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:
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Authors | A Raviele, M Brignole, R Sutton, P Alboni, P Giani, C Menozzi, A Moya |
Journal | Circulation
(Circulation)
Vol. 99
Issue 11
Pg. 1452-7
(Mar 23 1999)
ISSN: 0009-7322 [Print] United States |
PMID | 10086969
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Adrenergic alpha-Agonists
- Vasoconstrictor Agents
- Etilefrine
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Topics |
- Adrenergic alpha-Agonists
(adverse effects, pharmacology, therapeutic use)
- Adult
- Cohort Studies
- Disease-Free Survival
- Double-Blind Method
- Etilefrine
(adverse effects, pharmacology, therapeutic use)
- Female
- Humans
- Life Tables
- Male
- Middle Aged
- Reflex, Abnormal
(drug effects)
- Syncope, Vasovagal
(etiology, prevention & control)
- Tilt-Table Test
- Treatment Outcome
- Vasoconstrictor Agents
(adverse effects, pharmacology, therapeutic use)
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