Effects of Azimilide on Heart Rate and ECG Conduction Intervals during Sinus Rhythm in Patients with a History of Atrial Fibrillation
The purpose of this study was to assess the effect of azimilide, a Class III antiarrhythmic drug, on ECG conduction intervals recorded during sinus rhythm in patients with a history of symptomatic atrial fibrillation or atrial flutter. In Phase I clinical pharmacology studies, azimilide was associat...
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| Veröffentlicht in: | Journal of clinical pharmacology 2002-04, Vol.42 (4), p.388-394 |
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| creator | Pritchett, Edward L. C. Schulte, Marcia C. Schnell, Daniel Marcello, Stephen R. Wilkinson, William E. Page, Richard L. Connolly, Stuart J. |
| description | The purpose of this study was to assess the effect of azimilide, a Class III antiarrhythmic drug, on ECG conduction intervals recorded during sinus rhythm in patients with a history of symptomatic atrial fibrillation or atrial flutter. In Phase I clinical pharmacology studies, azimilide was associated with prolongation of the QT and QTc intervals on electrocardiograms recorded during sinus rhythm in normal subjects, but the effect of azimilide on the target population of patients with atrial fibrillation has not been reported in detail previously. Patients with a history of atrial fibrillation, atrial flutter, or both were randomly assigned to receive placebo or azimilide twice daily for 3 days and then qd thereafter. Azimilide doses of 50 mg, 100 mg, or 125 mg were tested. The RR, PR, QRS, QT, QTc(Bazett), and QTc(Fridericia) intervals were measured from electrocardiograms recorded at baseline and on Day 4 of test therapy. Increasing azimilide doses were associated with significant increases in the RR, QT, QTc(Bazett), and QTc(Fridericia) compared with changes in the placebo group based on the F‐test for differences among treatment groups and the test for a dose response. In the azimilide 125 mg dose group, the mean change in RR was significantly greater than the mean change in the placebo group (+61.4 ms in the azimilide 125 mg group vs. −14.1 ms in the placebo group). The mean change in QT was significantly greater in the azimilide 125 mg group than the mean change in the placebo group (+44.2 ms in the azimilide 125 mg group vs. −1.0 ms in the placebo group). The mean change in QTc using both correction methods was significantly greater in the azimilide 125 mg group than the mean change in the respective placebo group: QTc(Bazett) +31.6 ms in the azimilide 125 mg group versus +2.1 ms in the placebo group and QTc(Fridericia) +35.8 in the azimilide 125 mg group versus +1.0 ms in the placebo group. It was concluded that in patients with a history of atrial fibrillation or flutter, azimilide was associated with statistically significant increases in RR, QT, QTc(Bazett), and QTc(Fridericia) when patients were in sinus rhythm. |
| doi_str_mv | 10.1177/00912700222011436 |
| format | Article |
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C. ; Schulte, Marcia C. ; Schnell, Daniel ; Marcello, Stephen R. ; Wilkinson, William E. ; Page, Richard L. ; Connolly, Stuart J.</creator><creatorcontrib>Pritchett, Edward L. C. ; Schulte, Marcia C. ; Schnell, Daniel ; Marcello, Stephen R. ; Wilkinson, William E. ; Page, Richard L. ; Connolly, Stuart J. ; Azimilide Supraventricular Arrhythmia Program 3 (SVA-3) Investigators</creatorcontrib><description>The purpose of this study was to assess the effect of azimilide, a Class III antiarrhythmic drug, on ECG conduction intervals recorded during sinus rhythm in patients with a history of symptomatic atrial fibrillation or atrial flutter. In Phase I clinical pharmacology studies, azimilide was associated with prolongation of the QT and QTc intervals on electrocardiograms recorded during sinus rhythm in normal subjects, but the effect of azimilide on the target population of patients with atrial fibrillation has not been reported in detail previously. Patients with a history of atrial fibrillation, atrial flutter, or both were randomly assigned to receive placebo or azimilide twice daily for 3 days and then qd thereafter. Azimilide doses of 50 mg, 100 mg, or 125 mg were tested. The RR, PR, QRS, QT, QTc(Bazett), and QTc(Fridericia) intervals were measured from electrocardiograms recorded at baseline and on Day 4 of test therapy. Increasing azimilide doses were associated with significant increases in the RR, QT, QTc(Bazett), and QTc(Fridericia) compared with changes in the placebo group based on the F‐test for differences among treatment groups and the test for a dose response. In the azimilide 125 mg dose group, the mean change in RR was significantly greater than the mean change in the placebo group (+61.4 ms in the azimilide 125 mg group vs. −14.1 ms in the placebo group). The mean change in QT was significantly greater in the azimilide 125 mg group than the mean change in the placebo group (+44.2 ms in the azimilide 125 mg group vs. −1.0 ms in the placebo group). The mean change in QTc using both correction methods was significantly greater in the azimilide 125 mg group than the mean change in the respective placebo group: QTc(Bazett) +31.6 ms in the azimilide 125 mg group versus +2.1 ms in the placebo group and QTc(Fridericia) +35.8 in the azimilide 125 mg group versus +1.0 ms in the placebo group. It was concluded that in patients with a history of atrial fibrillation or flutter, azimilide was associated with statistically significant increases in RR, QT, QTc(Bazett), and QTc(Fridericia) when patients were in sinus rhythm.</description><identifier>ISSN: 0091-2700</identifier><identifier>EISSN: 1552-4604</identifier><identifier>DOI: 10.1177/00912700222011436</identifier><identifier>PMID: 11936563</identifier><identifier>CODEN: JCPCBR</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Analysis of Variance ; Anti-Arrhythmia Agents - pharmacology ; Anti-Arrhythmia Agents - therapeutic use ; Antiarythmic agents ; Arrhythmia, Sinus - drug therapy ; Arrhythmia, Sinus - physiopathology ; Atrial Fibrillation - drug therapy ; Atrial Fibrillation - physiopathology ; Biological and medical sciences ; Cardiovascular system ; Dose-Response Relationship, Drug ; Double-Blind Method ; Electrocardiography - drug effects ; Female ; Heart Rate - drug effects ; Heart Rate - physiology ; Humans ; Hydantoins ; Imidazoles - pharmacology ; Imidazoles - therapeutic use ; Imidazolidines ; Male ; Medical sciences ; Pharmacology. Drug treatments ; Piperazines - pharmacology ; Piperazines - therapeutic use</subject><ispartof>Journal of clinical pharmacology, 2002-04, Vol.42 (4), p.388-394</ispartof><rights>2002 American College of Clinical Pharmacology</rights><rights>2002 SAGE Publications</rights><rights>2002 INIST-CNRS</rights><rights>Copyright SAGE PUBLICATIONS, INC. Apr 2002</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3994-b56f31fd97a8d89d86f3f12a5975c111a6487be467deea21202dec5e0569510f3</citedby><cites>FETCH-LOGICAL-c3994-b56f31fd97a8d89d86f3f12a5975c111a6487be467deea21202dec5e0569510f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1177%2F00912700222011436$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1177%2F00912700222011436$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13597120$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11936563$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pritchett, Edward L. C.</creatorcontrib><creatorcontrib>Schulte, Marcia C.</creatorcontrib><creatorcontrib>Schnell, Daniel</creatorcontrib><creatorcontrib>Marcello, Stephen R.</creatorcontrib><creatorcontrib>Wilkinson, William E.</creatorcontrib><creatorcontrib>Page, Richard L.</creatorcontrib><creatorcontrib>Connolly, Stuart J.</creatorcontrib><creatorcontrib>Azimilide Supraventricular Arrhythmia Program 3 (SVA-3) Investigators</creatorcontrib><title>Effects of Azimilide on Heart Rate and ECG Conduction Intervals during Sinus Rhythm in Patients with a History of Atrial Fibrillation</title><title>Journal of clinical pharmacology</title><addtitle>J Clin Pharmacol</addtitle><description>The purpose of this study was to assess the effect of azimilide, a Class III antiarrhythmic drug, on ECG conduction intervals recorded during sinus rhythm in patients with a history of symptomatic atrial fibrillation or atrial flutter. In Phase I clinical pharmacology studies, azimilide was associated with prolongation of the QT and QTc intervals on electrocardiograms recorded during sinus rhythm in normal subjects, but the effect of azimilide on the target population of patients with atrial fibrillation has not been reported in detail previously. Patients with a history of atrial fibrillation, atrial flutter, or both were randomly assigned to receive placebo or azimilide twice daily for 3 days and then qd thereafter. Azimilide doses of 50 mg, 100 mg, or 125 mg were tested. The RR, PR, QRS, QT, QTc(Bazett), and QTc(Fridericia) intervals were measured from electrocardiograms recorded at baseline and on Day 4 of test therapy. Increasing azimilide doses were associated with significant increases in the RR, QT, QTc(Bazett), and QTc(Fridericia) compared with changes in the placebo group based on the F‐test for differences among treatment groups and the test for a dose response. In the azimilide 125 mg dose group, the mean change in RR was significantly greater than the mean change in the placebo group (+61.4 ms in the azimilide 125 mg group vs. −14.1 ms in the placebo group). The mean change in QT was significantly greater in the azimilide 125 mg group than the mean change in the placebo group (+44.2 ms in the azimilide 125 mg group vs. −1.0 ms in the placebo group). The mean change in QTc using both correction methods was significantly greater in the azimilide 125 mg group than the mean change in the respective placebo group: QTc(Bazett) +31.6 ms in the azimilide 125 mg group versus +2.1 ms in the placebo group and QTc(Fridericia) +35.8 in the azimilide 125 mg group versus +1.0 ms in the placebo group. It was concluded that in patients with a history of atrial fibrillation or flutter, azimilide was associated with statistically significant increases in RR, QT, QTc(Bazett), and QTc(Fridericia) when patients were in sinus rhythm.</description><subject>Analysis of Variance</subject><subject>Anti-Arrhythmia Agents - pharmacology</subject><subject>Anti-Arrhythmia Agents - therapeutic use</subject><subject>Antiarythmic agents</subject><subject>Arrhythmia, Sinus - drug therapy</subject><subject>Arrhythmia, Sinus - physiopathology</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Atrial Fibrillation - physiopathology</subject><subject>Biological and medical sciences</subject><subject>Cardiovascular system</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Electrocardiography - drug effects</subject><subject>Female</subject><subject>Heart Rate - drug effects</subject><subject>Heart Rate - physiology</subject><subject>Humans</subject><subject>Hydantoins</subject><subject>Imidazoles - pharmacology</subject><subject>Imidazoles - therapeutic use</subject><subject>Imidazolidines</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Piperazines - pharmacology</subject><subject>Piperazines - therapeutic use</subject><issn>0091-2700</issn><issn>1552-4604</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU9v1DAQxSMEokvhA3BBFhLcAh7Hf-Jjiba7Xa2gKiCOljdxiNusU2yHZbnzvfF2IyrBgZM1nt97M6OXZc8BvwEQ4i3GEojAmBCCAWjBH2QzYIzklGP6MJsd-vkBOMmehHCNMXDK4HF2AiALzngxy37N29bUMaChRWc_7db2tjFocGhptI_oSkeDtGvQvFqganDNWEebuhcuGv9d9wE1o7fuK_po3RjQVbeP3RZZhy51tMYl352NHdJoaUMc_P5uTPRW9-jcbrzte33we5o9apOZeTa9p9nn8_mnapmvPywuqrN1XhdS0nzDeFtA20ihy6aUTZnKFohmUrAaADSnpdgYykVjjCZAMGlMzQxmXDLAbXGavT763vrh22hCVFsbapO2cGYYgxLAhGRUJPDlX-D1MHqXdlOkYCUHVkKC4AjVfgjBm1bdervVfq8Aq0NA6p-AkubFZDxutqa5V0yJJODVBOhQ67712tU23HNFOjYdljh65HZDn7IIN_24M151RvexS4MxpmlwTtJwTFOV330lGZ9ktjf7_y-sVtXlUmKWhPlRmII0P_4Itb9RXBSCqS_vF2pFqxLW76RaFb8BqOvEtA</recordid><startdate>200204</startdate><enddate>200204</enddate><creator>Pritchett, Edward L. C.</creator><creator>Schulte, Marcia C.</creator><creator>Schnell, Daniel</creator><creator>Marcello, Stephen R.</creator><creator>Wilkinson, William E.</creator><creator>Page, Richard L.</creator><creator>Connolly, Stuart J.</creator><general>Blackwell Publishing Ltd</general><general>SAGE Publications</general><general>Sage Science</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>IQODW</scope><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>7QP</scope><scope>7QR</scope><scope>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>200204</creationdate><title>Effects of Azimilide on Heart Rate and ECG Conduction Intervals during Sinus Rhythm in Patients with a History of Atrial Fibrillation</title><author>Pritchett, Edward L. 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C.</creatorcontrib><creatorcontrib>Schulte, Marcia C.</creatorcontrib><creatorcontrib>Schnell, Daniel</creatorcontrib><creatorcontrib>Marcello, Stephen R.</creatorcontrib><creatorcontrib>Wilkinson, William E.</creatorcontrib><creatorcontrib>Page, Richard L.</creatorcontrib><creatorcontrib>Connolly, Stuart J.</creatorcontrib><creatorcontrib>Azimilide Supraventricular Arrhythmia Program 3 (SVA-3) Investigators</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pritchett, Edward L. C.</au><au>Schulte, Marcia C.</au><au>Schnell, Daniel</au><au>Marcello, Stephen R.</au><au>Wilkinson, William E.</au><au>Page, Richard L.</au><au>Connolly, Stuart J.</au><aucorp>Azimilide Supraventricular Arrhythmia Program 3 (SVA-3) Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of Azimilide on Heart Rate and ECG Conduction Intervals during Sinus Rhythm in Patients with a History of Atrial Fibrillation</atitle><jtitle>Journal of clinical pharmacology</jtitle><addtitle>J Clin Pharmacol</addtitle><date>2002-04</date><risdate>2002</risdate><volume>42</volume><issue>4</issue><spage>388</spage><epage>394</epage><pages>388-394</pages><issn>0091-2700</issn><eissn>1552-4604</eissn><coden>JCPCBR</coden><abstract>The purpose of this study was to assess the effect of azimilide, a Class III antiarrhythmic drug, on ECG conduction intervals recorded during sinus rhythm in patients with a history of symptomatic atrial fibrillation or atrial flutter. In Phase I clinical pharmacology studies, azimilide was associated with prolongation of the QT and QTc intervals on electrocardiograms recorded during sinus rhythm in normal subjects, but the effect of azimilide on the target population of patients with atrial fibrillation has not been reported in detail previously. Patients with a history of atrial fibrillation, atrial flutter, or both were randomly assigned to receive placebo or azimilide twice daily for 3 days and then qd thereafter. Azimilide doses of 50 mg, 100 mg, or 125 mg were tested. The RR, PR, QRS, QT, QTc(Bazett), and QTc(Fridericia) intervals were measured from electrocardiograms recorded at baseline and on Day 4 of test therapy. Increasing azimilide doses were associated with significant increases in the RR, QT, QTc(Bazett), and QTc(Fridericia) compared with changes in the placebo group based on the F‐test for differences among treatment groups and the test for a dose response. In the azimilide 125 mg dose group, the mean change in RR was significantly greater than the mean change in the placebo group (+61.4 ms in the azimilide 125 mg group vs. −14.1 ms in the placebo group). The mean change in QT was significantly greater in the azimilide 125 mg group than the mean change in the placebo group (+44.2 ms in the azimilide 125 mg group vs. −1.0 ms in the placebo group). The mean change in QTc using both correction methods was significantly greater in the azimilide 125 mg group than the mean change in the respective placebo group: QTc(Bazett) +31.6 ms in the azimilide 125 mg group versus +2.1 ms in the placebo group and QTc(Fridericia) +35.8 in the azimilide 125 mg group versus +1.0 ms in the placebo group. It was concluded that in patients with a history of atrial fibrillation or flutter, azimilide was associated with statistically significant increases in RR, QT, QTc(Bazett), and QTc(Fridericia) when patients were in sinus rhythm.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>11936563</pmid><doi>10.1177/00912700222011436</doi><tpages>7</tpages></addata></record> |
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| subjects | Analysis of Variance Anti-Arrhythmia Agents - pharmacology Anti-Arrhythmia Agents - therapeutic use Antiarythmic agents Arrhythmia, Sinus - drug therapy Arrhythmia, Sinus - physiopathology Atrial Fibrillation - drug therapy Atrial Fibrillation - physiopathology Biological and medical sciences Cardiovascular system Dose-Response Relationship, Drug Double-Blind Method Electrocardiography - drug effects Female Heart Rate - drug effects Heart Rate - physiology Humans Hydantoins Imidazoles - pharmacology Imidazoles - therapeutic use Imidazolidines Male Medical sciences Pharmacology. Drug treatments Piperazines - pharmacology Piperazines - therapeutic use |
| title | Effects of Azimilide on Heart Rate and ECG Conduction Intervals during Sinus Rhythm in Patients with a History of Atrial Fibrillation |
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