Intravenous iloprost infusion in patients with Raynaud phenomenon secondary to systemic sclerosis. A multicenter, placebo-controlled, double-blind study.
OBJECTIVE
To evaluate the efficacy and safety of iloprost, a prostacyclin analog, administered intravenously in patients with Raynaud phenomenon secondary to systemic sclerosis.


METHODS
Multicenter, randomized, parallel placebo-controlled, double-blind study.


METHODS
University medical centers.


METHODS
131 patients with systemic sclerosis (101 women, 30 men) ages 20 to 79 years.


METHODS
Patients were randomly assigned to receive one of two parallel treatments of five daily sequential, 6-hour intravenous infusions of iloprost (0.5 to 2.0 ng/kg per min) or to receive a similar volume of placebo.


METHODS
Frequency of Raynaud attacks, Raynaud severity score, physician's overall rating of treatment effect, and digital cutaneous lesion healing.


RESULTS
Of the 131 patients enrolled, 126 completed the 5-day infusion and 114 (87%) completed at least 6 weeks of follow-up. Sixty-four patients were randomly assigned to receive iloprost and 67 patients, to receive placebo. The mean weekly number of Raynaud attacks decreased 39.1% with iloprost and 22.2% with placebo (P = 0.005). In addition, the mean 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 physician's overall rating of treatment effect showed greater improvement with 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 compared with those given placebo (95% CI, 0.9% to 30%). During the infusion, 59 (92%) of the patients receiving iloprost had one or more side effects compared with 38 (57%) of the patients receiving placebo.


CONCLUSIONS
Iloprost is effective for the short-term palliation of severe Raynaud phenomenon in patients with systemic sclerosis.
Wigley
F M
FM
Johns Hopkins University, Division of Molecular and Clinical Rheumatology, Baltimore, MD 21205.
Wise
R A
RA
Seibold
J R
JR
McCloskey
D A
DA
Kujala
G
G
Medsger
T A
TA
Steen
V D
VD
Varga
J
J
Jimenez
S
S
Mayes
M
M
Clements
P J
PJ
Weiner
S R
SR
Porter
J
J
Ellman
M
M
Wise
C
C
Kaufman
L D
LD
Williams
J
J
Dole
W
W
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D003080:Cold Temperature; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016285:Iloprost / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011928:Raynaud Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D012595:Scleroderma, Systemic / Q000150:complications*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D016285:Iloprost