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Lipid‐lowering efficacy and safety of alirocumab in patients with or without diabetes: A sub‐analysis of ODYSSEY COMBO II
Author(s) -
Leiter Lawrence A.,
Zamorano José Luis,
BujasBobanovic Maja,
Louie Michael J.,
Lecorps Guillaume,
Can Christopher P.,
Handelsman Yehuda
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.12909
Subject(s) - alirocumab , ezetimibe , pcsk9 , medicine , statin , diabetes mellitus , adverse effect , gastroenterology , urology , pharmacology , endocrinology , cholesterol , lipoprotein , ldl receptor , apolipoprotein a1
Aim This sub‐analysis of the ODYSSEY COMBO II study compared the effects of alirocumab, a proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) inhibitor, in high cardiovascular risk patients with or without diabetes mellitus ( DM ) receiving maximally tolerated statin therapy. Methods COMBO II was a 104‐week, double‐blind study (n = 720) enrolling patients with documented atherosclerotic cardiovascular disease ( ASCVD ) and baseline LDL‐C ≥70 mg/dL (1.8 mmol/L), and patients without documented ASCVD at high cardiovascular risk with LDL‐C ≥100 mg/dL (2.6 mmol/L). Patients receiving maximally tolerated statin therapy were randomized (2:1) to alirocumab 75 mg every 2 weeks ( Q2W ; 1 mL subcutaneous injection) or oral ezetimibe 10 mg daily. Alirocumab dose was increased to 150 mg Q2W (also 1 mL) at W eek 12 if W eek 8 LDL‐C was ≥70 mg/dL. Results History of DM was reported in 31% (n = 148) of patients on alirocumab and 32% (n = 77) of patients on ezetimibe. At W eek 24, alirocumab consistently reduced LDL‐C from baseline in patients with (−49.1%) or without DM (−51.2%) to a significantly greater extent than ezetimibe (−18.4% and −21.8%, respectively). Occurrence of treatment‐emergent adverse events was similar between groups. Efficacy results at 104 weeks were similar to those at 24 weeks. Conclusions Over a 104‐week double‐blind study period, alirocumab provided consistently greater LDL‐C reductions than ezetimibe, with similar LDL‐C results in patients with or without DM . Safety of alirocumab was similar regardless of baseline DM status.