Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis: A multicenter, placebo-controlled, double-blind study

Fredrick Wigley, Joseph H. Korn, M. E. Csuka, Thomas A. Medsger, Naomi F. Rothfield, Michael Ellman, Richard Martin, David H. Collier, Arthur Weinstein, Daniel E. Furst, Sergio A. Jimenez, Maureen D. Mayes, Peter A. Merkel, Barry Gruber, Lee Kaufman, John Varga, Patrice Bell, John Kern, Pran Marrott, Barbara WhiteRobert W. Simms, Andree C. Phillips, James R. Seibold

Research output: Contribution to journalArticle

Abstract

Objective. To evaluate the efficacy and tolerability of an oral preparation of iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon (RP) secondary to systemic sclerosis (scleroderma). Methods. A multicenter, randomized, parallel-group, placebo-controlled double-blind study was performed at university and community-based medical centers. Patients were randomly assigned to receive either 50 μg of iloprost orally twice daily or an identical gelatin-coated capsule containing placebo for 6 weeks. Outcome measures included average total daily duration of RP attacks, average number of RP attacks, and RP condition scored via a standardized daily diary. Results. Three hundred eight patients with scleroderma (272 women, 36 men, mean age 49 years [range 18-80]) were enrolled. One hundred fifty seven were assigned to receive iloprost and 151 to receive placebo. One hundred forty-three patients in the iloprost group (91.1%) and 144 in the placebo group (95.4%) completed the 6-week treatment phase. Fifteen of these treated patients (8 iloprost, 7 placebo) failed to complete all of the followup visits. The mean reduction in the average duration of attacks from baseline to week 5-6 was 24.32 minutes in the iloprost group and 34.34 minutes in the placebo group (P = 0.569). Likewise, the mean reduction from baseline to week 5-6 in the daily frequency of attacks was 1.02 in the iloprost group and 0.83 in the placebo group (P = 0.459). The Raynaud's condition score, a patient-completed assessment of the severity of RP attacks, was reduced by 1.32 in the iloprost group and 1.00 in the placebo group (P = 0.323). The lack of significant difference between treatment groups did not change when a variety of factors, including use of other vasodilators, duration of disease, classification of scleroderma (limited versus diffuse), or number of baseline digital ulcers were taken into account. Premature withdrawal from the study due to adverse events occurred in 10 patients (6.4%) in the iloprost group and 3 (2.0%) in the placebo group (P = 0.058). Conclusion. Oral iloprost at a dosage of 50 μg twice daily is no better than placebo for management of RP secondary to scleroderma, either during 6 weeks of treatment or during 6 weeks of posttreatment followup.

Original languageEnglish (US)
Pages (from-to)670-677
Number of pages8
JournalArthritis and Rheumatism
Volume41
Issue number4
DOIs
StatePublished - Apr 1998

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Iloprost
Raynaud Disease
Systemic Scleroderma
Double-Blind Method
Placebos
Therapeutics
Limited Scleroderma
Epoprostenol
Gelatin
Vasodilator Agents
Ulcer
Capsules
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Immunology
  • Rheumatology

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Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis : A multicenter, placebo-controlled, double-blind study. / Wigley, Fredrick; Korn, Joseph H.; Csuka, M. E.; Medsger, Thomas A.; Rothfield, Naomi F.; Ellman, Michael; Martin, Richard; Collier, David H.; Weinstein, Arthur; Furst, Daniel E.; Jimenez, Sergio A.; Mayes, Maureen D.; Merkel, Peter A.; Gruber, Barry; Kaufman, Lee; Varga, John; Bell, Patrice; Kern, John; Marrott, Pran; White, Barbara; Simms, Robert W.; Phillips, Andree C.; Seibold, James R.

In: Arthritis and Rheumatism, Vol. 41, No. 4, 04.1998, p. 670-677.

Research output: Contribution to journalArticle

Wigley, F, Korn, JH, Csuka, ME, Medsger, TA, Rothfield, NF, Ellman, M, Martin, R, Collier, DH, Weinstein, A, Furst, DE, Jimenez, SA, Mayes, MD, Merkel, PA, Gruber, B, Kaufman, L, Varga, J, Bell, P, Kern, J, Marrott, P, White, B, Simms, RW, Phillips, AC & Seibold, JR 1998, 'Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis: A multicenter, placebo-controlled, double-blind study', Arthritis and Rheumatism, vol. 41, no. 4, pp. 670-677. https://doi.org/10.1002/1529-0131(199804)41:4<670::AID-ART14>3.0.CO;2-I
Wigley, Fredrick ; Korn, Joseph H. ; Csuka, M. E. ; Medsger, Thomas A. ; Rothfield, Naomi F. ; Ellman, Michael ; Martin, Richard ; Collier, David H. ; Weinstein, Arthur ; Furst, Daniel E. ; Jimenez, Sergio A. ; Mayes, Maureen D. ; Merkel, Peter A. ; Gruber, Barry ; Kaufman, Lee ; Varga, John ; Bell, Patrice ; Kern, John ; Marrott, Pran ; White, Barbara ; Simms, Robert W. ; Phillips, Andree C. ; Seibold, James R. / Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis : A multicenter, placebo-controlled, double-blind study. In: Arthritis and Rheumatism. 1998 ; Vol. 41, No. 4. pp. 670-677.
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title = "Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis: A multicenter, placebo-controlled, double-blind study",
abstract = "Objective. To evaluate the efficacy and tolerability of an oral preparation of iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon (RP) secondary to systemic sclerosis (scleroderma). Methods. A multicenter, randomized, parallel-group, placebo-controlled double-blind study was performed at university and community-based medical centers. Patients were randomly assigned to receive either 50 μg of iloprost orally twice daily or an identical gelatin-coated capsule containing placebo for 6 weeks. Outcome measures included average total daily duration of RP attacks, average number of RP attacks, and RP condition scored via a standardized daily diary. Results. Three hundred eight patients with scleroderma (272 women, 36 men, mean age 49 years [range 18-80]) were enrolled. One hundred fifty seven were assigned to receive iloprost and 151 to receive placebo. One hundred forty-three patients in the iloprost group (91.1{\%}) and 144 in the placebo group (95.4{\%}) completed the 6-week treatment phase. Fifteen of these treated patients (8 iloprost, 7 placebo) failed to complete all of the followup visits. The mean reduction in the average duration of attacks from baseline to week 5-6 was 24.32 minutes in the iloprost group and 34.34 minutes in the placebo group (P = 0.569). Likewise, the mean reduction from baseline to week 5-6 in the daily frequency of attacks was 1.02 in the iloprost group and 0.83 in the placebo group (P = 0.459). The Raynaud's condition score, a patient-completed assessment of the severity of RP attacks, was reduced by 1.32 in the iloprost group and 1.00 in the placebo group (P = 0.323). The lack of significant difference between treatment groups did not change when a variety of factors, including use of other vasodilators, duration of disease, classification of scleroderma (limited versus diffuse), or number of baseline digital ulcers were taken into account. Premature withdrawal from the study due to adverse events occurred in 10 patients (6.4{\%}) in the iloprost group and 3 (2.0{\%}) in the placebo group (P = 0.058). Conclusion. Oral iloprost at a dosage of 50 μg twice daily is no better than placebo for management of RP secondary to scleroderma, either during 6 weeks of treatment or during 6 weeks of posttreatment followup.",
author = "Fredrick Wigley and Korn, {Joseph H.} and Csuka, {M. E.} and Medsger, {Thomas A.} and Rothfield, {Naomi F.} and Michael Ellman and Richard Martin and Collier, {David H.} and Arthur Weinstein and Furst, {Daniel E.} and Jimenez, {Sergio A.} and Mayes, {Maureen D.} and Merkel, {Peter A.} and Barry Gruber and Lee Kaufman and John Varga and Patrice Bell and John Kern and Pran Marrott and Barbara White and Simms, {Robert W.} and Phillips, {Andree C.} and Seibold, {James R.}",
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TY - JOUR

T1 - Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis

T2 - A multicenter, placebo-controlled, double-blind study

AU - Wigley, Fredrick

AU - Korn, Joseph H.

AU - Csuka, M. E.

AU - Medsger, Thomas A.

AU - Rothfield, Naomi F.

AU - Ellman, Michael

AU - Martin, Richard

AU - Collier, David H.

AU - Weinstein, Arthur

AU - Furst, Daniel E.

AU - Jimenez, Sergio A.

AU - Mayes, Maureen D.

AU - Merkel, Peter A.

AU - Gruber, Barry

AU - Kaufman, Lee

AU - Varga, John

AU - Bell, Patrice

AU - Kern, John

AU - Marrott, Pran

AU - White, Barbara

AU - Simms, Robert W.

AU - Phillips, Andree C.

AU - Seibold, James R.

PY - 1998/4

Y1 - 1998/4

N2 - Objective. To evaluate the efficacy and tolerability of an oral preparation of iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon (RP) secondary to systemic sclerosis (scleroderma). Methods. A multicenter, randomized, parallel-group, placebo-controlled double-blind study was performed at university and community-based medical centers. Patients were randomly assigned to receive either 50 μg of iloprost orally twice daily or an identical gelatin-coated capsule containing placebo for 6 weeks. Outcome measures included average total daily duration of RP attacks, average number of RP attacks, and RP condition scored via a standardized daily diary. Results. Three hundred eight patients with scleroderma (272 women, 36 men, mean age 49 years [range 18-80]) were enrolled. One hundred fifty seven were assigned to receive iloprost and 151 to receive placebo. One hundred forty-three patients in the iloprost group (91.1%) and 144 in the placebo group (95.4%) completed the 6-week treatment phase. Fifteen of these treated patients (8 iloprost, 7 placebo) failed to complete all of the followup visits. The mean reduction in the average duration of attacks from baseline to week 5-6 was 24.32 minutes in the iloprost group and 34.34 minutes in the placebo group (P = 0.569). Likewise, the mean reduction from baseline to week 5-6 in the daily frequency of attacks was 1.02 in the iloprost group and 0.83 in the placebo group (P = 0.459). The Raynaud's condition score, a patient-completed assessment of the severity of RP attacks, was reduced by 1.32 in the iloprost group and 1.00 in the placebo group (P = 0.323). The lack of significant difference between treatment groups did not change when a variety of factors, including use of other vasodilators, duration of disease, classification of scleroderma (limited versus diffuse), or number of baseline digital ulcers were taken into account. Premature withdrawal from the study due to adverse events occurred in 10 patients (6.4%) in the iloprost group and 3 (2.0%) in the placebo group (P = 0.058). Conclusion. Oral iloprost at a dosage of 50 μg twice daily is no better than placebo for management of RP secondary to scleroderma, either during 6 weeks of treatment or during 6 weeks of posttreatment followup.

AB - Objective. To evaluate the efficacy and tolerability of an oral preparation of iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon (RP) secondary to systemic sclerosis (scleroderma). Methods. A multicenter, randomized, parallel-group, placebo-controlled double-blind study was performed at university and community-based medical centers. Patients were randomly assigned to receive either 50 μg of iloprost orally twice daily or an identical gelatin-coated capsule containing placebo for 6 weeks. Outcome measures included average total daily duration of RP attacks, average number of RP attacks, and RP condition scored via a standardized daily diary. Results. Three hundred eight patients with scleroderma (272 women, 36 men, mean age 49 years [range 18-80]) were enrolled. One hundred fifty seven were assigned to receive iloprost and 151 to receive placebo. One hundred forty-three patients in the iloprost group (91.1%) and 144 in the placebo group (95.4%) completed the 6-week treatment phase. Fifteen of these treated patients (8 iloprost, 7 placebo) failed to complete all of the followup visits. The mean reduction in the average duration of attacks from baseline to week 5-6 was 24.32 minutes in the iloprost group and 34.34 minutes in the placebo group (P = 0.569). Likewise, the mean reduction from baseline to week 5-6 in the daily frequency of attacks was 1.02 in the iloprost group and 0.83 in the placebo group (P = 0.459). The Raynaud's condition score, a patient-completed assessment of the severity of RP attacks, was reduced by 1.32 in the iloprost group and 1.00 in the placebo group (P = 0.323). The lack of significant difference between treatment groups did not change when a variety of factors, including use of other vasodilators, duration of disease, classification of scleroderma (limited versus diffuse), or number of baseline digital ulcers were taken into account. Premature withdrawal from the study due to adverse events occurred in 10 patients (6.4%) in the iloprost group and 3 (2.0%) in the placebo group (P = 0.058). Conclusion. Oral iloprost at a dosage of 50 μg twice daily is no better than placebo for management of RP secondary to scleroderma, either during 6 weeks of treatment or during 6 weeks of posttreatment followup.

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