The National Institute for Health and Clinical Excellence has now published final guidance updating prior recommendations on the use of Boehringer Ingelheim's Actilyse for the treatment of acute ischaemic stroke.

Reflecting a change in the drug's license, the cost watchdog is now endorsing its use to treat patients as early as possible but up to four and a half hours after they experienced a stroke, extending its scope from the original three-hour limit.

Actilyse (alteplase) is a tissue plasminogen activator that, when administered during the acute phase of the stroke, triggers the production of plasmin, which busts clots and so helps restore blood flow through the blocked artery. 

Approval to extend the time-limit for the drug's use was given in Europe last year, on the back of a pooled analysis of studies showing that patients treated up to 180 minutes after symptoms onset are at least 30% more likely to have minimal/no disability at three months compared with those patients who didn’t receive thrombolysis.

Benefits recognised

"The benefits of alteplase in reducing long term disability caused by stroke are well recognised," said Professor Carole Longson, NICE Health Technology Evaluation Centre Director. 

However, because of the relatively small window of treatment opportunity, the benefits of Actilyse 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, she stressed.

Nevertheless, the new guidelines have the potential to have "a significant impact on the treatment of thousands of patients,” Longson noted.

According to the UK Stroke Association, more than 130,000 people in England and Wales have a stroke each year. Around 43,000 people died from stroke in England and Wales in 2009, while more than 450,000 people live with severe disabilities as a result of stroke in England alone.