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Michele Brignole - One of the best experts on this subject based on the ideXlab platform.
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Finally, a Drug Proves to Be Effective Against Vasovagal Syncope!: But Not in All Patients∗
Journal of the American College of Cardiology, 2016Co-Authors: Michele BrignoleAbstract:Many drugs have been tested for the treatment of vasovagal syncope; for the most part, the results have been disappointing. The list includes beta-blockers, disopyramide, scopolamine, theophylline, ephedrine, Etilefrine, midodrine, clonidine, and serotonin reuptake inhibitors. Although results have
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effect of Etilefrine in preventing syncopal recurrence in patients with vasovagal syncope a double blind randomized placebo controlled trial
Circulation, 1999Co-Authors: Antonio Raviele, Paolo Giani, Michele Brignole, Richard S Sutton, Paolo Alboni, Carlo Menozzi, Angel MoyaAbstract:Background —Etilefrine is an α-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.
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Effect of Etilefrine in Preventing Syncopal Recurrence in Patients With Vasovagal Syncope
Circulation, 1999Co-Authors: Antonio Raviele, Paolo Giani, Michele Brignole, Richard S Sutton, Paolo Alboni, Carlo Menozzi, Angel MoyaAbstract:Background—Etilefrine is an α-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 syncopa...
Angel Moya - One of the best experts on this subject based on the ideXlab platform.
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Effect of Etilefrine in Preventing Syncopal Recurrence in Patients With Vasovagal Syncope
Circulation, 1999Co-Authors: Antonio Raviele, Paolo Giani, Michele Brignole, Richard S Sutton, Paolo Alboni, Carlo Menozzi, Angel MoyaAbstract:Background—Etilefrine is an α-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 syncopa...
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effect of Etilefrine in preventing syncopal recurrence in patients with vasovagal syncope a double blind randomized placebo controlled trial
Circulation, 1999Co-Authors: Antonio Raviele, Paolo Giani, Michele Brignole, Richard S Sutton, Paolo Alboni, Carlo Menozzi, Angel MoyaAbstract:Background —Etilefrine is an α-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.
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Limitations of head-up tilt test for evaluating the efficacy of therapeutic interventions in patients with vasovagal syncope: Results of a controlled study of Etilefrine versus placebo
Journal of the American College of Cardiology, 1995Co-Authors: Angel Moya, Xavier Carne, Teresa Rius, Gaietà Permanyer-miralda, Jaume Sagristà-sauleda, Lluis Mont, Jordi Soler-solerAbstract:Abstract Objectives . This study assessed the efficacy of oral Etilefrine (10 mg three times a day) in preventing a positive response to head-up tilt testing. Background . Previous reports have suggested that oral Etilefrine can be effective either in preventing a positive response to head-up tilt testing or in reducing syncopal recurrences in patients with vasovagal syncope. Up to now most studies assessing drug therapy in these patients have been uncontrolled. Methods . This was a randomized double-blind crossover study of Etilefrine versus placebo in 30 consecutive patients with syncope and a baseline positive head-up tilt test. After the first test, patients had no treatment for 3 days and were randomized to receive Etilefrine or placebo for 4 additional days. They underwent tilt testing under treatment and again after 3 days of washout; they then received the alternative treatment for 4 days, and a third test was performed. Results . Head-up tilt test results were negative in 13 (43%) patients with Etilefrine and 15 (50%) with placebo (p = NS). Therefore, the statistical power of the study was only 10%. The rate of positive responses decreased with repeated testing irrespective of the assigned treatment: A positive response was obtained during the second head-up tilt test in 20 patients (10 with placebo, 10 with Etilefrine) but in only 12 during the third (7 with Etilefrine, 5 with placebo) (p Conclusions . Oral Etilefrine (10 mg three times a day) was not superior to placebo in preventing a positive response to head-up tilt testing. Despite a low statistical power, the high rate of negative response with placebo (50%) suggests that controlled trials are needed to assess the real efficacy of any treatment in patients with vasovagal syncope.
Antonio Raviele - One of the best experts on this subject based on the ideXlab platform.
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effect of Etilefrine in preventing syncopal recurrence in patients with vasovagal syncope a double blind randomized placebo controlled trial
Circulation, 1999Co-Authors: Antonio Raviele, Paolo Giani, Michele Brignole, Richard S Sutton, Paolo Alboni, Carlo Menozzi, Angel MoyaAbstract:Background —Etilefrine is an α-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.
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Effect of Etilefrine in Preventing Syncopal Recurrence in Patients With Vasovagal Syncope
Circulation, 1999Co-Authors: Antonio Raviele, Paolo Giani, Michele Brignole, Richard S Sutton, Paolo Alboni, Carlo Menozzi, Angel MoyaAbstract:Background—Etilefrine is an α-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 syncopa...
Paolo Giani - One of the best experts on this subject based on the ideXlab platform.
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Effect of Etilefrine in Preventing Syncopal Recurrence in Patients With Vasovagal Syncope
2016Co-Authors: A Double-blind, Placebo-controlled Trial, Paolo GianiAbstract:Background—Etilefrine is an a-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. (Circulation. 1999;99:1452-1457.
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effect of Etilefrine in preventing syncopal recurrence in patients with vasovagal syncope a double blind randomized placebo controlled trial
Circulation, 1999Co-Authors: Antonio Raviele, Paolo Giani, Michele Brignole, Richard S Sutton, Paolo Alboni, Carlo Menozzi, Angel MoyaAbstract:Background —Etilefrine is an α-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.
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Effect of Etilefrine in Preventing Syncopal Recurrence in Patients With Vasovagal Syncope
Circulation, 1999Co-Authors: Antonio Raviele, Paolo Giani, Michele Brignole, Richard S Sutton, Paolo Alboni, Carlo Menozzi, Angel MoyaAbstract:Background—Etilefrine is an α-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 syncopa...
Jordi Soler-soler - One of the best experts on this subject based on the ideXlab platform.
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Limitations of head-up tilt test for evaluating the efficacy of therapeutic interventions in patients with vasovagal syncope: Results of a controlled study of Etilefrine versus placebo
Journal of the American College of Cardiology, 1995Co-Authors: Angel Moya, Xavier Carne, Teresa Rius, Gaietà Permanyer-miralda, Jaume Sagristà-sauleda, Lluis Mont, Jordi Soler-solerAbstract:Abstract Objectives . This study assessed the efficacy of oral Etilefrine (10 mg three times a day) in preventing a positive response to head-up tilt testing. Background . Previous reports have suggested that oral Etilefrine can be effective either in preventing a positive response to head-up tilt testing or in reducing syncopal recurrences in patients with vasovagal syncope. Up to now most studies assessing drug therapy in these patients have been uncontrolled. Methods . This was a randomized double-blind crossover study of Etilefrine versus placebo in 30 consecutive patients with syncope and a baseline positive head-up tilt test. After the first test, patients had no treatment for 3 days and were randomized to receive Etilefrine or placebo for 4 additional days. They underwent tilt testing under treatment and again after 3 days of washout; they then received the alternative treatment for 4 days, and a third test was performed. Results . Head-up tilt test results were negative in 13 (43%) patients with Etilefrine and 15 (50%) with placebo (p = NS). Therefore, the statistical power of the study was only 10%. The rate of positive responses decreased with repeated testing irrespective of the assigned treatment: A positive response was obtained during the second head-up tilt test in 20 patients (10 with placebo, 10 with Etilefrine) but in only 12 during the third (7 with Etilefrine, 5 with placebo) (p Conclusions . Oral Etilefrine (10 mg three times a day) was not superior to placebo in preventing a positive response to head-up tilt testing. Despite a low statistical power, the high rate of negative response with placebo (50%) suggests that controlled trials are needed to assess the real efficacy of any treatment in patients with vasovagal syncope.