Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study

Jean-Marc Davy; Martin Herold; Christer Hoglund; Alphons Timmermans; Antonio Alings; David Radzik; Louis Van Kempen

doi:10.1016/j.ahj.2008.06.010

Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study

Jean-Marc Davy, Martin Herold, Christer Hoglund, Alphons Timmermans, Antonio Alings, David Radzik, Louis Van Kempen,

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: Dronedarone is a new multichannel blocker for atrial fibrillation (AF) previously demonstrated to have both rhythm and rate control properties in paroxysmal and persistent AF. The Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation (ERATO) trial assessed the efficacy of dronedarone in the control of ventricular rate in patients with permanent AF, when added to standard therapy.

METHODS: In this randomized, double-blind, multinational trial, dronedarone, 400 mg twice a day (n = 85), or matching placebo (n = 89) was administered for 6 months to adult patients with permanent AF, in addition to standard therapy. The primary end point was the change in mean ventricular rate between baseline and day 14, as assessed by 24-hour Holter. Ventricular rate was also assessed during submaximal and maximal exercise.

RESULTS: Dronedarone significantly decreased mean 24-hour ventricular rate. Compared with placebo, the mean treatment effect at day 14 was a reduction of 11.7 beats per minute (beat/min; P < .0001). Comparable reductions were sustained throughout the 6-month trial. During maximal exercise and compared to placebo, there was a mean reduction of 24.5 beat/min (P < .0001), without any reduction in exercise tolerance as measured by maximal exercise duration. The effects of dronedarone were additive to those of other rate-control agents, including beta-blockers, calcium antagonists, and digoxin. Dronedarone was well tolerated, with no organ toxicities or proarrhythmia.

CONCLUSION: In addition to its reported rhythm-targeting and rate-targeting therapeutic actions in paroxysmal and persistent AF, dronedarone improves ventricular rate control in patients with permanent AF. Dronedarone was well tolerated with no evidence of organ toxicities or proarrhythmias in this short-term study.

Original language	English
Pages (from-to)	527.e1-9
Journal	American Heart Journal
Volume	156
Issue number	3
DOIs	https://doi.org/10.1016/j.ahj.2008.06.010
Publication status	Published - Sept 2008
Externally published	Yes

Keywords

Adult
Aged
Aged, 80 and over
Amiodarone/adverse effects
Atrial Fibrillation/drug therapy
Circadian Rhythm
Double-Blind Method
Dronedarone
Exercise
Female
Heart Rate/drug effects
Humans
Internationality
Male
Middle Aged
Physical Endurance
Time Factors
Treatment Outcome
Ventricular Function/drug effects

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10.1016/j.ahj.2008.06.010

Cite this

Davy, J.-M., Herold, M., Hoglund, C., Timmermans, A., Alings, A., Radzik, D., Van Kempen, L. (2008). Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study. American Heart Journal, 156(3), 527.e1-9. https://doi.org/10.1016/j.ahj.2008.06.010

@article{a40edb412a83475c8344f0646c409fd6,

title = "Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study",

abstract = "BACKGROUND: Dronedarone is a new multichannel blocker for atrial fibrillation (AF) previously demonstrated to have both rhythm and rate control properties in paroxysmal and persistent AF. The Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation (ERATO) trial assessed the efficacy of dronedarone in the control of ventricular rate in patients with permanent AF, when added to standard therapy.METHODS: In this randomized, double-blind, multinational trial, dronedarone, 400 mg twice a day (n = 85), or matching placebo (n = 89) was administered for 6 months to adult patients with permanent AF, in addition to standard therapy. The primary end point was the change in mean ventricular rate between baseline and day 14, as assessed by 24-hour Holter. Ventricular rate was also assessed during submaximal and maximal exercise.RESULTS: Dronedarone significantly decreased mean 24-hour ventricular rate. Compared with placebo, the mean treatment effect at day 14 was a reduction of 11.7 beats per minute (beat/min; P < .0001). Comparable reductions were sustained throughout the 6-month trial. During maximal exercise and compared to placebo, there was a mean reduction of 24.5 beat/min (P < .0001), without any reduction in exercise tolerance as measured by maximal exercise duration. The effects of dronedarone were additive to those of other rate-control agents, including beta-blockers, calcium antagonists, and digoxin. Dronedarone was well tolerated, with no organ toxicities or proarrhythmia.CONCLUSION: In addition to its reported rhythm-targeting and rate-targeting therapeutic actions in paroxysmal and persistent AF, dronedarone improves ventricular rate control in patients with permanent AF. Dronedarone was well tolerated with no evidence of organ toxicities or proarrhythmias in this short-term study.",

keywords = "Adult, Aged, Aged, 80 and over, Amiodarone/adverse effects, Atrial Fibrillation/drug therapy, Circadian Rhythm, Double-Blind Method, Dronedarone, Exercise, Female, Heart Rate/drug effects, Humans, Internationality, Male, Middle Aged, Physical Endurance, Time Factors, Treatment Outcome, Ventricular Function/drug effects",

author = "Jean-Marc Davy and Martin Herold and Christer Hoglund and Alphons Timmermans and Antonio Alings and David Radzik and {Van Kempen}, Louis and Marco Alings",

year = "2008",

month = sep,

doi = "10.1016/j.ahj.2008.06.010",

language = "English",

volume = "156",

pages = "527.e1--9",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Mosby Inc.",

number = "3",

}

Davy, J-M, Herold, M, Hoglund, C, Timmermans, A, Alings, A, Radzik, D, Van Kempen, L 2008, 'Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study', American Heart Journal, vol. 156, no. 3, pp. 527.e1-9. https://doi.org/10.1016/j.ahj.2008.06.010

Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study. / Davy, Jean-Marc; Herold, Martin; Hoglund, Christer et al.
In: American Heart Journal, Vol. 156, No. 3, 09.2008, p. 527.e1-9.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Dronedarone for the control of ventricular rate in permanent atrial fibrillation

T2 - the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study

AU - Davy, Jean-Marc

AU - Herold, Martin

AU - Hoglund, Christer

AU - Timmermans, Alphons

AU - Alings, Antonio

AU - Radzik, David

AU - Van Kempen, Louis

AU - Alings, Marco

PY - 2008/9

Y1 - 2008/9

N2 - BACKGROUND: Dronedarone is a new multichannel blocker for atrial fibrillation (AF) previously demonstrated to have both rhythm and rate control properties in paroxysmal and persistent AF. The Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation (ERATO) trial assessed the efficacy of dronedarone in the control of ventricular rate in patients with permanent AF, when added to standard therapy.METHODS: In this randomized, double-blind, multinational trial, dronedarone, 400 mg twice a day (n = 85), or matching placebo (n = 89) was administered for 6 months to adult patients with permanent AF, in addition to standard therapy. The primary end point was the change in mean ventricular rate between baseline and day 14, as assessed by 24-hour Holter. Ventricular rate was also assessed during submaximal and maximal exercise.RESULTS: Dronedarone significantly decreased mean 24-hour ventricular rate. Compared with placebo, the mean treatment effect at day 14 was a reduction of 11.7 beats per minute (beat/min; P < .0001). Comparable reductions were sustained throughout the 6-month trial. During maximal exercise and compared to placebo, there was a mean reduction of 24.5 beat/min (P < .0001), without any reduction in exercise tolerance as measured by maximal exercise duration. The effects of dronedarone were additive to those of other rate-control agents, including beta-blockers, calcium antagonists, and digoxin. Dronedarone was well tolerated, with no organ toxicities or proarrhythmia.CONCLUSION: In addition to its reported rhythm-targeting and rate-targeting therapeutic actions in paroxysmal and persistent AF, dronedarone improves ventricular rate control in patients with permanent AF. Dronedarone was well tolerated with no evidence of organ toxicities or proarrhythmias in this short-term study.

AB - BACKGROUND: Dronedarone is a new multichannel blocker for atrial fibrillation (AF) previously demonstrated to have both rhythm and rate control properties in paroxysmal and persistent AF. The Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation (ERATO) trial assessed the efficacy of dronedarone in the control of ventricular rate in patients with permanent AF, when added to standard therapy.METHODS: In this randomized, double-blind, multinational trial, dronedarone, 400 mg twice a day (n = 85), or matching placebo (n = 89) was administered for 6 months to adult patients with permanent AF, in addition to standard therapy. The primary end point was the change in mean ventricular rate between baseline and day 14, as assessed by 24-hour Holter. Ventricular rate was also assessed during submaximal and maximal exercise.RESULTS: Dronedarone significantly decreased mean 24-hour ventricular rate. Compared with placebo, the mean treatment effect at day 14 was a reduction of 11.7 beats per minute (beat/min; P < .0001). Comparable reductions were sustained throughout the 6-month trial. During maximal exercise and compared to placebo, there was a mean reduction of 24.5 beat/min (P < .0001), without any reduction in exercise tolerance as measured by maximal exercise duration. The effects of dronedarone were additive to those of other rate-control agents, including beta-blockers, calcium antagonists, and digoxin. Dronedarone was well tolerated, with no organ toxicities or proarrhythmia.CONCLUSION: In addition to its reported rhythm-targeting and rate-targeting therapeutic actions in paroxysmal and persistent AF, dronedarone improves ventricular rate control in patients with permanent AF. Dronedarone was well tolerated with no evidence of organ toxicities or proarrhythmias in this short-term study.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Amiodarone/adverse effects

KW - Atrial Fibrillation/drug therapy

KW - Circadian Rhythm

KW - Double-Blind Method

KW - Dronedarone

KW - Exercise

KW - Female

KW - Heart Rate/drug effects

KW - Humans

KW - Internationality

KW - Male

KW - Middle Aged

KW - Physical Endurance

KW - Time Factors

KW - Treatment Outcome

KW - Ventricular Function/drug effects

U2 - 10.1016/j.ahj.2008.06.010

DO - 10.1016/j.ahj.2008.06.010

M3 - Article

C2 - 18760136

SN - 0002-8703

VL - 156

SP - 527.e1-9

JO - American Heart Journal

JF - American Heart Journal

IS - 3

ER -

Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study

Abstract

Keywords

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