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Med."],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the lipid\u2010lowering efficacy and safety of alirocumab, a proprotein convertase subtilisin\/kexin type 9 (<jats:styled-content style=\"fixed-case\">PCSK<\/jats:styled-content>9) inhibitor, in people with hypercholesterolaemia and prediabetes at baseline vs people with normoglycaemia at baseline in a pooled analysis of 10 <jats:styled-content style=\"fixed-case\">ODYSSEY<\/jats:styled-content> phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>People classified as having prediabetes had baseline HbA<jats:sub>1c<\/jats:sub> \u226539 mmol\/mol (5.7%) and &lt;48 mmol\/mol (6.5%), or two baseline fasting plasma glucose values \u22655.6 mmol\/l (100 mg\/dl) but no more than one fasting plasma glucose value \u22657.0 mmol\/l (126 mg\/dl), or had specific terms reported in their medical history; people diagnosed with diabetes at baseline were excluded, and the remainder were classified as having normoglycaemia. Participants received alirocumab or control (placebo\/ezetimibe) for 24\u2013104 weeks, with maximally tolerated statin in most cases. The primary efficacy endpoint was <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content> cholesterol reductions from baseline to week 24 in the intention\u2010to\u2010treat population using the mixed\u2010effect model with a repeated measures approach.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Reductions in <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content> cholesterol from baseline to week 24 with alirocumab were 44.0\u201361.8% (prediabetes group) and 45.8\u201359.5% (normoglycaemia group). In both subgroups, <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content> cholesterol reductions were generally similar in those with and without baseline triglycerides \u22651.7 mmol\/l (150 mg\/dl). Alirocumab was not associated with changes in HbA<jats:sub>1c<\/jats:sub> or fasting plasma glucose over time in either subgroup (up to 24 months' follow\u2010up). Adverse event rates were generally similar in those with and without prediabetes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Over a mean follow\u2010up of 24\u2013104 weeks, alirocumab treatment resulted in significant <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content> cholesterol reductions from baseline that were similar in participants with prediabetes and those with normoglycaemia at baseline, with no effect on glycaemia and a safety profile similar to that of the control.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dme.13450","type":"journal-article","created":{"date-parts":[[2017,8,11]],"date-time":"2017-08-11T06:53:44Z","timestamp":1502434424000},"page":"121-130","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["Efficacy and safety of alirocumab in people with prediabetes vs those with normoglycaemia at baseline: a pooled analysis of 10 phase <scp>III ODYSSEY<\/scp> clinical trials"],"prefix":"10.1111","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1040-6229","authenticated-orcid":false,"given":"L. 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