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Evaluation of the efficacy, safety and glycaemic effects of evolocumab ( AMG 145) in hypercholesterolaemic patients stratified by glycaemic status and metabolic syndrome
Author(s) -
Blom Dirk J.,
Koren Michael J.,
Roth Eli,
Monsalvo Maria Laura,
Djedjos C. Stephen,
Nelson Patric,
Elliott Mary,
Wasserman Scott M.,
Ballantyne Christie M.,
Holman Rury R.
Publication year - 2017
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12788
Subject(s) - evolocumab , placebo , medicine , type 2 diabetes , metabolic syndrome , diabetes mellitus , impaired fasting glucose , endocrinology , post hoc analysis , gastroenterology , cholesterol , impaired glucose tolerance , lipoprotein , alternative medicine , apolipoprotein a1 , pathology
Aim To examine the lipid and glycaemic effects of 52 weeks of treatment with evolocumab. Materials and M ethods The D urable E ffect of PCSK9 A ntibody C ompared with P lacebo S tudy ( DESCARTES ) was a 52‐week placebo‐controlled trial of evolocumab that randomized 905 patients from 88 study centres in 9 countries, with 901 receiving at least one dose of study drug. For this post‐hoc analysis, DESCARTES patients were categorized by baseline glycaemic status: type 2 diabetes, impaired fasting glucose ( IFG ), metabolic syndrome ( MetS ) or none of these. Monthly subcutaneous evolocumab (420 mg) or placebo was administered. The main outcomes measured were percentage change in LDL ‐cholesterol ( LDL‐C ) at week 52 and safety. Results A total of 413 patients had dysglycaemia (120, type 2 diabetes; 293, IFG ), 289 had MetS (194 also had IFG ) and 393 had none of these conditions. At week 52, evolocumab reduced LDL‐C by >50% in all subgroups, with favourable effects on other lipids. No significant differences in fasting plasma glucose, HbA1c , insulin, C ‐peptide or HOMA indices were seen in any subgroup between evolocumab and placebo at week 52. The overall incidence of new‐onset diabetes mellitus did not differ between placebo (6.6%) and evolocumab (5.6%); in those with baseline normoglycaemia, the incidences were 1.9% and 2.7%, respectively. Incidences of AEs were similar in evolocumab‐ and placebo‐treated patients. Conclusions Evolocumab showed encouraging safety and efficacy at 52 weeks in patients with or without dysglycaemia or MetS . Changes in glycaemic parameters did not differ between evolocumab‐ and placebo‐treated patients within the glycaemic subgroups examined.