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 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).
  
  
  CONCLUSIONS
  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.affiliation: The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: F M
authors.initials: FM
authors.lastname: Wigley
authors.forename: J H
authors.initials: JH
authors.lastname: Korn
authors.forename: M E
authors.initials: ME
authors.lastname: Csuka
authors.forename: T A
authors.initials: TA
authors.lastname: Medsger
authors.forename: N F
authors.initials: NF
authors.lastname: Rothfield
authors.forename: M
authors.initials: M
authors.lastname: Ellman
authors.forename: R
authors.initials: R
authors.lastname: Martin
authors.forename: D H
authors.initials: DH
authors.lastname: Collier
authors.forename: A
authors.initials: A
authors.lastname: Weinstein
authors.forename: D E
authors.initials: DE
authors.lastname: Furst
authors.forename: S A
authors.initials: SA
authors.lastname: Jimenez
authors.forename: M D
authors.initials: MD
authors.lastname: Mayes
authors.forename: P A
authors.initials: PA
authors.lastname: Merkel
authors.forename: B
authors.initials: B
authors.lastname: Gruber
authors.forename: L
authors.initials: L
authors.lastname: Kaufman
authors.forename: J
authors.initials: J
authors.lastname: Varga
authors.forename: P
authors.initials: P
authors.lastname: Bell
authors.forename: J
authors.initials: J
authors.lastname: Kern
authors.forename: P
authors.initials: P
authors.lastname: Marrott
authors.forename: B
authors.initials: B
authors.lastname: White
authors.forename: R W
authors.initials: RW
authors.lastname: Simms
authors.forename: A C
authors.initials: AC
authors.lastname: Phillips
authors.forename: J R
authors.initials: JR
authors.lastname: Seibold
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D016285:Iloprost / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010919:Placebos; D011928:Raynaud Disease / Q000188:drug therapy* / Q000209:etiology; D012008:Recurrence; D012595:Scleroderma, Systemic / Q000150:complications / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014664:Vasodilation / Q000187:drug effects; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D014665:Vasodilator Agents; D016285:Iloprost