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

Background-Etilefrine is an alpha-agonist agent with a potent vasoconstrict or effect, which is potentially useful in preventing vasovagal syncope by r educing venous pooling and/or by counteracting reflex arteriolar vasodilata tion, The present multicenter, randomized, placebo-controlled study was des igned 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 recu rrent vasovagal syncope (at least 3 episodes in the last 2 years) and a pos itive 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 follo wed up for I year or until syncope recurred. The primary end-point of the s tudy 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 syn copal recurrence to that of placebo group both in the intention-to-treat an alysis (24% versus 24%) and in on-treatment analysis (26% versus 24%). More over, the median time to the first syncopal recurrence did not significantl y 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 sponta neous episodes of vasovagal syncope. Randomized controlled studies are esse ntial to assess the red usefulness of any proposed therapy for patients wit h vasovagal syncope.