Is eptacog alfa a safe bet for treating ICH?
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Is eptacog alfa a safe bet for treating ICH? The use of eptacog alfa [recombinant factor VIIa] appears to be associated with myocardial infarction (MI) and elevated troponin levels,1 and hydrocephalus 2, in patients with intracerebral haemorrhage (ICH), according to the results of two open-label studies. In the first study, US-based researchers identified 130 eligible patients with ICH who either received eptacog alfa 80 µg/kg by IV push within 4 hours of symptom onset (n = 20) or no treatment;1 mean admission troponin T levels were 0.011 and 0.016 ng/mL in the treated and nontreated groups, respectively. Within 30 hours of admission, the mean number of troponin measurements per patient were 2.45 and 2.04 for the treated and nontreated groups, respectively. Compared with the nontreated group, the treated group had significantly higher percentage of elevated troponin measurements* (10% vs 3%), percentage of patients with elevated troponin levels (20% vs 3%) and percentage of patients with MI (10% vs 1%). In the second study, researchers from Canada studied nine patients (mean age 66 years for five patients) with ICH who received eptacog alfa 40 µg/kg within 3 hours of symptom onset.2 At a 24-hour follow-up, a CT scan showed that 55% of patients (n = 5) had developed radiographic hydrocephalus; at baseline, these patients had a mean modified Graeb score of 3 (< 10% probability of developing hydrocephalus). Clinical condition deteriorated in two of the five patients with hydrocephalus, who subsequently underwent urgent ventriculostomy, but later died. * elevation of troponin was defined as a level ≥ 0.1 ng/mL 1. Sugg RM, et al. Myocardial injury in patients with intracerebral hemorrhage treated with recombinant factor VIIa. Neurology 67: 1053-1055, No. 6, 26 Sep 2006. 2. Subramaniam S, et al. Unexpected posthemorrhagic hydrocephalus in patients treated with rFVIIa. Neurology 67: 1096, No. 6, 26 Sep 2006. 801013745
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Reactions 4 Nov 2006 No. 1126
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