Tolerability, safety and efficacy of Iloprost infusion without peristaltic pump in systemic sclerosis

Abstract

OBJECTIVE: To evaluate safety, tolerability and efficacy on Raynaud's phenomenon (Rp) of iloprost infusion without peristaltic pump in patients with systemic sclerosis (SSc). PATIENTS AND METHODS: The inclusion criteria were diagnosis of SSc, age between 18 and 65 years, presence of Rp, and absence of any contraindication to the use of iloprost. The treatment was carried out in a day hospital setting and consisted first of 5 consecutive days of iloprost infusion (from an initial dose of 1.0 ng/Kg/min up to 2 ng/kg/min), and then of 2 days of infusions at the maximum possible dose every 45 days for one year. All of the adverse events were carefully recorded and the changes in the Rp were measured by a 5 grade scale (worsened, unmodified, slightly improved, very improved, disappeared). RESULTS: Thirty-eight SSc patients (all females), mean age 49 years (range 18.5-65), disease duration 1.5 years (range 0.5-10.8) were enrolled in the study. During the first cycle of therapy, 14 adverse events occurred in 11 (28.9%) patients and during the next cycles, 3 adverse events were seen in 3 (7.9%) patients. In all of the cases they were mild and transient. Rp was considered very improved in 15 (39.5%) patients, slightly improved in 13 (34.2%), unmodified in 8 (21%) and worse in 2 (5.2%). DISCUSSION: In this study intravenous iloprost without peristaltic pump proved to be safe, well tolerated, and as effective as traditional infusion through peristaltic pump in improving Rp in patients with SSc.