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Risk/Benefit Assessment

Risk/Benefit Assessment. Jeremy N. Ruskin, M.D. Director, Cardiac Arrhythmia Services Massachusetts General Hospital. AF Population Baseline Characteristics. Nieuwlaat R et al. Eur Heart J. 2005; 26:2422-34 The AFFIRM Writing Group N Engl J Med, 2002;347:1825-33.

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Risk/Benefit Assessment

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  1. Risk/Benefit Assessment Jeremy N. Ruskin, M.D. Director, Cardiac Arrhythmia Services Massachusetts General Hospital

  2. AF PopulationBaseline Characteristics Nieuwlaat R et al. Eur Heart J. 2005; 26:2422-34 The AFFIRM Writing Group N Engl J Med, 2002;347:1825-33

  3. Risks of Vernakalant Injection0-24 Hours – All Patients * Based on Exact Methodology, 1-sided 95% confidence interval † SAE or discontinuation of study drug due to hypotension or bradycardia

  4. Risks of Vernakalant Injection • QT prolongation – moderate, transient • TdP – 1 event within 24 hours of vernakalant infusion and immediately following infusion of ibutilide • Hypotension – peri-infusional, generally transient, usually responds to saline and positioning • Bradycardia – associated with cardioversion

  5. Risks of Vernakalant Injection By History of CHF * Based on events occurring within 0-24 hour time period

  6. Benefits of Vernakalant Injection Patients withoutAF Symptoms at Min. 90 (AF >3h - ≤7d) Consistent Conversion Rates All Patients

  7. Benefits of Vernakalant Injection • Maintenance of sinus rhythm at 24 hours - 97% • Can be administered with background rate (72%) or rhythm control (20%) medications • Electrical cardioversion is effective in non-responders (vernakalant - 88%; placebo - 90%) • Safe and effective in patients with common co-morbidities, including: • Hypertension (52% of patients in P2/3 studies) • History of ischemic heart disease (24% of patients in P2/3 studies)

  8. Risk/Benefit of Vernakalant Injection Profile of ventricular arrhythmias within the first 24 hours • Ventricular Fibrillation – 2/773 (0.26%) • Torsade de Pointes (TdP) – 1/773 (0.13%) • Ventricular Tachycardia

  9. Vernakalant Injection Risk/Benefit Summary • Effective for the rapid conversion of AF to sinus rhythm with reduction of AF symptoms • An important treatment alternative for patients with acute symptomatic atrial fibrillation, including post-cardiac surgery patients

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