ORAL ILOPROST AS A TREATMENT FOR RAYNAUDS SYNDROME - A DOUBLE-BLIND MULTICENTER PLACEBO-CONTROLLED STUDY

Objective-To compare the efficacy, tolerance and safety of 50-150 mu g orally administered iloprost given twice a day versus placebo in pati ents with Raynaud's syndrome. Methods-The study was multicentre (n = 3 ), double blind and placebo controlled. Sixty three patients who had e ight or more vasospastic attacks per week were enrolled. After a one w eek run-in period, all patients received either iloprost or placebo tr eatment to a maximum tolerated dose of 150 mu g twice a day for 10 day s. Diary cards assessed the duration and severity of the vasospastic a ttacks. Side effects were monitored by direct questioning, A global as sessment of treatment efficacy was made by the patient at the end of t reatment and two weeks later. Results-Patient opinion tended to favour iloprost at the end of the 10 day treatment phase (p = 0.09) and this was significant at day 24 (the follow up visit) (p = 0.011). Although the duration and severity of attacks tended to decrease in the ilopro st treated group, these results tended not to reach statistical signif icance (for severity p = 0.06 at end of treatment, p = 0.09 on day 24) . Conclusion-Iloprost administered intravenously has been shown to be of benefit in the treatment of the Raynaud's syndrome associated with systemic sclerosis, but this route of administration is inconvenient. This study evaluated the use of iloprost administered orally to patien ts with Raynaud's syndrome. Patient documented improvement was signifi cantly improved by iloprost. Diary card analysis showed a trend in fav our of iloprost, but these results did not reach statistical significa nce.