An in-depth independent expert review of a clot-busting drug used in the treatment of acute ischaemic stroke has provided a firm reassurance that it is safe and effective for use up to 4.5 hours after the onset of symptoms. The earlier the treatment is given the greater the chance of a more favourable outcome for patients.
Alteplase acts by breaking down blood clots and can benefit patients by restoring blood flow to areas of the brain that have been affected by a stroke, thereby reducing the risk of long-term disability.
An independent expert working group of the UK’s Commission on Human Medicines (CHM) was formed to consider the latest data on the benefits and risks of alteplase in strokes, with a particular focus on the time window for effective treatment. This was in response to questions raised about the evidence base for treatment.
The independent scientific group, chaired by Professor Sir Ian Weller, comprised members with expertise in neurology, cardiology, emergency medicine, statistics, epidemiology and patient representation.
Following a review of all the latest available evidence the group reached the these conclusions:
- the benefit of using alteplase outweighs the risk when used up to 4.5 hours after the onset of symptoms in accordance with the licence
- the benefit of alteplase in the treatment of stroke is highly time-dependent and therefore minimising the time to the start of treatment is critical to ensuring the best possible outcome
- the latest available data strengthen the existing evidence base for the current authorised use of alteplase
Alteplase: Independent expert review conclusions
Professor Sir Ian Weller said:
Patients, the public and healthcare professionals should be reassured that the independent expert working group has rigorously reviewed and discussed all available data and unanimously concluded that alteplase remains safe and effective for use in the treatment of acute ischaemic stroke.
The evidence shows that for every 100 patients treated with alteplase, whilst there is an early risk of a fatal bleed in 2 patients, after 3 to 6 months, around 10 more in every 100 are disability free when treated within three hours. In addition 5 more patients in every 100 are disability free when treated between 3 and 4.5 hours after a stroke.
The conclusion of the group is very clear in that the current time-frame for treatment is supported by strong evidence.
MHRA’s Director of Vigilance and Risk Management of Medicines Dr June Raine said:
A thorough scientific assessment was conducted by staff not involved in the licensing of alteplase. They reviewed all the latest available evidence. We will continue to monitor the safety of alteplase and if any new evidence emerges we will reassess the benefit-risk balance. Patients treated with alteplase should be reassured that this continues to be an effective medicine when used within 4.5 hours after the onset of stroke symptoms.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health.
- The Commission on Human Medicines (CHM) is a non-departmental public body that advises ministers on the safety, efficacy and quality of medicinal products.
- See the data taken into consideration for the review.