Dronedarone in High-Risk Permanent Atrial Fibrillation
Identifieur interne : 006B75 ( Main/Exploration ); précédent : 006B74; suivant : 006B76Dronedarone in High-Risk Permanent Atrial Fibrillation
Auteurs : Stuart J. Connolly [Canada] ; A. John Camm [Royaume-Uni] ; Jonathan L. Halperin [États-Unis] ; Campbell Joyner [Canada] ; Marco Alings [Pays-Bas] ; John Amerena [Australie] ; Dan Atar [Norvège] ; Alvaro Avezum [États-Unis] ; Per Blomström [Suède] ; Martin Borggrefe [Allemagne] ; Andrzej Budaj [Pologne] ; Shih-Ann Chen [Taïwan] ; CHI KEONG CHING [Singapour] ; Patrick Commerford [Afrique du Sud] ; Antonio Dans [Philippines] ; M. D. Jean-Marc Davy [France] ; Etienne Delacretaz [Suisse] ; Giuseppe Di Pasquale [Italie] ; Rafael Diaz [Argentine] ; Paul Dorian [Canada] ; Greg Flaker [États-Unis] ; Sergey Golitsyn [Russie] ; Antonio Gonzalez-Hermosillo [Mexique] ; Christopher B. Granger [Royaume-Uni] ; Hein Heidbüchel [Belgique] ; Josef Kautzner ; JUNE SOO KIM ; Fernando Lanas ; Basil S. Lewis ; Jose L. Merino ; Carlos Morillo [Canada] ; 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 [Canada] ; Susan Chrolavicius [Canada] ; Rizwan Afzal [Canada] ; Stefan H. HohnloserSource :
- The New England journal of medicine [ 0028-4793 ] ; 2011.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Médecine.
English descriptors
- KwdEn :
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.).
Affiliations:
- Afrique du Sud, Allemagne, Argentine, Australie, Belgique, Canada, France, Italie, Mexique, Norvège, Pays-Bas, Philippines, Pologne, Royaume-Uni, Russie, Singapour, Suisse, Suède, Taïwan, États-Unis
- Angleterre, Bade-Wurtemberg, Canton de Berne, District de Karlsruhe, District fédéral central, Grand Londres, Languedoc-Roussillon, Occitanie (région administrative), État de New York, État de São Paulo, Østlandet
- Berne, Londres, Mannheim, Montpellier, Moscou, Oslo, São Paulo
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Le document en format XML
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Granger</name><affiliation wicri:level="1"><inist:fA14 i1="24"><s1>Duke University Medical Center</s1><s2>Durham, NC</s2><s3>GBR</s3><sZ>24 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Duke University Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Heidbuchel, Hein" sort="Heidbuchel, Hein" uniqKey="Heidbuchel H" first="Hein" last="Heidbüchel">Hein Heidbüchel</name><affiliation wicri:level="1"><inist:fA14 i1="25"><s1>UZ Gasthuisberg</s1><s2>Leuven</s2><s3>BEL</s3><sZ>25 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>UZ Gasthuisberg</wicri:noRegion></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 wicri:level="1"><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><country>Canada</country><wicri:noRegion>Population Health Research Institute</wicri:noRegion></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 wicri:level="1"><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><country>Canada</country><wicri:noRegion>Population Health Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Chrolavicius, Susan" sort="Chrolavicius, Susan" uniqKey="Chrolavicius S" first="Susan" last="Chrolavicius">Susan Chrolavicius</name><affiliation wicri:level="1"><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><country>Canada</country><wicri:noRegion>Population Health Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Afzal, Rizwan" sort="Afzal, Rizwan" uniqKey="Afzal R" first="Rizwan" last="Afzal">Rizwan Afzal</name><affiliation wicri:level="1"><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><country>Canada</country><wicri:noRegion>Population Health Research Institute</wicri:noRegion></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></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><idno type="wicri:Area/PascalFrancis/Curation">004814</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001B72</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">001B72</idno><idno type="wicri:doubleKey">0028-4793:2011:Connolly S:dronedarone:in:high</idno><idno type="wicri:Area/Main/Merge">007023</idno><idno type="wicri:Area/Main/Curation">006B75</idno><idno type="wicri:Area/Main/Exploration">006B75</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 wicri:level="1"><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><country>Canada</country><wicri:noRegion>Population Health Research Institute</wicri:noRegion></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 wicri:level="3"><inist:fA14 i1="02"><s1>St. George's University</s1><s2>London</s2><s3>GBR</s3><sZ>2 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></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 wicri:level="2"><inist:fA14 i1="03"><s1>Mount Sinai Medical Center</s1><s2>New York</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Joyner, Campbell" sort="Joyner, Campbell" uniqKey="Joyner C" first="Campbell" last="Joyner">Campbell Joyner</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Sunnybrook Health Sciences Center</s1><s2>Toronto</s2><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Sunnybrook Health Sciences Center</wicri:noRegion></affiliation></author><author><name sortKey="Alings, Marco" sort="Alings, Marco" uniqKey="Alings M" first="Marco" last="Alings">Marco Alings</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Amphia Hospital, Breda</s1><s3>NLD</s3><sZ>5 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Amphia Hospital, Breda</wicri:noRegion></affiliation></author><author><name sortKey="Amerena, John" sort="Amerena, John" uniqKey="Amerena J" first="John" last="Amerena">John Amerena</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Kardinia House</s1><s2>Geelong, VIC</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Kardinia House</wicri:noRegion></affiliation></author><author><name sortKey="Atar, Dan" sort="Atar, Dan" uniqKey="Atar D" first="Dan" last="Atar">Dan Atar</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Oslo University Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>7 aut.</sZ></inist:fA14><country>Norvège</country><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Avezum, Alvaro" sort="Avezum, Alvaro" uniqKey="Avezum A" first="Alvaro" last="Avezum">Alvaro Avezum</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Estudios Clínicos Latinoamérica</s1><s2>São Paulo</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Blomstrom, Per" sort="Blomstrom, Per" uniqKey="Blomstrom P" first="Per" last="Blomström">Per Blomström</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>University Hospital Uppsala</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>9 aut.</sZ></inist:fA14><country>Suède</country><wicri:noRegion>University Hospital Uppsala</wicri:noRegion></affiliation></author><author><name sortKey="Borggrefe, Martin" sort="Borggrefe, Martin" uniqKey="Borggrefe M" first="Martin" last="Borggrefe">Martin Borggrefe</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>University Medical Center Mannheim</s1><s2>Mannheim</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author><author><name sortKey="Budaj, Andrzej" sort="Budaj, Andrzej" uniqKey="Budaj A" first="Andrzej" last="Budaj">Andrzej Budaj</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Grochowski Hospital</s1><s2>Warsaw</s2><s3>POL</s3><sZ>11 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Grochowski Hospital</wicri:noRegion></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 wicri:level="1"><inist:fA14 i1="12"><s1>Veterans General Hospital-Taipei</s1><s2>Taipei</s2><s3>TWN</s3><sZ>12 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>Veterans General Hospital-Taipei</wicri:noRegion></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 wicri:level="1"><inist:fA14 i1="13"><s1>National Heart Center</s1><s3>SGP</s3><sZ>13 aut.</sZ></inist:fA14><country>Singapour</country><wicri:noRegion>National Heart Center</wicri:noRegion></affiliation></author><author><name sortKey="Commerford, Patrick" sort="Commerford, Patrick" uniqKey="Commerford P" first="Patrick" last="Commerford">Patrick Commerford</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>University of Cape Town</s1><s2>Cape Town</s2><s3>ZAF</s3><sZ>14 aut.</sZ></inist:fA14><country>Afrique du Sud</country><wicri:noRegion>University of Cape Town</wicri:noRegion></affiliation></author><author><name sortKey="Dans, Antonio" sort="Dans, Antonio" uniqKey="Dans A" first="Antonio" last="Dans">Antonio Dans</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Philippine General Hospital</s1><s2>Manila</s2><s3>PHL</s3><sZ>15 aut.</sZ></inist:fA14><country>Philippines</country><wicri:noRegion>Philippine General Hospital</wicri:noRegion></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 wicri:level="3"><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><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Delacretaz, Etienne" sort="Delacretaz, Etienne" uniqKey="Delacretaz E" first="Etienne" last="Delacretaz">Etienne Delacretaz</name><affiliation wicri:level="3"><inist:fA14 i1="17"><s1>Universitätsklinik</s1><s2>Inselspital, Bern</s2><s3>CHE</s3><sZ>17 aut.</sZ></inist:fA14><country>Suisse</country><placeName><settlement type="city">Berne</settlement><region type="région" nuts="3">Canton de Berne</region></placeName></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 wicri:level="1"><inist:fA14 i1="18"><s1>Maggiore Hospital</s1><s2>Bologna</s2><s3>ITA</s3><sZ>18 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Maggiore Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Diaz, Rafael" sort="Diaz, Rafael" uniqKey="Diaz R" first="Rafael" last="Diaz">Rafael Diaz</name><affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Estudios Clinicos Latino America</s1><s2>Rosario</s2><s3>ARG</s3><sZ>19 aut.</sZ></inist:fA14><country>Argentine</country><wicri:noRegion>Estudios Clinicos Latino America</wicri:noRegion></affiliation></author><author><name sortKey="Dorian, Paul" sort="Dorian, Paul" uniqKey="Dorian P" first="Paul" last="Dorian">Paul Dorian</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>St. Michael's Hospital</s1><s2>Toronto</s2><s3>CAN</s3><sZ>20 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>St. Michael's Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Flaker, Greg" sort="Flaker, Greg" uniqKey="Flaker G" first="Greg" last="Flaker">Greg Flaker</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>University of Missouri</s1><s2>Columbia</s2><s3>USA</s3><sZ>21 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Missouri</wicri:noRegion></affiliation></author><author><name sortKey="Golitsyn, Sergey" sort="Golitsyn, Sergey" uniqKey="Golitsyn S" first="Sergey" last="Golitsyn">Sergey Golitsyn</name><affiliation wicri:level="3"><inist:fA14 i1="22"><s1>Russian Cardiology Research and Production Center</s1><s2>Moscow</s2><s3>RUS</s3><sZ>22 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></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 wicri:level="1"><inist:fA14 i1="23"><s1>Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City</s1><s3>MEX</s3><sZ>23 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City</wicri:noRegion></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 wicri:level="1"><inist:fA14 i1="24"><s1>Duke University Medical Center</s1><s2>Durham, NC</s2><s3>GBR</s3><sZ>24 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Duke University Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Heidbuchel, Hein" sort="Heidbuchel, Hein" uniqKey="Heidbuchel H" first="Hein" last="Heidbüchel">Hein Heidbüchel</name><affiliation wicri:level="1"><inist:fA14 i1="25"><s1>UZ Gasthuisberg</s1><s2>Leuven</s2><s3>BEL</s3><sZ>25 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>UZ Gasthuisberg</wicri:noRegion></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 wicri:level="1"><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><country>Canada</country><wicri:noRegion>Population Health Research Institute</wicri:noRegion></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 wicri:level="1"><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><country>Canada</country><wicri:noRegion>Population Health Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Chrolavicius, Susan" sort="Chrolavicius, Susan" uniqKey="Chrolavicius S" first="Susan" last="Chrolavicius">Susan Chrolavicius</name><affiliation wicri:level="1"><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><country>Canada</country><wicri:noRegion>Population Health Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Afzal, Rizwan" sort="Afzal, Rizwan" uniqKey="Afzal R" first="Rizwan" last="Afzal">Rizwan Afzal</name><affiliation wicri:level="1"><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><country>Canada</country><wicri:noRegion>Population Health Research Institute</wicri:noRegion></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><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</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><affiliations><list><country><li>Afrique du Sud</li><li>Allemagne</li><li>Argentine</li><li>Australie</li><li>Belgique</li><li>Canada</li><li>France</li><li>Italie</li><li>Mexique</li><li>Norvège</li><li>Pays-Bas</li><li>Philippines</li><li>Pologne</li><li>Royaume-Uni</li><li>Russie</li><li>Singapour</li><li>Suisse</li><li>Suède</li><li>Taïwan</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Bade-Wurtemberg</li><li>Canton de Berne</li><li>District de Karlsruhe</li><li>District fédéral central</li><li>Grand Londres</li><li>Languedoc-Roussillon</li><li>Occitanie (région administrative)</li><li>État de New York</li><li>État de São Paulo</li><li>Østlandet</li></region><settlement><li>Berne</li><li>Londres</li><li>Mannheim</li><li>Montpellier</li><li>Moscou</li><li>Oslo</li><li>São Paulo</li></settlement></list><tree><noCountry><name sortKey="Baret Cormel, Lydie" sort="Baret Cormel, Lydie" uniqKey="Baret Cormel L" first="Lydie" last="Baret-Cormel">Lydie Baret-Cormel</name><name sortKey="Hohnloser, Stefan H" sort="Hohnloser, Stefan H" uniqKey="Hohnloser S" first="Stefan H." last="Hohnloser">Stefan H. Hohnloser</name><name sortKey="Jun Zhu" sort="Jun Zhu" uniqKey="Jun Zhu" last="Jun Zhu">JUN ZHU</name><name sortKey="June Soo Kim" sort="June Soo Kim" uniqKey="June Soo Kim" last="June Soo Kim">JUNE SOO KIM</name><name sortKey="Kautzner, Josef" sort="Kautzner, Josef" uniqKey="Kautzner J" first="Josef" last="Kautzner">Josef Kautzner</name><name sortKey="Lanas, Fernando" sort="Lanas, Fernando" uniqKey="Lanas F" first="Fernando" last="Lanas">Fernando Lanas</name><name sortKey="Lewis, Basil S" sort="Lewis, Basil S" uniqKey="Lewis B" first="Basil S." last="Lewis">Basil S. Lewis</name><name sortKey="Merino, Jose L" sort="Merino, Jose L" uniqKey="Merino J" first="Jose L." last="Merino">Jose L. Merino</name><name sortKey="Murin, Jan" sort="Murin, Jan" uniqKey="Murin J" first="Jan" last="Murin">Jan Murin</name><name sortKey="Narasimhan, Calambur" sort="Narasimhan, Calambur" uniqKey="Narasimhan C" first="Calambur" last="Narasimhan">Calambur Narasimhan</name><name sortKey="Paolasso, Ernesto" sort="Paolasso, Ernesto" uniqKey="Paolasso E" first="Ernesto" last="Paolasso">Ernesto Paolasso</name><name sortKey="Parkhomenko, Alexander" sort="Parkhomenko, Alexander" uniqKey="Parkhomenko A" first="Alexander" last="Parkhomenko">Alexander Parkhomenko</name><name sortKey="Peters, Nicholas S" sort="Peters, Nicholas S" uniqKey="Peters N" first="Nicholas S." last="Peters">Nicholas S. 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D." last="Jean-Marc Davy">M. D. Jean-Marc Davy</name></region></country><country name="Suisse"><region name="Canton de Berne"><name sortKey="Delacretaz, Etienne" sort="Delacretaz, Etienne" uniqKey="Delacretaz E" first="Etienne" last="Delacretaz">Etienne Delacretaz</name></region></country><country name="Italie"><noRegion><name sortKey="Di Pasquale, Giuseppe" sort="Di Pasquale, Giuseppe" uniqKey="Di Pasquale G" first="Giuseppe" last="Di Pasquale">Giuseppe Di Pasquale</name></noRegion></country><country name="Argentine"><noRegion><name sortKey="Diaz, Rafael" sort="Diaz, Rafael" uniqKey="Diaz R" first="Rafael" last="Diaz">Rafael Diaz</name></noRegion></country><country name="Russie"><region name="District fédéral central"><name sortKey="Golitsyn, Sergey" sort="Golitsyn, Sergey" uniqKey="Golitsyn S" first="Sergey" last="Golitsyn">Sergey Golitsyn</name></region></country><country name="Mexique"><noRegion><name sortKey="Gonzalez Hermosillo, Antonio" sort="Gonzalez Hermosillo, Antonio" uniqKey="Gonzalez Hermosillo A" first="Antonio" last="Gonzalez-Hermosillo">Antonio Gonzalez-Hermosillo</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Heidbuchel, Hein" sort="Heidbuchel, Hein" uniqKey="Heidbuchel H" first="Hein" last="Heidbüchel">Hein Heidbüchel</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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