Effect of etilefrine in preventing syncopal recurrence in patients with vasovagal syncope - A double-blind, randomized, placebo-controlled trial

被引:129
作者
Raviele, A [1 ]
Brignole, M
Sutton, R
Alboni, P
Giani, P
Menozzi, C
Moya, A
机构
[1] Osped Umberto 1, Div Cardiol, I-30174 Venice, Italy
[2] Osped Riuniti Bergamo, Sect Arrhythmol, Lavagna Genoa, Italy
[3] Royal Brompton Natl Heart & Lung Hosp, Div Cardiol, London SW3 6NP, England
[4] Osped Civile, Div Cardiol, Cento Ferrara, Italy
[5] Osped Bolognini, Div Cardiol, Seriate Bergamo, Italy
[6] Osped S Maria Nuova, Sect Arrhythmol, Reggio Emilia, Italy
[7] Univ Barcelona, Hosp Gen Valle Hebron, Div Cardiol, Barcelona, Spain
关键词
drugs; nervous system; autonomic; reflex; syncope; trials;
D O I
10.1161/01.CIR.99.11.1452
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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-ln 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 I year or until syncope recurred. The primary end-point of the study was the first recurrence of-syncope. Then 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 red usefulness of any proposed therapy for patients with vasovagal syncope.
引用
收藏
页码:1452 / 1457
页数:6
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