Thursday, July 11, 2019

Alteplase (rtPA) now included on the WHO’s List of Essential Medicines (EML) for acute ischemic stroke

Alteplase (rtPA) has made it on to the WHO’s List of Essential Medicines (EML) for acute ischemic stroke

 In the last 25 years, several studies have shown the efficacy of alteplase for acute ischemic stroke. If given within three hours, about one in four patients will have a reduced long-term handicap. This important effect of alteplase already includes its haemorrhage risk of 3-4%.

Despite this important reduction of brain damage, alteplase is only available in two thirds of countries and remains much underused in low and middle income countries. In order to increase access and use of thrombolysis around the globe, the World Stroke Organization (WSO) assembled 13 stroke experts from five continents under the leadership of Patrik Michel (Switzerland) and Michael Brainin (Austria). In 2018, this group submitted a 30 page application to the World Health Organization (WHO) for alteplase to be included in the EML ( describing all the pros, cons, conditions, and costs of alteplase.

This week, the WHO informed the WSO that the application was successful: alteplase is now included in the 21st EML, to be used in specialized diagnostic or monitoring facilities and with specialist medical care, as described for example in the WSO's Road Map for Quality Stroke Care.

This new inclusion of alteplase in the EML marks a major step forward for better stroke treatment worldwide, in particular in less affluent countries. All UN-member states are now encouraged to offer thrombolysis for a reasonable cost or for free, such as through Universal Health Coverage (UHC).

And in other good news for the stroke community, the new EML also increases the options for stroke prevention: it now lists fixed-dose dual combinations of antihypertensives, and four direct oral anticoagulants (dabigatran, apixaban, edoxaban and rivaroxaban) as essential medicines. Furthermore, a WSO expert group is currently working with WHO on a list of Priority Medical Devices for stroke prevention and treatment.

These new treatment options are likely to have an important impact on stroke incidence and long-term outcome worldwide, especially in combination with health policy, organized stroke care systems and lifestyle changes. 

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