Intra-arterial prostacyclin compared to Praxilene in the management of severe lower limb ischaemia: a double blind trial. The usefulness of naftidrofuryl in severe peripheral ischaemia--a symptomatic assessment using linear analogue scales.
The effectiveness of a 72 h. intra-arterial prostacyclin infusion has been compared to that of naftidrofuryl oxalate (Praxilene) in a double blind study of 29 patients with ischaemic rest pain in 30 legs. Long-term relief of symptoms was achieved in 14 legs (47%) and major limb amputation avoided in 18 (60%). No significant difference was demonstrated between the results of prostacyclin infusion and those of Praxilene. 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.
Based on the results of these trials, it cannot be confirmed that intravenous naftidrofuryl is effective in the treatment of people with critical limb ischaemia. However, these results were based on trials of generally low methodological quality which had only a small number of participants, the duration of treatment was extremely short, and the methods varied between the trials. The wide range of endpoints effectively precluded any meaningful pooling of the results. Intravenous naftidrofuryl was withdrawn as a treatment for severe peripheral arterial disease in 1995 because of reported side effects.