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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThis article presents results from the Phase 2 Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation trial [HARMONY; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01522651\u0026amp;atom=%2Fspmdc%2F14%2F9%2F23.atom\u0022\u003ENCT01522651\u003C\/a\u003E]. This randomized, double-blind, placebo-controlled trial demonstrated that a combination of ranolazine and low-dose dronedarone reduced the burden of paroxysmal atrial fibrillation when compared with either drug alone.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArrhythmias\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArrhythmias\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EPeter R. Kowey, MD, Lankenau Medical Center, Wynnewood, Philadelphia, Pennsylvania, USA, presented results from the Phase 2 Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation trial [HARMONY; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01522651\u0026amp;atom=%2Fspmdc%2F14%2F9%2F23.atom\u0022\u003ENCT01522651\u003C\/a\u003E]. This randomized, double-blind, placebo-controlled trial demonstrated that a combination of ranolazine and low-dose dronedarone reduced the burden of paroxysmal atrial fibrillation (PAF) when compared with either drug alone.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EBoth ranolazine and dronedarone are drugs that block multiple ion channels. Dronedarone is approved for management of patients with PAF. Ranolazine not only is approved for chronic angina but also has been shown to have antiarrhythmic effects [Mason PK, DiMarco JP. \u003Cem\u003ECirc Arrhythm Electrophysiol\u003C\/em\u003E 2009]. Neither of these drugs, however, has proved very effective for the treatment of PAF when used as monotherapy.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDr. Kowey and colleagues conducted a study to determine if the combination of ranolazine and low-dose dronedarone is superior to individual drug therapy in reducing the burden of atrial fibrillation (AF) in patients with PAF.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ETo be included in the trial, patients were required to be aged \u226518 years, with a history of PAF documented within the prior 12 months, and a dual-chamber programmable pacemaker with AF detection capabilities (implanted at least 3 months prior to screening).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EExclusion criteria included persistent or permanent AF, a history of atrial flutter or atrial tachycardia without successful ablation, other acutely reversible causes of AF, a prior heart transplant, or a history of stroke 3 months prior to screening.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EIn total, 134 patients were enrolled and randomly assigned to five groups: placebo (n=26), ranolazine 750 mg twice daily (BID) (n=26), dronedarone 225 mg BID (n=26), ranolazine 750 mg and dronedarone 225 mg BID (n=27), or ranolazine 750 mg and dronedarone 150 mg BID (n=26).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe primary end points were the relative and absolute changes from baseline in AF burden (AFB) at 12 weeks. Secondary end points included the change in AFB at each study visit, the percentage of patients with a 50% reduction of AFB, and the safety and tolerability of dronedarone and ranolazine when used as monotherapy and\/or in combination.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003ECompared with placebo, the patient group treated with ranolazine 750 mg and dronedarone 225 mg BID had a statistically significant reduction in AFB from baseline to 12 weeks (p=0.008; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The reduction in AFB for those in the ranolazine group and in the dronedarone 150 mg BID and ranolazine 750 mg daily group was not statistically significant (p=0.072 and p=0.49, respectively). In addition, the patient group treated with dronedarone 225 mg BID showed no difference in percentage change in AFB when compared to placebo (p=0.78).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/9\/23\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Percentage Change in AFB From Baseline to 12 Weeks\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2079993593\u0022 data-figure-caption=\u0022Percentage Change in AFB From Baseline to 12 Weeks\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/9\/23\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/9\/23\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/9\/23\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15902\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003EPercentage Change in AFB From Baseline to 12 Weeks\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EAFB=atrial fibrillation burden; D225=dronedarone 225 mg BID; R750=ranolazine 750 mg BID; R750\/D150=ranolazine 750 mg and dronedarone 150 mg BID; R750\/D225=ranolazine 750 mg and dronedarone 225 mg; PL=placebo.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from PR Kowey, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003EFrom baseline to 12 weeks, a \u226570% reduction of AFB occurred in 45% and 27% of patients in the ranolazine 750 mg-dronedarone 225 mg BID and ranolazine 750 mg- dronedarone 150 mg BID groups, respectively, compared to an 11% reduction in the placebo group. Neither ranolazine nor dronedarone 225 mg BID alone reduced AFB when compared with placebo (only 17% and 9%, respectively).\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EThere were very few serious adverse events (AEs) reported in the treatment groups, and there was no dose relationship with respect to either serious AEs or those leading to treatment discontinuation. Dizziness and constipation were some of the most frequent serious AEs reported.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EIn summary, the HARMONY trial showed that ranolazine and dronedarone lowered AFB as compared to placebo or either agent when used as monotherapy. In addition, there was a dose-response relationship seen with the effects of dronedarone when used in combination with ranolazine.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EDr. Kowey concluded by noting that plans are now underway to further study these agents with 2 large Phase 3 trials. One trial plans to study the effects of dronedarone and ranolazine on the time to recurrent atrial fibrillation. The other trial will study the effects of dronedarone and ranolazine on cardiovascular death or hospitalization.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/9\/23.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzp6mp\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzp6mp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}