title: Fludrocortisone for the Prevention of Vasovagal Syncope: A Randomized, Placebo-Controlled Trial.
abstract: There is limited evidence whether being on fludrocortisone prevents vasovagal syncope.
  
  
  
  The authors sought to determine whether treatment with fludrocortisone reduces the proportion of patients with recurrent vasovagal syncope by at least 40%, representing a pre-specified minimal clinically important relative risk reduction.
  
  
  
  The multicenter POST 2 (Prevention of Syncope Trial 2) was a randomized, placebo-controlled, double-blind trial that assessed the effects of fludrocortisone in vasovagal syncope over a 1-year treatment period. All patients had >2 syncopal spells and a Calgary Syncope Symptom Score >-3. Patients received either fludrocortisone or matching placebo at highest tolerated doses from 0.05 mg to 0.2 mg daily. The main outcome measure was the first recurrence of syncope.
  
  
  
  The authors randomized 210 patients (71% female, median age 30 years) with a median 15 syncopal spells over a median of 9 years equally to fludrocortisone or placebo. Of these, 96 patients had ≥1 syncope recurrences, and only 14 patients were lost to follow-up before syncope recurrence. There was a marginally nonsignificant reduction in syncope in the fludrocortisone group (hazard ratio [HR]: 0.69: 95% confidence interval [CI]: 0.46 to 1.03; p = 0.069). In a multivariable model, fludrocortisone significantly reduced the likelihood of syncope (HR: 0.63; 95% CI: 0.42 to 0.94; p = 0.024). When the analysis was restricted to outcomes after 2 weeks of dose stabilization, there was a significant benefit due to fludrocortisone (HR: 0.51; 95% CI: 0.28 to 0.89; p = 0.019).
  
  
  
  The study did not meet its primary objective of demonstrating that fludrocortisone reduced the likelihood of vasovagal syncope by the specified risk reduction of 40%. The study demonstrated a significant effect after dose stabilization, and there were significant findings in post hoc multivariable and on-treatment analyses. (A randomised clinical trial of fludrocortisone for the prevention of vasovagal syncope; ISRCTN51802652; Prevention of Syncope Trial 2 [POST 2]; NCT00118482).
authors.affiliation: Division of Cardiology, Department of Cardiac Sciences, University of Calgary, Calgary, Canada. Electronic address: sheldon@ucalgary.ca.
authors.forename: Robert
authors.initials: R
authors.lastname: Sheldon
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee.
authors.forename: Satish R
authors.initials: SR
authors.lastname: Raj
authors.affiliation: Division of Cardiology, Department of Cardiac Sciences, University of Calgary, Calgary, Canada.
authors.forename: M Sarah
authors.initials: MS
authors.lastname: Rose
authors.affiliation: Division of Cardiology, Department of Medicine, McMaster University, Hamilton, Canada.
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Morillo
authors.affiliation: Division of Cardiology, Department of Medicine, University of British Columbia, Vancouver, Canada.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Krahn
authors.affiliation: Neurocardiology Department, CES University, Medellin, Colombia.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Medina
authors.affiliation: Division of Cardiology, Department of Medicine, University of Montreal, Montreal, Canada.
authors.forename: Mario
authors.initials: M
authors.lastname: Talajic
authors.affiliation: Department of Pharmacology, Universite de Montreal, Montreal, Canada.
authors.forename: Teresa
authors.initials: T
authors.lastname: Kus
authors.affiliation: Division of Cardiology, Department of Medicine, University of Manitoba, Winnipeg, Canada.
authors.forename: Colette M
authors.initials: CM
authors.lastname: Seifer
authors.affiliation: Department of Cardiology, Medical University of Lodz, Lodz, Poland.
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Lelonek
authors.affiliation: Praxis für Kardiologie, JW Goethe University, Frankfurt, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Klingenheben
authors.affiliation: Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Canada.
authors.forename: Ratika
authors.initials: R
authors.lastname: Parkash
authors.affiliation: Division of Cardiology, Department of Cardiac Sciences, University of Calgary, Calgary, Canada.
authors.forename: Debbie
authors.initials: D
authors.lastname: Ritchie
authors.affiliation: Division of Cardiology, Department of Cardiac Sciences, University of Calgary, Calgary, Canada.
authors.forename: Maureen
authors.initials: M
authors.lastname: McRae
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005438:Fludrocortisone / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D019462:Syncope, Vasovagal / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D005438:Fludrocortisone
keywords: faint; mineralocorticoid; recurrence; reflex