Alexia Letierce

Alirocumab versus usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial

To compare alirocumab, a proprotein convertase subtilisin‐kexin type 9 inhibitor, with usual care (UC) in individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia not optimally managed by maximally tolerated statins in the ODYSSEY DM‐DYSLIPIDEMIA trial (NCT02642159).

Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk: Rationale and design of the ODYSSEY DM–INSULIN trial

AIMS The coadministration of alirocumab, a PCSK9 inhibitor for treatment of hypercholesterolaemia, and insulin in diabetes mellitus (DM) requires further study. Described here is the rationale behind a phase-IIIb study designed to characterize the efficacy and safety of alirocumab in insulin-treated patients with type 1 (T1) or type 2 (T2) DM with hypercholesterolaemia and high cardiovascular (CV) risk. METHODS ODYSSEY DM-INSULIN (NCT02585778) is a randomized, double-blind, placebo-controlled, multicentre study that planned to enrol around 400 T2 and up to 100 T1 insulin-treated DM patients. Participants had low-density lipoprotein cholesterol (LDL-C) levels at screening≥70mg/dL (1.81mmol/L) with stable maximum tolerated statin therapy or were statin-intolerant, and taking (or not) other lipid-lowering therapy; they also had established CV disease or at least one additional CV risk factor. Eligible patients were randomized 2:1 to 24weeks of alirocumab 75mg every 2weeks (Q2W) or a placebo. Alirocumab-treated patients with LDL-C≥70mg/dL at week 8 underwent a blinded dose increase to 150mg Q2W at week 12. Primary endpoints were the difference between treatment arms in percentage change of calculated LDL-C from baseline to week 24, and alirocumab safety. RESULTS This is an ongoing clinical trial, with 76 T1 and 441 T2 DM patients enrolled; results are expected in mid-2017. CONCLUSION The ODYSSEY DM-INSULIN study will provide information on the efficacy and safety of alirocumab in insulin-treated individuals with T1 or T2 DM who are at high CV risk and have hypercholesterolaemia not adequately controlled by the maximum tolerated statin therapy.

ALIROCUMAB SAFETY IN INDIVIDUALS WITH AND WITHOUT DIABETES MELLITUS: POOLED DATA FROM 14 ODYSSEY TRIALS

Background: Individuals with diabetes mellitus (DM) and elevated low density lipoprotein cholesterol (LDL-C) are at increased cardiovascular risk. Methods: We analyzed alirocumab (ALI) safety in hypercholesterolemic individuals with and without DM (defined by medical history) across 14 double-blind

Effect of alirocumab on lipids and lipoproteins in individuals with metabolic syndrome without diabetes: Pooled data from 10 phase 3 trials

This analysis assessed the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, in patients with or without metabolic syndrome (MetS) using pooled data from 10 phase 3 ODYSSEY trials.

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

Individuals with both diabetes mellitus (DM) and atherosclerotic cardiovascular disease (ASCVD) are at very high risk of cardiovascular events. This post‐hoc analysis evaluated efficacy and safety of the PCSK9 inhibitor alirocumab among 984 individuals with DM and ASCVD pooled from 9 ODYSSEY Phase 3 trials.

LOWER ON-TREATMENT LOW-DENSITY LIPOPROTEIN CHOLESTEROL IS ASSOCIATED WITH LOWER CARDIOVASCULAR RISK IN VERY HIGH RISK PATIENTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE: ANALYSES FROM THE ODYSSEY TRIALS

Background: Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibition was approved for treating patients with atherosclerotic cardiovascular disease (ASCVD) and elevated low-density lipoprotein cholesterol (LDL-C) despite maximally tolerated statin. We assessed the relationship between lower

LOWER ON-TREATMENT LOW-DENSITY LIPOPROTEIN CHOLESTEROL IS ASSOCIATED WITH LOWER CARDIOVASCULAR RISK IN WOMEN: ANALYSES FROM THE ODYSSEY TRIALS OF ALIROCUMAB VERSUS CONTROL

Introduction: In statin trials, men and women derived similar relative risk reductions in cardiovascular disease (CVD) events for each 39 mg/dL reduction in low-density lipoprotein cholesterol (LDL-C). We explored whether lower LDL-C levels would be associated with a lower major adverse CV event (

ALIROCUMAB EFFICACY AND SAFETY IN PATIENTS WITH HYPERCHOLESTEROLEMIA AND WITH OR WITHOUT CLINICAL ATHEROSCLEROTIC CARDIOVASCULAR DISEASE: POOLED ANALYSIS OF 10 ODYSSEY RANDOMIZED TRIALS

Background: The alirocumab (ALI) ODYSSEY clinical trial program recruited patients with hypercholesterolemia, ∼70% of whom had atherosclerotic cardiovascular disease (ASCVD) and were at very high ASCVD risk. This analysis evaluated the lipid-lowering efficacy and safety of ALI among patients with