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CLINICAL STUDY: ELECTROPHYSIOLOGY

Lack of efficacy of atenolol for the prevention of neurally mediated syncope in a highly symptomatic population: a prospective, double-blind, randomized and placebo-controlled study

^a Arrhythmia Unit, Cardiology Department, Ramón y Cajal Hospital, Alcalá University, Department of Medicine, Madrid, Spain

Manuscript received November 16, 1999; revised manuscript received September 5, 2000, accepted October 26, 2000.

Reprint requests and correspondence: Concepción Moro, Unidad de Arritmias, Hospital Ramón y Cajal, Carretera Colmenar Viejo Km. 9, 100, 28034 Madrid, Spain
cmoro{at}hrc.insalud.es

OBJECTIVES

This study was designed to evaluate the efficacy of atenolol for the long-term management of patients with vasovagal syncope. The primary hypothesis was that atenolol is not superior to placebo for the treatment of vasovagal syncope.

BACKGROUND

There is no definitive well-controlled analysis of the efficacy of beta-adrenergic blocking agents in patients with recurrent vasovagal syncope.

METHODS

This is a prospective, randomized, double-blind, placebo-controlled study. Fifty patients with recurrent vasovagal syncope were included (at least two episodes in the last year). A baseline tilt test was performed. Twenty patients (40%) had a positive tilt test. Intravenous atenolol prevented a second positive tilt in five patients. The patients were randomized to receive either atenolol or a placebo (26 patients atenolol 50 mg/day, 24 patients placebo). The follow-up procedure lasted one year. The primary end point of the study was the time to first recurrence of syncope.

RESULTS

In the intention-to-treat analysis, the group treated with atenolol had a similar number of patients with recurrent syncopal episodes as the placebo group. The Kaplan-Meier actuarial estimates of time to first syncopal recurrence showed that the probability of remaining free of syncope drops similarly in both groups and that there was no statistical difference between both curves (patients treated with atenolol vs. the placebo) with a log-rank test p value of 0.4517.

CONCLUSIONS

The recurrence of neurocardiogenic syncope in highly symptomatic patients treated with atenolol is similar to that of patients treated with placebo.

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