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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\u003EThis article discusseds a post hoc analysis of data from the phase 3 Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus study [BLOOM-DM; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00603291\u0026amp;atom=%2Fspmdc%2F14%2F47%2F12.2.atom\u0022\u003ENCT00603291\u003C\/a\u003E], concerning the effects of the weight loss drug lorcaserin in patients with type 2 diabetes mellitus who are overweight or obese.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Endocrinology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EObesity\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENutrition Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Endocrinology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EEndocrinology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Metabolic Syndrome\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EObesity\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENutrition Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EElisa Fabbrini, MD, PhD, Washington University School of Medicine, St Louis, Missouri, USA, discussed a post hoc analysis of data from the phase 3 Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus study [BLOOM-DM; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00603291\u0026amp;atom=%2Fspmdc%2F14%2F47%2F12.2.atom\u0022\u003ENCT00603291\u003C\/a\u003E], concerning the effects of the weight loss drug lorcaserin in patients with type 2 diabetes mellitus (T2DM) who are overweight or obese.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAbout 85% of Americans with T2DM are overweight or obese [Centers for Disease Control and Prevention. \u003Cem\u003EMorb Mortal Wkly Rep.\u003C\/em\u003E 2004]. Sustained weight reduction of 3% to 5% is advantageous in improving glycemic control [Jensen MD et al. \u003Cem\u003ECirculation\u003C\/em\u003E. 2014; Wing RR et al. \u003Cem\u003EDiabet Care\u003C\/em\u003E. 2011]. Lorcaserin is a selective 5-HT\u003Csub\u003E2c\u003C\/sub\u003E receptor agonist that acts to decrease food consumption and promote satiety, and it has been approved for weight loss in conjunction with diet and exercise.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the 52-week BLOOM-DM trial, obese and overweight T2DM patients were randomized 1:1:1 in a double-blind manner to placebo, lorcaserin-10 mg QD, or lorcaserin-10 mg BID, in conjunction with a calorie-reduced diet and exercise. Significant reductions versus placebo were evident in HbA\u003Csub\u003E1c\u003C\/sub\u003E and fasting plasma glucose levels in patients receiving lorcaserin BID [O\u0027Neil PM et al. \u003Cem\u003EObesity\u003C\/em\u003E. 2012].\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe present post hoc analysis involved patients who were randomized to either placebo or lorcaserin BID, who received \u2265 1 dose of study drug, and whose post-baseline weight was measured at least once\u2014that is, the modified intention-to-treat population. This retrospective analysis aimed to evaluate the putative weight-loss independent effects of lorcaserin on HbA\u003Csub\u003E1c\u003C\/sub\u003E, fasting plasma glucose, and fasting plasma insulin.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe baseline characteristics of patients treated with placebo or lorcaserin BID were comparable (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\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\/15546\/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\/15546\/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\/15546\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-7\u0022 class=\u0022first-child\u0022\u003EBaseline Characteristics of Patients Receiving Lorcaserin BID or Placebo, Mean \u00b1 SD\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-12\u0022\u003EPatients receiving lorcaserin BID displayed significant reductions (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001) in fasting plasma glucose when compared with the placebo group, beginning at week 2 and continuing through to week 52. The drop in glucose levels preceded any significant weight loss. A similar pattern of glucose reduction was also evident among a subgroup of patients who did not lose weight while on lorcaserin treatment and who were therefore considered nonresponders (defined as weight loss \u2265 5% at 12 weeks).\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EReductions in HbA\u003Csub\u003E1c\u003C\/sub\u003E were significantly greater in the lorcaserin-treated group as compared with the placebo group starting at week 12 (first measurement of HbA\u003Csub\u003E1c\u003C\/sub\u003E) throughout week 52. A similar pattern of reduction in HbA\u003Csub\u003E1c\u003C\/sub\u003E was evident in the nonresponder group, even though no changes in body weight occurred. Mean changes in fasting plasma insulin from baseline were not significantly different in patients treated with lorcaserin BID and placebo.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EExamination of 256 patients receiving lorcaserin BID and 252 receiving placebo revealed increased treatment-related adverse events of hypoglycemia (29.3% vs 21.0%), headache (14.5% vs 7.1%), back pain (11.7% vs 7.9%), cough (8.2% vs 4.4%), and fatigue (7.4% vs 4.0%).\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003EThese post hoc observations of a significant lorcaserin-mediated reduction in fasting plasma glucose and HbA\u003Csub\u003E1c\u003C\/sub\u003E before or in the absence of significant weight loss suggest that lorcaserin might affect glucose homeostasis, at least in part, independently from weight loss. Further prospective randomized clinical trials are needed to confirm these observations.\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\/47\/12.2.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?nzogm1\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?nzogm1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}