Dronedarone in High-Risk Permanent Atrial Fibrillation
Identifieur interne : 001695 ( PascalFrancis/Corpus ); précédent : 001694; suivant : 001696Dronedarone in High-Risk Permanent Atrial Fibrillation
Auteurs : Stuart J. Connolly ; A. John Camm ; Jonathan L. Halperin ; Campbell Joyner ; Marco Alings ; John Amerena ; Dan Atar ; Alvaro Avezum ; Per Blomström ; Martin Borggrefe ; Andrzej Budaj ; Shih-Ann Chen ; CHI KEONG CHING ; Patrick Commerford ; Antonio Dans ; M. D. Jean-Marc Davy ; Etienne Delacretaz ; Giuseppe Di Pasquale ; Rafael Diaz ; Paul Dorian ; Greg Flaker ; Sergey Golitsyn ; Antonio Gonzalez-Hermosillo ; Christopher B. Granger ; Hein Heidbüchel ; Josef Kautzner ; JUNE SOO KIM ; Fernando Lanas ; Basil S. Lewis ; Jose L. Merino ; Carlos Morillo ; Jan Murin ; Calambur Narasimhan ; Ernesto Paolasso ; Alexander Parkhomenko ; Nicholas S. Peters ; Kui-Hian Sim ; Martin K. Stiles ; Supachai Tanomsup ; Lauri Toivonen ; János Tomcsanyi ; Christian Torp-Pedersen ; Hung-Fat Tse ; Panos Vardas ; Dragos Vinereanu ; Denis Xavier ; JUN ZHU ; Jun-Ren Zhu ; Lydie Baret-Cormel ; Estelle Weinling ; Christoph Staiger ; Salim Yusuf ; Susan Chrolavicius ; Rizwan Afzal ; Stefan H. HohnloserSource :
- The New England journal of medicine [ 0028-4793 ] ; 2011.
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English descriptors
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Abstract
BACKGROUND Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation. METHODS We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death. RESULTS After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02). CONCLUSIONS Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.).
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Format Inist (serveur)
| NO : | PASCAL 12-0033827 INIST |
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| ET : | Dronedarone in High-Risk Permanent Atrial Fibrillation |
| AU : | CONNOLLY (Stuart J.); CAMM (A. John); HALPERIN (Jonathan L.); JOYNER (Campbell); ALINGS (Marco); AMERENA (John); ATAR (Dan); AVEZUM (Alvaro); BLOMSTRÖM (Per); BORGGREFE (Martin); BUDAJ (Andrzej); CHEN (Shih-Ann); CHI KEONG CHING; COMMERFORD (Patrick); DANS (Antonio); JEAN-MARC DAVY (M. D.); DELACRETAZ (Etienne); DI PASQUALE (Giuseppe); DIAZ (Rafael); DORIAN (Paul); FLAKER (Greg); GOLITSYN (Sergey); GONZALEZ-HERMOSILLO (Antonio); GRANGER (Christopher B.); HEIDBÜCHEL (Hein); KAUTZNER (Josef); JUNE SOO KIM; LANAS (Fernando); LEWIS (Basil S.); MERINO (Jose L.); MORILLO (Carlos); MURIN (Jan); NARASIMHAN (Calambur); PAOLASSO (Ernesto); PARKHOMENKO (Alexander); PETERS (Nicholas S.); SIM (Kui-Hian); STILES (Martin K.); TANOMSUP (Supachai); TOIVONEN (Lauri); TOMCSANYI (János); TORP-PEDERSEN (Christian); TSE (Hung-Fat); VARDAS (Panos); VINEREANU (Dragos); XAVIER (Denis); JUN ZHU; ZHU (Jun-Ren); BARET-CORMEL (Lydie); WEINLING (Estelle); STAIGER (Christoph); YUSUF (Salim); CHROLAVICIUS (Susan); AFZAL (Rizwan); HOHNLOSER (Stefan H.) |
| AF : | Population Health Research Institute/Hamilton, ON/Canada (1 aut., 31 aut., 52 aut., 53 aut., 54 aut.); St. George's University/London/Royaume-Uni (2 aut.); Mount Sinai Medical Center/New York/Etats-Unis (3 aut.); Sunnybrook Health Sciences Center/Toronto/Canada (4 aut.); Amphia Hospital, Breda/Pays-Bas (5 aut.); Kardinia House/Geelong, VIC/Australie (6 aut.); Oslo University Hospital/Oslo/Norvège (7 aut.); Estudios Clínicos Latinoamérica/São Paulo/Etats-Unis (8 aut.); University Hospital Uppsala/Uppsala/Suède (9 aut.); University Medical Center Mannheim/Mannheim/Allemagne (10 aut.); Grochowski Hospital/Warsaw/Pologne (11 aut.); Veterans General Hospital-Taipei/Taipei/Taïwan (12 aut.); National Heart Center/Singapour (13 aut.); University of Cape Town/Cape Town/Afrique du Sud (14 aut.); Philippine General Hospital/Manila/Philippines (15 aut.); Centre Hospitalier Universitaire de Montpellier-Hôpital Arnaud de Villeneuve/Montpellier/France (16 aut.); Universitätsklinik/Inselspital, Bern/Suisse (17 aut.); Maggiore Hospital/Bologna/Italie (18 aut.); Estudios Clinicos Latino America/Rosario/Argentine (19 aut.); St. Michael's Hospital/Toronto/Canada (20 aut.); University of Missouri/Columbia/Etats-Unis (21 aut.); Russian Cardiology Research and Production Center/Moscow/Russie (22 aut.); Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City/Mexique (23 aut.); Duke University Medical Center/Durham, NC/Royaume-Uni (24 aut.); UZ Gasthuisberg/Leuven/Belgique (25 aut.) |
| DT : | Publication en série; Niveau analytique |
| SO : | The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2011; Vol. 365; No. 24; Pp. 2268-2276; Bibl. 24 ref. |
| LA : | Anglais |
| EA : | BACKGROUND Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation. METHODS We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death. RESULTS After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02). CONCLUSIONS Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.). |
| CC : | 002B01; 002B12A02 |
| FD : | Dronédarone; Risque élevé; Médecine; Fibrillation auriculaire; Antiangoreux; Antiarythmique |
| FG : | Sulfamides; Pathologie de l'appareil circulatoire; Cardiopathie; Trouble de l'excitabilité; Trouble du rythme cardiaque |
| ED : | Dronedarone; High risk; Medicine; Atrial fibrillation; Antianginal agent; Antiarrhythmic agent |
| EG : | Sulfonamides; Cardiovascular disease; Heart disease; Excitability disorder; Arrhythmia |
| SD : | Dronedarona; Riesgo alto; Medicina; Fibrilación auricular; Antianginoso; Antiarrítmico |
| LO : | INIST-6013.354000506007910060 |
| ID : | 12-0033827 |
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Pascal:12-0033827Le document en format XML
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Granger</name><affiliation><inist:fA14 i1="24"><s1>Duke University Medical Center</s1><s2>Durham, NC</s2><s3>GBR</s3><sZ>24 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Heidbuchel, Hein" sort="Heidbuchel, Hein" uniqKey="Heidbuchel H" first="Hein" last="Heidbüchel">Hein Heidbüchel</name><affiliation><inist:fA14 i1="25"><s1>UZ Gasthuisberg</s1><s2>Leuven</s2><s3>BEL</s3><sZ>25 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Kautzner, Josef" sort="Kautzner, Josef" uniqKey="Kautzner J" first="Josef" last="Kautzner">Josef Kautzner</name></author><author><name sortKey="June Soo Kim" sort="June Soo Kim" uniqKey="June Soo Kim" last="June Soo Kim">JUNE SOO KIM</name></author><author><name sortKey="Lanas, Fernando" sort="Lanas, Fernando" uniqKey="Lanas F" first="Fernando" last="Lanas">Fernando Lanas</name></author><author><name sortKey="Lewis, Basil S" sort="Lewis, Basil S" uniqKey="Lewis B" first="Basil S." last="Lewis">Basil S. Lewis</name></author><author><name sortKey="Merino, Jose L" sort="Merino, Jose L" uniqKey="Merino J" first="Jose L." last="Merino">Jose L. Merino</name></author><author><name sortKey="Morillo, Carlos" sort="Morillo, Carlos" uniqKey="Morillo C" first="Carlos" last="Morillo">Carlos Morillo</name><affiliation><inist:fA14 i1="01"><s1>Population Health Research Institute</s1><s2>Hamilton, ON</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>31 aut.</sZ><sZ>52 aut.</sZ><sZ>53 aut.</sZ><sZ>54 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Murin, Jan" sort="Murin, Jan" uniqKey="Murin J" first="Jan" last="Murin">Jan Murin</name></author><author><name sortKey="Narasimhan, Calambur" sort="Narasimhan, Calambur" uniqKey="Narasimhan C" first="Calambur" last="Narasimhan">Calambur Narasimhan</name></author><author><name sortKey="Paolasso, Ernesto" sort="Paolasso, Ernesto" uniqKey="Paolasso E" first="Ernesto" last="Paolasso">Ernesto Paolasso</name></author><author><name sortKey="Parkhomenko, Alexander" sort="Parkhomenko, Alexander" uniqKey="Parkhomenko A" first="Alexander" last="Parkhomenko">Alexander Parkhomenko</name></author><author><name sortKey="Peters, Nicholas S" sort="Peters, Nicholas S" uniqKey="Peters N" first="Nicholas S." last="Peters">Nicholas S. Peters</name></author><author><name sortKey="Sim, Kui Hian" sort="Sim, Kui Hian" uniqKey="Sim K" first="Kui-Hian" last="Sim">Kui-Hian Sim</name></author><author><name sortKey="Stiles, Martin K" sort="Stiles, Martin K" uniqKey="Stiles M" first="Martin K." last="Stiles">Martin K. 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Hohnloser</name></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">12-0033827</idno><date when="2011">2011</date><idno type="stanalyst">PASCAL 12-0033827 INIST</idno><idno type="RBID">Pascal:12-0033827</idno><idno type="wicri:Area/PascalFrancis/Corpus">001695</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Dronedarone in High-Risk Permanent Atrial Fibrillation</title><author><name sortKey="Connolly, Stuart J" sort="Connolly, Stuart J" uniqKey="Connolly S" first="Stuart J." last="Connolly">Stuart J. Connolly</name><affiliation><inist:fA14 i1="01"><s1>Population Health Research Institute</s1><s2>Hamilton, ON</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>31 aut.</sZ><sZ>52 aut.</sZ><sZ>53 aut.</sZ><sZ>54 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Camm, A John" sort="Camm, A John" uniqKey="Camm A" first="A. John" last="Camm">A. John Camm</name><affiliation><inist:fA14 i1="02"><s1>St. George's University</s1><s2>London</s2><s3>GBR</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Halperin, Jonathan L" sort="Halperin, Jonathan L" uniqKey="Halperin J" first="Jonathan L." last="Halperin">Jonathan L. Halperin</name><affiliation><inist:fA14 i1="03"><s1>Mount Sinai Medical Center</s1><s2>New York</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Joyner, Campbell" sort="Joyner, Campbell" uniqKey="Joyner C" first="Campbell" last="Joyner">Campbell Joyner</name><affiliation><inist:fA14 i1="04"><s1>Sunnybrook Health Sciences Center</s1><s2>Toronto</s2><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Alings, Marco" sort="Alings, Marco" uniqKey="Alings M" first="Marco" last="Alings">Marco Alings</name><affiliation><inist:fA14 i1="05"><s1>Amphia Hospital, Breda</s1><s3>NLD</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Amerena, John" sort="Amerena, John" uniqKey="Amerena J" first="John" last="Amerena">John Amerena</name><affiliation><inist:fA14 i1="06"><s1>Kardinia House</s1><s2>Geelong, VIC</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Atar, Dan" sort="Atar, Dan" uniqKey="Atar D" first="Dan" last="Atar">Dan Atar</name><affiliation><inist:fA14 i1="07"><s1>Oslo University Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Avezum, Alvaro" sort="Avezum, Alvaro" uniqKey="Avezum A" first="Alvaro" last="Avezum">Alvaro Avezum</name><affiliation><inist:fA14 i1="08"><s1>Estudios Clínicos Latinoamérica</s1><s2>São Paulo</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Blomstrom, Per" sort="Blomstrom, Per" uniqKey="Blomstrom P" first="Per" last="Blomström">Per Blomström</name><affiliation><inist:fA14 i1="09"><s1>University Hospital Uppsala</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>9 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Borggrefe, Martin" sort="Borggrefe, Martin" uniqKey="Borggrefe M" first="Martin" last="Borggrefe">Martin Borggrefe</name><affiliation><inist:fA14 i1="10"><s1>University Medical Center Mannheim</s1><s2>Mannheim</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Budaj, Andrzej" sort="Budaj, Andrzej" uniqKey="Budaj A" first="Andrzej" last="Budaj">Andrzej Budaj</name><affiliation><inist:fA14 i1="11"><s1>Grochowski Hospital</s1><s2>Warsaw</s2><s3>POL</s3><sZ>11 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Chen, Shih Ann" sort="Chen, Shih Ann" uniqKey="Chen S" first="Shih-Ann" last="Chen">Shih-Ann Chen</name><affiliation><inist:fA14 i1="12"><s1>Veterans General Hospital-Taipei</s1><s2>Taipei</s2><s3>TWN</s3><sZ>12 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Chi Keong Ching" sort="Chi Keong Ching" uniqKey="Chi Keong Ching" last="Chi Keong Ching">CHI KEONG CHING</name><affiliation><inist:fA14 i1="13"><s1>National Heart Center</s1><s3>SGP</s3><sZ>13 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Commerford, Patrick" sort="Commerford, Patrick" uniqKey="Commerford P" first="Patrick" last="Commerford">Patrick Commerford</name><affiliation><inist:fA14 i1="14"><s1>University of Cape Town</s1><s2>Cape Town</s2><s3>ZAF</s3><sZ>14 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Dans, Antonio" sort="Dans, Antonio" uniqKey="Dans A" first="Antonio" last="Dans">Antonio Dans</name><affiliation><inist:fA14 i1="15"><s1>Philippine General Hospital</s1><s2>Manila</s2><s3>PHL</s3><sZ>15 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Jean Marc Davy, M D" sort="Jean Marc Davy, M D" uniqKey="Jean Marc Davy M" first="M. D." last="Jean-Marc Davy">M. D. Jean-Marc Davy</name><affiliation><inist:fA14 i1="16"><s1>Centre Hospitalier Universitaire de Montpellier-Hôpital Arnaud de Villeneuve</s1><s2>Montpellier</s2><s3>FRA</s3><sZ>16 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Delacretaz, Etienne" sort="Delacretaz, Etienne" uniqKey="Delacretaz E" first="Etienne" last="Delacretaz">Etienne Delacretaz</name><affiliation><inist:fA14 i1="17"><s1>Universitätsklinik</s1><s2>Inselspital, Bern</s2><s3>CHE</s3><sZ>17 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Di Pasquale, Giuseppe" sort="Di Pasquale, Giuseppe" uniqKey="Di Pasquale G" first="Giuseppe" last="Di Pasquale">Giuseppe Di Pasquale</name><affiliation><inist:fA14 i1="18"><s1>Maggiore Hospital</s1><s2>Bologna</s2><s3>ITA</s3><sZ>18 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Diaz, Rafael" sort="Diaz, Rafael" uniqKey="Diaz R" first="Rafael" last="Diaz">Rafael Diaz</name><affiliation><inist:fA14 i1="19"><s1>Estudios Clinicos Latino America</s1><s2>Rosario</s2><s3>ARG</s3><sZ>19 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Dorian, Paul" sort="Dorian, Paul" uniqKey="Dorian P" first="Paul" last="Dorian">Paul Dorian</name><affiliation><inist:fA14 i1="20"><s1>St. Michael's Hospital</s1><s2>Toronto</s2><s3>CAN</s3><sZ>20 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Flaker, Greg" sort="Flaker, Greg" uniqKey="Flaker G" first="Greg" last="Flaker">Greg Flaker</name><affiliation><inist:fA14 i1="21"><s1>University of Missouri</s1><s2>Columbia</s2><s3>USA</s3><sZ>21 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Golitsyn, Sergey" sort="Golitsyn, Sergey" uniqKey="Golitsyn S" first="Sergey" last="Golitsyn">Sergey Golitsyn</name><affiliation><inist:fA14 i1="22"><s1>Russian Cardiology Research and Production Center</s1><s2>Moscow</s2><s3>RUS</s3><sZ>22 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Gonzalez Hermosillo, Antonio" sort="Gonzalez Hermosillo, Antonio" uniqKey="Gonzalez Hermosillo A" first="Antonio" last="Gonzalez-Hermosillo">Antonio Gonzalez-Hermosillo</name><affiliation><inist:fA14 i1="23"><s1>Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City</s1><s3>MEX</s3><sZ>23 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Granger, Christopher B" sort="Granger, Christopher B" uniqKey="Granger C" first="Christopher B." last="Granger">Christopher B. Granger</name><affiliation><inist:fA14 i1="24"><s1>Duke University Medical Center</s1><s2>Durham, NC</s2><s3>GBR</s3><sZ>24 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Heidbuchel, Hein" sort="Heidbuchel, Hein" uniqKey="Heidbuchel H" first="Hein" last="Heidbüchel">Hein Heidbüchel</name><affiliation><inist:fA14 i1="25"><s1>UZ Gasthuisberg</s1><s2>Leuven</s2><s3>BEL</s3><sZ>25 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Kautzner, Josef" sort="Kautzner, Josef" uniqKey="Kautzner J" first="Josef" last="Kautzner">Josef Kautzner</name></author><author><name sortKey="June Soo Kim" sort="June Soo Kim" uniqKey="June Soo Kim" last="June Soo Kim">JUNE SOO KIM</name></author><author><name sortKey="Lanas, Fernando" sort="Lanas, Fernando" uniqKey="Lanas F" first="Fernando" last="Lanas">Fernando Lanas</name></author><author><name sortKey="Lewis, Basil S" sort="Lewis, Basil S" uniqKey="Lewis B" first="Basil S." last="Lewis">Basil S. Lewis</name></author><author><name sortKey="Merino, Jose L" sort="Merino, Jose L" uniqKey="Merino J" first="Jose L." last="Merino">Jose L. Merino</name></author><author><name sortKey="Morillo, Carlos" sort="Morillo, Carlos" uniqKey="Morillo C" first="Carlos" last="Morillo">Carlos Morillo</name><affiliation><inist:fA14 i1="01"><s1>Population Health Research Institute</s1><s2>Hamilton, ON</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>31 aut.</sZ><sZ>52 aut.</sZ><sZ>53 aut.</sZ><sZ>54 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Murin, Jan" sort="Murin, Jan" uniqKey="Murin J" first="Jan" last="Murin">Jan Murin</name></author><author><name sortKey="Narasimhan, Calambur" sort="Narasimhan, Calambur" uniqKey="Narasimhan C" first="Calambur" last="Narasimhan">Calambur Narasimhan</name></author><author><name sortKey="Paolasso, Ernesto" sort="Paolasso, Ernesto" uniqKey="Paolasso E" first="Ernesto" last="Paolasso">Ernesto Paolasso</name></author><author><name sortKey="Parkhomenko, Alexander" sort="Parkhomenko, Alexander" uniqKey="Parkhomenko A" first="Alexander" last="Parkhomenko">Alexander Parkhomenko</name></author><author><name sortKey="Peters, Nicholas S" sort="Peters, Nicholas S" uniqKey="Peters N" first="Nicholas S." last="Peters">Nicholas S. Peters</name></author><author><name sortKey="Sim, Kui Hian" sort="Sim, Kui Hian" uniqKey="Sim K" first="Kui-Hian" last="Sim">Kui-Hian Sim</name></author><author><name sortKey="Stiles, Martin K" sort="Stiles, Martin K" uniqKey="Stiles M" first="Martin K." last="Stiles">Martin K. Stiles</name></author><author><name sortKey="Tanomsup, Supachai" sort="Tanomsup, Supachai" uniqKey="Tanomsup S" first="Supachai" last="Tanomsup">Supachai Tanomsup</name></author><author><name sortKey="Toivonen, Lauri" sort="Toivonen, Lauri" uniqKey="Toivonen L" first="Lauri" last="Toivonen">Lauri Toivonen</name></author><author><name sortKey="Tomcsanyi, Janos" sort="Tomcsanyi, Janos" uniqKey="Tomcsanyi J" first="János" last="Tomcsanyi">János Tomcsanyi</name></author><author><name sortKey="Torp Pedersen, Christian" sort="Torp Pedersen, Christian" uniqKey="Torp Pedersen C" first="Christian" last="Torp-Pedersen">Christian Torp-Pedersen</name></author><author><name sortKey="Tse, Hung Fat" sort="Tse, Hung Fat" uniqKey="Tse H" first="Hung-Fat" last="Tse">Hung-Fat Tse</name></author><author><name sortKey="Vardas, Panos" sort="Vardas, Panos" uniqKey="Vardas P" first="Panos" last="Vardas">Panos Vardas</name></author><author><name sortKey="Vinereanu, Dragos" sort="Vinereanu, Dragos" uniqKey="Vinereanu D" first="Dragos" last="Vinereanu">Dragos Vinereanu</name></author><author><name sortKey="Xavier, Denis" sort="Xavier, Denis" uniqKey="Xavier D" first="Denis" last="Xavier">Denis Xavier</name></author><author><name sortKey="Jun Zhu" sort="Jun Zhu" uniqKey="Jun Zhu" last="Jun Zhu">JUN ZHU</name></author><author><name sortKey="Zhu, Jun Ren" sort="Zhu, Jun Ren" uniqKey="Zhu J" first="Jun-Ren" last="Zhu">Jun-Ren Zhu</name></author><author><name sortKey="Baret Cormel, Lydie" sort="Baret Cormel, Lydie" uniqKey="Baret Cormel L" first="Lydie" last="Baret-Cormel">Lydie Baret-Cormel</name></author><author><name sortKey="Weinling, Estelle" sort="Weinling, Estelle" uniqKey="Weinling E" first="Estelle" last="Weinling">Estelle Weinling</name></author><author><name sortKey="Staiger, Christoph" sort="Staiger, Christoph" uniqKey="Staiger C" first="Christoph" last="Staiger">Christoph Staiger</name></author><author><name sortKey="Yusuf, Salim" sort="Yusuf, Salim" uniqKey="Yusuf S" first="Salim" last="Yusuf">Salim Yusuf</name><affiliation><inist:fA14 i1="01"><s1>Population Health Research Institute</s1><s2>Hamilton, ON</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>31 aut.</sZ><sZ>52 aut.</sZ><sZ>53 aut.</sZ><sZ>54 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Chrolavicius, Susan" sort="Chrolavicius, Susan" uniqKey="Chrolavicius S" first="Susan" last="Chrolavicius">Susan Chrolavicius</name><affiliation><inist:fA14 i1="01"><s1>Population Health Research Institute</s1><s2>Hamilton, ON</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>31 aut.</sZ><sZ>52 aut.</sZ><sZ>53 aut.</sZ><sZ>54 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Afzal, Rizwan" sort="Afzal, Rizwan" uniqKey="Afzal R" first="Rizwan" last="Afzal">Rizwan Afzal</name><affiliation><inist:fA14 i1="01"><s1>Population Health Research Institute</s1><s2>Hamilton, ON</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>31 aut.</sZ><sZ>52 aut.</sZ><sZ>53 aut.</sZ><sZ>54 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Hohnloser, Stefan H" sort="Hohnloser, Stefan H" uniqKey="Hohnloser S" first="Stefan H." last="Hohnloser">Stefan H. Hohnloser</name></author></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antianginal agent</term><term>Antiarrhythmic agent</term><term>Atrial fibrillation</term><term>Dronedarone</term><term>High risk</term><term>Medicine</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Dronédarone</term><term>Risque élevé</term><term>Médecine</term><term>Fibrillation auriculaire</term><term>Antiangoreux</term><term>Antiarythmique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation. METHODS We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death. RESULTS After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02). CONCLUSIONS Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.).</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0028-4793</s0></fA01><fA02 i1="01"><s0>NEJMAG</s0></fA02><fA03 i2="1"><s0>N. Engl. j. med.</s0></fA03><fA05><s2>365</s2></fA05><fA06><s2>24</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Dronedarone in High-Risk Permanent Atrial Fibrillation</s1></fA08><fA11 i1="01" i2="1"><s1>CONNOLLY (Stuart J.)</s1></fA11><fA11 i1="02" i2="1"><s1>CAMM (A. John)</s1></fA11><fA11 i1="03" i2="1"><s1>HALPERIN (Jonathan L.)</s1></fA11><fA11 i1="04" i2="1"><s1>JOYNER (Campbell)</s1></fA11><fA11 i1="05" i2="1"><s1>ALINGS (Marco)</s1></fA11><fA11 i1="06" i2="1"><s1>AMERENA (John)</s1></fA11><fA11 i1="07" i2="1"><s1>ATAR (Dan)</s1></fA11><fA11 i1="08" i2="1"><s1>AVEZUM (Alvaro)</s1></fA11><fA11 i1="09" i2="1"><s1>BLOMSTRÖM (Per)</s1></fA11><fA11 i1="10" i2="1"><s1>BORGGREFE (Martin)</s1></fA11><fA11 i1="11" i2="1"><s1>BUDAJ (Andrzej)</s1></fA11><fA11 i1="12" i2="1"><s1>CHEN (Shih-Ann)</s1></fA11><fA11 i1="13" i2="1"><s1>CHI KEONG CHING</s1></fA11><fA11 i1="14" i2="1"><s1>COMMERFORD (Patrick)</s1></fA11><fA11 i1="15" i2="1"><s1>DANS (Antonio)</s1></fA11><fA11 i1="16" i2="1"><s1>JEAN-MARC DAVY (M. D.)</s1></fA11><fA11 i1="17" i2="1"><s1>DELACRETAZ (Etienne)</s1></fA11><fA11 i1="18" i2="1"><s1>DI PASQUALE (Giuseppe)</s1></fA11><fA11 i1="19" i2="1"><s1>DIAZ (Rafael)</s1></fA11><fA11 i1="20" i2="1"><s1>DORIAN (Paul)</s1></fA11><fA11 i1="21" i2="1"><s1>FLAKER (Greg)</s1></fA11><fA11 i1="22" i2="1"><s1>GOLITSYN (Sergey)</s1></fA11><fA11 i1="23" i2="1"><s1>GONZALEZ-HERMOSILLO (Antonio)</s1></fA11><fA11 i1="24" i2="1"><s1>GRANGER (Christopher B.)</s1></fA11><fA11 i1="25" i2="1"><s1>HEIDBÜCHEL (Hein)</s1></fA11><fA11 i1="26" i2="1"><s1>KAUTZNER (Josef)</s1></fA11><fA11 i1="27" i2="1"><s1>JUNE SOO KIM</s1></fA11><fA11 i1="28" i2="1"><s1>LANAS (Fernando)</s1></fA11><fA11 i1="29" i2="1"><s1>LEWIS (Basil S.)</s1></fA11><fA11 i1="30" i2="1"><s1>MERINO (Jose L.)</s1></fA11><fA11 i1="31" i2="1"><s1>MORILLO (Carlos)</s1></fA11><fA11 i1="32" i2="1"><s1>MURIN (Jan)</s1></fA11><fA11 i1="33" i2="1"><s1>NARASIMHAN (Calambur)</s1></fA11><fA11 i1="34" i2="1"><s1>PAOLASSO (Ernesto)</s1></fA11><fA11 i1="35" i2="1"><s1>PARKHOMENKO (Alexander)</s1></fA11><fA11 i1="36" i2="1"><s1>PETERS (Nicholas S.)</s1></fA11><fA11 i1="37" i2="1"><s1>SIM (Kui-Hian)</s1></fA11><fA11 i1="38" i2="1"><s1>STILES (Martin K.)</s1></fA11><fA11 i1="39" i2="1"><s1>TANOMSUP (Supachai)</s1></fA11><fA11 i1="40" i2="1"><s1>TOIVONEN (Lauri)</s1></fA11><fA11 i1="41" i2="1"><s1>TOMCSANYI (János)</s1></fA11><fA11 i1="42" i2="1"><s1>TORP-PEDERSEN (Christian)</s1></fA11><fA11 i1="43" i2="1"><s1>TSE (Hung-Fat)</s1></fA11><fA11 i1="44" i2="1"><s1>VARDAS (Panos)</s1></fA11><fA11 i1="45" i2="1"><s1>VINEREANU (Dragos)</s1></fA11><fA11 i1="46" i2="1"><s1>XAVIER (Denis)</s1></fA11><fA11 i1="47" i2="1"><s1>JUN ZHU</s1></fA11><fA11 i1="48" i2="1"><s1>ZHU (Jun-Ren)</s1></fA11><fA11 i1="49" i2="1"><s1>BARET-CORMEL (Lydie)</s1></fA11><fA11 i1="50" i2="1"><s1>WEINLING (Estelle)</s1></fA11><fA11 i1="51" i2="1"><s1>STAIGER (Christoph)</s1></fA11><fA11 i1="52" i2="1"><s1>YUSUF (Salim)</s1></fA11><fA11 i1="53" i2="1"><s1>CHROLAVICIUS (Susan)</s1></fA11><fA11 i1="54" i2="1"><s1>AFZAL (Rizwan)</s1></fA11><fA11 i1="55" i2="1"><s1>HOHNLOSER (Stefan H.)</s1></fA11><fA14 i1="01"><s1>Population Health Research Institute</s1><s2>Hamilton, ON</s2><s3>CAN</s3><sZ>1 aut.</sZ><sZ>31 aut.</sZ><sZ>52 aut.</sZ><sZ>53 aut.</sZ><sZ>54 aut.</sZ></fA14><fA14 i1="02"><s1>St. George's University</s1><s2>London</s2><s3>GBR</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Mount Sinai Medical Center</s1><s2>New York</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Sunnybrook Health Sciences Center</s1><s2>Toronto</s2><s3>CAN</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Amphia Hospital, Breda</s1><s3>NLD</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Kardinia House</s1><s2>Geelong, VIC</s2><s3>AUS</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Oslo University Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>7 aut.</sZ></fA14><fA14 i1="08"><s1>Estudios Clínicos Latinoamérica</s1><s2>São Paulo</s2><s3>USA</s3><sZ>8 aut.</sZ></fA14><fA14 i1="09"><s1>University Hospital Uppsala</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>9 aut.</sZ></fA14><fA14 i1="10"><s1>University Medical Center Mannheim</s1><s2>Mannheim</s2><s3>DEU</s3><sZ>10 aut.</sZ></fA14><fA14 i1="11"><s1>Grochowski Hospital</s1><s2>Warsaw</s2><s3>POL</s3><sZ>11 aut.</sZ></fA14><fA14 i1="12"><s1>Veterans General Hospital-Taipei</s1><s2>Taipei</s2><s3>TWN</s3><sZ>12 aut.</sZ></fA14><fA14 i1="13"><s1>National Heart Center</s1><s3>SGP</s3><sZ>13 aut.</sZ></fA14><fA14 i1="14"><s1>University of Cape Town</s1><s2>Cape Town</s2><s3>ZAF</s3><sZ>14 aut.</sZ></fA14><fA14 i1="15"><s1>Philippine General Hospital</s1><s2>Manila</s2><s3>PHL</s3><sZ>15 aut.</sZ></fA14><fA14 i1="16"><s1>Centre Hospitalier Universitaire de Montpellier-Hôpital Arnaud de Villeneuve</s1><s2>Montpellier</s2><s3>FRA</s3><sZ>16 aut.</sZ></fA14><fA14 i1="17"><s1>Universitätsklinik</s1><s2>Inselspital, Bern</s2><s3>CHE</s3><sZ>17 aut.</sZ></fA14><fA14 i1="18"><s1>Maggiore Hospital</s1><s2>Bologna</s2><s3>ITA</s3><sZ>18 aut.</sZ></fA14><fA14 i1="19"><s1>Estudios Clinicos Latino America</s1><s2>Rosario</s2><s3>ARG</s3><sZ>19 aut.</sZ></fA14><fA14 i1="20"><s1>St. Michael's Hospital</s1><s2>Toronto</s2><s3>CAN</s3><sZ>20 aut.</sZ></fA14><fA14 i1="21"><s1>University of Missouri</s1><s2>Columbia</s2><s3>USA</s3><sZ>21 aut.</sZ></fA14><fA14 i1="22"><s1>Russian Cardiology Research and Production Center</s1><s2>Moscow</s2><s3>RUS</s3><sZ>22 aut.</sZ></fA14><fA14 i1="23"><s1>Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City</s1><s3>MEX</s3><sZ>23 aut.</sZ></fA14><fA14 i1="24"><s1>Duke University Medical Center</s1><s2>Durham, NC</s2><s3>GBR</s3><sZ>24 aut.</sZ></fA14><fA14 i1="25"><s1>UZ Gasthuisberg</s1><s2>Leuven</s2><s3>BEL</s3><sZ>25 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>PALLAS Investigators</s1><s3>INC</s3></fA17><fA20><s1>2268-2276</s1></fA20><fA21><s1>2011</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>6013</s2><s5>354000506007910060</s5></fA43><fA44><s0>0000</s0><s1>© 2012 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>24 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>12-0033827</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>The New England journal of medicine</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>BACKGROUND Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation. METHODS We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death. RESULTS After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02). CONCLUSIONS Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.).</s0></fC01><fC02 i1="01" i2="X"><s0>002B01</s0></fC02><fC02 i1="02" i2="X"><s0>002B12A02</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Dronédarone</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Dronedarone</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Dronedarona</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Risque élevé</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>High risk</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Riesgo alto</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Médecine</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Medicine</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Medicina</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Fibrillation auriculaire</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Atrial fibrillation</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Fibrilación auricular</s0><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Antiangoreux</s0><s5>25</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Antianginal agent</s0><s5>25</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Antianginoso</s0><s5>25</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Antiarythmique</s0><s5>26</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Antiarrhythmic agent</s0><s5>26</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Antiarrítmico</s0><s5>26</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Sulfamides</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Sulfonamides</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Sulfamidas</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Pathologie de l'appareil circulatoire</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Cardiovascular disease</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Aparato circulatorio patología</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Cardiopathie</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Heart disease</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Cardiopatía</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Trouble de l'excitabilité</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Excitability disorder</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Trastorno excitabilidad</s0><s5>40</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Trouble du rythme cardiaque</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Arrhythmia</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Arritmia</s0><s5>41</s5></fC07><fN21><s1>016</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard><server><NO>PASCAL 12-0033827 INIST</NO><ET>Dronedarone in High-Risk Permanent Atrial Fibrillation</ET><AU>CONNOLLY (Stuart J.); CAMM (A. John); HALPERIN (Jonathan L.); JOYNER (Campbell); ALINGS (Marco); AMERENA (John); ATAR (Dan); AVEZUM (Alvaro); BLOMSTRÖM (Per); BORGGREFE (Martin); BUDAJ (Andrzej); CHEN (Shih-Ann); CHI KEONG CHING; COMMERFORD (Patrick); DANS (Antonio); JEAN-MARC DAVY (M. D.); DELACRETAZ (Etienne); DI PASQUALE (Giuseppe); DIAZ (Rafael); DORIAN (Paul); FLAKER (Greg); GOLITSYN (Sergey); GONZALEZ-HERMOSILLO (Antonio); GRANGER (Christopher B.); HEIDBÜCHEL (Hein); KAUTZNER (Josef); JUNE SOO KIM; LANAS (Fernando); LEWIS (Basil S.); MERINO (Jose L.); MORILLO (Carlos); MURIN (Jan); NARASIMHAN (Calambur); PAOLASSO (Ernesto); PARKHOMENKO (Alexander); PETERS (Nicholas S.); SIM (Kui-Hian); STILES (Martin K.); TANOMSUP (Supachai); TOIVONEN (Lauri); TOMCSANYI (János); TORP-PEDERSEN (Christian); TSE (Hung-Fat); VARDAS (Panos); VINEREANU (Dragos); XAVIER (Denis); JUN ZHU; ZHU (Jun-Ren); BARET-CORMEL (Lydie); WEINLING (Estelle); STAIGER (Christoph); YUSUF (Salim); CHROLAVICIUS (Susan); AFZAL (Rizwan); HOHNLOSER (Stefan H.)</AU><AF>Population Health Research Institute/Hamilton, ON/Canada (1 aut., 31 aut., 52 aut., 53 aut., 54 aut.); St. George's University/London/Royaume-Uni (2 aut.); Mount Sinai Medical Center/New York/Etats-Unis (3 aut.); Sunnybrook Health Sciences Center/Toronto/Canada (4 aut.); Amphia Hospital, Breda/Pays-Bas (5 aut.); Kardinia House/Geelong, VIC/Australie (6 aut.); Oslo University Hospital/Oslo/Norvège (7 aut.); Estudios Clínicos Latinoamérica/São Paulo/Etats-Unis (8 aut.); University Hospital Uppsala/Uppsala/Suède (9 aut.); University Medical Center Mannheim/Mannheim/Allemagne (10 aut.); Grochowski Hospital/Warsaw/Pologne (11 aut.); Veterans General Hospital-Taipei/Taipei/Taïwan (12 aut.); National Heart Center/Singapour (13 aut.); University of Cape Town/Cape Town/Afrique du Sud (14 aut.); Philippine General Hospital/Manila/Philippines (15 aut.); Centre Hospitalier Universitaire de Montpellier-Hôpital Arnaud de Villeneuve/Montpellier/France (16 aut.); Universitätsklinik/Inselspital, Bern/Suisse (17 aut.); Maggiore Hospital/Bologna/Italie (18 aut.); Estudios Clinicos Latino America/Rosario/Argentine (19 aut.); St. Michael's Hospital/Toronto/Canada (20 aut.); University of Missouri/Columbia/Etats-Unis (21 aut.); Russian Cardiology Research and Production Center/Moscow/Russie (22 aut.); Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City/Mexique (23 aut.); Duke University Medical Center/Durham, NC/Royaume-Uni (24 aut.); UZ Gasthuisberg/Leuven/Belgique (25 aut.)</AF><DT>Publication en série; Niveau analytique</DT><SO>The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2011; Vol. 365; No. 24; Pp. 2268-2276; Bibl. 24 ref.</SO><LA>Anglais</LA><EA>BACKGROUND Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation. METHODS We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death. RESULTS After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02). CONCLUSIONS Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.).</EA><CC>002B01; 002B12A02</CC><FD>Dronédarone; Risque élevé; Médecine; Fibrillation auriculaire; Antiangoreux; Antiarythmique</FD><FG>Sulfamides; Pathologie de l'appareil circulatoire; Cardiopathie; Trouble de l'excitabilité; Trouble du rythme cardiaque</FG><ED>Dronedarone; High risk; Medicine; Atrial fibrillation; Antianginal agent; Antiarrhythmic agent</ED><EG>Sulfonamides; Cardiovascular disease; Heart disease; Excitability disorder; Arrhythmia</EG><SD>Dronedarona; Riesgo alto; Medicina; Fibrilación auricular; Antianginoso; Antiarrítmico</SD><LO>INIST-6013.354000506007910060</LO><ID>12-0033827</ID></server></inist></record>Pour manipuler ce document sous Unix (Dilib)
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