Low versus high-dose iloprost therapy over 21 days in patients with secondary Raynaud's phenomenon and systemic sclerosis: a randomized, open, single-center study.

OBJECTIVE

We compared the efficacy of different dosages of longterm iloprost treatment on Raynaud's phenomenon (RP), ulcer healing, skin thickening, and progression of internal organ sclerosis in patients with systemic sclerosis (SSc).

METHODS

Fifty patients with SSc were randomized 1:1 for the maximally tolerated dose up to 2 ng/kg body weight per minute or low-dose (0.5 ng/kg bw per min) intravenous iloprost administration, applied for 6 hours daily over 21 days. Effects on RP, ulcer healing, skin thickness, esophageal function, and lung involvement assessed by forced vital capacity (FVC) and DLCO were measured, as well as side effects.

RESULTS

Both regimens yielded 70% reduction of digital ulcers, 40% reduction in frequency of RP, and 30% reduction in duration of RP. One year after therapy, the modified Rodnan skin score appeared to be unchanged. FVC and DLCO-SB were stable in 87% and 74% of the patients, respectively. The effect of iloprost on skin thickness and lung function was sustained in a subgroup of patients receiving several courses of iloprost. As assessed by a patient questionnaire, 12% of all patients did not respond to iloprost therapy, but 78% experienced a longlasting effect. Mild side effects were common in both groups, but did not lead to discontinuation of therapy.

CONCLUSION

Low-dose iloprost was shown to be equally effective as high-dose iloprost in longterm treatment and was very effective in therapy of digital ulcers. Registered in www.ClinicalTrials.gov (registration no. NCT00622687).