Generic placeholder image

Current Vascular Pharmacology

Editor-in-Chief

ISSN (Print): 1570-1611
ISSN (Online): 1875-6212

Review Article

Efficacy and Safety of Bempedoic Acid in Patients with High Cardiovascular Risk: An Update

Author(s): Ozge Telci Caklili*, Manfredi Rizzo and Mustafa Cesur

Volume 22, Issue 4, 2024

Published on: 07 February, 2024

Page: [242 - 250] Pages: 9

DOI: 10.2174/0115701611290763240126045433

Price: $65

Abstract

Statins play a significant role in the prevention of cardiovascular (CV) diseases (CVDs); however, non-adherence with statin treatment or statin intolerance (mainly attributed to muscleassociated side effects) is not uncommon. New agents such as bempedoic acid (BA) can provide more treatment options. BA is administered orally, once daily, at a dose of 180 mg in current clinical practice. It can decrease circulating low-density lipoprotein cholesterol (LDL-C) levels by nearly 30% as monotherapy or by 20% as an add-on to statins. CV outcome studies have shown that BA decreases major adverse CV event risk in patients with established CVD or high CV risk by 13%. When patients with high CV risk were analyzed alone, the risk reduction was 30%. Its side effects include a rise in serum uric acid levels and liver enzyme activity, whereas it does not increase diabetes risk as statins do. BA can be used as adjunctive therapy to statins in patients at high CV risk in whom lipid targets cannot be achieved or as an alternative to statins in patients with statin intolerance.

[1]
Roth GA, Mensah GA, Johnson CO, et al. Global burden of cardiovascular diseases and risk factors, 1990-2019. J Am Coll Cardiol 2020; 76(25): 2982-3021.
[http://dx.doi.org/10.1016/j.jacc.2020.11.010] [PMID: 33309175]
[2]
O’Rourke K, VanderZanden A, Shepard D, Leach-Kemon K. Cardiovascular disease worldwide, 1990-2013. JAMA 2015; 314(18): 1905.
[http://dx.doi.org/10.1001/jama.2015.14994]
[3]
Naghavi M, Wang H, Lozano R, et al. Global, regional, and national age–sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: A systematic analysis for the Global Burden of Disease Study 2013. Lancet 2015; 385(9963): 117-71.
[http://dx.doi.org/10.1016/S0140-6736(14)61682-2] [PMID: 25530442]
[4]
Khan MAB, Hashim MJ, Mustafa H, et al. Global epidemiology of ischemic heart disease: Results from the global burden of disease study. Cureus 2020; 12(7): e9349.
[http://dx.doi.org/10.7759/cureus.9349] [PMID: 32742886]
[5]
Finegold JA, Asaria P, Francis DP. Mortality from ischaemic heart disease by country, region, and age: Statistics from World Health Organisation and United Nations. Int J Cardiol 2013; 168(2): 934-45.
[http://dx.doi.org/10.1016/j.ijcard.2012.10.046] [PMID: 23218570]
[6]
Rosamond W, Flegal K, Furie K, et al. Heart disease and stroke statistics--2008 update: A report from the American heart association statistics committee and stroke statistics subcommittee. Circulation 2008; 117(4): e25-e146.
[PMID: 18086926]
[7]
Yusuf S, Islam S, Chow CK, et al. Use of secondary prevention drugs for cardiovascular disease in the community in high-income, middle-income, and low-income countries (the PURE Study): A prospective epidemiological survey. Lancet 2011; 378(9798): 1231-43.
[http://dx.doi.org/10.1016/S0140-6736(11)61215-4] [PMID: 21872920]
[8]
Adhyaru BB, Jacobson TA. Safety and efficacy of statin therapy. Nat Rev Cardiol 2018; 15(12): 757-69.
[http://dx.doi.org/10.1038/s41569-018-0098-5] [PMID: 30375494]
[9]
Tarn DM, Barrientos M, Pletcher MJ, et al. Perceptions of patients with primary nonadherence to statin medications. J Am Board Fam Med 2021; 34(1): 123-31.
[http://dx.doi.org/10.3122/jabfm.2021.01.200262] [PMID: 33452090]
[10]
Diaconu CC, Iorga RA, Furtunescu F, Katsiki N, Stoian AP, Rizzo M. Statin intolerance: New data and further options for treatment. Curr Opin Cardiol 2021; 36(4): 487-93.
[http://dx.doi.org/10.1097/HCO.0000000000000874] [PMID: 33929368]
[11]
Bytyçi I, Penson PE, Mikhailidis DP, et al. Prevalence of statin intolerance: A meta-analysis. Eur Heart J 2022; 43(34): 3213-23.
[http://dx.doi.org/10.1093/eurheartj/ehac015] [PMID: 35169843]
[12]
Penson PE, Bruckert E, Marais D, et al. Step-by-step diagnosis and management of the nocebo/drucebo effect in statin-associated muscle symptoms patients: A position paper from the International Lipid Expert Panel (ILEP). J Cachexia Sarcopenia Muscle 2022; 13(3): 1596-622.
[http://dx.doi.org/10.1002/jcsm.12960] [PMID: 35969116]
[13]
Thompson PD, Panza G, Zaleski A, Taylor B. Statin-associated side effects. J Am Coll Cardiol 2016; 67(20): 2395-410.
[http://dx.doi.org/10.1016/j.jacc.2016.02.071] [PMID: 27199064]
[14]
Hajjar I, Schumpert J, Hirth V, Wieland D, Eleazer GP. The impact of the use of statins on the prevalence of dementia and the progression of cognitive impairment. J Gerontol A Biol Sci Med Sci 2002; 57(7): M414-8.
[http://dx.doi.org/10.1093/gerona/57.7.M414] [PMID: 12084801]
[15]
Calderon RM, Cubeddu LX, Goldberg RB, Schiff ER. Statins in the treatment of dyslipidemia in the presence of elevated liver aminotransferase levels: A therapeutic dilemma. Mayo Clin Proc 2010; 85(4): 349-56.
[http://dx.doi.org/10.4065/mcp.2009.0365] [PMID: 20360293]
[16]
Kiortsis DN, Filippatos TD, Mikhailidis DP, Elisaf MS, Liberopoulos EN. Statin-associated adverse effects beyond muscle and liver toxicity. Atherosclerosis 2007; 195(1): 7-16.
[http://dx.doi.org/10.1016/j.atherosclerosis.2006.10.001] [PMID: 17094994]
[17]
Jang AY, Lim S, Jo SH, Han SH, Koh KK. New trends in dyslipidemia treatment. Circ J 2021; 85(6): 759-68.
[http://dx.doi.org/10.1253/circj.CJ-20-1037] [PMID: 33177309]
[18]
Giglio RV, Pantea Stoian A, Al-Rasadi K, et al. Novel therapeutical approaches to managing atherosclerotic risk. Int J Mol Sci 2021; 22(9): 4633.
[http://dx.doi.org/10.3390/ijms22094633] [PMID: 33924893]
[19]
Phan BAP, Dayspring TD, Toth PP. Ezetimibe therapy: Mechanism of action and clinical update. Vasc Health Risk Manag 2012; 8: 415-27.
[PMID: 22910633]
[20]
Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk. Atherosclerosis 2019; 290: 140-205.
[http://dx.doi.org/10.1016/j.atherosclerosis.2019.08.014] [PMID: 31591002]
[21]
Battaggia A, Donzelli A, Font M, Molteni D, Galvano A. Clinical efficacy and safety of Ezetimibe on major cardiovascular endpoints: Systematic review and meta-analysis of randomized controlled trials. PLoS One 2015; 10(4): e0124587.
[http://dx.doi.org/10.1371/journal.pone.0124587] [PMID: 25915909]
[22]
Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015; 372(25): 2387-97.
[http://dx.doi.org/10.1056/NEJMoa1410489] [PMID: 26039521]
[23]
Steffens D, Bramlage P, Scheeff C, et al. PCSK9 inhibitors and cardiovascular outcomes. Expert Opin Biol Ther 2020; 20(1): 35-47.
[http://dx.doi.org/10.1080/14712598.2020.1677604] [PMID: 31593483]
[24]
National Center for Biotechnology Information Bempedoic Acid 2023. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Bempedoic-Acid
[25]
Burke AC, Huff MW. ATP-citrate lyase: Genetics, molecular biology and therapeutic target for dyslipidemia. Curr Opin Lipidol 2017; 28(2): 193-200.
[http://dx.doi.org/10.1097/MOL.0000000000000390] [PMID: 28059952]
[26]
Ballantyne CM, Bays H, Catapano AL, Goldberg A, Ray KK, Saseen JJ. Role of bempedoic acid in clinical practice. Cardiovasc Drugs Ther 2021; 35(4): 853-64.
[http://dx.doi.org/10.1007/s10557-021-07147-5] [PMID: 33818688]
[27]
Lemus HN, Mendivil CO. Adenosine triphosphate citrate lyase: Emerging target in the treatment of dyslipidemia. J Clin Lipidol 2015; 9(3): 384-9.
[http://dx.doi.org/10.1016/j.jacl.2015.01.002] [PMID: 26073398]
[28]
Cramer CT, Goetz B, Hopson KLM, et al. Effects of a novel dual lipid synthesis inhibitor and its potential utility in treating dyslipidemia and metabolic syndrome. J Lipid Res 2004; 45(7): 1289-301.
[http://dx.doi.org/10.1194/jlr.M400018-JLR200] [PMID: 15102884]
[29]
Cicero AFG, Fogacci F, Cincione I. Evaluating pharmacokinetics of bempedoic acid in the treatment of hypercholesterolemia. Expert Opin Drug Metab Toxicol 2021; 17(9): 1031-8.
[http://dx.doi.org/10.1080/17425255.2021.1951222] [PMID: 34197267]
[30]
Hegele RA, Tsimikas S. Lipid-lowering agents. Circ Res 2019; 124(3): 386-404.
[http://dx.doi.org/10.1161/CIRCRESAHA.118.313171] [PMID: 30702996]
[31]
Keaney JF Jr. Bempedoic acid and the prevention of cardiovascular disease. N Engl J Med 2023; 388(15): 1427-30.
[http://dx.doi.org/10.1056/NEJMe2300793] [PMID: 36876758]
[32]
Biolo G, Vinci P, Mangogna A, et al. Mechanism of action and therapeutic use of bempedoic acid in atherosclerosis and metabolic syndrome. Front Cardiovasc Med 2022; 9: 1028355.
[http://dx.doi.org/10.3389/fcvm.2022.1028355] [PMID: 36386319]
[33]
Pinkosky SL, Newton RS, Day EA, et al. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun 2016; 7(1): 13457.
[http://dx.doi.org/10.1038/ncomms13457] [PMID: 27892461]
[34]
Tummala R, Gupta M, Devanabanda AR, et al. Bempedoic acid and its role in contemporary management of hyperlipidemia in atherosclerosis. Ann Med 2022; 54(1): 1287-96.
[http://dx.doi.org/10.1080/07853890.2022.2059559] [PMID: 35533049]
[35]
Thompson PD, Rubino J, Janik MJ, et al. Use of ETC-1002 to treat hypercholesterolemia in patients with statin intolerance. J Clin Lipidol 2015; 9(3): 295-304.
[http://dx.doi.org/10.1016/j.jacl.2015.03.003] [PMID: 26073387]
[36]
Gutierrez MJ, Rosenberg NL, MacDougall DE, et al. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol 2014; 34(3): 676-83.
[http://dx.doi.org/10.1161/ATVBAHA.113.302677] [PMID: 24385236]
[37]
Ballantyne CM, Davidson MH, MacDougall DE, et al. Efficacy and safety of a novel dual modulator of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase in patients with hypercholesterolemia: Results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. J Am Coll Cardiol 2013; 62(13): 1154-62.
[http://dx.doi.org/10.1016/j.jacc.2013.05.050] [PMID: 23770179]
[38]
Ballantyne CM, Banach M, Mancini GBJ, et al. Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study. Atherosclerosis 2018; 277: 195-203.
[http://dx.doi.org/10.1016/j.atherosclerosis.2018.06.002] [PMID: 29910030]
[39]
Natale F, Molinari R, Franzese R, Mollo N, Cimmino G. Bempedoic acid and statins in lipid-lowering strategy: Which came first, the egg or the chicken? Fut Pharmacol 2023; 3(2): 392-406.
[http://dx.doi.org/10.3390/futurepharmacol3020024]
[40]
Ray KK, Bays HE, Catapano AL, et al. Safety and efficacy of bempedoic acid to reduce LDL cholesterol. N Engl J Med 2019; 380(11): 1022-32.
[http://dx.doi.org/10.1056/NEJMoa1803917] [PMID: 30865796]
[41]
Ballantyne CM, Banach M, Bays HE, et al. Long-term safety and efficacy of bempedoic acid in patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia (from the CLEAR Harmony Open-Label Extension Study). Am J Cardiol 2022; 174: 1-11.
[http://dx.doi.org/10.1016/j.amjcard.2022.03.020] [PMID: 35483979]
[42]
Shapiro MD, Minnier J, Tavori H, et al. Relationship between low‐density lipoprotein cholesterol and lipoprotein(a) lowering in response to PCSK9 inhibition with evolocumab. J Am Heart Assoc 2019; 8(4): e010932.
[http://dx.doi.org/10.1161/JAHA.118.010932] [PMID: 30755061]
[43]
Koren MJ, Scott R, Kim JB, et al. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): A randomised, double-blind, placebo-controlled, phase 2 study. Lancet 2012; 380(9858): 1995-2006.
[http://dx.doi.org/10.1016/S0140-6736(12)61771-1] [PMID: 23141812]
[44]
Farnier M, Guyton JR, Jensen E, Polis AB, Johnson-Levonas AO, Brudi P. Effects of ezetimibe, simvastatin and ezetimibe/simvastatin on correlations between apolipoprotein B, LDL cholesterol and non-HDL cholesterol in patients with primary hypercholesterolemia. Atherosclerosis 2013; 229(2): 415-22.
[http://dx.doi.org/10.1016/j.atherosclerosis.2013.05.010] [PMID: 23880197]
[45]
Mikhailidis DP, Sibbring GC, Ballantyne CM, Davies GM, Catapano AL. Meta-analysis of the cholesterol-lowering effect of ezetimibe added to ongoing statin therapy. Curr Med Res Opin 2007; 23(8): 2009-26.
[http://dx.doi.org/10.1185/030079907X210507] [PMID: 17659159]
[46]
Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic acid and cardiovascular outcomes in statin-intolerant patients. N Engl J Med 2023; 388(15): 1353-64.
[http://dx.doi.org/10.1056/NEJMoa2215024] [PMID: 36876740]
[47]
Goldberg AC, Leiter LA, Stroes ESG, et al. Effect of bempedoic acid vs. placebo added to maximally tolerated statins on low-density lipoprotein cholesterol in patients at high risk for cardiovascular disease. JAMA 2019; 322(18): 1780-8.
[http://dx.doi.org/10.1001/jama.2019.16585] [PMID: 31714986]
[48]
Krishna Mohan GV, Chenna VSH, Tirumandyam G, Mian AR, Rashid A, Saleem F. Efficacy and safety of bempedoic acid to prevent cardiovascular events in individuals at risk of cardiovascular diseases: A meta-analysis of randomized-control trials. Cureus 2023; 15(5): e38662.
[http://dx.doi.org/10.7759/cureus.38662] [PMID: 37288183]
[49]
Zhang J, Guan X, Zhang B, et al. Bempedoic acid can reduce cardiovascular events in combination with statins or as monotherapy: A systematic review and meta-analysis. Am J Cardiovasc Drugs 2023; 23(6): 695-708.
[http://dx.doi.org/10.1007/s40256-023-00606-4] [PMID: 37672202]
[50]
Laufs U, Banach M, Mancini GBJ, et al. Efficacy and safety of bempedoic acid in patients with hypercholesterolemia and statin intolerance. J Am Heart Assoc 2019; 8(7): e011662.
[http://dx.doi.org/10.1161/JAHA.118.011662] [PMID: 30922146]
[51]
Nissen SE, Menon V, Nicholls SJ, et al. Bempedoic acid for primary prevention of cardiovascular events in statin-intolerant patients. JAMA 2023; 330(2): 131-40.
[http://dx.doi.org/10.1001/jama.2023.9696] [PMID: 37354546]
[52]
Boekholdt SM, Arsenault BJ, Mora S, et al. Association of LDL cholesterol, non-HDL cholesterol, and apolipoprotein B levels with risk of cardiovascular events among patients treated with statins: A meta-analysis. JAMA 2012; 307(12): 1302-9.
[http://dx.doi.org/10.1001/jama.2012.366] [PMID: 22453571]
[53]
Rizzo M. Lipid guidelines and cardiovascular prevention: Let’s manage the risk of our patients! Curr Pharm Des 2023; 29(6): 466-7.
[http://dx.doi.org/10.2174/1381612829666230220121711] [PMID: 36803764]
[54]
Thanassoulis G, Williams K, Ye K, et al. Relations of change in plasma levels of LDL-C, non-HDL-C and apoB with risk reduction from statin therapy: A meta-analysis of randomized trials. J Am Heart Assoc 2014; 3(2): e000759.
[http://dx.doi.org/10.1161/JAHA.113.000759] [PMID: 24732920]
[55]
Koren MJ, Lundqvist P, Bolognese M, et al. Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol 2014; 63(23): 2531-40.
[http://dx.doi.org/10.1016/j.jacc.2014.03.018] [PMID: 24691094]
[56]
Blom DJ, Hala T, Bolognese M, et al. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med 2014; 370(19): 1809-19.
[http://dx.doi.org/10.1056/NEJMoa1316222] [PMID: 24678979]
[57]
Roth EM, Taskinen MR, Ginsberg HN, et al. Monotherapy with the PCSK9 inhibitor alirocumab versus ezetimibe in patients with hypercholesterolemia: Results of a 24week, double-blind, randomized Phase 3 trial. Int J Cardiol 2014; 176(1): 55-61.
[http://dx.doi.org/10.1016/j.ijcard.2014.06.049] [PMID: 25037695]
[58]
Roth EM, McKenney JM, Hanotin C, Asset G, Stein EA. Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. N Engl J Med 2012; 367(20): 1891-900.
[http://dx.doi.org/10.1056/NEJMoa1201832] [PMID: 23113833]
[59]
Kalogirou M, Tsimihodimos V, Gazi I, et al. Effect of ezetimibe monotherapy on the concentration of lipoprotein subfractions in patients with primary dyslipidaemia. Curr Med Res Opin 2007; 23(5): 1169-76.
[http://dx.doi.org/10.1185/030079907X188062] [PMID: 17519084]
[60]
Sakamoto K, Kawamura M, Tagami M, et al. Effect of Ezetimibe Add-On Therapy on Non-HDL-C in Type 2 Diabetes Subjects-A post hoc Analysis of RESEARCH Study. Diabetes 2018; 67(S1): 625.
[61]
Ballantyne CM, Laufs U, Ray KK, et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol 2020; 27(6): 593-603.
[http://dx.doi.org/10.1177/2047487319864671] [PMID: 31357887]
[62]
A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia. NCT01779453, 2023.
[63]
Nikolic D, Mikhailidis DP, Davidson MH, Rizzo M, Banach M. ETC-1002: A future option for lipid disorders? Atherosclerosis 2014; 237(2): 705-10.
[http://dx.doi.org/10.1016/j.atherosclerosis.2014.10.099] [PMID: 25463109]
[64]
Bilen O, Ballantyne CM. Bempedoic Acid (ETC-1002): An Investigational Inhibitor of ATP Citrate Lyase. Curr Atheroscler Rep 2016; 18(10): 61.
[http://dx.doi.org/10.1007/s11883-016-0611-4] [PMID: 27663902]
[65]
Danesh J, Wheeler JG, Hirschfield GM, et al. C-reactive protein and other circulating markers of inflammation in the prediction of coronary heart disease. N Engl J Med 2004; 350(14): 1387-97.
[http://dx.doi.org/10.1056/NEJMoa032804] [PMID: 15070788]
[66]
Ridker PM, Rifai N, Rose L, Buring JE, Cook NR. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. N Engl J Med 2002; 347(20): 1557-65.
[http://dx.doi.org/10.1056/NEJMoa021993] [PMID: 12432042]
[67]
Ridker PM, Danielson E, Fonseca FAH, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359(21): 2195-207.
[http://dx.doi.org/10.1056/NEJMoa0807646] [PMID: 18997196]
[68]
Ballantyne CM, McKenney JM, MacDougall DE, et al. Effect of ETC-1002 on serum low-density lipoprotein cholesterol in hypercholesterolemic patients receiving statin therapy. Am J Cardiol 2016; 117(12): 1928-33.
[http://dx.doi.org/10.1016/j.amjcard.2016.03.043] [PMID: 27138185]
[69]
Ballantyne CM, Bertolami M, Garcia HRH, et al. Achieving LDL cholesterol, non-HDL cholesterol, and apolipoprotein B target levels in high-risk patients: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY (MERCURY) II. Am Heart J 2006; 151(5): 975.e1-9.
[http://dx.doi.org/10.1016/j.ahj.2005.12.013] [PMID: 16644314]
[70]
Seed M, Hoppichler F, Reaveley D, et al. Relation of serum lipoprotein(a) concentration and apolipoprotein(a) phenotype to coronary heart disease in patients with familial hypercholesterolemia. N Engl J Med 1990; 322(21): 1494-9.
[http://dx.doi.org/10.1056/NEJM199005243222104] [PMID: 2139920]
[71]
Tsimikas S, Gordts PLSM, Nora C, Yeang C, Witztum JL. Statin therapy increases lipoprotein(a) levels. Eur Heart J 2020; 41(24): 2275-84.
[http://dx.doi.org/10.1093/eurheartj/ehz310] [PMID: 31111151]
[72]
Zhu L, Fang Y, Gao B, et al. Effect of an increase in Lp(a) following statin therapy on cardiovascular prognosis in secondary prevention population of coronary artery disease. BMC Cardiovasc Disord 2022; 22: 1-9.
[73]
Ridker PM, Lei L, Ray KK, Ballantyne CM, Bradwin G, Rifai N. Effects of bempedoic acid on CRP, IL-6, fibrinogen and lipoprotein(a) in patients with residual inflammatory risk: A secondary analysis of the CLEAR harmony trial. J Clin Lipidol 2023; 17(2): 297-302.
[http://dx.doi.org/10.1016/j.jacl.2023.02.002] [PMID: 36813656]
[74]
Awad K, Mikhailidis DP, Katsiki N, Muntner P, Banach M. Effect of ezetimibe monotherapy on plasma lipoprotein(a) concentrations in patients with primary hypercholesterolemia: A systematic review and meta-analysis of randomized controlled trials. Drugs 2018; 78(4): 453-62.
[http://dx.doi.org/10.1007/s40265-018-0870-1] [PMID: 29396832]
[75]
Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): Results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol 2023; 11(2): 109-19.
[http://dx.doi.org/10.1016/S2213-8587(22)00353-9] [PMID: 36620965]
[76]
Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med 2020; 382(16): 1507-19.
[http://dx.doi.org/10.1056/NEJMoa1912387] [PMID: 32187462]
[77]
Alexander JH. Benefits of bempedoic acid - clearer now. N Engl J Med 2023; 388(15): 1425-6.
[http://dx.doi.org/10.1056/NEJMe2301490] [PMID: 36876748]
[78]
Jacomelli I, Monzo L, Panattoni G, Lanzillo C, Rebecchi M, Calò L. Bempedoic acid: What prospective uses? Eur Heart J Suppl 2023; 25: C109-11.
[http://dx.doi.org/10.1093/eurheartjsupp/suad012] [PMID: 37125277]
[79]
Bays HE, Banach M, Catapano AL, et al. Bempedoic acid safety analysis: Pooled data from four phase 3 clinical trials. J Clin Lipidol 2020; 14(5): 649-659.e6.
[http://dx.doi.org/10.1016/j.jacl.2020.08.009] [PMID: 32980290]
[80]
Ray K, Bakris G, Banach M. Effect of bempedoic acid on uric acid and gout in 3621 patients with hypercholesterolemia: pooled analyses from phase 3 trials. Eur Heart J 2021; 41: 001.
[81]
Katsiki N, Mikhailidis DP, Banach M. Lipid-lowering agents for concurrent cardiovascular and chronic kidney disease. Expert Opin Pharmacother 2019; 20(16): 2007-17.
[http://dx.doi.org/10.1080/14656566.2019.1649394] [PMID: 31344332]
[82]
Kanbay M, Segal M, Afsar B, Kang DH, Rodriguez-Iturbe B, Johnson RJ. The role of uric acid in the pathogenesis of human cardiovascular disease. Heart 2013; 99(11): 759-66.
[http://dx.doi.org/10.1136/heartjnl-2012-302535] [PMID: 23343689]
[83]
Katsiki N, Dimitriadis GD, Mikhailidis DP. Serum uric acid and diabetes: From pathophysiology to cardiovascular disease. Curr Pharm Des 2021; 27(16): 1941-51.
[http://dx.doi.org/10.2174/18734286MTEzfMDAF1] [PMID: 33397230]
[84]
Georgoulis M, Mikhailidis DP, Panagiotakos DB. Are serum uric acid levels predictors of cardiovascular risk? An update. Curr Opin Cardiol 2023; 38(4): 337-43.
[http://dx.doi.org/10.1097/HCO.0000000000001029] [PMID: 36789778]
[85]
Katsiki N, Rizzo M, Mikhailidis DP. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors and uric acid: More good news! J Diabetes Complications 2023; 37(7): 108510.
[http://dx.doi.org/10.1016/j.jdiacomp.2023.108510] [PMID: 37235924]
[86]
Daskalopoulou S, Tzovaras V, Mikhailidis D, Elisaf M. Effect on serum uric acid levels of drugs prescribed for indications other than treating hyperuricaemia. Curr Pharm Des 2005; 11(32): 4161-75.
[http://dx.doi.org/10.2174/138161205774913309] [PMID: 16375738]
[87]
Athyros VG, Mikhailidis DP, Liberopoulos EN, et al. Effect of statin treatment on renal function and serum uric acid levels and their relation to vascular events in patients with coronary heart disease and metabolic syndrome: A subgroup analysis of the GREek Atorvastatin and Coronary heart disease Evaluation (GREACE) Study. Nephrol Dial Transplant 2006; 22(1): 118-27.
[http://dx.doi.org/10.1093/ndt/gfl538] [PMID: 16998214]
[88]
Sandhu S, Wiebe N, Fried LF, Tonelli M. Statins for improving renal outcomes: A meta-analysis. J Am Soc Nephrol 2006; 17(7): 2006-16.
[http://dx.doi.org/10.1681/ASN.2006010012] [PMID: 16762986]
[89]
Derosa G, Maffioli P, Reiner Ž, Simental-Mendía LE, Sahebkar A. Impact of statin therapy on plasma uric acid concentrations: A systematic review and meta-analysis. Drugs 2016; 76(9): 947-56.
[http://dx.doi.org/10.1007/s40265-016-0591-2] [PMID: 27260336]
[90]
Akbari A, Razmi M, Rafiee M, Watts GF, Sahebkar A. The effect of statin therapy on serum uric acid levels: A systematic review and meta-analysis. Curr Med Chem 2023; 30: 7.
[http://dx.doi.org/10.2174/0929867330666230207124516] [PMID: 36748810]
[91]
Giordano C, Karasik O, King-Morris K, Asmar A. Uric acid as a marker of kidney disease: Review of the current literature. Dis Markers 2015; 2015: 1-6.
[http://dx.doi.org/10.1155/2015/382918] [PMID: 26106252]
[92]
Iseki K, Oshiro S, Tozawa M, Iseki C, Ikemiya Y, Takishita S. Significance of hyperuricemia on the early detection of renal failure in a cohort of screened subjects. Hypertens Res 2001; 24(6): 691-7.
[http://dx.doi.org/10.1291/hypres.24.691] [PMID: 11768729]
[93]
Amore BM, Sasiela WJ, Ries DK, Tresh P, Emery MG. Pharmacokinetics of bempedoic acid in patients with renal impairment. Clin Transl Sci 2022; 15(3): 789-98.
[http://dx.doi.org/10.1111/cts.13202] [PMID: 34800002]
[94]
Bays HE, Bloedon LT, Lin G, et al. Safety of bempedoic acid in patients at high cardiovascular risk and with statin intolerance. J Clin Lipidol 2023; 12: 1-11.
[http://dx.doi.org/10.1016/j.jacl.2023.10.011] [PMID: 37951797]
[95]
Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: A collaborative meta-analysis of randomised statin trials. Lancet 2010; 375(9716): 735-42.
[http://dx.doi.org/10.1016/S0140-6736(09)61965-6] [PMID: 20167359]
[96]
Banach M, Surma S, Reiner Z, et al. Personalized management of dyslipidemias in patients with diabetes-it is time for a new approach (2022). Cardiovasc Diabetol 2022; 21(1): 263.
[http://dx.doi.org/10.1186/s12933-022-01684-5] [PMID: 36443827]
[97]
Masson W, Lobo M, Lavalle-Cobo A, Masson G, Molinero G. Effect of bempedoic acid on new onset or worsening diabetes: A meta-analysis. Diabetes Res Clin Pract 2020; 168: 108369.
[http://dx.doi.org/10.1016/j.diabres.2020.108369] [PMID: 32827596]
[98]
Ray KK, Nicholls SJ, Li N, et al. Efficacy and safety of bempedoic acid among patients with and without diabetes: prespecified analysis of the CLEAR Outcomes randomised trial. Lancet Diabetes Endocrinol 2023; 8587(23): 00316-9.
[http://dx.doi.org/10.1016/S2213-8587(23)00316-9]
[99]
Leiter LA, Banach M, Catapano AL, et al. Bempedoic acid in patients with type 2 diabetes mellitus, prediabetes, and normoglycaemia: A post hoc analysis of efficacy and glycaemic control using pooled data from phase 3 clinical trials. Diabetes Obes Metab 2022; 24(5): 868-80.
[http://dx.doi.org/10.1111/dom.14645] [PMID: 34981622]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy