The EC approved the use of the Actilyse treatment of selected patients with acute ischaemic stroke in the 0-3 hour window, based on the results of international clinical trials.
"This development represents an important first step forward in a disease area that has traditionally been limited to supportive and rehabilitative care," said Dr. Andreas Barner, a member of Boehringer Ingelheim’s board of managing directors and responsible for research and development and medicine.
Barner said, "A treatment which can reduce the disabling effects of acute stroke will improve the quality of life for a significant number of people who would otherwise survive a stroke but remain permanently disabled. We consider it to be very important that Actilyse is used in the patient population where benefit has been demonstrated.
"We will work hard to ensure that Actilyse is used in specialist stroke units that are registered with the Safe Implementation of Thrombolysis in Stroke Monitory System (SITS-MOST).
"An accompanying clinical trial investigating treatment in the 3-4 hour time window after stroke onset will also be performed, although it is emphasized that the earlier the patient can receive treatment with Actilyse, the better."
Prof. Nils Wahlgren, head of stroke research at the Karolinska Hospital in Stockholm and chairman of SITS-MOST, added, "The introduction of alteplase in conjunction with the development of SITS-MOST, will ensure that patients receive maximum benefit from this new development in stroke management. Patient safety is paramount, so the SITS register has been developed to provide guidance and support for all those clinicians wishing to use alteplase, and SITS-MOST will document that."
People who survive a stroke with permanent disabilities place an enormous burden on health and social services budgets. There is evidence to show that treating stroke patients in the short-term brings about long-term cost benefits:
• A recent economic evaluation found that the increase in hospitalization costs associated with alteplase treatment were more than offset by savings in rehabilitation and nursing home care.
• The National Institute of Neurological Disorders and Stroke (NINDS) trial reported that the average length of hospital stay was significantly shorter in alteplase-treated patients, who were also more likely to be sent home rather than being discharged to a nursing home or to in-patient rehabilitation.
• The NINDS trial demonstrated that patients receiving alteplase within three hours of onset of symptoms were at least 30 percent more likely to have minimal, or no disability, three months after their stroke.