Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis: A multicenter, placebo-controlled, double-blind study

摘要: Objective To evaluate the efficacy and tolerability of an oral preparation iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon (RP) secondary to systemic sclerosis (scleroderma). Methods A multicenter, randomized, parallel-group, placebo-controlled double-blind study was performed at university community-based medical centers. Patients were randomly assigned receive either 50 µg iloprost orally twice daily or identical gelatin-coated capsule containing placebo for 6 weeks. Outcome measures included average total duration RP attacks, number condition scored via standardized diary. Results Three hundred eight scleroderma (272 women, 36 men, mean age 49 years [range 18-80]) enrolled. One fifty seven 151 placebo. forty-three group (91.1%) 144 (95.4%) completed 6-week treatment phase. Fifteen these treated (8 7 placebo) failed complete all followup visits. The reduction attacks from baseline week 5-6 24.32 minutes 34.34 (P = 0.569). Likewise, frequency 1.02 0.83 0.459). score, patient-completed assessment severity reduced by 1.32 1.00 0.323). lack significant difference between groups did not change when variety factors, including use other vasodilators, disease, classification (limited versus diffuse), digital ulcers taken into account. Premature withdrawal due adverse events occurred 10 (6.4%) 3 (2.0%) 0.058). Conclusion Oral dosage is better than management scleroderma, during weeks posttreatment followup.