Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events

Efficacy and safety of alirocumab among individuals with diabetes mellitus and atherosclerotic cardiovascular disease in the ODYSSEY phase 3 trials

“…Alirocumab is a PCSK9 inhibitor that signficantly reduced LDL‐C and other atherogenic lipid parameters in participants with hypercholesterolaemia in Phase 3 ODYSSEY trials,19, 20, 21, 22, 23, 24, 25, 26 including dedicated trials involving individuals with DM who were receiving insulin therapy27 or with mixed dyslipidaemia,28 with a safety profile comparable to controls. Alirocumab has also been demonstrated to reduce major adverse cardiovascular events vs placebo in patients with recent acute coronary syndrome in the ODYSSEY OUTCOMES trial 29.…”

“…Alirocumab has also been demonstrated to reduce major adverse cardiovascular events vs placebo in patients with recent acute coronary syndrome in the ODYSSEY OUTCOMES trial 29. Subgroup analyses have suggested similar efficacy and tolerability of alirocumab in individuals with and without DM 26, 30, 31, 32, 33. However, it is important to examine the effects of alirocumab in the specific subgroup of individuals with both DM and ASCVD who are at particularly high risk and may benefit from additional lipid‐lowering therapy beyond a statin 7, 8, 9, 10, 15.…”

PCSK9 Inhibitors in Lipid Management of Patients With Diabetes Mellitus and High Cardiovascular Risk: A Review

“…Alirocumab and evolocumab, either alone or in combination with statins and/or other lipid‐lowering therapies, have been shown in their respective phase 3 clinical trial programs (ODYSSEY and PROFICIO [Program to Reduce LDL‐C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different Populations]) to significantly reduce LDL‐C levels by up to 60% from baseline (depending on dosing regimen; Table) in patients with hypercholesterolemia, including those with familial hypercholesterolemia, moderate to very high cardiovascular risk, and statin intolerance 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62. The inclusion/exclusion criteria and other details of each phase 3 ODYSSEY and PROFICIO trial are shown in Table S2.…”

“…Subanalyses of the diabetes mellitus subpopulations in the alirocumab and evolocumab phase 3 trials (Table) showed significant reductions in LDL‐C that were generally similar between individuals with and without diabetes mellitus 46, 47, 62, 66, 67, 68, 69, 70. Findings were consistent in the prespecified diabetes mellitus subanalysis of FOURIER, which analyzed 11 031 patients with diabetes mellitus versus 16 533 patients without diabetes mellitus; compared with placebo, median LDL‐C levels were reduced by 57% in those with diabetes mellitus and by 60% in those without diabetes mellitus 71.…”

“…The cardiovascular benefits of LDL‐C reductions with a PCSK9 inhibitor were first suggested by the post‐hoc analyses of the phase 3 LONG TERM and OSLER trials 58, 62. Recently, the GLAGOV study found that the addition of evolocumab to statin therapy in patients with angiographic coronary artery disease could lead to regression of atherosclerotic plaques after 76 weeks of treatment in those patients with LDL‐C reductions 64.…”