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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 Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy trial [ODYSSEY FH I; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01623115\u0026amp;atom=%2Fspmdc%2F14%2F27%2F18.atom\u0022\u003ENCT01623115\u003C\/a\u003E] and the Study of Alirocumab (REGN727\/ SAR236553) in Patients With HeFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) trial [ODYSSEY FH II; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01709500\u0026amp;atom=%2Fspmdc%2F14%2F27%2F18.atom\u0022\u003ENCT01709500\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELipid Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELipid Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EMichel Farnier, MD, PhD, Point Medical, Dijon, France, presented results from the Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy trial [ODYSSEY FH I; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01623115\u0026amp;atom=%2Fspmdc%2F14%2F27%2F18.atom\u0022\u003ENCT01623115\u003C\/a\u003E] and the Study of Alirocumab (REGN727\/SAR236553) in Patients With HeFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) trial [ODYSSEY FH II; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01709500\u0026amp;atom=%2Fspmdc%2F14%2F27%2F18.atom\u0022\u003ENCT01709500\u003C\/a\u003E]. These trials demonstrated that, in patients with heterozygous familial hypercholesterolemia (HeFH) whose low-density lipoprotein cholesterol (LDL-C) levels were inadequately controlled by statin and other lipid-lowering therapy (LLT), alirocumab produced significantly greater reductions in LDL-C compared with placebo.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EMutations in the LDL receptor gene, which cause HeFH, lead to elevated plasma levels of LDL-C and an increased risk of premature atherosclerosis and cardiovascular disease (CVD) [Pijlman AH et al. \u003Cem\u003EAtherosclerosis\u003C\/em\u003E. 2010].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EAccording to Prof Farnier, patients with HeFH are challenging to treat in clinical practice. Statins are the drug of first choice; however, even at the maximum tolerated dose, approximately 80% of adult patients with HeFH fail to reach the LDL-C target of \u0026lt; 2.5 mmol\/L (100 mg\/dL) with monotherapy [Pijlman AH et al. \u003Cem\u003EAtherosclerosis\u003C\/em\u003E. 2010]. The LDL-C target for adults with HeFH who also have coronary heart disease or diabetes is \u0026lt; 1.8 mmol\/L (\u0026lt; 70 mg\/dL) [Nordestgaard BG et al. \u003Cem\u003EEur Heart J\u003C\/em\u003E. 2013].\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EODYSSEY FH I and II were double-blind, placebo-controlled trials, conducted in North America, Europe, and South Africa for ODYSSEY FH I and across Europe for ODYSSEY FH II, that enrolled a total of 735 participants (aged approximately 52 to 53 years). Inclusion criteria included patients who had HeFH, a history of CVD, LDL-C \u2265 1.81 mmol\/L (\u2265 70 mg\/dL), or no history of CVD and LDL-C \u2265 2.59 mmol\/L (\u2265 100 mg\/dL), and who were receiving a maximally tolerated daily statin dose with or without other LLT. Patients were randomized to alirocumab (75 to 150 mg subcutaneously Q2W; n = 490 across both studies), or matching placebo (n = 245 across both studies) for 78 weeks, in addition to current therapy.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary end point was the percentage change in LDL-C from baseline to week 24. At week 24, alirocumab significantly reduced LDL-C levels compared with placebo in both FH I and II trials (\u2212 48.8% and \u2212 48.7% vs 9.1% and 2.8%, respectively; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001). To reach a prespecified LDL-C level \u0026lt; 1.81 mmol\/L (70 mg\/dL), an uptitration to 150 mg Q2W at week 12 was necessary in 43.4% and 38.6% of patients receiving alirocumab treatment in both trials.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ESimilarly, by week 24, significantly more alirocumab-treated patients compared to those on placebo had reached the LDL-C goal of a level \u0026lt; 2.59 mmol\/L (100 mg\/dL) in high-risk patients or \u0026lt; 1.81 mmol\/L (70 mg\/dL) in very high-risk patients (72.2% vs 2.4% in FH I, and 81.4% vs 11.3% in FH II; both \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001). Most patients receiving alirocumab achieved their LDL-C goals at week 24 in both trials (72.2% and 81.4% vs 2.4% and 11.3%; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001), and this reduction was maintained to 52 weeks (1.7 mmol\/L and 1.9 mmol\/L [65.9 mg\/dL and 74.3 mg\/dL]).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EIn an analysis of pooled data from the 2 trials at week 52, alirocumab appeared to be well tolerated. Treatment-emergent adverse events (TEAEs) occurred in a similar proportion of patients treated with alirocumab and placebo (74.8% vs 75.4%) and led to discontinuation in 3.1% and 3.7% of patients, respectively. The most commonly reported TEAEs (occurring in \u2265 5% of patients in each treatment arm) were injection-site reactions, naso-pharyngitis, influenza, and headaches.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EWith such a large proportion of patients achieving their target LDL-C levels, and the lack of major adverse safety signals compared with placebo, alirocumab represents a very promising treatment approach for this very high-risk patient population, concluded Prof Farnier.\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\/27\/18.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?nzou4p\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}