RT Journal Article
T1 Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk.
A1 Müller-Wieland, Dirk
A1 Leiter, Lawrence A
A1 Cariou, Bertrand
A1 Letierce, Alexia
A1 Colhoun, Helen M
A1 Del Prato, Stefano
A1 Henry, Robert R
A1 Tinahones, Francisco J
A1 Aurand, Lisa
A1 Maroni, Jaman
A1 Ray, Kausik K
A1 Bujas-Bobanovic, Maja
K1 Alirocumab
K1 Diabetes
K1 Mixed dyslipidaemia
K1 Non-HDL-C
K1 ODYSSEY
K1 PCSK9
AB Type 2 diabetes mellitus (T2DM) is often associated with mixed dyslipidaemia, where non-high-density lipoprotein cholesterol (non-HDL-C) levels may more closely align with cardiovascular risk than low-density lipoprotein cholesterol (LDL-C). We describe the design and rationale of the ODYSSEY DM-DYSLIPIDEMIA study that assesses the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk with non-HDL-C inadequately controlled despite maximally tolerated statin therapy. For the first time, atherogenic cholesterol-lowering with a PCSK9 inhibitor will be assessed with non-HDL-C as the primary endpoint with usual care as the comparator. DM-DYSLIPIDEMIA is a Phase 3b/4, randomised, open-label, parallel group, multinational study that planned to enrol 420 individuals. Main inclusion criteria were T2DM and mixed dyslipidaemia (non-HDL-C ≥100 mg/dl [≥2.59 mmol/l], and triglycerides ≥150 and  Recruitment completed with 413 individuals randomised in 14 countries worldwide. Results of this trial are expected in the second quarter of 2017. ODYSSEY DM-DYSLIPIDEMIA will provide information on the efficacy and safety of alirocumab versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk using non-HDL-C as the primary efficacy endpoint. Trial registration NCT02642159 (registered December 24, 2015).
YR 2017
FD 2017-05-25
LK http://hdl.handle.net/10668/11240
UL http://hdl.handle.net/10668/11240
LA en
DS RISalud
RD Apr 6, 2025