EFFECT OF ORAL NAFTIDROFURYL ON ISCHEMIC STROKE RECOVERY IN A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Although the effect of naftidrofuryl on ischemic stroke recovery has b een investigated in a number of studies, considerable variation occurr ed in time to treatment initiation and in evaluation criteria. A multi center, double-blind, placebo-controlled study was conducted to evalua te whether recovery in patients with middle cerebral artery infarction was improved by one year of oral naftidrofuryl started two weeks afte r the event. The primary endpoint was survival with a Barthel index sc ore greater than 85 at study completion. In the intention-to-treat ana lysis, the proportions of patients who reached the study endpoint were 47% in the naftidrofuryl group versus 28% in the placebo group (P = 0 .027), yielding a relative benefit of 1.67 (CI, 1.04-2.67). In the act uarial survival analysis, the time needed to achieve the primary endpo int was significantly shorter in the naftidrofuryl group than in the p lacebo group (P = 0.025). The per protocol analysis confirmed that rec overy measured as significant improvements in neurological and functio nal scores, occurred faster in the naftidrofuryl group. In addition me an hospital stay duration was shorter in the patients on naftidrofuryl (P = 0.041).