Iloprost (ILO) is employed intravenously for the treatment of severe Raynaud phenomenon (RP) and digital ulcers (DU) in systemic sclerosis (SSc). The aim of this study was to evaluate the safety and tolerability of the intravenous treatment with ILO in different phases of SSc. Eighty-one consecutive non-selected SSc patients, all on nifedipine, with moderate RP, treated with ILO infusion, were retrospectively evaluated. Patients were sub classified according to the edematous or fibrotic/atrophic cutaneous phase of the disease. ILO was infused with a progressive increase of the dosage up to the achievement of patient’s tolerance, 1 day/week. In cases of slower infusion regimen due to adverse events (AE) at the beginning of the administration, patients received a lower dose of the drug (not possible to quantify precisely the final cumulative dosage). 16/81 SSc patients presented digital edema, 5 developed diarrhea, and 9 developed transient hypotension during the infusion at 20 ml/h that ameliorated when the drug was withdrawn. Moreover, 10/16 edematous patients experienced significant and painful digital swelling, unlike patients in the fibrotic group (p < 0.0001); 11/16 patients reported flushing and 7/16 headache, always controlled with dose tapering below 10 ml/h. In the atrophic/fibrotic phase patients (65/81), 10 developed diarrhea and 24 hypotension at infusion rate of 20 ml/h that led to temporary withdrawal of the drug. When ILO was restarted and kept below 10 ml/h, no side effects were experienced. 23/65 patients experienced flushing and 8/65 headache, all controlled with infusion reduction below 10 ml/h. In these patients, adverse events were significantly less frequent than in the edematous group (p = 0.023 and p = 0.008, respectively). Our data suggest that calcium channel blockers should be transitorily stopped while using ILO and that a pre-treatment approach might reduce or control adverse events. In patients with digital edema, ILO infusion should be carefully employed after the evaluation of patient’s drug tolerance.

The safety of iloprost in systemic sclerosis in a real-life experience / Bellando-Randone, S.; Bruni, C.; Lepri, G.; Fiori, G.; Bartoli, F.; Conforti, Ml; Moggi-Pignone, A.; Guiducci, S.; Giuggioli, D.; Colaci, M.; Spinella, A.; Ferri, C.; Matucci-Cerinic, M.. - In: CLINICAL RHEUMATOLOGY. - ISSN 0770-3198. - 37:5(2018), pp. 1249-1255. [10.1007/s10067-018-4043-0]

The safety of iloprost in systemic sclerosis in a real-life experience

Lepri, G.;Fiori, G.;Guiducci, S.;Giuggioli, D.;Colaci, M.;Spinella, A.;
2018

Abstract

Iloprost (ILO) is employed intravenously for the treatment of severe Raynaud phenomenon (RP) and digital ulcers (DU) in systemic sclerosis (SSc). The aim of this study was to evaluate the safety and tolerability of the intravenous treatment with ILO in different phases of SSc. Eighty-one consecutive non-selected SSc patients, all on nifedipine, with moderate RP, treated with ILO infusion, were retrospectively evaluated. Patients were sub classified according to the edematous or fibrotic/atrophic cutaneous phase of the disease. ILO was infused with a progressive increase of the dosage up to the achievement of patient’s tolerance, 1 day/week. In cases of slower infusion regimen due to adverse events (AE) at the beginning of the administration, patients received a lower dose of the drug (not possible to quantify precisely the final cumulative dosage). 16/81 SSc patients presented digital edema, 5 developed diarrhea, and 9 developed transient hypotension during the infusion at 20 ml/h that ameliorated when the drug was withdrawn. Moreover, 10/16 edematous patients experienced significant and painful digital swelling, unlike patients in the fibrotic group (p < 0.0001); 11/16 patients reported flushing and 7/16 headache, always controlled with dose tapering below 10 ml/h. In the atrophic/fibrotic phase patients (65/81), 10 developed diarrhea and 24 hypotension at infusion rate of 20 ml/h that led to temporary withdrawal of the drug. When ILO was restarted and kept below 10 ml/h, no side effects were experienced. 23/65 patients experienced flushing and 8/65 headache, all controlled with infusion reduction below 10 ml/h. In these patients, adverse events were significantly less frequent than in the edematous group (p = 0.023 and p = 0.008, respectively). Our data suggest that calcium channel blockers should be transitorily stopped while using ILO and that a pre-treatment approach might reduce or control adverse events. In patients with digital edema, ILO infusion should be carefully employed after the evaluation of patient’s drug tolerance.
2018
22-feb-2018
37
5
1249
1255
The safety of iloprost in systemic sclerosis in a real-life experience / Bellando-Randone, S.; Bruni, C.; Lepri, G.; Fiori, G.; Bartoli, F.; Conforti, Ml; Moggi-Pignone, A.; Guiducci, S.; Giuggioli, D.; Colaci, M.; Spinella, A.; Ferri, C.; Matucci-Cerinic, M.. - In: CLINICAL RHEUMATOLOGY. - ISSN 0770-3198. - 37:5(2018), pp. 1249-1255. [10.1007/s10067-018-4043-0]
Bellando-Randone, S.; Bruni, C.; Lepri, G.; Fiori, G.; Bartoli, F.; Conforti, Ml; Moggi-Pignone, A.; Guiducci, S.; Giuggioli, D.; Colaci, M.; Spinella...espandi
File in questo prodotto:
File Dimensione Formato  
bellando-randone2018.pdf

Accesso riservato

Tipologia: Versione pubblicata dall'editore
Dimensione 475 kB
Formato Adobe PDF
475 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1164616
Citazioni
  • ???jsp.display-item.citation.pmc??? 3
  • Scopus 17
  • ???jsp.display-item.citation.isi??? 17
social impact