < 1 Million
2009 Nearly 1.2 Million
Future Aging Baby Boomers
Stop the Clot ™
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Stop the Clot ™ www.stoptheclot.org
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
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Tom Hogan
Stop the Clot ™
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Stop the Clot ™ www.stoptheclot.org
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)
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Stop the Clot ™ www.stoptheclot.org
If potential benefits are realized…
Close to optimal care +
Reduced risks for complications =
Increased acceptance/use for TKR/THR +
Reduced morbidity and mortality
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Stop the Clot ™ www.stoptheclot.org
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