Fludrocortisone for the Prevention of Vasovagal Syncope: A Randomized, Placebo-Controlled Trial.

Abstract

BACKGROUND:

There is limited evidence whether being on fludrocortisone prevents vasovagal syncope.

OBJECTIVES:

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.

METHODS:

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.

RESULTS:

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).

CONCLUSIONS:

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: Robert Sheldon, Satish R Raj, M Sarah Rose, Carlos A Morillo, Andrew D Krahn, Eduardo Medina, Mario Talajic, Teresa Kus, Colette M Seifer, Malgorzata Lelonek, Thomas Klingenheben, Ratika Parkash, Debbie Ritchie, Maureen McRae, POST 2 Investigators
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 68 Issue 1 Pg. 1-9 (07 05 2016) ISSN: 1558-3597 [Electronic] United States
• PMID: 27364043 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Fludrocortisone

Topics

• Adult
• Double-Blind Method
• Female
• Fludrocortisone (therapeutic use)
• Humans
• Male
• Middle Aged
• Recurrence
• Syncope, Vasovagal (prevention & control)
• Young Adult