Transcript Slide 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
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
NATT’s Mission. . .
To prevent, diagnose and treat
thrombosis and thrombophilia through
research, education, support and
advocacy
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NATT-CDC COOPERATIVE
AGREEMENT 2007-2009
Patient Education and Support
Health Professional Education
Website Development
Development of Nationwide Chapter Network
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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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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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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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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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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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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
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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
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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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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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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
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