Tags

Type your tag names separated by a space and hit enter

Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis: a multicenter, placebo-controlled, double-blind study.
Arthritis Rheum. 1998 Apr; 41(4):670-7.AR

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 microg 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 microg 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.

Authors+Show Affiliations

The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9550476

Citation

Wigley, F M., et al. "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, 1998, pp. 670-7.
Wigley FM, Korn JH, Csuka ME, et al. Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis: a multicenter, placebo-controlled, double-blind study. Arthritis Rheum. 1998;41(4):670-7.
Wigley, F. M., Korn, J. H., Csuka, M. E., Medsger, T. A., Rothfield, N. F., Ellman, M., Martin, R., Collier, D. H., Weinstein, A., Furst, D. E., Jimenez, S. A., Mayes, M. D., Merkel, P. A., Gruber, B., Kaufman, L., Varga, J., Bell, P., Kern, J., Marrott, P., ... Seibold, J. R. (1998). Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis: a multicenter, placebo-controlled, double-blind study. Arthritis and Rheumatism, 41(4), 670-7.
Wigley FM, et al. Oral Iloprost Treatment in Patients With Raynaud's Phenomenon Secondary to Systemic Sclerosis: a Multicenter, Placebo-controlled, Double-blind Study. Arthritis Rheum. 1998;41(4):670-7. PubMed PMID: 9550476.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis: a multicenter, placebo-controlled, double-blind study. AU - Wigley,F M, AU - Korn,J H, AU - Csuka,M E, AU - Medsger,T A,Jr AU - Rothfield,N F, AU - Ellman,M, AU - Martin,R, AU - Collier,D H, AU - Weinstein,A, AU - Furst,D E, AU - Jimenez,S A, AU - Mayes,M D, AU - Merkel,P A, AU - Gruber,B, AU - Kaufman,L, AU - Varga,J, AU - Bell,P, AU - Kern,J, AU - Marrott,P, AU - White,B, AU - Simms,R W, AU - Phillips,A C, AU - Seibold,J R, PY - 1998/4/29/pubmed PY - 2001/3/28/medline PY - 1998/4/29/entrez SP - 670 EP - 7 JF - Arthritis and rheumatism JO - Arthritis Rheum. VL - 41 IS - 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 microg 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 microg 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. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/9550476/Oral_iloprost_treatment_in_patients_with_Raynaud's_phenomenon_secondary_to_systemic_sclerosis:_a_multicenter_placebo_controlled_double_blind_study_ L2 - https://doi.org/10.1002/1529-0131(199804)41:4<670::AID-ART14>3.0.CO;2-I DB - PRIME DP - Unbound Medicine ER -