PMID- 33941192 OWN - NLM STAT- MEDLINE DCOM- 20211101 LR - 20211204 IS - 1475-2840 (Electronic) IS - 1475-2840 (Linking) VI - 20 IP - 1 DP - 2021 Apr 30 TI - Effects of evolocumab in individuals with type 2 diabetes with and without atherogenic dyslipidemia: An analysis from BANTING and BERSON. PG - 94 LID - 10.1186/s12933-021-01287-6 [doi] LID - 94 AB - BACKGROUND: Atherogenic dyslipidemia (AD), characterized by increased concentrations of apolipoprotein B (ApoB)-containing particles, is often present in individuals with type 2 diabetes mellitus (T2DM). Non-high-density lipoprotein cholesterol (non-HDL-C), cholesterol transported by apolipoprotein B (ApoB)-containing particles), and total apoB are considered secondary goals of lipid-lowering therapy to guide treatment of residual cardiovascular risk. The BANTING and BERSON studies demonstrated that evolocumab added to statin therapy reduced atherogenic lipid and lipoproteins concentrations in patients with T2DM. METHODS: This post-hoc analysis combined data from two randomized, placebo-controlled trials, BANTING and BERSON, to investigate the effect of evolocumab (140 mg every two weeks [Q2W] or 420 mg monthly [QM]) on atherogenic lipid (LDL-C, non-HDL-C, VLDL-C, remnant cholesterol) and lipoproteins (ApoB, lipoprotein(a) (Lp[a])), and achievement of 2019 European Society of Cardiology/European Atherosclerosis Society lipid treatment goals in individuals with and without AD. RESULTS: In individuals with high TGs with (n = 389) and without (n = 196) AD receiving background statin therapy, evolocumab, compared with placebo, substantially reduced the cholesterol levels from all ApoB atherogenic lipoproteins (least squares (LS) mean LDL-C by 66.7% to 74.3%, non-HDL-C by 53.4% to 65.8%, median remnant cholesterol by 28.9% to 34.2%, VLDL-C by 16.1% to 19.6%) and median TGs levels (by 17.5% to 19.6%) at the mean of weeks 10 and 12. LS mean ApoB was significantly reduced by 41.5% to 56.6% at week 12. Results were consistent in diabetic individuals with normal TGs (n = 519). Evolocumab was also associated with a significant reduction in median Lp(a) by 35.0% to 53.9% at the mean of weeks 10 and 12. A majority (74.7% to 79.8%) of evolocumab-treated individuals achieved the goal of both an LDL-C < 1.4 mmol/L and an LDL-C reduction of at least 50%, > 75% achieved non-HDL-C < 2.2 mmol/L at the mean of weeks 10 and 12, and > 67% achieved ApoB < 65 mg/dL at week 12. CONCLUSIONS: Evolocumab effectively reduced LDL-C, non-HDL-C, ApoB, Lp(a), and remnant cholesterol in individuals with T2DM with and without AD. Evolocumab Q2W or QM enabled most individuals at high/very-high cardiovascular disease risk to achieve their LDL-C, non-HDL-C, and ApoB recommended goals. FAU - Lorenzatti, Alberto J AU - Lorenzatti AJ AUID- ORCID: 0000-0003-4180-2010 AD - Clinical Research and Cardiology, Instituto Medico DAMIC/Fundacion Rusculleda, Cordoba, Argentina. alorenzatti@damic.com.ar. FAU - Monsalvo, Maria Laura AU - Monsalvo ML AD - Amgen Inc, Thousand Oaks, CA, USA. FAU - Lopez, J Antonio G AU - Lopez JAG AD - Amgen Inc, Thousand Oaks, CA, USA. FAU - Wang, Huei AU - Wang H AD - Amgen Inc, Newbury Park, CA, USA. FAU - Rosenson, Robert S AU - Rosenson RS AD - Icahn School of Medicine At Mount Sinai, New York, NY, USA. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20210430 PL - England TA - Cardiovasc Diabetol JT - Cardiovascular diabetology JID - 101147637 RN - 0 (APOB protein, human) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Anticholesteremic Agents) RN - 0 (Apolipoprotein B-100) RN - 0 (Biomarkers) RN - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors) RN - 0 (Lipids) RN - 0 (PCSK9 Inhibitors) RN - 0 (Triglycerides) RN - 97C5T2UQ7J (Cholesterol) RN - EC 3.4.21.- (PCSK9 protein, human) RN - LKC0U3A8NJ (evolocumab) SB - IM MH - Aged MH - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use MH - Anticholesteremic Agents/adverse effects/*therapeutic use MH - Apolipoprotein B-100/blood MH - Biomarkers/blood MH - Cholesterol/blood MH - Clinical Trials, Phase III as Topic MH - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy MH - Drug Therapy, Combination MH - Dyslipidemias/blood/diagnosis/*drug therapy MH - Female MH - Humans MH - Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use MH - Lipids/*blood MH - Male MH - Middle Aged MH - PCSK9 Inhibitors MH - Randomized Controlled Trials as Topic MH - Time Factors MH - Treatment Outcome MH - Triglycerides/blood PMC - PMC8091704 OTO - NOTNLM OT - Atherogenic dyslipidemia OT - Cardiovascular disease OT - Diabetes mellitus OT - Evolocumab OT - Lipid-lowering therapy OT - Lipoproteins OT - PCSK9 inhibition OT - Treatment goals COIS- AJ Lorenzatti was the Principal Investigator in the BERSON trial and reports research support from Amgen, Novo Nordisk and Esperion; a consulting role for Amgen, Kowa, and PTC; and speaking activities with Amgen, Novo Nordisk, Pfizer, and PTC. RS Rosenson reports research support from Amgen, Novartis, NIH, and Regeneron; consulting/advisory roles for Amgen, Amyrt C5, CVS Caremark, The Medicines Company, Novartis, Regeneron, and 89 BioMedicines Company; speaking (non-promotional) roles with Amgen, Kowa, and Regeneron; stock holdings with MediMergent; royalties from Wolters Kluwer (UpToDate); and patents for biocellular inflammatory pathways. ML Monsalvo, JAG Lopez, and H Wang are employees and shareholders of Amgen. EDAT- 2021/05/05 06:00 MHDA- 2021/11/03 06:00 PMCR- 2021/04/30 CRDT- 2021/05/04 05:52 PHST- 2020/12/28 00:00 [received] PHST- 2021/04/24 00:00 [accepted] PHST- 2021/05/04 05:52 [entrez] PHST- 2021/05/05 06:00 [pubmed] PHST- 2021/11/03 06:00 [medline] PHST- 2021/04/30 00:00 [pmc-release] AID - 10.1186/s12933-021-01287-6 [pii] AID - 1287 [pii] AID - 10.1186/s12933-021-01287-6 [doi] PST - epublish SO - Cardiovasc Diabetol. 2021 Apr 30;20(1):94. doi: 10.1186/s12933-021-01287-6.