CoChat
Sign Up
Cited by 155Cardiovascular Syncope and Autonomic DisordersAdrenal Hormones and DisordersElectrolyte and hormonal disorders

Fludrocortisone for the Prevention of Vasovagal Syncope

Open access
Sheldon, Robert, Raj, Satish R., Rose, M. Sarah, Morillo, Carlos A., Krahn, Andrew D., Medina, Eduardo, Talajic, Mario, Kus, Teresa +38 more·2016·Journal of the American College of Cardiology
DOI 10.1016/j.jacc.2016.04.030
Open this paper in CoChat — free accountOpen PDF

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).

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1016/j.jacc.2016.04.030

Cites

32 of 32 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • In POST 2, a similar number of patients discontinued fludrocortisone therapy owing to side effects, equating the benefit/risk ratio.

    “In the meantime, a similar number of patients discontinued fludrocortisone therapy owing to side effects, thus equating the benefit/risk ratio.”

    From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [275]

    The Results (page not available) report that 11 patients in the fludrocortisone arm and 5 in the placebo arm stopped prematurely because of presumed side effects. Figure 1 shows 15 patients in each arm discontinued the intervention overall, but those equal totals were not all due to side effects. The paper does not establish that these discontinuations equated the benefit–risk balance. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

  • Data from a 2016 RCT suggest fludrocortisone suppresses vasovagal syncope.

    “Although data from a 2016 RCT suggest fludrocortisone suppresses vasovagal syncope,52”

    From Diagnosis and management of postural orthostatic tachycardia syndrome (2022) · cites this paper as [52]

  • In POST 2, at 12 months, 44% of patients in the fludrocortisone arm continued to suffer syncope, compared with 60.5% in the placebo arm.

    “at 12 months, 44% of patients in the fludrocortisone arm continued to suffer syncope, a rate only slightly lower than the 60.5% rate observed in the placebo arm.”

    From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [275]

  • In POST 2, fludrocortisone showed only a marginal non-significant reduction in syncope compared with placebo (hazard ratio 0.69, 95% CI 0.46-1.03; P=0.069).

    “The primary endpoint showed only a marginal non-significant reduction in syncope in the fludrocortisone group compared with the placebo group (hazard ratio 0.69, 95% CI 0.46-1.03; P =0.069)”

    From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [275]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 2

  1. Saklani P, Krahn A, Klein G. Syncope. Circulation 2013;127:1330-9.
  2. Shibao C, Okamoto L, Biaggioni I. Pharmaco- therapy of autonomic failure. Pharmacol Ther 2012;134:279-86.

Cited by

Sorted by citations

Related

Authors
Sheldon, R., Raj, S. R., Rose, M. S., Morillo, C. A., Krahn, A. D., Medina, E., Talajic, M., Kus, T., Seifer, C. M., Lelonek, M., Klingenheben, T., Parkash, R., Ritchie, D., McRae, M., Sheldon, R. S., Rose, S. M., Ritchie, D. A., McCrae, M., Morillo, C., Malcolm, V. M., Krahn, A. D., Spindler, B., Medina, E., Talajic, M., Kus, T., Langlois, A., Lelonek, M., Raj, S., Seifer, C., Gardner, M., Romeo, M., Poirier, P., Simpson, C., Abdollah, H., Reynolds, J., Dorian, P., Birnie, D., Giuffre, M., Gilligan, D., Benditt, D., Sheldon, R. S., Raj, S. R., Rose, M. S., Krahn, A., Morillo, C., & Medina, E.
Affiliations
  • University of Calgary (CA)
  • Goethe University Frankfurt (DE)
  • Dalhousie University (CA)
  • Université de Montréal (CA)
ORCID
Venue
Journal of the American College of Cardiology
Publisher
Elsevier BV
Published
2016-07
Volume
68
Issue
1
Pages
1-9
ISSN
0735-1097 (ISSN-L)
DOI
10.1016/j.jacc.2016.04.030
OpenAlex
W2465056121
Cited by
155
References
32
Citations by year
2026: 12 · 2025: 13 · 2024: 15 · 2023: 11 · 2022: 18 · 2021: 23 · 2020: 13 · 2019: 14 · 2018: 12 · 2017: 15 · 2016: 9
FWCI
18.45
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of the American College of Cardiology (publishedVersion)
  • PubMed (publishedVersion)
Funders
University of Calgary
Topics
  • Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Electrolyte and hormonal disorders
Keywords
fludrocortisone, vasovagal syncope, syncope prevention, recurrent syncope, risk mitigation, orthostatic hypotension, postural orthostatic tachycardia syndrome
MeSH terms
Adult, Double-Blind Method, Female, Fludrocortisone, Humans, Male, Middle Aged, Recurrence, Syncope, Vasovagal, Young Adult

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review