Efficacy and safety of dronedarone across age and sex subgroups: a post hoc analysis of the ATHENA study among patients with non-permanent atrial fibrillation/flutter
Age and sex may impact the efficacy of antiarrhythmic drugs on cardiovascular outcomes and arrhythmia recurrences in patients with atrial fibrillation (AF). We report on a post hoc analysis of the ATHENA study (NCT00174785), which examined cardiovascular outcomes in patients with non-permanent AF tr...
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| Veröffentlicht in: | Europace (London, England) England), 2022-11, Vol.24 (11), p.1754-1762 |
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| creator | Curtis, Anne B Zeitler, Emily P Malik, Aysha Bogard, Andrew Bhattacharyya, Nidhi Stewart, John Hohnloser, Stefan H |
| description | Age and sex may impact the efficacy of antiarrhythmic drugs on cardiovascular outcomes and arrhythmia recurrences in patients with atrial fibrillation (AF). We report on a post hoc analysis of the ATHENA study (NCT00174785), which examined cardiovascular outcomes in patients with non-permanent AF treated with dronedarone vs. placebo.
Efficacy and safety of dronedarone were assessed in patients according to age and sex. Baseline characteristics were comparable across subgroups, except for cardiovascular comorbidities, which were more frequent with increasing age. Dronedarone significantly reduced the risk of cardiovascular hospitalization or death due to any cause among patients 65-74 [n = 1830; hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.60-0.83; P < 0.0001] and ≥75 (n = 1925; HR 0.75, 95% CI 0.65-0.88; P = 0.0002) years old and among males (n = 2459; HR 0.74, 95% CI 0.64-0.84; P < 0.00001) and females (n = 2169; HR 0.77, 95% CI 0.67-0.89; P = 0.0002); outcomes were similar for time to AF/AFL recurrence. Among patients aged |
| doi_str_mv | 10.1093/europace/euab208 |
| format | Article |
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Efficacy and safety of dronedarone were assessed in patients according to age and sex. Baseline characteristics were comparable across subgroups, except for cardiovascular comorbidities, which were more frequent with increasing age. Dronedarone significantly reduced the risk of cardiovascular hospitalization or death due to any cause among patients 65-74 [n = 1830; hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.60-0.83; P < 0.0001] and ≥75 (n = 1925; HR 0.75, 95% CI 0.65-0.88; P = 0.0002) years old and among males (n = 2459; HR 0.74, 95% CI 0.64-0.84; P < 0.00001) and females (n = 2169; HR 0.77, 95% CI 0.67-0.89; P = 0.0002); outcomes were similar for time to AF/AFL recurrence. Among patients aged <65 years (n = 873), cardiovascular hospitalization or death due to any cause with dronedarone vs. placebo was associated with an HR of 0.89 (95% CI 0.71-1.11; P = 0.3). The incidence of all treatment-emergent adverse events (TEAEs) and TEAEs leading to treatment discontinuation was comparable among males and females, and increased with increasing age.
These results support the use of dronedarone for the improvement of clinical outcomes among patients aged ≥65 years and regardless of sex.</description><identifier>ISSN: 1099-5129</identifier><identifier>EISSN: 1532-2092</identifier><identifier>DOI: 10.1093/europace/euab208</identifier><identifier>PMID: 34374766</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Amiodarone - adverse effects ; Anti-Arrhythmia Agents - adverse effects ; Atrial Fibrillation - diagnosis ; Atrial Fibrillation - drug therapy ; Atrial Fibrillation - epidemiology ; Atrial Flutter - diagnosis ; Atrial Flutter - drug therapy ; Clinical Research ; Dronedarone - adverse effects ; Female ; Humans ; Infant, Newborn ; Male</subject><ispartof>Europace (London, England), 2022-11, Vol.24 (11), p.1754-1762</ispartof><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.</rights><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c354t-1d5006862ab9987bb8eab3ebf48db21948ad22c63296d0b83a8ed2e008df3da23</citedby><cites>FETCH-LOGICAL-c354t-1d5006862ab9987bb8eab3ebf48db21948ad22c63296d0b83a8ed2e008df3da23</cites><orcidid>0000-0002-9115-8051</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9681127/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9681127/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34374766$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Curtis, Anne B</creatorcontrib><creatorcontrib>Zeitler, Emily P</creatorcontrib><creatorcontrib>Malik, Aysha</creatorcontrib><creatorcontrib>Bogard, Andrew</creatorcontrib><creatorcontrib>Bhattacharyya, Nidhi</creatorcontrib><creatorcontrib>Stewart, John</creatorcontrib><creatorcontrib>Hohnloser, Stefan H</creatorcontrib><title>Efficacy and safety of dronedarone across age and sex subgroups: a post hoc analysis of the ATHENA study among patients with non-permanent atrial fibrillation/flutter</title><title>Europace (London, England)</title><addtitle>Europace</addtitle><description>Age and sex may impact the efficacy of antiarrhythmic drugs on cardiovascular outcomes and arrhythmia recurrences in patients with atrial fibrillation (AF). We report on a post hoc analysis of the ATHENA study (NCT00174785), which examined cardiovascular outcomes in patients with non-permanent AF treated with dronedarone vs. placebo.
Efficacy and safety of dronedarone were assessed in patients according to age and sex. Baseline characteristics were comparable across subgroups, except for cardiovascular comorbidities, which were more frequent with increasing age. Dronedarone significantly reduced the risk of cardiovascular hospitalization or death due to any cause among patients 65-74 [n = 1830; hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.60-0.83; P < 0.0001] and ≥75 (n = 1925; HR 0.75, 95% CI 0.65-0.88; P = 0.0002) years old and among males (n = 2459; HR 0.74, 95% CI 0.64-0.84; P < 0.00001) and females (n = 2169; HR 0.77, 95% CI 0.67-0.89; P = 0.0002); outcomes were similar for time to AF/AFL recurrence. Among patients aged <65 years (n = 873), cardiovascular hospitalization or death due to any cause with dronedarone vs. placebo was associated with an HR of 0.89 (95% CI 0.71-1.11; P = 0.3). The incidence of all treatment-emergent adverse events (TEAEs) and TEAEs leading to treatment discontinuation was comparable among males and females, and increased with increasing age.
These results support the use of dronedarone for the improvement of clinical outcomes among patients aged ≥65 years and regardless of sex.</description><subject>Amiodarone - adverse effects</subject><subject>Anti-Arrhythmia Agents - adverse effects</subject><subject>Atrial Fibrillation - diagnosis</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Atrial Fibrillation - epidemiology</subject><subject>Atrial Flutter - diagnosis</subject><subject>Atrial Flutter - drug therapy</subject><subject>Clinical Research</subject><subject>Dronedarone - adverse effects</subject><subject>Female</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Male</subject><issn>1099-5129</issn><issn>1532-2092</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkctOHDEQRa0oUXjuWUX-gQ5-9MPOAmmEJgEJwYasW-W2PWPUY7dsN2F-KN-JhwEEm6qSb91jyxehM0p-UiL5uZljmGAwZQDFiPiCDmnDWcWIZF_LTKSsGsrkATpK6YEQ0jHZfEcHvOZd3bXtIfq_tNYNMGwxeI0TWJO3OFisY_BGw65iGGJICcPK7JfME06zWsUwT-kXBjyFlPE6DEWFcZtc2gHy2uDF_dXydoFTnnXhb4Jf4QmyMz4n_M_lNfbBV5OJG_DlDEOODkZsnYpuHMti8Od2nHM28QR9szAmc_raj9Hf38v7y6vq5u7P9eXiphp4U-eK6oaQVrQMlJSiU0oYUNwoWwutGJW1AM3Y0HImW02U4CCMZoYQoS3XwPgxuthzp1ltjB7KsyKM_RTdBuK2D-D6z4p3634VHnvZCkpZVwBkD3j5s2jsu5eSfpdZ_5ZZ_5pZsfz4eOe74S0k_gy_WJvh</recordid><startdate>20221122</startdate><enddate>20221122</enddate><creator>Curtis, Anne B</creator><creator>Zeitler, Emily P</creator><creator>Malik, Aysha</creator><creator>Bogard, Andrew</creator><creator>Bhattacharyya, Nidhi</creator><creator>Stewart, John</creator><creator>Hohnloser, Stefan H</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-9115-8051</orcidid></search><sort><creationdate>20221122</creationdate><title>Efficacy and safety of dronedarone across age and sex subgroups: a post hoc analysis of the ATHENA study among patients with non-permanent atrial fibrillation/flutter</title><author>Curtis, Anne B ; Zeitler, Emily P ; Malik, Aysha ; Bogard, Andrew ; Bhattacharyya, Nidhi ; Stewart, John ; Hohnloser, Stefan H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c354t-1d5006862ab9987bb8eab3ebf48db21948ad22c63296d0b83a8ed2e008df3da23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Amiodarone - adverse effects</topic><topic>Anti-Arrhythmia Agents - adverse effects</topic><topic>Atrial Fibrillation - diagnosis</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Atrial Fibrillation - epidemiology</topic><topic>Atrial Flutter - diagnosis</topic><topic>Atrial Flutter - drug therapy</topic><topic>Clinical Research</topic><topic>Dronedarone - adverse effects</topic><topic>Female</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Male</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Curtis, Anne B</creatorcontrib><creatorcontrib>Zeitler, Emily P</creatorcontrib><creatorcontrib>Malik, Aysha</creatorcontrib><creatorcontrib>Bogard, Andrew</creatorcontrib><creatorcontrib>Bhattacharyya, Nidhi</creatorcontrib><creatorcontrib>Stewart, John</creatorcontrib><creatorcontrib>Hohnloser, Stefan H</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Europace (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Curtis, Anne B</au><au>Zeitler, Emily P</au><au>Malik, Aysha</au><au>Bogard, Andrew</au><au>Bhattacharyya, Nidhi</au><au>Stewart, John</au><au>Hohnloser, Stefan H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of dronedarone across age and sex subgroups: a post hoc analysis of the ATHENA study among patients with non-permanent atrial fibrillation/flutter</atitle><jtitle>Europace (London, England)</jtitle><addtitle>Europace</addtitle><date>2022-11-22</date><risdate>2022</risdate><volume>24</volume><issue>11</issue><spage>1754</spage><epage>1762</epage><pages>1754-1762</pages><issn>1099-5129</issn><eissn>1532-2092</eissn><abstract>Age and sex may impact the efficacy of antiarrhythmic drugs on cardiovascular outcomes and arrhythmia recurrences in patients with atrial fibrillation (AF). We report on a post hoc analysis of the ATHENA study (NCT00174785), which examined cardiovascular outcomes in patients with non-permanent AF treated with dronedarone vs. placebo.
Efficacy and safety of dronedarone were assessed in patients according to age and sex. Baseline characteristics were comparable across subgroups, except for cardiovascular comorbidities, which were more frequent with increasing age. Dronedarone significantly reduced the risk of cardiovascular hospitalization or death due to any cause among patients 65-74 [n = 1830; hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.60-0.83; P < 0.0001] and ≥75 (n = 1925; HR 0.75, 95% CI 0.65-0.88; P = 0.0002) years old and among males (n = 2459; HR 0.74, 95% CI 0.64-0.84; P < 0.00001) and females (n = 2169; HR 0.77, 95% CI 0.67-0.89; P = 0.0002); outcomes were similar for time to AF/AFL recurrence. Among patients aged <65 years (n = 873), cardiovascular hospitalization or death due to any cause with dronedarone vs. placebo was associated with an HR of 0.89 (95% CI 0.71-1.11; P = 0.3). The incidence of all treatment-emergent adverse events (TEAEs) and TEAEs leading to treatment discontinuation was comparable among males and females, and increased with increasing age.
These results support the use of dronedarone for the improvement of clinical outcomes among patients aged ≥65 years and regardless of sex.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>34374766</pmid><doi>10.1093/europace/euab208</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-9115-8051</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Europace (London, England), 2022-11, Vol.24 (11), p.1754-1762 |
| issn | 1099-5129 1532-2092 |
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| source | Oxford Journals Open Access Collection; MEDLINE; EZB-FREE-00999 freely available EZB journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Amiodarone - adverse effects Anti-Arrhythmia Agents - adverse effects Atrial Fibrillation - diagnosis Atrial Fibrillation - drug therapy Atrial Fibrillation - epidemiology Atrial Flutter - diagnosis Atrial Flutter - drug therapy Clinical Research Dronedarone - adverse effects Female Humans Infant, Newborn Male |
| title | Efficacy and safety of dronedarone across age and sex subgroups: a post hoc analysis of the ATHENA study among patients with non-permanent atrial fibrillation/flutter |
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