Effect of dronedarone on cardiovascular events in atrial fibrillation

Research output: Contribution to journalJournal articleResearchpeer-review

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Effect of dronedarone on cardiovascular events in atrial fibrillation. / Hohnloser, Stefan H; Crijns, Harry J G M; van Eickels, Martin; Gaudin, Christophe; Page, Richard L; Torp-Pedersen, Christian; Connolly, Stuart J; ATHENA Investigators; Hohnloser, Stefan H; Crijns, Harry J G M; van Eickels, Martin; Gaudin, Christophe; Page, Richard L; Torp-Pedersen, Christian; Connolly, Stuart J; ATHENA Investigators.

In: New England Journal of Medicine, Vol. 360, No. 7, 12.02.2009, p. 668-78.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Hohnloser, SH, Crijns, HJGM, van Eickels, M, Gaudin, C, Page, RL, Torp-Pedersen, C, Connolly, SJ, ATHENA Investigators, Hohnloser, SH, Crijns, HJGM, van Eickels, M, Gaudin, C, Page, RL, Torp-Pedersen, C, Connolly, SJ & ATHENA Investigators 2009, 'Effect of dronedarone on cardiovascular events in atrial fibrillation', New England Journal of Medicine, vol. 360, no. 7, pp. 668-78. https://doi.org/10.1056/NEJMoa0803778, https://doi.org/10.1056/NEJMoa0803778

APA

Hohnloser, S. H., Crijns, H. J. G. M., van Eickels, M., Gaudin, C., Page, R. L., Torp-Pedersen, C., Connolly, S. J., ATHENA Investigators, Hohnloser, S. H., Crijns, H. J. G. M., van Eickels, M., Gaudin, C., Page, R. L., Torp-Pedersen, C., Connolly, S. J., & ATHENA Investigators (2009). Effect of dronedarone on cardiovascular events in atrial fibrillation. New England Journal of Medicine, 360(7), 668-78. https://doi.org/10.1056/NEJMoa0803778, https://doi.org/10.1056/NEJMoa0803778

Vancouver

Hohnloser SH, Crijns HJGM, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C et al. Effect of dronedarone on cardiovascular events in atrial fibrillation. New England Journal of Medicine. 2009 Feb 12;360(7):668-78. https://doi.org/10.1056/NEJMoa0803778, https://doi.org/10.1056/NEJMoa0803778

Author

Hohnloser, Stefan H ; Crijns, Harry J G M ; van Eickels, Martin ; Gaudin, Christophe ; Page, Richard L ; Torp-Pedersen, Christian ; Connolly, Stuart J ; ATHENA Investigators ; Hohnloser, Stefan H ; Crijns, Harry J G M ; van Eickels, Martin ; Gaudin, Christophe ; Page, Richard L ; Torp-Pedersen, Christian ; Connolly, Stuart J ; ATHENA Investigators. / Effect of dronedarone on cardiovascular events in atrial fibrillation. In: New England Journal of Medicine. 2009 ; Vol. 360, No. 7. pp. 668-78.

Bibtex

@article{1289bd80785e11df928f000ea68e967b,
title = "Effect of dronedarone on cardiovascular events in atrial fibrillation",
abstract = "BACKGROUND: Dronedarone is a new antiarrhythmic drug that is being developed for the treatment of patients with atrial fibrillation. METHODS: We conducted a multicenter trial to evaluate the use of dronedarone in 4628 patients with atrial fibrillation who had additional risk factors for death. Patients were randomly assigned to receive dronedarone, 400 mg twice a day, or placebo. The primary outcome was the first hospitalization due to cardiovascular events or death. Secondary outcomes were death from any cause, death from cardiovascular causes, and hospitalization due to cardiovascular events. RESULTS: The mean follow-up period was 21+/-5 months, with the study drug discontinued prematurely in 696 of the 2301 patients (30.2%) receiving dronedarone and in 716 of the 2327 patients (30.8%) receiving placebo, mostly because of adverse events. The primary outcome occurred in 734 patients (31.9%) in the dronedarone group and in 917 patients (39.4%) in the placebo group, with a hazard ratio for dronedarone of 0.76 (95% confidence interval [CI], 0.69 to 0.84; P<0.001). There were 116 deaths (5.0%) in the dronedarone group and 139 (6.0%) in the placebo group (hazard ratio, 0.84; 95% CI, 0.66 to 1.08; P=0.18). There were 63 deaths from cardiovascular causes (2.7%) in the dronedarone group and 90 (3.9%) in the placebo group (hazard ratio, 0.71; 95% CI, 0.51 to 0.98; P=0.03), largely due to a reduction in the rate of death from arrhythmia with dronedarone. The dronedarone group had higher rates of bradycardia, QT-interval prolongation, nausea, diarrhea, rash, and an increased serum creatinine level than the placebo group. Rates of thyroid- and pulmonary-related adverse events were not significantly different between the two groups. CONCLUSIONS: Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation. (ClinicalTrials.gov number, NCT00174785.)",
author = "Hohnloser, {Stefan H} and Crijns, {Harry J G M} and {van Eickels}, Martin and Christophe Gaudin and Page, {Richard L} and Christian Torp-Pedersen and Connolly, {Stuart J} and {ATHENA Investigators} and Hohnloser, {Stefan H} and Crijns, {Harry J G M} and {van Eickels}, Martin and Christophe Gaudin and Page, {Richard L} and Christian Torp-Pedersen and Connolly, {Stuart J} and Torp-Pedersen, {Christian Tobias}",
note = "Keywords: Aged; Amiodarone; Anti-Arrhythmia Agents; Atrial Fibrillation; Bradycardia; Cardiovascular Diseases; Creatinine; Double-Blind Method; Female; Follow-Up Studies; Hospitalization; Humans; Kaplan-Meiers Estimate; Male; Middle Aged; Risk Factors; Secondary Prevention; Treatment Outcome",
year = "2009",
month = feb,
day = "12",
doi = "10.1056/NEJMoa0803778",
language = "English",
volume = "360",
pages = "668--78",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachusetts Medical Society",
number = "7",

}

RIS

TY - JOUR

T1 - Effect of dronedarone on cardiovascular events in atrial fibrillation

AU - Hohnloser, Stefan H

AU - Crijns, Harry J G M

AU - van Eickels, Martin

AU - Gaudin, Christophe

AU - Page, Richard L

AU - Torp-Pedersen, Christian

AU - Connolly, Stuart J

AU - ATHENA Investigators

AU - Hohnloser, Stefan H

AU - Crijns, Harry J G M

AU - van Eickels, Martin

AU - Gaudin, Christophe

AU - Page, Richard L

AU - Torp-Pedersen, Christian

AU - Connolly, Stuart J

AU - ATHENA Investigators

N1 - Keywords: Aged; Amiodarone; Anti-Arrhythmia Agents; Atrial Fibrillation; Bradycardia; Cardiovascular Diseases; Creatinine; Double-Blind Method; Female; Follow-Up Studies; Hospitalization; Humans; Kaplan-Meiers Estimate; Male; Middle Aged; Risk Factors; Secondary Prevention; Treatment Outcome

PY - 2009/2/12

Y1 - 2009/2/12

N2 - BACKGROUND: Dronedarone is a new antiarrhythmic drug that is being developed for the treatment of patients with atrial fibrillation. METHODS: We conducted a multicenter trial to evaluate the use of dronedarone in 4628 patients with atrial fibrillation who had additional risk factors for death. Patients were randomly assigned to receive dronedarone, 400 mg twice a day, or placebo. The primary outcome was the first hospitalization due to cardiovascular events or death. Secondary outcomes were death from any cause, death from cardiovascular causes, and hospitalization due to cardiovascular events. RESULTS: The mean follow-up period was 21+/-5 months, with the study drug discontinued prematurely in 696 of the 2301 patients (30.2%) receiving dronedarone and in 716 of the 2327 patients (30.8%) receiving placebo, mostly because of adverse events. The primary outcome occurred in 734 patients (31.9%) in the dronedarone group and in 917 patients (39.4%) in the placebo group, with a hazard ratio for dronedarone of 0.76 (95% confidence interval [CI], 0.69 to 0.84; P<0.001). There were 116 deaths (5.0%) in the dronedarone group and 139 (6.0%) in the placebo group (hazard ratio, 0.84; 95% CI, 0.66 to 1.08; P=0.18). There were 63 deaths from cardiovascular causes (2.7%) in the dronedarone group and 90 (3.9%) in the placebo group (hazard ratio, 0.71; 95% CI, 0.51 to 0.98; P=0.03), largely due to a reduction in the rate of death from arrhythmia with dronedarone. The dronedarone group had higher rates of bradycardia, QT-interval prolongation, nausea, diarrhea, rash, and an increased serum creatinine level than the placebo group. Rates of thyroid- and pulmonary-related adverse events were not significantly different between the two groups. CONCLUSIONS: Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation. (ClinicalTrials.gov number, NCT00174785.)

AB - BACKGROUND: Dronedarone is a new antiarrhythmic drug that is being developed for the treatment of patients with atrial fibrillation. METHODS: We conducted a multicenter trial to evaluate the use of dronedarone in 4628 patients with atrial fibrillation who had additional risk factors for death. Patients were randomly assigned to receive dronedarone, 400 mg twice a day, or placebo. The primary outcome was the first hospitalization due to cardiovascular events or death. Secondary outcomes were death from any cause, death from cardiovascular causes, and hospitalization due to cardiovascular events. RESULTS: The mean follow-up period was 21+/-5 months, with the study drug discontinued prematurely in 696 of the 2301 patients (30.2%) receiving dronedarone and in 716 of the 2327 patients (30.8%) receiving placebo, mostly because of adverse events. The primary outcome occurred in 734 patients (31.9%) in the dronedarone group and in 917 patients (39.4%) in the placebo group, with a hazard ratio for dronedarone of 0.76 (95% confidence interval [CI], 0.69 to 0.84; P<0.001). There were 116 deaths (5.0%) in the dronedarone group and 139 (6.0%) in the placebo group (hazard ratio, 0.84; 95% CI, 0.66 to 1.08; P=0.18). There were 63 deaths from cardiovascular causes (2.7%) in the dronedarone group and 90 (3.9%) in the placebo group (hazard ratio, 0.71; 95% CI, 0.51 to 0.98; P=0.03), largely due to a reduction in the rate of death from arrhythmia with dronedarone. The dronedarone group had higher rates of bradycardia, QT-interval prolongation, nausea, diarrhea, rash, and an increased serum creatinine level than the placebo group. Rates of thyroid- and pulmonary-related adverse events were not significantly different between the two groups. CONCLUSIONS: Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation. (ClinicalTrials.gov number, NCT00174785.)

U2 - 10.1056/NEJMoa0803778

DO - 10.1056/NEJMoa0803778

M3 - Journal article

C2 - 19213680

VL - 360

SP - 668

EP - 678

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 7

ER -

ID: 20320279