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(Brinavess) for the Treatment of Recent Onset Atrial Fibrillation May 2010

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(Brinavess) for the Treatment of Recent Onset Atrial Fibrillation May 2010 Vernakalant (IV) (Brinavess) for the treatment of recent onset atrial fibrillation May 2010 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes. The National Horizon Scanning Centre Research Programme is part of the National Institute for Health Research May 2010 Vernakalant (IV) (Brinavess) for the treatment of recent onset atrial fibrillation Target group • Atrial fibrillation (AF) - rapid conversion to normal sinus rhythm (NSR) in haemodynamically stable patients with recent onset AF (≤3 days post cardiac surgery, or ≤7 days otherwise). Technology description Vernakalant (Brinavess, Kynapid, MK-6621, RSD-1235) is an atrial selective mixed sodium and potassium channel blocker with class I and III actions. It selectively prolongs the atrial refractory period and atrioventricular nodal conduction without inducing ventricular arrhythmias. Vernakalant is administered by peripheral intravenous infusion (IV) with 3mg/kg given over 10 minutes followed by an observation period of 15 minutes. If cardioversion is not achieved a second dose of 2mg/kg over 10 minutes may be administered. An oral formulation of vernakalant is in phase II development for the treatment of chronic atrial fibrillation. Innovation and/or advantages Vernakalant would provide an alternative to current pharmaceutical treatments for recent onset AF. Developer MSD (Merk Sharpe & Dohme). Availability, launch or marketing dates, and licensing plans Phase III clinical trials completed. Marketing Authorisation for the EU granted in September 2010. NHS or Government priority area This topic is relates to the National Service Framework for Older People and Coronary heart Disease. Relevant guidance • NICE technology appraisal in development. Dronedarone for atrial fibrillation and atrial flutter. Expected June 20101. 2 • NICE clinical guideline. The management of atrial fibrillation. 2006 . 3 • SIGN. Cardiac arrhythmias in coronary heart disease. 2007 . • American College of Cardiology (ACC), American Heart Association (AHA) and National Library for Health Guidance. Atrial fibrillation. 20074. 5 • Clinical Knowledge Summaries. Atrial fibrillation - management. 2007 . • European Society of Cardiology (ESC) guidelines. Guidelines for the management of patients with atrial fibrillation. 20066. • Clinical Knowledge Summaries. Cardiovascular risk - assessment and management. 20037. Clinical need and burden of disease In 2008-09 there were 120,200 finished consultant episodes for atrial fibrillation and atrial flutter with people age 60+ years accounting for approximately 80% of this 2 May 2010 population. This represents 88,931 admissions, of which 55,522 were emergency admissions (I48)8. Atrial fibrillation is the most common cardiac arrhythmia and its prevalence increases with age from 0.5% at age 50-59 years to 9% at age 80-89 years. More than 46,000 new cases are diagnosed each year in the UK1. Existing comparators and treatments In haemodynamically stable patients with AF without an acute identifiable precipitant (e.g. alcohol intake) which may revert spontaneously, a rhythm control strategy is preferred9, with: Cardioversion to restore NSR2: • pharmacological cardioversion (PCV) – preferred strategy in very recent onset AF (<48 hours) o flecainide (IV). o amiodarone (IV, via central venous catheter). • electrical cardioversion (ECV) by cardiac pacing or direct current – preferred in more prolonged AF. Maintenance of NSR after cardioversion: • beta-blockers. • oral anti-arrhythmic agents e.g. sotalol, flecainide, propafenone, amiodarone. Cardioversion is not always successful and follow-up studies show that approximately 50% of patients will be back in AF one year post conversion2. Efficacy and safety Trial NCT00125320, 1235-0104, NCT00468767, 1235-0703, NCT00115791, 04-7-010, ACT 2; AF and atrial flutter ACT 1; short and long-term Cardiome 1235-0504, ACT (AFL) after heart surgery; AF; vernakalant vs placebo; 3; AF or AFL; vernakalant vernakalant vs placebo; phase III. vs placebo; phase III. phase III. Sponsor Astellas Pharma Inc. Astellas Pharma Inc. Astellas Pharma Inc. Status Published. Published. Trial complete and published in abstract. Source of Publication10, trial Publication12, trial Abstract14, trial registry15. information registry11. registry13. Location EU, USA, Canada, Canada, USA, Denmark EU, USA, Canada, Argentina and India. and Sweden. Argentina, Chile, Mexico. Design Randomised placebo- Randomised, stratified, Randomised, stratified, controlled, unstratified. placebo-controlled. placebo-controlled. Participants n=190; adults; AF or AFL n=336; adults; stratified by n=276; adults; stratified by and schedule lasting 3-72 hours; after AF duration: 3 hours-7 days AF or AFL duration: 3 coronary artery bypass (short-term; n=237) or 8-45 hours-7 days (recent onset) surgery and/or valvular days (long-term). or 8-45 days. surgery; haemo- Randomised to vernakalant Randomised to vernakalant dynamically stable. 3mg/kg or placebo, with a 3mg/kg of placebo, with a Randomised to vernakalant second infusion of 2mg/kg second infusion of 2mg/kg 3mg/kg or placebo, with a or placebo if no conversion or placebo if no conversion second infusion of 2mg/kg to NSR observed after 15 to NSR observed after 15 or placebo if no conversion minutes. minutes. to NSR observed after 15 minutes. Follow-up Intense monitoring for 24 Intense monitoring for 24 30 days. hours; follow-up to day 30. hours; follow-up to day 30. 3 May 2010 Primary Conversion to NSR ≥1 Conversion to NSR ≥1 Conversion to NSR ≥1 outcome minute within 90 minutes minute within 90 minutes minute within 90 minutes (responders). (responders). (responders). Secondary For responders - time to For responders - time to For responders - time to outcomes conversion, time to conversion, NSR at 24 conversion. conversion for AF and AFL hours, proportion in NSR. sub-groups, NSR at 24 hours and 7 days, patient reported symptoms. Key results n=161 received therapy, of n=220 received therapy for n=190 received therapy for which 150 had AF. short-term AF. Conversion recent onset AF/AFL, of For vernakalant and to NSR in 51.7% with which 170 had AF. placebo respectively: vernakalant and 4% with For vernakalant and NSR conversion 44.9% vs. placebo (p<0.001). With placebo respectively: NSR 14.8% (p<0.001); for vernakalant, 76% converted conversion 47% and 3.3%. patients with AF NSR after a single dose, median Median time to conversion conversion 47% vs. 14% time to conversion 11 of 8 minutes. (p<0.001). minutes. 1 relapse to AF by For AF sub-group NSR Median time to conversion 24 hours. conversion: 52% and 3.6%. with vernakalant of 12 minutes, 75% responding to a single dose. 60% of responders in NSR at 24 hours, 57% at day 7. Adverse Serious AEs: 9.3% with Serious AEs: 13.1% with Severe AEs: 10% with effects vernakalant and 11.1% with vernakalant and 18.3% with vernakalant and 13% with (AEs) placebo. In first 24 hours 2 placebo. Most common placebo. Treatment related serious AEs reported with cardiac serious AE: serious AE in 3 patients vernakalant - hypotension recurrent AF requiring with vernakalant and 1 with and complete hospitalisation, 5.9% with placebo. 1 death with atrioventricular block. vernakalant and 12.2% with vernakalant. Most common Treatment emergent AEs placebo. Treatment AEs: transient dysgeusia within 24 hours: 38.4% emergent AEs with (22%) and sneezing (19%). with vernakalant and 31.5% vernakalant: hypotension with placebo; most and complete heart block in common were AF 8.4% vs. 3 patients. 9.3%, and nausea 5.6% vs. Rate of ventricular 3.7%. arrhythmias: 9.0% with Rate of ventricular vernakalant and 17.4% with arrhythmias similar in both placebo. groups; bradycardia events Most common AEs in the slightly more common with first 24 hours from vernakalant (6.3%) than vernakalant and placebo placebo (1.9%). respectively: dysgeusia (altered taste); 29.9%, 0.9%), sneezing (16.3%, 0%), paraesthesia (10.9%, 0%), nausea (9.0%, 0.9%), and hypotension (6.3%, 3.5%). Trial NCT00281554, 05-7-012, NCT00668759, VERI-305- NCT00989001, 6517-CL- ACT 4; AF; vernakalant; AMIO, AVRO; AF; 0020, ACT V; AF; phase III. vernakalant vs amiodarone; vernakalant vs placebo; phase III. phase III. 4 May 2010 Sponsor Astellas Pharma Inc. Cardiome Pharma. Astellas Pharma Inc Status Trial complete and Trial complete and Ongoing. published in abstract. published in abstract. Source of Abstract16, trial registry17. Trial registry18, press Trial registry20, press information release19 release21. Location USA, Canada, EU, EU, Australia, Canada, USA, Canada, South Argentina and South Serbia and Ukraine. America and other Africa. countries. Design Uncontrolled, single arm. Randomised, double Randomised, placebo- placebo, active-controlled. controlled. Participants n=236; adults; symptomatic n=254; adults; symptomatic n=470 (planned); adults; and schedule AF for 3 hours - 45 days. AF for 3 - 48 hours. symptomatic AF for 3 Received vernakalant Randomised to vernakalant hours - 7 days; 3mg/kg with a second 3mg/kg with a second Randomised to vernakalant infusion of 2mg/kg if no infusion of 2mg/kg if no 3mg/kg or placebo, with a conversion to NSR conversion to NSR second infusion of 2mg/kg observed after 15 minutes. observed after 15 minutes; or placebo if no conversion or amiodarone 5mg/kg over to NSR observed after 15 60 minutes
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