Comparison of β-Blockers, Amiodarone Plus β-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators: The OPTIC Study: A Randomized Trial

CONTEXT Implantable cardioverter defibrillator (ICD) therapy is effective but is associated with high-voltage shocks that are painful. OBJECTIVE To determine whether amiodarone plus β-blocker or sotalol are better than β-blocker alone for prevention of ICD shocks. DESIGN, SETTING, AND PATIENTS A ran...

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Published in:JAMA : the journal of the American Medical Association 2006-01, Vol.295 (2), p.165-171
Main Authors: Connolly, Stuart J, Dorian, Paul, Roberts, Robin S, Gent, Michael, Bailin, Steven, Fain, Eric S, Thorpe, Kevin, Champagne, Jean, Talajic, Mario, Coutu, Benoit, Gronefeld, Gerian C, Hohnloser, Stefan H, Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators, for the
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Language:English
Subjects:
Adrenergic beta-Antagonists - administration & dosage
Adrenergic beta-Antagonists - therapeutic use
Aged
Amiodarone - administration & dosage
Amiodarone - therapeutic use
Anti-Arrhythmia Agents - administration & dosage
Anti-Arrhythmia Agents - therapeutic use
Biological and medical sciences
Defibrillators, Implantable - adverse effects
Equipment Failure
Female
General aspects
Humans
Male
Medical sciences
Middle Aged
Proportional Hazards Models
Sotalol - administration & dosage
Sotalol - therapeutic use
Ventricular Fibrillation - etiology
Ventricular Fibrillation - prevention & control
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container_issue 2
container_start_page 165
container_title JAMA : the journal of the American Medical Association
container_volume 295
creator Connolly, Stuart J
Dorian, Paul
Roberts, Robin S
Gent, Michael
Bailin, Steven
Fain, Eric S
Thorpe, Kevin
Champagne, Jean
Talajic, Mario
Coutu, Benoit
Gronefeld, Gerian C
Hohnloser, Stefan H
Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators, for the
description CONTEXT Implantable cardioverter defibrillator (ICD) therapy is effective but is associated with high-voltage shocks that are painful. OBJECTIVE To determine whether amiodarone plus β-blocker or sotalol are better than β-blocker alone for prevention of ICD shocks. DESIGN, SETTING, AND PATIENTS A randomized controlled trial with blinded adjudication of events of 412 patients from 39 outpatient ICD clinical centers located in Canada, Germany, United States, England, Sweden, and Austria, conducted from January 13, 2001, to September 28, 2004. Patients were eligible if they had received an ICD within 21 days for inducible or spontaneously occurring ventricular tachycardia or fibrillation. INTERVENTION Patients were randomized to treatment for 1 year with amiodarone plus β-blocker, sotalol alone, or β-blocker alone. MAIN OUTCOME MEASURE Primary outcome was ICD shock for any reason. RESULTS Shocks occurred in 41 patients (38.5%) assigned to β-blocker alone, 26 (24.3%) assigned to sotalol, and 12 (10.3%) assigned to amiodarone plus β-blocker. A reduction in the risk of shock was observed with use of either amiodarone plus β-blocker or sotalol vs β-blocker alone (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.28-0.68; P
doi_str_mv 10.1001/jama.295.2.165
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OBJECTIVE To determine whether amiodarone plus β-blocker or sotalol are better than β-blocker alone for prevention of ICD shocks. DESIGN, SETTING, AND PATIENTS A randomized controlled trial with blinded adjudication of events of 412 patients from 39 outpatient ICD clinical centers located in Canada, Germany, United States, England, Sweden, and Austria, conducted from January 13, 2001, to September 28, 2004. Patients were eligible if they had received an ICD within 21 days for inducible or spontaneously occurring ventricular tachycardia or fibrillation. INTERVENTION Patients were randomized to treatment for 1 year with amiodarone plus β-blocker, sotalol alone, or β-blocker alone. MAIN OUTCOME MEASURE Primary outcome was ICD shock for any reason. RESULTS Shocks occurred in 41 patients (38.5%) assigned to β-blocker alone, 26 (24.3%) assigned to sotalol, and 12 (10.3%) assigned to amiodarone plus β-blocker. A reduction in the risk of shock was observed with use of either amiodarone plus β-blocker or sotalol vs β-blocker alone (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.28-0.68; P&lt;.001). Amiodarone plus β-blocker significantly reduced the risk of shock compared with β-blocker alone (HR, 0.27; 95% CI, 0.14-0.52; P&lt;.001) and sotalol (HR, 0.43; 95% CI, 0.22-0.85; P = .02). There was a trend for sotalol to reduce shocks compared with β-blocker alone (HR, 0.61; 95% CI, 0.37-1.01; P = .055). The rates of study drug discontinuation at 1 year were 18.2% for amiodarone, 23.5% for sotalol, and 5.3% for β-blocker alone. Adverse pulmonary and thyroid events and symptomatic bradycardia were more common among patients randomized to amiodarone. CONCLUSIONS Despite use of advanced ICD technology and treatment with a β-blocker, shocks occur commonly in the first year after ICD implant. Amiodarone plus β-blocker is effective for preventing these shocks and is more effective than sotalol but has an increased risk of drug-related adverse effects. 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OBJECTIVE To determine whether amiodarone plus β-blocker or sotalol are better than β-blocker alone for prevention of ICD shocks. DESIGN, SETTING, AND PATIENTS A randomized controlled trial with blinded adjudication of events of 412 patients from 39 outpatient ICD clinical centers located in Canada, Germany, United States, England, Sweden, and Austria, conducted from January 13, 2001, to September 28, 2004. Patients were eligible if they had received an ICD within 21 days for inducible or spontaneously occurring ventricular tachycardia or fibrillation. INTERVENTION Patients were randomized to treatment for 1 year with amiodarone plus β-blocker, sotalol alone, or β-blocker alone. MAIN OUTCOME MEASURE Primary outcome was ICD shock for any reason. RESULTS Shocks occurred in 41 patients (38.5%) assigned to β-blocker alone, 26 (24.3%) assigned to sotalol, and 12 (10.3%) assigned to amiodarone plus β-blocker. A reduction in the risk of shock was observed with use of either amiodarone plus β-blocker or sotalol vs β-blocker alone (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.28-0.68; P&lt;.001). Amiodarone plus β-blocker significantly reduced the risk of shock compared with β-blocker alone (HR, 0.27; 95% CI, 0.14-0.52; P&lt;.001) and sotalol (HR, 0.43; 95% CI, 0.22-0.85; P = .02). There was a trend for sotalol to reduce shocks compared with β-blocker alone (HR, 0.61; 95% CI, 0.37-1.01; P = .055). The rates of study drug discontinuation at 1 year were 18.2% for amiodarone, 23.5% for sotalol, and 5.3% for β-blocker alone. Adverse pulmonary and thyroid events and symptomatic bradycardia were more common among patients randomized to amiodarone. CONCLUSIONS Despite use of advanced ICD technology and treatment with a β-blocker, shocks occur commonly in the first year after ICD implant. Amiodarone plus β-blocker is effective for preventing these shocks and is more effective than sotalol but has an increased risk of drug-related adverse effects. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov Identifier: NCT00257959</description><subject>Adrenergic beta-Antagonists - administration &amp; dosage</subject><subject>Adrenergic beta-Antagonists - therapeutic use</subject><subject>Aged</subject><subject>Amiodarone - administration &amp; dosage</subject><subject>Amiodarone - therapeutic use</subject><subject>Anti-Arrhythmia Agents - administration &amp; dosage</subject><subject>Anti-Arrhythmia Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Defibrillators, Implantable - adverse effects</subject><subject>Equipment Failure</subject><subject>Female</subject><subject>General aspects</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Proportional Hazards Models</subject><subject>Sotalol - administration &amp; dosage</subject><subject>Sotalol - therapeutic use</subject><subject>Ventricular Fibrillation - etiology</subject><subject>Ventricular Fibrillation - prevention &amp; control</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><recordid>eNqFkc9uEzEQxi0EoqFwReKCfIETG_xnvfb2FhYKkSo1IuEcjeNZ1cW7Tu1NpfadeuFBeCa2TQBxYi4zmu-nT6P5CHnJ2ZQzxt9fQgdTUaupmPJKPSITrqQppKrNYzJhrDaFLk15RJ7lfMnG4lI_JUe8KpmshZmQuyZ2W0g-x57Glv78UXwIcfMdU35HZ52PDlLskS7CLv8rxkSXcYAQA23HeZHwGvvB722WFyOW6WmKHZ132wD9ADYgbSA5H68xDZjoR2y9TT4EGGLKJ3R1gfR8sZo3dDns3M0JndGv0LvY-Vt0dJU8hOfkSQsh44tDPybfTj-tmi_F2fnneTM7K0AKMxSqFLXlRjumTI1QMWZLido65Kp1FdfWKlFJ-7B4-ERlLEqulQOmkMtj8nbvu03xaod5WHc-b3A8tce4y2vNKi2FMP8FeV1XvNT3jq8P4M526Nbb5DtIN-vfSYzAmwMAeQOhTdBvfP7LaWmU4vfcqz03Bv9HFUxwbeQv9nuibw</recordid><startdate>20060111</startdate><enddate>20060111</enddate><creator>Connolly, Stuart J</creator><creator>Dorian, Paul</creator><creator>Roberts, Robin S</creator><creator>Gent, Michael</creator><creator>Bailin, Steven</creator><creator>Fain, Eric S</creator><creator>Thorpe, Kevin</creator><creator>Champagne, Jean</creator><creator>Talajic, Mario</creator><creator>Coutu, Benoit</creator><creator>Gronefeld, Gerian C</creator><creator>Hohnloser, Stefan H</creator><creator>Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators, for the</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QO</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20060111</creationdate><title>Comparison of β-Blockers, Amiodarone Plus β-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators: The OPTIC Study: A Randomized Trial</title><author>Connolly, Stuart J ; Dorian, Paul ; Roberts, Robin S ; Gent, Michael ; Bailin, Steven ; Fain, Eric S ; Thorpe, Kevin ; Champagne, Jean ; Talajic, Mario ; Coutu, Benoit ; Gronefeld, Gerian C ; Hohnloser, Stefan H ; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators, for the</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a328t-5429b187d0589ea600b43e7bde15fd617bb5263bbde154039268be3175da05e13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adrenergic beta-Antagonists - administration &amp; dosage</topic><topic>Adrenergic beta-Antagonists - therapeutic use</topic><topic>Aged</topic><topic>Amiodarone - administration &amp; dosage</topic><topic>Amiodarone - therapeutic use</topic><topic>Anti-Arrhythmia Agents - administration &amp; dosage</topic><topic>Anti-Arrhythmia Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Defibrillators, Implantable - adverse effects</topic><topic>Equipment Failure</topic><topic>Female</topic><topic>General aspects</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Proportional Hazards Models</topic><topic>Sotalol - administration &amp; dosage</topic><topic>Sotalol - therapeutic use</topic><topic>Ventricular Fibrillation - etiology</topic><topic>Ventricular Fibrillation - prevention &amp; control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Connolly, Stuart J</creatorcontrib><creatorcontrib>Dorian, Paul</creatorcontrib><creatorcontrib>Roberts, Robin S</creatorcontrib><creatorcontrib>Gent, Michael</creatorcontrib><creatorcontrib>Bailin, Steven</creatorcontrib><creatorcontrib>Fain, Eric S</creatorcontrib><creatorcontrib>Thorpe, Kevin</creatorcontrib><creatorcontrib>Champagne, Jean</creatorcontrib><creatorcontrib>Talajic, Mario</creatorcontrib><creatorcontrib>Coutu, Benoit</creatorcontrib><creatorcontrib>Gronefeld, Gerian C</creatorcontrib><creatorcontrib>Hohnloser, Stefan H</creatorcontrib><creatorcontrib>Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators, for the</creatorcontrib><creatorcontrib>Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Connolly, Stuart J</au><au>Dorian, Paul</au><au>Roberts, Robin S</au><au>Gent, Michael</au><au>Bailin, Steven</au><au>Fain, Eric S</au><au>Thorpe, Kevin</au><au>Champagne, Jean</au><au>Talajic, Mario</au><au>Coutu, Benoit</au><au>Gronefeld, Gerian C</au><au>Hohnloser, Stefan H</au><au>Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators, for the</au><aucorp>Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of β-Blockers, Amiodarone Plus β-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators: The OPTIC Study: A Randomized Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2006-01-11</date><risdate>2006</risdate><volume>295</volume><issue>2</issue><spage>165</spage><epage>171</epage><pages>165-171</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><abstract>CONTEXT Implantable cardioverter defibrillator (ICD) therapy is effective but is associated with high-voltage shocks that are painful. OBJECTIVE To determine whether amiodarone plus β-blocker or sotalol are better than β-blocker alone for prevention of ICD shocks. DESIGN, SETTING, AND PATIENTS A randomized controlled trial with blinded adjudication of events of 412 patients from 39 outpatient ICD clinical centers located in Canada, Germany, United States, England, Sweden, and Austria, conducted from January 13, 2001, to September 28, 2004. Patients were eligible if they had received an ICD within 21 days for inducible or spontaneously occurring ventricular tachycardia or fibrillation. INTERVENTION Patients were randomized to treatment for 1 year with amiodarone plus β-blocker, sotalol alone, or β-blocker alone. MAIN OUTCOME MEASURE Primary outcome was ICD shock for any reason. RESULTS Shocks occurred in 41 patients (38.5%) assigned to β-blocker alone, 26 (24.3%) assigned to sotalol, and 12 (10.3%) assigned to amiodarone plus β-blocker. A reduction in the risk of shock was observed with use of either amiodarone plus β-blocker or sotalol vs β-blocker alone (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.28-0.68; P&lt;.001). Amiodarone plus β-blocker significantly reduced the risk of shock compared with β-blocker alone (HR, 0.27; 95% CI, 0.14-0.52; P&lt;.001) and sotalol (HR, 0.43; 95% CI, 0.22-0.85; P = .02). There was a trend for sotalol to reduce shocks compared with β-blocker alone (HR, 0.61; 95% CI, 0.37-1.01; P = .055). The rates of study drug discontinuation at 1 year were 18.2% for amiodarone, 23.5% for sotalol, and 5.3% for β-blocker alone. Adverse pulmonary and thyroid events and symptomatic bradycardia were more common among patients randomized to amiodarone. CONCLUSIONS Despite use of advanced ICD technology and treatment with a β-blocker, shocks occur commonly in the first year after ICD implant. Amiodarone plus β-blocker is effective for preventing these shocks and is more effective than sotalol but has an increased risk of drug-related adverse effects. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov Identifier: NCT00257959</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>16403928</pmid><doi>10.1001/jama.295.2.165</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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subjects Adrenergic beta-Antagonists - administration & dosage
Adrenergic beta-Antagonists - therapeutic use
Aged
Amiodarone - administration & dosage
Amiodarone - therapeutic use
Anti-Arrhythmia Agents - administration & dosage
Anti-Arrhythmia Agents - therapeutic use
Biological and medical sciences
Defibrillators, Implantable - adverse effects
Equipment Failure
Female
General aspects
Humans
Male
Medical sciences
Middle Aged
Proportional Hazards Models
Sotalol - administration & dosage
Sotalol - therapeutic use
Ventricular Fibrillation - etiology
Ventricular Fibrillation - prevention & control
title Comparison of β-Blockers, Amiodarone Plus β-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators: The OPTIC Study: A Randomized Trial
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