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Published on 15 May 2014

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Eliquis receives ‘positive opinion’ from EMA

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended an addition to the current Summary of Product Characteristics (SmPC) and stated that ‘Patients can stay on apixaban while being cardioverted.’(1)

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended an addition to the current Summary of Product Characteristics (SmPC) and stated that ‘Patients can stay on apixaban while being cardioverted.’(1)

Cardioversion is a procedure that attempts to restore the normal heart rhythm in patients with arrhythmias such as atrial fibrillation (AF).(2) There are 8.8 million people with AF in Europe,(3) (1.2 million of whom are in the UK(4) many of whom undergo cardioversion as part of their management.(5)

The CHMP’s positive opinion was based on a post-hoc analysis of the outcomes of the ARISTOTLE study. ARISTOTLE was designed to evaluate the efficacy and safety of apixaban compared with warfarin for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).(6) In ARISTOTLE, 540 patients underwent 743 cardioversions for non-valvular AF (NVAF). The outcomes of patients treated with apixaban (n=265) compared with those treated with warfarin (n=275) were assessed in the 30 days following cardioversion attempts.(7)

Adverse clinical events occurring after cardioversion were found to be similar between the warfarin and apixaban groups with no reported stroke or systemic emboli in either group and low observed rates of myocardial infarction, major bleeding or death.(7)

“The SmPC update is significant because it means that NVAF patients will no longer have to change anticoagulation therapy prior to cardioversion, and apixaban therapy can now be continued without interruption,” said Professor John Camm, Clinical Cardiologist, St George’s Hospital, London.

“The fact that this ARISTOTLE analysis showed that there were no strokes or systemic emboli in the apixaban group, and that adverse events were low and balanced between the treatment arms, provides reassurance that patients already taking apixaban who need cardioversion can continue to take this oral anticoagulant while they are being cardioverted.”

Cardioversion is widely used as part of AF management in Europe.(5) Cardioversion may be associated with increased risk of thromboembolism,(8) and AF patients with an elevated stroke risk usually require therapeutic anticoagulation before, and for a time after, the procedure.(9)

References

1. Opinion of the committee for medicinal products for human use on a type II variation to the terms of the marketing authorisation for Eliquis (apixaban) – EMA/CHMP/233170/2014 – 25 April 2014.

2. WebMD. Electrical Cardioversion for Atrial Fibrillation. Available at: http://www.webmd.com/heart-disease/atrial-fibrillation/electrical-cardioversion-for-atrial-fibrillation (accessed 14 April 2014).

3. Krijthe BP et al. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J 2013;34:2746–51.

4. National Institute for Health and Clinical Excellence. Medical Technology Guidance. SCOPE. WatchBP Home A for diagnosing and monitoring hypertension and detecting atrial fibrillation. Available at: http://www.nice.org.uk/nicemedia/live/13570/60600/60600.pdf (accessed 24 April 2014).

5. Hernández-Madrid A et al. Cardioversion for atrial fibrillation in current European practice: results of the European Heart Rhythm Association survey. Europace 2013;15(6):915-8.

6. Granger, CB et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981–92.

7. Flaker G et al. Efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation: Insights from the ARISTOTLE trial. J Am Col Card 2014;63(11):1082–7.

8. Camm AJ et al. 2012 Focussed update of the ESC Guidelines for the Management of Atrial Fibrillation. Eur Heart J 2012;33: 2719–47.

9. Prystowsky E et al. Management of Patients with Atrial Fibrillation, Circulation, 2014. Available at: http://circ.ahajournals.org/content/early/2014/04/10/CIR.0000000000000041 (accessed 15 March 2014).



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