INTRAVENOUS ILOPROST INFUSION IN PATIENTS WITH RAYNAUD PHENOMENON SECONDARY TO SYSTEMIC-SCLEROSIS - A MULTICENTER, PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY
Fm. Wigley et al., INTRAVENOUS ILOPROST INFUSION IN PATIENTS WITH RAYNAUD PHENOMENON SECONDARY TO SYSTEMIC-SCLEROSIS - A MULTICENTER, PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY, Annals of internal medicine, 120(3), 1994, pp. 199-206
Objective: To evaluate the efficacy and safety of iloprost, a prostacy
clin analog, administered intravenously in patients with Raynaud pheno
menon secondary to systemic sclerosis. Design: Multicenter, randomized
, parallel placebo-controlled, double-blind study. Setting: University
medical centers. Patients: 131 patients with systemic sclerosis (101
women, 30 men) ages 20 to 79 years. Intervention: Patients were random
ly assigned to receive one of two parallel treatments of five daily se
quential, 6-hour intravenous infusions of iloprost (0.5 to 2.0 ng/kg p
er min) or to receive a similar volume of placebo. Measurements: Frequ
ency of Raynaud attacks, Raynaud severity score, physician's overall r
ating of treatment effect, and digital cutaneous lesion healing. Resul
ts: Of the 131 patients enrolled, 126 completed the 5-day infusion and
114 (87%) completed at least 6 weeks of follow-up. Sixty-four patient
s were randomly assigned to receive iloprost and 67 patients, to recei
ve placebo. The mean weekly number of Raynaud attacks decreased 39.1%
with iloprost and 22.2% with placebo (P = 0.005). In addition, the moa
n percentage of improvement in a global Raynaud severity score during
the entire 9-week follow-up was greater in patients given iloprost (34
.8%) than in those receiving placebo (19.7%) (P = 0.011). The physicia
n's overall rating of, treatment effect showed greater improvement wit
h iloprost than with placebo at week 6 (52.4% compared with 27.4%; P =
0.008) and week 9 (60.9% compared with 26.9%; P < 0.001). At week 3,
14.6% more patients receiving iloprost had 50% or more lesions heal co
mpared with those given placebo (95% CI, 0.9% to 30%). During the infu
sion, 59 (92%) of the patients receiving iloprost had one or more side
effects compared with 38 (57%) of the patients receiving placebo. Con
clusion: iloprost is effective for the short-term palliation of severe
Raynaud phenomenon in patients with systemic sclerosis.