The British Journal of Rheumatology, Vol 37, 952-960, Copyright © 1998 by British Society for Rheumatology
CM Black, L Halkier-Sorensen, JJ Belch, S Ullman, R Madhok, AJ Smit, JD Banga and HR Watson
OBJECTIVE: To identify the optimal dose of oral iloprost on the basis of
efficacy and tolerability in patients with Raynaud's phenomenon secondary
to systemic sclerosis. DESIGN: Multicentre, randomized, parallel-group
comparison of two different doses of oral iloprost and placebo. SETTING:
European university hospitals. PATIENTS: A total of 103 patients with
Raynaud's phenomenon secondary to systemic sclerosis. INTERVENTION:
Patients received one of three treatments for 6 weeks: placebo, oral
iloprost 50 microg or oral iloprost 100 microg. Each treatment was taken
twice daily, giving total daily doses of iloprost of 100 and 200 microg.
MEASUREMENTS: The frequency, total daily duration and severity of Raynaud's
attacks were recorded in a specially designed patient diary; physician's
global assessment and adverse events were recorded at visits to the clinic.
Analysis was performed on an intention-to-treat population. RESULTS: A
total of 103 patients were recruited, 89 completed the assessments
throughout the treatment period and 82 completed an additional 6 weeks of
follow-up after treatment. Thirty-five patients received placebo, 33
received iloprost 50 microg and 35 received iloprost 100 microg. The mean
percentage reductions in the frequency, total daily duration and severity
of Raynaud's attacks were numerically greater in the iloprost groups at the
end of treatment and at the end of follow-up. At the end of treatment (6
weeks), there were significant treatment differences in the total daily
duration of attacks (P = 0.03), but not in the severity (P = 0.07) or the
frequency of attacks (P = 0.37). At the end of follow-up (12 weeks), there
were significant treatment differences in the total daily duration of
attacks (P = 0.001) and in the severity of attacks (P = 0.007), but not in
the frequency of attacks (P = 0.07). Percentages of patients improved at
the end of treatment as assessed by the physician were 44% placebo, 57%
iloprost 50 microg and 64% iloprost 100 microg (not significant).
Side-effects were reported by 80% of patients on placebo, 85% on oral
iloprost 50 microg and 97% on oral iloprost 100 microg. Premature
discontinuations of treatment in each group were 9, 30 and 51%,
respectively, with 6, 27 and 51% being due to adverse events. CONCLUSION:
The results on the daily duration of Raynaud's attacks suggest that both 50
and 100 microg oral iloprost twice daily may be effective in the treatment
of Raynaud's phenomenon secondary to systemic sclerosis. The 50 microg
iloprost dose was better tolerated in this patient group.
ORIGINAL PAPERS
Oral iloprost in Raynaud's phenomenon secondary to systemic sclerosis: a multicentre, placebo-controlled, dose-comparison study
Royal Free Hospital, London.
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