Reteplase compares favourably with alteplase for acute ischaemic stroke

Administering the new-generation thrombolytic reteplase within 4.5 hours of acute ischaemic stroke onset appears to be safe and as efficacious as alteplase, according to a phase II study.

In the study, researchers determined the safety dose range of reteplase for the treatment of acute ischemic stroke. A total of 180 adult patients who were eligible for standard intravenous thrombolysis were included.

The patients were randomly assigned to receive intravenous reteplase at 12+12 mg (n=61) or at 18+18 mg (n=67) or intravenous alteplase at 0.9 mg/kg (n=52). There were four patients did not receive the assigned study drug.

Symptomatic intracranial haemorrhage according to SITS* within 36 hours was designated as the primary safety outcome. The proportion of patients with the National Institutes of Health Stroke Scale score of no more than 1 or a decrease of at least 4 points from the baseline at 14 days after thrombolysis was the primary efficacy outcome.

The primary safety outcome occurred in three patients (5.0 percent) in the reteplase 12+12 mg group, one patient (1.5 percent) in the reteplase 18+18 mg group, and one patient (2.0 percent) in the alteplase group, with no significant between-group difference (p=0.53).

Likewise, the proportion of patients who achieved the primary efficacy outcome was similar across the treatment groups: 75.0 percent of patients in the reteplase 12+12 mg group and 72.7 percent in the reteplase 18+18 mg group versus 78.0 percent in alteplase group (odds ratio [OR], 0.85, 95 percent confidence interval [CI], 0.35–2.06 and OR, 0.75, 95 percent CI, 0.32–1.78, respectively).

Further studies are needed to establish the efficacy and appropriate dosage of reteplase for patients with acute ischaemic stroke.

*Safe Implementation of Thrombolysis in Stroke