Iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis and the quality of life: a new therapeutic protocol

Abstract

Objectives: to evaluate the clinical efficacy and the effects on the quality of life of Iloprost, a prostacyclin analogue, used, according to a new protocol, in patients with Raynaud’s phenomenon secondary to Systemic Sclerosis. Methods: in this randomized study we treated 30 patients with Iloprost given by intravenous infusion, at progressively increasing doses (starting from 0.5 ng/Kg/min up 2 ng/Kg/min) over a period of 6 hours a day for ten days in two consecutive weeks, with repeated cycles at regular intervals of three months for 18 months. The results were compared with those obtained in 30 other patients, who had received the same drug but with different posologic schemes. Results: the total average daily duration of the attacks, the average duration of a single attack and the average daily frequency of the attacks were reduced significantly in all groups of treatment, but the comparison between the groups demonstrated significant differences between patients treated with the new protocol and the others at later times (T12 and T18). The effects on the quality of life, evaluated by SF-36, demonstrate, in the group treated with the new protocol, a marked improvement both regarding the scale relative to the physical aspect of the illness, and especially regarding the scale relative to the mental aspect. Conclusions: in SSc patients, cyclic intravenous Iloprost infusion is efficacious in the treatment of Raynaud’s phenomenon. The protocol that we used, compared with others, is able to determine not only favourable clinical effects but also a marked improvement in the quality of life.