Vnitr Lek 2021, 67(4):206-211 | DOI: 10.36290/vnl.2021.054
Biologic therapy for dyslipidemia
- III. interní klinika - nefrologická, revmatologická a endokrinologická, LF UP a FN Olomouc
Dyslipidemia treatment represents a very dynamically growing segment of pharmacotherapy, including a production of biological agents. Nowadays, they are targeting at various proteins that are involved in the synthesis, transport, or metabolism of lipoproteins. This review provides a statement of current options for the biological treatment of dyslipidemias and for other products that have the potential to broaden its spectrum in the near future.
Keywords: PCSK9-inhibitors, inclisiran, evinacumab, volanesorsen, APO(a)-LRx, mipomersen.
Published: June 29, 2021 Show citation
References
- Davidson MH. Biologic therapies for dyslipidemia. Curr Atheroscler Rep 2004; 6: 69-72.
Go to original source...
Go to PubMed...
- Jia X, Liu J, Mehta A et al. Lipid-Lowering Biotechnological Drugs: from Monoclonal Antibodies to Antisense Therapies-a Clinical Perspective. Cardiovasc Drugs Ther 2020; doi: 10.1007/s10557-020-07082-x.
Go to original source...
Go to PubMed...
- Navarese EP, Kolodziejczak M, Schulze V et al. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis. Ann Intern Med 2015; 163: 40-51.
Go to original source...
Go to PubMed...
- Squizzato A, Suter MB, Nerone M et al. PCSK9 inhibitors for treating dyslipidemia in patients at different cardiovascular risk: a systematic review and a meta-analysis. Intern Emerg Med 2017; 12: 1043-1053.
Go to original source...
Go to PubMed...
- Zhang J, Tecson KM, Rocha NA, McCullough PA. Usefulness of alirocumab and evolocumab for the treatment of patients with diabetic dyslipidemia. Proc (Bayl Univ Med Cent) 2018; 31: 180-184.
Go to original source...
Go to PubMed...
- Taskinen MR, Del Prato S, Bujas-Bobanovic M et al. Efficacy and safety of alirocumab in individuals with type 2 diabetes mellitus with or without mixed dyslipidaemia: Analysis of the ODYSSEY LONG TERM trial. Atherosclerosis 2018; 276: 124-130.
Go to original source...
Go to PubMed...
- Ray KK, Leiter LA, Müller-Wieland D et al. Alirocumab vs 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. Diabetes Obes Metab 2018; 20: 1479-1489.
Go to original source...
Go to PubMed...
- Sabatine MS, Giugliano RP, Keech AC et al. FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med 2017; 376: 1713-1722.
Go to original source...
Go to PubMed...
- Sabatine MS, De Ferrari GM, Giugliano RP et al. Clinical Benefit of Evolocumab by Severity and Extent of Coronary Artery Disease: Analysis From FOURIER. Circulation 2018; 138: 756-766.
Go to original source...
Go to PubMed...
- Bonaca MP, Nault P, Giugliano RP et al. Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk). Circulation 2018; 137: 338-350.
Go to original source...
Go to PubMed...
- Giugliano RP, Pedersen TR, Park JG et al. FOURIER Investigators. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet 2017; 390: 1962-1971.
Go to original source...
Go to PubMed...
- Sabatine MS, Leiter LA, Wiviott SD et al. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial. Lancet Diabetes Endocrinol 2017; 5: 941-950.
Go to original source...
Go to PubMed...
- Charytan DM, Sabatine MS, Pedersen TR et al. FOURIER Steering Committee and Investigators. Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial. J Am Coll Cardiol 2019; 73: 2961-2970.
Go to original source...
Go to PubMed...
- Schwartz GG, Steg PG, Szarek M et al. ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes After Acute Coronary Syndrome. N Engl J Med 2018; 379: 2097-2107.
Go to original source...
Go to PubMed...
- Steg PG, Szarek M, Bhatt DL et al. Effect of Alirocumab on Mortality After Acute Coronary Syndromes. Circulation 2019; 140: 103-112.
Go to original source...
Go to PubMed...
- Jukema JW, Szarek M, Zijlstra LE et al. ODYSSEY OUTCOMES Committees and Investigators. Alirocumab in Patients With Polyvascular Disease and Recent Acute Coronary Syndrome: ODYSSEY OUTCOMES Trial. J Am Coll Cardiol 2019; 74: 1167-1176.
Go to original source...
Go to PubMed...
- Goodman SG, Aylward PE, Szarek M el al. ODYSSEY OUTCOMES Committees and Investigators. Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery. J Am Coll Cardiol 2019; 74: 1177-1186.
Go to original source...
Go to PubMed...
- Schwartz GG, Steg PG, Szarek M et al. ODYSSEY OUTCOMES Committees and Investigators. Peripheral Artery Disease and Venous Thromboembolic Events After Acute Coronary Syndrome: Role of Lipoprotein(a) and Modification by Alirocumab: Prespecified Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial. Circulation 2020; 141: 1608-1617.
Go to original source...
Go to PubMed...
- Bittner VA, Szarek M, Aylward PE et al. ODYSSEY OUTCOMES Committees and Investigators. Effect of Alirocumab on Lipoprotein(a) and Cardiovascular Risk After Acute Coronary Syndrome. J Am Coll Cardiol 2020; 75: 133-144.
Go to original source...
Go to PubMed...
- Ray KK, Colhoun HM, Szarek M et al. ODYSSEY OUTCOMES Committees and Investigators. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial. Lancet Diabetes Endocrinol 2019; 7: 618-628.
Go to original source...
Go to PubMed...
- Ridker PM, Revkin J, Amarenco P et al. SPIRE Cardiovascular Outcome Investigators. Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients. N Engl J Med 2017; 376: 1527-1539.
Go to original source...
Go to PubMed...
- Ridker PM, Tardif JC, Amarenco P et al. SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med 2017; 376: 1517-1526.
Go to original source...
Go to PubMed...
- Cui Y, Huo Y, Li X et al. Tafolecimab, a novel potential long-acting PCSK9 monoclonal antibody: efficacy and safety in healthy and hypercholesterolemia subjects. Eur Heart J 2020; doi.org/10.1093/ehjci/ehaa946.3327.
Go to original source...
- Pisciotta L, Favari E, Magnolo L et al. Characterization of three kindreds with familial combined hypolipidemia caused by loss-of-function mutations of ANGPTL3. Circ Cardiovasc Genet 2012; 5: 42-50.
Go to original source...
Go to PubMed...
- Ahmad Z, Banerjee P, Hamon S et al. Inhibition of Angiopoietin-Like Protein 3 With a Monoclonal Antibody Reduces Triglycerides in Hypertriglyceridemia. Circulation 2019; 140: 470-486.
Go to original source...
Go to PubMed...
- Raal FJ, Rosenson RS, Reeskamp LF et al. ELIPSE HoFH Investigators. Evinacumab for Homozygous Familial Hypercholesterolemia. N Engl J Med 2020; 383: 711-720.
Go to original source...
Go to PubMed...
- Rosenson RS, Burgess LJ, Ebenbichler CF et al. Evinacumab in Patients with Refractory Hypercholesterolemia. N Engl J Med 2020; 383: 2307-2319.
Go to original source...
Go to PubMed...
- Macchi C, Sirtori CR, Corsini A et al. A new dawn for managing dyslipidemias: The era of rna-based therapies. Pharmacol Res 2019; 150: 104413.
Go to original source...
Go to PubMed...
- https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-19/new-drugs-coming-up-in-the-field-of-lipid-control.
- Ray KK, Landmesser U, Leiter LA et al. Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol. N Engl J Med 2017; 376: 1430-1440.
Go to original source...
Go to PubMed...
- Wright RS, Collins MG, Stoekenbroek RM et al. Effects of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Inclisiran: An Analysis of the ORION-7 and ORION-1 Studies. Mayo Clin Proc 2020; 95: 77-89.
Go to original source...
Go to PubMed...
- Hovingh GK, Lepor NE, Kallend D et al. Inclisiran Durably Lowers Low-Density Lipoprotein Cholesterol and Proprotein Convertase Subtilisin/Kexin Type 9 Expression in Homozygous Familial Hypercholesterolemia: The ORION-2 Pilot Study. Circulation 2020; 141: 1829-1831.
Go to original source...
Go to PubMed...
- Raal FJ, Kallend D, Ray KK et al. ORION-9 Investigators. Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia. N Engl J Med 2020; 382: 1520-1530.
Go to original source...
Go to PubMed...
- Ray KK, Wright RS, Kallend D et al. ORION-10 and ORION-11 Investigators. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med 2020; 382: 1507-1519.
Go to original source...
Go to PubMed...
- Graham MJ, Lee RG, Brandt TA et al. Cardiovascular and Metabolic Effects of ANGPTL3 Antisense Oligonucleotides. N Engl J Med 2017; 377: 222-232.
Go to original source...
Go to PubMed...
- Tirronen A, Hokkanen K, Vuorio T, Ylä-Herttuala S. Recent advances in novel therapies for lipid disorders. Hum Mol Genet 2019; 28: R49-R54.
Go to original source...
Go to PubMed...
- Zwol WV, Rimbert A, Kuivenhoven JA. The Future of Lipid-lowering Therapy. J Clin Med 2019; 8: 1085.
Go to original source...
Go to PubMed...
- Witztum JL, Gaudet D, Freedman SD et al. Volanesorsen and Triglyceride Levels in Familial Chylomicronemia Syndrome. N Engl J Med 2019; 381: 531-542.
Go to original source...
Go to PubMed...
- Gouni-Berthold I, Alexander V, Digenio A et al. Apolipoprotein C-III inhibition with volanesorsen in patients with hypertriglyceridemia (COMPASS): a randomized, double-blind, placebo-controlled trial. Atheroscler Suppl 2017; 28: e1-e2.
Go to original source...
- Gelrud A, Digenio A, Alexander V et al. Treatment with volanesorsen (VLN) reduced triglycerides and pancreatitis in patients with FCS and sHTG vs placebo: results of the APPROACH and COMPASS. J Clin Lipidol 2018; 12: 537.
Go to original source...
- https://ir.ionispharma.com/news-releases/news-release-details/akcea-and-ionis-report-top-line-results-broaden-study-waylivrar.
- Alexander VJ, Xia S, Hurh E et al. N-acetyl galactosamine-conjugated antisense drug to APOC3 mRNA, triglycerides and atherogenic lipoprotein levels. Eur Heart J 2019; 40: 2785-2796.
Go to original source...
Go to PubMed...
- Tsimikas S, Viney NJ, Hughes SG et al. Antisense therapy targeting apolipoprotein(a): a randomised, double-blind, placebo-controlled phase 1 study. Lancet 2015; 386: 1472-1483.
Go to original source...
Go to PubMed...
- Viney NJ, van Capelleveen JC, Geary RS et al. Antisense oligonucleotides targeting apolipoprotein(a) in people with raised lipoprotein(a): two randomised, double-blind, placebo-controlled, dose-ranging trials. Lancet 2016; 388: 2239-2253.
Go to original source...
Go to PubMed...
- Tsimikas S, Karwatowska-Prokopczuk E, Gouni-Berthold I et al. AKCEA-APO(a)-LRx Study Investigators. Lipoprotein(a) Reduction in Persons with Cardiovascular Disease. N Engl J Med 2020; 382: 244-255.
Go to original source...
Go to PubMed...