ORAL ILOPROST IN THE TREATMENT OF THROMBOANGIITIS-OBLITERANS (BUERGERS-DISEASE) - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Objectives: To assess efficacy and tolerability of two dosages of the oral prostacyclin analogue iloprost versus placebo in thromboangiitis obliterans (TAO). Design: Placebo-controlled, double-blind, study; TAO patients randomised to iloprost 100, 200 mu g, or placebo bid for 8 w eeks, with 6 months' follow-up. Methods: Three-hundred and nineteen TA O patients with rest pain, trophic lesions (or both) from 23 clinics i n six European countries. Primary endpoint: total healing of most impo rtant lesion. Secondary endpoint: relief of vest pain without need of analgesics. Combined endpoint: alive without major amputation, no lesi ons, no vest pain, no use of analgesics. Results: Total healing of les ions was not significantly different between treatment groups at any t ime point. For relief of rest pain without need of analgesics, low dos e (LD) iloprost was significantly more effective than placebo at end o f follow-up (placebo 49%; LD iloprost 63%; p=0.020). This also applied to the combined endpoint (placebo 35%; LD iloprost 50%; p=0.016). Hig h dose iloprost (HD) failed to show significant treatment effects over placebo. Conclusions: Iloprost LD was significantly more effective th an placebo for relief of rest pain without need of analgesics and for a combined endpoint, at 6 months of follow-up, whilst both iloprost do ses showed no significant effects vs. placebo on total healing of lesi ons.