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- Title
Intravenous iloprost infusion in patients with Raynaud phenomenon secondary to systemic sclerosis. A multicenter, placebo-controlled, double-blind study.
- Authors
Wigley, Fredrick M.; Wise, Robert A.; Seibold, James R.; McCloskey, Deborah A.; Kujala, Gregory; Medsger Jr., Thomas A.; Steen, Virginia D.; Varga, John; Jimenez, Sergio; Mayes, Maureen; Clements, Philip J.; Weiner, Steven R.; Porter, John; Ellman, Michael; Wise, Christopher; Kaufman, Lee D.; Williams, John; Dole, William; Wigley, F M; Wise, R A
- Abstract
<bold>Objective: </bold>To evaluate the efficacy and safety of iloprost, a prostacyclin analog, administered intravenously in patients with Raynaud phenomenon secondary to systemic sclerosis.<bold>Design: </bold>Multicenter, randomized, parallel placebo-controlled, double-blind study.<bold>Setting: </bold>University medical centers.<bold>Patients: </bold>131 patients with systemic sclerosis (101 women, 30 men) ages 20 to 79 years.<bold>Intervention: </bold>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.<bold>Measurements: </bold>Frequency of Raynaud attacks, Raynaud severity score, physician's overall rating of treatment effect, and digital cutaneous lesion healing.<bold>Results: </bold>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.<bold>Conclusion: </bold>Iloprost is effective for the short-term palliation of severe Raynaud phenomenon in patients with systemic sclerosis.
- Subjects
RAYNAUD'S disease; ILOPROST; DRUG side effects; THERAPEUTICS
- Publication
Annals of Internal Medicine, 1994, Vol 120, Issue 3, p199
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-120-3-199402010-00004