The National Institute for Health and Clinical Excellence (NICE) has published new draft guidance updating its previous recommendations on the use of Boehringer Ingelheim's Actilyse (alteplase) for the treatment of acute ischaemic stroke.

The new draft guidance says that Actilyse should be used within the NHS as long as treatment is started as early as possible within four and a half hours after onset of stroke symptoms, and after intracranial haemorrhage has been excluded by appropriate imaging techniques.

The update has been prompted by a change in the drug's licence, which allows an extension in the time period it can be used from within three hours to within four and a half hours of the onset of symptoms.

Ischaemic strokes, which account for 80% of strokes, occur 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, says NICE. According to the UK Stroke Association, more than 130,000 people in England and Wales have a stroke each year, and statistics from 2009 indicated that around 43,000 people in England and Wales died from stroke that year. More than 450,000 people in England live with severe disabilities as a result of stroke, it adds.

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. 

Actilyse is a tissue plasminogen activator which 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.

"We know that strokes are 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," said Professor Carole Longson, director of NICE's health technology evaluation centre.

The benefits of alteplase in reducing long-term disability caused by stroke are well-recognised. However, because the drug needs to be given within four and a half 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 hospital, as per the NICE Quality Standard for Stroke, she added.

To that end, NICE's independent appraisal committee heard from clinical specialists that A&E departments of all acute care hospitals in England and Wales must have access to 24-hour, seven-day-a-week brain imaging facilities, said Prof Longson, and she added that the new draft guidance recommending 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."