Bellando-Randone S, et al. - In order to assess the safety and tolerability of the intravenous treatment with iloprost (ILO) in different phases of systemic sclerosis (SSc), authors conducted this study. They noted that while using ILO, calcium channel blockers ought to be transitorily stopped. It was noted that a pre-treatment approach could reduce or control adverse events. In patients with digital edema, careful employment of ILO infusion following the evaluation of patient’s drug tolerance was recommended.

Methods

• Experts retrospectively evaluated 81 consecutive non-selected SSc patients, all on nifedipine, with moderate RP, treated with ILO infusion.
• They sub classified the patients according to the edematous or fibrotic/atrophic cutaneous phase of the disease.
• Up to the achievement of patient’s tolerance, ILO was infused with a progressive increase in the dosage, 1 day/week.
• The cases demonstrating slower infusion regimen because of adverse events (AE) at the beginning of the administration, received a lower dose of the drug (not possible to quantify precisely the final cumulative dosage).

Results

• Results suggested that during the infusion at 20 ml/h, 16/81 SSc patients presented with digital edema, 5 developed diarrhea, and 9 developed transient hypotension that ameliorated when the drug was withdrawn.
• It was observed that 10/16 edematous patients experienced notable and painful digital swelling, unlike patients in the fibrotic group (p < 0.0001); 11/16 patients reported flushing and 7/16 headache, which was always controlled by tapering the dose below 10 ml/h.
• Ten developed diarrhea and 24 hypotension, in the atrophic/fibrotic phase patients (65/81), at infusion rate of 20 ml/h that led to temporary withdrawal of the drug.
• No side effects were experienced when ILO was restarted and kept below 10 ml/h.
• Flushing was experienced by 23/65 patients and 8/65 experienced headache, all controlled with infusion reduction below 10 ml/h.
• Adverse events were significantly less frequent in these patients as compared to the edematous group (p=0.023 and p=0.008, respectively).