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Diabetes Obes Metab. 2017 Jul;19(7):989-996. doi: 10.1111/dom.12909. Epub 2017 Apr 18.

Lipid-lowering efficacy and safety of alirocumab in patients with or without diabetes: A sub-analysis of ODYSSEY COMBO II.

Author information

1
Li Ka Shing Knowledge Institute and Keenan Research Center for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto, Canada.
2
Hospital Universitario Ramon y Cajal, University Alcala de Henares, Madrid, Spain.
3
Sanofi, Paris, France.
4
Regeneron Pharmaceuticals, Tarrytown, New York.
5
Brigham and Women's Hospital, Boston, Massachusetts.
6
Metabolic Institute of America, Tarzana, California.

Abstract

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 Week 12 if Week 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 Week 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.

KEYWORDS:

cardiovascular disease; clinical trial; dyslipidaemia; type 1 diabetes; type 2 diabetes

PMID:
28206704
PMCID:
PMC5485164
DOI:
10.1111/dom.12909
[Indexed for MEDLINE]
Free PMC Article

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