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The National Alliance for Thrombosis and Thrombophilia (NATT) focuses on preventing, diagnosing, and treating blood clots through advocacy, education, and research. Highlighting the urgent public health threat posed by DVT/PE, NATT collaborates with the Surgeon General’s Call to Action to improve awareness and reinforce evidence-based prevention strategies. Key recommendations include fostering innovative treatments with minimal adverse effects and enhancing patient education. Join NATT in their mission to combat the significant health risks associated with blood clotting disorders.
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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 • 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 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 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 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! 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! 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 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 Stop the Clot ™ www.stoptheclot.org
SURGEON GENERAL RECOMMENDATIONS • Conduct further research on anticoagulants: • Best or optimal choice for designated populations • Safest dosing Stop the Clot ™ www.stoptheclot.org
HIP/KNEE REPLACEMENT TRENDS • 2005 < 1 Million • 2009 Nearly 1.2 Million • Future Aging Baby Boomers Stop the Clot ™
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
Tom Hogan Stop the Clot ™
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
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 • 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