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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\u003ESimvastatin in addition to usual care did not reduce the rate of or time to exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD) in the Simvastatin Therapy for Moderate and Severe COPD study [STATCOPE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01061671\u0026amp;atom=%2Fspmdc%2F14%2F11%2F13.2.atom\u0022\u003ENCT01061671\u003C\/a\u003E; Criner GJ et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2014]. This multicenter study conducted in the United States and Canada and sponsored by respective federal agencies sought to validate benefits seen with statins, perhaps related to their anti-inflammatory effects, in retrospective studies of COPD.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EChronic Obstructive Pulmonary Disease Pulmonary Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ELipid Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EChronic Obstructive Pulmonary Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary \u0026amp; Critical Care\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ELipid Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ESimvastatin in addition to usual care did not reduce the rate of or time to exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD) in the Simvastatin Therapy for Moderate and Severe COPD study [STATCOPE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01061671\u0026amp;atom=%2Fspmdc%2F14%2F11%2F13.2.atom\u0022\u003ENCT01061671\u003C\/a\u003E; Criner GJ et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2014]. This multicenter study conducted in the United States and Canada and sponsored by respective federal agencies sought to validate benefits seen with statins, perhaps related to their anti-inflammatory effects, in retrospective studies of COPD, stated Gerard J. Criner, MD, Temple University, Philadelphia, Pennsylvania, USA. The study was terminated early for futility.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EIn total, 885 patients were randomized to simvastatin 40 mg\/day (n=430) or placebo (n=329) on top of usual care for COPD; 74% of each group completed the 12-month follow-up, and 20% of the simvastatin and 18% of the placebo groups completed the 36-month follow-up. The patients (44% women) had a mean age of 62 years, a mean smoking history of 50.6 pack-years, and a mean forced expiratory volume in 1 second of 41.6% of the predicted value. Key exclusion criteria were the presence of diabetes or cardiovascular disease, need for statins according to the Adult Treatment Panel III criteria, and treatment with amlodipine, verapamil, diltiazem, or ranolazine.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe primary outcome, mean number of COPD exacerbations per patient per year, was similar: 1.36 with simvastatin (95% CI, 1.20\u20131.51) versus 1.39 with placebo (95% CI, 1.22\u20131.54; p=0.54). The number of exacerbations per person-year is shown in \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E. The median time to first exacerbation was 223 days with simvastatin (95% CI, 195\u2013275 days), compared with 231 days with placebo (95% CI, 193\u2013303 days; p=0.34). There was no difference found in the severity of COPD exacerbations with simvastatin compared with placebo, with similar rates of mild, moderate, severe, and very severe exacerbations. No difference in the mean exacerbation rates was found with simvastatin compared with placebo for any prespecified subgroups, including smoking status, study center, gender, and race.\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\/11\/13.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Mean Number of Exacerbations Per Person-Year\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-598879554\u0022 data-figure-caption=\u0022Mean Number of Exacerbations Per Person-Year\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\/11\/13.2\/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\/11\/13.2\/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\/11\/13.2\/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\/14337\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-5\u0022 class=\u0022first-child\u0022\u003EMean Number of Exacerbations Per Person-Year\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from GJ Criner, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-6\u0022\u003EThere was no difference between simvastatin and placebo for the secondary endpoints of change in spirometric measures of lung function and quality of life, as assessed by the St. George\u0027s Respiratory Questionnaire. The rates of nonfatal serious adverse events (SAEs) were similar (0.63 and 0.62 per participant-year with simvastatin and placebo, respectively), but the overall number of SAEs was limited.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ESimvastatin was associated with improvements in total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, and high-density lipoprotein cholesterol (HDL-C). Baseline lipid levels were similar in study participants. LDL-C was decreased by 33.2 mg\/dL with simvastatin and 6.6 mg\/dL with placebo, and HDL-C was increased by 2.5 mg\/dL and decreased by 0.5 mg\/dL, respectively.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EStudy limitations included not using C-reactive protein level as an inclusion criterion and restriction of the patient population to those with moderate or severe COPD.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe STATCOPE trial did not demonstrate a therapeutic benefit, from a respiratory perspective, of statins in patients with moderate to severe COPD, stated Dr. Criner.\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\/11\/13.2.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_figures.js?nzp201\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?nzp201\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}