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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.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\u003EEmpagliflozin is a potent and selective inhibitor of sodium glucose cotransporter 2. This article discusses an extension study, the Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes study [EMPA-REG EXTEND MET; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01289990\u0026amp;atom=%2Fspmdc%2F14%2F20%2F15.atom\u0022\u003ENCT01289990\u003C\/a\u003E], assessed the long-term safety, tolerability, and efficacy of the empagliflozin add-on regimen.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eobesity\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ediabetes mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ediabetes \u0026amp; endocrinology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EEmpagliflozin, 10 or 25 mg, used as an add-on to metformin therapy for \u2265 76 weeks among patients with type 2 diabetes mellitus (T2DM) produces significant and sustained decreases in glycated hemoglobin (HbA\u003Csub\u003E1c\u003C\/sub\u003E), body weight, and systolic blood pressure (SBP), compared with placebo. The results of the extension portion of a randomized Phase 3 trial involving 637 patients were reported by Ludwig Merker, MD, Diabetes- und Nierenzentrum, Dormagen, Germany.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EEmpagliflozin is a potent and selective inhibitor of sodium glucose cotransporter 2 [Grempler R et al. \u003Cem\u003EDiabetes Obes Metab\u003C\/em\u003E 2012]. A prior Phase 3 trial [EMPA-REG MET; H\u00e4ring H-U et al. \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2014] showed improved glycemic control as measured by HbA\u003Csub\u003E1c\u003C\/sub\u003E and fasting plasma glucose, as well as body weight and blood pressure, among T2DM patients who received empagliflozin, 10 or 25 mg, as an add-on to metformin therapy over 24 weeks of treatment, compared with placebo. The present extension study, the Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes study [EMPA-REG EXTEND MET; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01289990\u0026amp;atom=%2Fspmdc%2F14%2F20%2F15.atom\u0022\u003ENCT01289990\u003C\/a\u003E], assessed the long-term safety, tolerability, and efficacy of the empagliflozin add-on regimen.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThe full analysis population included 637 patients with HbA\u003Csub\u003E1c\u003C\/sub\u003E between 7.0% and 10% despite a diet and exercise regimen. All patients received metformin (\u2265 1500 mg daily) and were randomly assigned to receive a daily add-on of placebo (n = 207); empagliflozin, 10 mg (n = 217); or empagliflozin, 25 mg (n = 213). The main outcomes were changes from baseline to Week 76 of treatment in HbA\u003Csub\u003E1c\u003C\/sub\u003E, body weight, and SBP. Safety was assessed among 463 patients (72.7% of total) who were treated at least once with empagliflozin. Patient demographics and characteristics for the full analysis population (N = 637) were similar among groups (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\n         \u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/16432\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/16432\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16432\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-5\u0022 class=\u0022first-child\u0022\u003EPatient Demographics and Characteristics\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EComparison of baseline and Week 76 values of HbA\u003Csub\u003E1c\u003C\/sub\u003E revealed changes from baseline of \u22120.01% for the placebo group. The difference to placebo was \u22120.61% (95% CI, \u22120.75 to \u22120.48) for the empagliflozin\u221210 mg group and \u22120.73% (95% CI, \u22120.88 to \u22120.58) for the empagliflozin\u2013 25 mg group. Both treatment groups differed significantly from the placebo group (both, p \u0026lt; .001). The greatest declines in HbA\u003Csub\u003E1c\u003C\/sub\u003E with 10 or 25 mg of empagliflozin occurred between Weeks 0 and 12. The use of rescue medication was 34.3% with placebo, 15.2% with empagliflozin\u221210 mg (OR versus placebo, 0.31; 95% CI, 0.19 to 0.50; p \u0026lt; .001), and 8.9% with empagliflozin\u221225 mg (OR versus placebo, 0.17; 95% CI, 0.09 to 0.30; p \u0026lt; .001).\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EBaseline and Week 76 comparison of body weight revealed changes from baseline of \u22120.5 kg for the placebo group. The difference to placebo was \u22121.9 kg (95% CI, \u22122.5 to \u22121.3) for the empagliflozin\u221210 mg group and \u22122.2 kg (95% CI, \u22122.8 to \u22121.6) for the empagliflozin\u221225 mg group. Both treatment groups differed significantly from the placebo group (both, p \u0026lt; .001).\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EComparison of baseline and Week 76 SBP revealed changes from baseline of \u22120.8 for the placebo group. The difference to placebo was \u22124.4 (95% CI, \u22126.6 to \u22122.3) for the empagliflozin\u221210 mg group and \u22123.7 (95% CI, \u22125.9 to \u22121.5) for the empagliflozin\u221225 mg group. Both treatment groups differed significantly from the placebo group (both, p \u0026lt; .001).\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EThere was a small but statistically significant increase in high-density lipoprotein cholesterol for the empagliflozin treatment groups, as well as total cholesterol, compared to placebo. Lipid parameters are summarized in \u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E.\u003C\/p\u003E\n         \u003Cdiv id=\u0022T2\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/16433\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/16433\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16433\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-12\u0022 class=\u0022first-child\u0022\u003ELipid Parameters\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-20\u0022\u003EThe proportion of patients reporting \u2265 1 adverse events was similar in the treatment groups. The researchers concluded that the use of 10 or 25 mg of empagliflozin as an add-on to metformin therapy for 76 weeks is well tolerated and produces significant and sustained reductions of HbA\u003Csub\u003E1c\u003C\/sub\u003E, body weight, and systolic blood pressure compared with placebo in patients with T2DM.\u003C\/p\u003E\n      \u003C\/div\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\/20\/15.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_openurl.js?nzoyap\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_tables.js?nzoyap\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}