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Review
. 2020 Aug 6;15(1):52.
doi: 10.5334/gh.608.

Inclusion in the World Health Organization Model List of Essential Medicines of Non-Vitamin K Anticoagulants for Treatment of Non-Valvular Atrial Fibrillation: A Step Towards Reducing the Burden of Cardiovascular Morbidity and Mortality

Ezequiel J Zaidel  1 , Xinyi Leng  2 , Abiodun Moshood Adeoye  3   4 , Ferdous Hakim  5 , Biraj Karmacharya  6 , Asim Katbeh  7 , Lis Neubeck  8   9 , Stephanie Partridge  10 , Pablo Perel  11 , Mark D Huffman  12   13 , Mariachiara Di Cesare  14
Affiliations
Review

Inclusion in the World Health Organization Model List of Essential Medicines of Non-Vitamin K Anticoagulants for Treatment of Non-Valvular Atrial Fibrillation: A Step Towards Reducing the Burden of Cardiovascular Morbidity and Mortality

Ezequiel J Zaidel et al. Glob Heart. .

Abstract

Non-vitamin K antagonist oral anticoagulants (NOACs) represent a paradigm shift in the treatment of non-valvular atrial fibrillation (AF) with major practice guidelines around the world recommending NOACs over vitamin K antagonist oral anticoagulants for initial treatment of AF for stroke prevention. Here we describe the evidence collated and the process followed for the successful inclusion of NOACs into the 21st WHO Model List of Essential Medicines (EML). Individual NOACs have been reported to be non-inferior or superior to warfarin in preventing stroke and systemic embolism in eligible AF patients with a reduction in the risk of stroke and systemic embolism and a lower risk of major bleeding in patients with non-valvular AF compared with warfarin in both RCTs and real-world data. The successful inclusion of NOACs in the WHO EML is an important step forward in the global fight against cardiovascular morbidity and mortality, especially in low- and middle-income countries, where the burden of disease is high and limited access to diagnosis and treatment translates into a higher burden of morbidity, mortality, and economic costs.

Keywords: Essential Medicine List; non-valvular atrial fibrillation; non-vitamin K antagonist oral anticoagulants (NOACs); prevention; stroke.

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Conflict of interest statement

MDH has received support from the American Heart Association, Verily, and AstraZeneca for work unrelated to this research. MDH has received salary support from the American Medical Association for his role as an associate editor for JAMA Cardiology. The George Institute for Global Health has a patent and license and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. LN received speakers fees from Daiichi Sankyo unrelated to this research. EJZ received speakers fees from Novartis, Pfizer and Bayer unrelated to this research. The author alone is responsible for the views expressed in this article, which do not necessarily represent the views, decisions or policies of the institution.

Figures

Figure 1
Figure 1
The efficacy of NOACs versus warfarin in preventing stroke and systemic embolism in patients with non-valvular AF based on data from RCTs and studies reporting real-world data (RWD).
Figure 2
Figure 2
The risks of major bleeding in non-valvular AF patients treated with NOACs versus warfarin based on data from RCTs and studies reporting real-world data (RWD).
See this image and copyright information in PMC

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