ORAL ILOPROST TREATMENT IN PATIENTS WITH RAYNAUDS-PHENOMENON SECONDARY TO SYSTEMIC-SCLEROSIS - A MULTICENTER, PLACEBO-CONTROLLED DOUBLE-BLIND STUDY

Objective. To evaluate the efficacy and tolerability of an oral prepar ation of iloprost, a prostacyclin analog? in patients with Raynaud's p henomenon (RP) secondary to systemic sclerosis (scleroderma), Methods. A multicenter, randomized, parallel-group, placebo-controlled double- blind study was performed at university and community-based medical ce nters, Patients were randomly assigned to receive either 50 mu g of il oprost orally twice daily or an identical gelatin-coated capsule conta ining placebo for 6 weeks, Outcome measures included average total dai ly duration of RP attacks, average number of RP attacks, and RP condit ion scored via a standardized daily diary, Results. Three hundred eigh t patients with scleroderma (272 women, 36 men, mean age 19 years [ran ge 18-80]) were enrolled. One hundred fifty seven were assigned to rec eive iloprost and 151 to receive placebo, One hundred forty-three pati ents in the iloprost group (91.1%) and 114 in the placebo group (95.4% ) completed the 6-week treatment phase, Fifteen of these treated patie nts (8 iloprost, 7 placebo) failed to complete all of the followup vis its, The mean reduction in the average duration of attacks from baseli ne to week 5-6 was 24.32 minutes in the iloprost group and 34.34 minut es in the placebo group (P = 0.569), Likewise, the mean reduction from baseline to week 5-6 in the daily frequency of attacks was 1.02 in th e iloprost group and 0.83 in the placebo group (P = 0.459). The Raynau d's condition score, a patient-completed assessment of the severity of RP attacks, was reduced by 1.32 in the iloprost group and 1.00 in the placebo group (P = 0.323), The lack of significant difference between treatment groups did not change when a variety of factors, including use of other vasodilators, duration of disease, classification of scle roderma (limited versus diffuse), or number of baseline digital ulcers were taken into account, Premature withdrawal from the study due to a dverse events occurred in 10 patients (6.4%) in the iloprost group and 3 (2.0%) in the placebo group (P = 0.058). Conclusion. Oral iloprost at a dosage of 50 mu g twice daily is no better than placebo for manag ement of RP secondary to scleroderma, either during 6 weeks of treatme nt or during 6 weeks of posttreatment followup.