Safety of alteplase confirmed for stroke treatment
Simon Fraser/Science Photo Library
Intracerebral haemorrhage a concern |
Data from a prospective study have confirmed the safety and efficacy in routine clinical practice of intravenous alteplase administered within three hours of onset of ischaemic stroke symptoms.
Concerns have been voiced over the applicability of clinical trial data
to routine practice, particularly given the potential risk of intracerebral
haemorrhage, say the researchers. A condition of alteplase being licensed
by the EU in 2002 was that a large observational study should be conducted
to assess its safety profile in comparison with pooled results of randomised
trials. The study — safe implementation of thrombolysis in stroke-monitoring
study (SITS-MOST) — is published in The Lancet (2007;369:275).
Researchers recruited 6,483 patients from 14 countries, including the
UK, between 2002 and 2006. After one week, the proportion of patients
with symptomatic intracerebral haemorrhage (using the Cochrane definition)
was 7.3 per cent (6.7–7.9) in SITS-MOST compared with 8.6 per cent
(6.3–11.6) in the pooled randomised controlled trials. Mortality
rate at three months was 11.3 per cent (10.5–12.1) in SITS-MOST
compared with 17.3 per cent (14.1–21.1) in randomised controlled
trials.
“Our data suggest that thrombolysis should now be considered a
part of routine care of suitable stroke patients,” the researchers
conclude.
The authors of an accompanying editorial (ibid, p249) point out that
SITS-MOST excluded patients over 80 years old, those with severe neurological
deficits or high blood pressure, or when treatment was started more than
three hours after symptom onset. They believe that these exclusions are
excessively restrictive and say that the eligibility criteria used in
the US National Institutes of Neurological Disorders and Stroke study
are still appropriate.
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