175-OR: Effect of Alirocumab in Individuals with Type 2 Diabetes and High Triglycerides and Low High-Density Lipoprotein Cholesterol
Authors: COLHOUN HELEN M. , LEITER LAWRENCE A. , MÜLLER-WIELAND DIRK , CARIOU BERTRAND , RAY KAUSIK K. , TINAHONES FRANCISCO , DOMENGER CATHERINE , LETIERCE ALEXIA , ISRAEL MARC , DEL PRATO STEFANO 
Published: June 2019

Mixed dyslipidemia (MD; elevated triglycerides [TG], apolipoprotein B [ApoB], and non-high-density lipoprotein cholesterol [non-HDL-C], and decreased HDL-C) is often observed in type 2 diabetes (T2D) and may contribute to increased cardiovascular (CV) risk. Non-HDL-C rather than TG has been proposed as a more useful lipid predictor of CV risk and an important therapeutic target in those with MD.

This post hoc subgroup analysis of the open label ODYSSEY DM-DYSLIPIDEMIA trial investigated effects of the PCSK9 inhibitor alirocumab (ALI; 75 mg every 2 weeks [Q2W] with possible increase to 150 mg Q2W at Week 12) vs. usual care (UC; ezetimibe [EZE], fenofibrate [FENO], or no additional lipid lowering therapy [LLT]) on non-HDL-C and other lipids in people with T2D and baseline non-HDL-C ≥100 mg/dL, TG ≥200 mg/dL, and HDL-C &lt;40 mg/dL (men) or &lt;50 mg/dL (women) on maximally tolerated statin dose.

Compared with UC, ALI significantly reduced non-HDL-C, ApoB, Lp(a) and LDL particle number from baseline to Week 24 (Table 1); TG reductions were greater with FENO vs. ALI but were not significantly different for any comparison. Adverse events frequency was similar in ALI and UC groups (67.2% vs. 70.7%).

ALI was generally well tolerated and effective at further reducing atherogenic lipids in this subgroup of people with T2D and high TG and low HDL-C levels already on maximally tolerated statin dose.

Disclosure

H.M. Colhoun: Advisory Panel; Self; Eli Lilly and Company, Novartis Pharmaceuticals Corporation, Sanofi-Aventis. Research Support; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk A/S, Pfizer Inc., Regeneron Pharmaceuticals, Roche Pharma, Sanofi-Aventis. Speaker's Bureau; Self; Eli Lilly and Company, Regeneron Pharmaceuticals, Sanofi. Stock/Shareholder; Self; Bayer AG, Roche Pharma. L.A. Leiter: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Servier. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi. D. Müller-Wieland: Advisory Panel; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. B. Cariou: Board Member; Self; Novo Nordisk A/S, Regeneron Pharmaceuticals. Consultant; Self; GENFIT, Sanofi-Aventis. Research Support; Self; Amgen Inc., Pfizer Inc. Speaker's Bureau; Self; Abbott, Akcea Therapeutics, Merck Sharp & Dohme Corp. K.K. Ray: Research Support; Self; Amgen Inc., MSD Pharma, Pfizer Inc., Regeneron Pharmaceuticals. Other Relationship; Self; AbbVie Inc., Akcea Therapeutics, Algorithm, Amgen Inc., Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Cerenis, Cipla, Eli Lilly and Company, Esperion, Kowa Pharmaceutical Europe Co. Ltd., Medco, Pfizer Inc., Regeneron Pharmaceuticals, Resverlogix Corp., Sanofi, Sanofi, Takeda Pharmaceutical Company Limited, Takeda Pharmaceutical Company Limited. F. Tinahones: Advisory Panel; Self; Lilly Diabetes, Novo Nordisk A/S, Regeneron Pharmaceuticals, Sanofi-Aventis. Consultant; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; Danone Nutricia Research, Lilly Diabetes, Novo Nordisk A/S, Regenerative Medical Solutions, Sanofi-Aventis. C. Domenger: Employee; Self; Sanofi. A. Letierce: Employee; Self; Sanofi Research & Development. M. Israel: Employee; Self; Regeneron Pharmaceuticals. Stock/Shareholder; Self; Regeneron Pharmaceuticals. S. Del Prato: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi, Servier, Takeda Pharmaceutical Company Limited. Board Member; Self; AstraZeneca. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited.

Funding

Sanofi; Regeneron Pharmaceuticals, Inc.