NICE issues final guidance on stroke drug
- Published on Wednesday, 26 September 2012 09:41
- Posted by Scott Buckler
NICE, the healthcare guidance body, has today issued final guidance on the use of alteplase (Actilyse, Boehringer Ingelheim) for the treatment of acute ischaemic stroke
NICE has recommended alteplase within the NHS as long as treatment is started as early as possible within 4.5 hours after onset of stroke symptoms, and after intracranial haemorrhage has been excluded by appropriate imaging techniques.
The update was prompted by a change in the drug's licence which allows an extension in the time period it can be used, from within 3 hours to within 4.5 hours of the onset of symptoms.
Ischaemic strokes, which account for 80% of strokes, happen when the normal blood supply to part of the brain is cut off. This starves the cells of oxygen in the area affected, causing them to become damaged or die. According to the UK Stroke Association, more than 130,000 people in England and Wales have a stroke each year. Mortality statistics from 2009 indicate that approximately 43,000 people died from stroke in England and Wales. More than 450,000 people in England live with severe disabilities as a result of stroke.
Standard treatment for stroke includes supportive and medical management in a specialist centre during the acute (early) phase, measures to prevent the damage to the brain from getting worse, and appropriate rehabilitative and physiotherapy programmes during the post-stroke period. Alteplase is a tissue plasminogen activator. It is administered during the acute phase of the stroke and activates the production of plasmin, an enzyme that degrades fibrin clots thereby helping to restore blood flow through the blocked artery.
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "We know that stroke is one of the biggest killers and causes of disability, therefore it is important that patients receive treatments that can help to reduce the effects of a stroke as quickly as possible. The benefits of alteplase in reducing long term disability caused by stroke are well recognised. However, because alteplase needs to be given within 4.5 hours of the onset of symptoms, these benefits can only be realised if brain imaging to confirm a diagnosis of acute ischaemic stroke is received as soon as possible, and certainly within one hour of arrival at the hospital, as per the NICE Quality Standard for Stroke. To that end the independent Appraisal Committee heard from clinical specialists that Accident and Emergency departments of all acute care hospitals in England and Wales must have access to 24-hour, 7-day a week brain imaging facilities. Today's guidance recommending the use of alteplase within the extended time frame for which it is now licensed has the potential to have a significant impact on the treatment of thousands of patients."