A randomized double-blind controlled trial of naftidrofuryl in acute stroke. New approach to treatment of recent stroke. The usefulness of naftidrofuryl in severe peripheral ischaemia--a symptomatic assessment using linear analogue scales.
There is evidence to support the use of naftidrofuryl in acute stroke with claims of increased recovery, reduced fatality and reduced bed occupancy in patients treated with either oral or intravenous preparations. One hundred patients presenting with acute hemisphere stroke (less than 72 hours) were randomized to receive either a new oral formulation of naftidrofuryl or placebo on a double-blind basis. Treatment was given for a total of 12 weeks and patients followed for 26 weeks with serial neurological and functional assessments by a single observer. Cumulative fatality and hospital-bed occupancy were determined at each assessment interval. No significant difference was demonstrated in cumulative fatality, hospital-bed occupancy or recovery of motor function in patients treated with either naftidrofuryl or placebo. There is no evidence from this study to support the use of oral naftidrofuryl in acute stroke. Ninety-one patients with acute stroke participated in a double-blind, placebo-controlled trial of naftidrofuryl. Treatment was allocated at random and given over 12 weeks, neurological and neurophysical scores being obtained before treatment and at weeks 2, 4, 8, and 12. Both treatment groups greatly improved over the 12 weeks, but the naftidrofuryl-treated patients made greater neurological progress. Of the patients eventually discharged, those given naftidrofuryl spent only half as long in hospital as the controls. Deaths attributable to stroke were significantly fewer in the active-treatment group. The effect of Naftidrofuryl (Nafronyl) on the symptoms of severe peripheral vascular disease has been studied in 40 hospital inpatients. Assessment of ischaemic symptoms and of symptoms which may occur with any type of chronic pain was made using a linear analogue system. Patients treated with naftidrofuryl showed a significant symptomatic improvement compared to patients treated without vasoactive drug therapy. These results show that this drug has a useful place in the treatment of severe ischaemic symptoms during assessment for vascular reconstruction and in those patients found to be unsuitable for limb-salvage operations.
There is not enough evidence to support the use of naftidrofuryl in the treatment of acute ischaemic or haemorrhagic stroke.