(Circulation. 1999;99:1452-1457.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Effect of Etilefrine in Preventing Syncopal Recurrence in Patients With Vasovagal Syncope
A Double-Blind, Randomized, Placebo-Controlled Trial
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, Hospital General Universitari Vall d'Hebron (A.M.), Barcelona, Spain.
Correspondence to Antonio Raviele, MD, Divisione di Cardiologia, Ospedale Umberto I, 30174 Mestre (Venezia), Italy. E-mail araviele{at}TIN.IT
Background—Etilefrine is an
-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.
Key Words: drugs • nervous system, autonomic • reflex • syncope • trials
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