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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
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Community-based, patient led, science
driven volunteer organization
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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
Stop the Clot ™
www.stoptheclot.org
NATT-CDC COOPERATIVE
AGREEMENT 2007-2009
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Patient Education and Support
Health Professional Education
Website Development
Development of Nationwide Chapter Network
Stop the Clot ™
www.stoptheclot.org
SURGEON GENERAL’S CALL TO ACTION
TO PREVENT DVT/PE
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Issued September 2008
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Spotlights public health urgency posed by DVT/PE
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CALL TO ACTION PUBLIC
HEALTH THREAT
Surgeon General’s Report
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350,000-600,000 Americans have blood clots
every year
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100,000 deaths
Blood clots are a leading cause of death!
Stop the Clot ™
www.stoptheclot.org
MAYO CLINIC DATA (Heit et al)
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900,000 Americans have blood clots
every year
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300,000 deaths
Blood clots are a leading cause of death!
Stop the Clot ™
www.stoptheclot.org
PRIORITY - REINFORCE
EVIDENCE-BASED PREVENTION
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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
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2005
< 1 Million
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2009
Nearly 1.2 Million
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Future
Aging Baby Boomers
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NEED TO REINFORCE
ESTABLISHED GUIDELINES
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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 ™
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Tom Hogan
Stop the Clot ™
POTENTIAL BENEFITS OF NEW
ORAL MEDICATION
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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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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
Stop the Clot ™
www.stoptheclot.org
NATT SUMMARY
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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