Oral iloprost in the treatment of thromboangiitis obliterans (Buerger's disease): a double-blind, randomised, placebo-controlled trial. The European TAO Study Group.
OBJECTIVE
To assess efficacy and tolerability of two dosages of the oral prostacyclin analogue iloprost versus placebo in thromboangiitis obliterans (TAO).


METHODS
Placebo-controlled, double-blind, study; TAO patients randomised to iloprost 100, 200 micrograms, or placebo bid for 8 weeks, with 6 months' follow-up.


METHODS
Three-hundred and nineteen TAO patients with rest pain, trophic lesions (or both) from 23 clinics in six European countries. Primary endpoint: total healing of most important lesion. Secondary endpoint: relief of rest pain without need of analgesics. Combined endpoint: alive without major amputation, no lesions, no rest pain, no use of analgesics.


RESULTS
Total healing of lesions was not significantly different between treatment groups at any time point. For relief of rest pain without need of analgesics, low dose (LD) iloprost was significantly more effective than placebo at end of 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). High dose iloprost (HD) failed to show significant treatment effects over placebo.


CONCLUSIONS
Iloprost LD was significantly more effective than placebo for relief of rest pain without need of analgesics and for a combined endpoint at 6 months of follow-up, whilst both iloprost doses showed no significant effects vs. placebo on total healing of lesions.
D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000139:chemically induced; D006801:Humans; D016285:Iloprost / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010147:Pain Measurement; D010349:Patient Compliance; D013919:Thromboangiitis Obliterans / Q000188:drug therapy*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood
D014665:Vasodilator Agents; D016285:Iloprost