Cited by 201Cardiovascular Syncope and Autonomic DisordersHeart Rate Variability and Autonomic ControlVestibular and auditory disorders

Effect of Etilefrine in Preventing Syncopal Recurrence in Patients With Vasovagal Syncope: A Double-Blind, Randomized, Placebo-Controlled Trial

Raviele, Antonio, Brignole, Michele, Sutton, Richard, Alboni, Paolo, Giani, Paolo, Menozzi, Carlo, Moya, Angel·1999·Circulation

Abstract

BACKGROUND: Etilefrine is an alpha-agonist agent with a potent vasoconstrictor effect, which is potentially useful in preventing vasovagal syncope by reducing venous pooling and/or by counteracting reflex arteriolar vasodilatation. The present multicenter, randomized, placebo-controlled study was designed to evaluate the efficacy of this drug for the long-term management of patients with recurrent vasovagal syncope. METHODS AND RESULTS: In the 20 participating centers, 126 patients with recurrent vasovagal syncope (at least 3 episodes in the last 2 years) and a positive baseline head-up tilt response were randomly assigned to placebo (63 patients) or etilefrine at a dosage of 75 mg/d (63 patients) and were followed up for 1 year or until syncope recurred. The primary end-point of the study was the first recurrence of syncope. There were no differences between the 2 study groups in the patients' baseline characteristics. During follow-up, the group treated with etilefrine had a similar incidence of first syncopal recurrence to that of placebo group both in the intention-to-treat analysis (24% versus 24%) and in on- treatment analysis (26% versus 24%). Moreover, the median time to the first syncopal recurrence did not significantly differ between the 2 study groups (106 days in the etilefrine arm and 112 days in the placebo arm). CONCLUSIONS: Oral etilefrine is not superior to placebo in preventing spontaneous episodes of vasovagal syncope. Randomized controlled studies are essential to assess the real usefulness of any proposed therapy for patients with vasovagal syncope.

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Crossref · 10.1161/01.cir.99.11.1452

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  • In a large randomized placebo-controlled double-blind trial, etilefrine 25 mg twice daily showed no difference in the frequency of syncope or the time to recurrence compared with placebo.

    “During follow-up, patients treated twice daily with etilefrine 25 mg or placebo showed no difference in the frequency of syncope or the time to recurrence.”

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Authors
Raviele, A., Brignole, M., Sutton, R., Alboni, P., Giani, P., Menozzi, C., & Moya, A.
Affiliations
  • Royal Brompton Hospital (GB)
  • From the Division of Cardiology, Ospedale Umberto I (A.R.), Mestre-Venice, Italy; Section of Arrhythmology, Ospedali Riuniti (M.B.), Lavagna-Genoa, Italy; Division of Cardiology, Royal Brompton National Heart and Lung Hospital (R.S.), London, UK; Division of Cardiology, Ospedale Civile (P.A.), Cento-Ferrara, Italy; Division of Cardiology, Ospedale Bolognini (P.G.), Seriate-Bergamo, Italy; Section of Arrhythmology, Ospedale S. Maria Nuova (C.M.), Reggio Emilia, Italy; and Division of Cardiology,...
Venue
Circulation
Published
1999-03-23
Volume
99
Issue
11
Pages
1452-1457
ISSN
  • 0009-7322 (ISSN-L)
  • 1524-4539
OpenAlex
W1971567816
Cited by
201
References
24
Citations by year
2025: 3 · 2024: 1 · 2022: 2 · 2021: 5 · 2020: 1 · 2019: 3 · 2018: 5 · 2017: 1 · 2016: 4 · 2015: 5 · 2014: 7 · 2013: 11 · 2012: 7
FWCI
17.53
Type
journal article
Language
en
Open access
closed
Locations
  • Circulation (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
  • Life Sciences › Neuroscience › Neurology › Vestibular and auditory disorders
Keywords
etilefrine, vasovagal syncope, alpha-adrenergic agonists, vasoconstriction, venous pooling, head-up tilt
MeSH terms
Adrenergic alpha-Agonists, Adult, Double-Blind Method, Etilefrine, Female, Humans, Male, Middle Aged, Reflex, Abnormal, Vasoconstrictor Agents, Cohort Studies, Life Tables, Treatment Outcome, Disease-Free Survival, Tilt-Table Test, Syncope, Vasovagal

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