PCSK9 inhibitors and cardiovascular outcomes

References

• GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980–2016: a systematic analysis for the global burden of disease study 2016. Lancet. 2017 Sep 16;390(10100):1151–1210. PubMed PMID: 28919116; PubMed Central PMCID: PMCPMC5605883. eng.
   PubMed Web of Science ®Google Scholar
• Herrington W, Lacey B, Sherliker P, et al. Epidemiology of atherosclerosis and the potential to reduce the global burden of atherothrombotic disease. Circ Res. 2016 Feb 19;118(4):535–546. . PubMed PMID: 26892956; eng.
   PubMed Web of Science ®Google Scholar
• Lewington S, Whitlock G, Clarke R, et al. Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths. Lancet. 2007 Dec 1;370(9602):1829–1839. PubMed PMID: 18061058; eng.
   PubMed Web of Science ®Google Scholar
• Baigent C, Blackwell L, Emberson J, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670–1681. . PubMed PMID: 21067804; PubMed Central PMCID: PMCPMC2988224. eng.
   PubMed Web of Science ®Google Scholar
• Last AR, Ference JD, Menzel ER. Hyperlipidemia: drugs for cardiovascular risk reduction in adults. Am Fam Physician. 2017 Jan 15;95(2):78–87. PubMed PMID: 28084704.
   PubMed Web of Science ®Google Scholar
• Collins R, Reith C, Emberson J, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet. 2016;388(10059):2532–2561.
   PubMed Web of Science ®Google Scholar
• AL C, Graham I, De BG, et al. 2016 ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J. 2016 Oct 14;37(39):2999–3058. PubMed PMID: 27567407.
   PubMed Web of Science ®Google Scholar
• Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American college of cardiology/American heart association task force on practice guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1–45. PubMed PMID: 24222016.
   PubMed Web of Science ®Google Scholar
• Taylor F, Huffman MD, Macedo AF, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013 Jan 31;1:CD004816. DOI:10.1002/14651858.CD004816.pub5. PubMed PMID: 23440795.
   PubMed Web of Science ®Google Scholar
• Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2017 focused update of the 2016 ACC expert consensus decision pathway on the role of non-statin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American college of cardiology task force on expert consensus decision pathways. J Am Coll Cardiol. 2017 Oct 3;70(14):1785–1822. PubMed PMID: 28886926.
   PubMed Web of Science ®Google Scholar
• Stefanutti C, Julius U, Watts GF, et al. Toward an international consensus-Integrating lipoprotein apheresis and new lipid-lowering drugs. J Clin Lipidol. 2017 Jul - Aug;11(4):858–871 e3. . PubMed PMID: 28572002.
   PubMed Web of Science ®Google Scholar
• Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015 Jun 18;372(25):2387–2397. PubMed PMID: 26039521.
   PubMed Web of Science ®Google Scholar
• Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017 May 4;376(18):1713–1722. PubMed PMID: 28304224.
   PubMed Web of Science ®Google Scholar
• Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018 Nov 29;379(22):2097–2107. . PubMed PMID: 30403574; eng.
   PubMed Web of Science ®Google Scholar
• Chaudhary R, Garg J, Shah N, et al. PCSK9 inhibitors: A new era of lipid lowering therapy. World J Cardiol. 2017 Feb 26;9(2):76–91. . PubMed PMID: 28289523; PubMed Central PMCID: PMCPMC5329749.
   PubMed Web of Science ®Google Scholar
• Cohen JC, Boerwinkle E, Mosley TH Jr. et al. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006 Mar 23;354(12):1264–1272. . PubMed PMID: 16554528; eng.
   PubMed Web of Science ®Google Scholar
• DL D, Trankle C, Buckley L, et al. A review of PCSK9 inhibition and its effects beyond LDL receptors. J Clin Lipidol. 2016 Sep-Oct;10(5):1073–1080. PubMed PMID: 27678423.
   PubMed Web of Science ®Google Scholar
• Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol. N Engl J Med. 2017 Apr 13;376(15):1430–1440. PubMed PMID: 28306389; eng.
   PubMed Web of Science ®Google Scholar
• Alirocumab (Praluent) summary of product characteristics: Sanofi-Aventis Groupe. 2015. [ cited 2019 June 6]. Available from: http://www.ema.europa.eu
   Google Scholar
• Evolocumab (Repatha) summary of product characteristics: Amgen Europe B.V. 2015. [ cited 2019 June 6]. Available from: http://www.ema.europa,eu
   Google Scholar
• Toth PP, Worthy G, SR G, et al. Systematic review and network meta-analysis on the efficacy of evolocumab and other therapies for the management of lipid levels in hyperlipidemia. J Am Heart Assoc. 2017 Oct 2;6(10). PubMed PMID: 28971955; PubMed Central PMCID: PMCPMC5721820.
   Web of Science ®Google Scholar
• Ferri N, Corsini A, Sirtori CR, et al. Bococizumab for the treatment of hypercholesterolaemia. Expert Opin Biol Ther. 2017 Feb;17(2):237–243. PubMed PMID: 28060539.
   PubMed Web of Science ®Google Scholar
• Patel RS, Scopelliti EM, Olugbile O. The role of PCSK9 inhibitors in the treatment of hypercholesterolemia. Ann Pharmacother. 2018 Apr 1:1060028018771670 PubMed PMID: 29667842. DOI:10.1177/1060028018771670.
   Web of Science ®Google Scholar
• Colletti A, Derosa G, Cicero AF. Retargeting the management of hypercholesterolemia - focus on evolocumab. Ther Clin Risk Manag. 2016;12:1365–1376. PubMed PMID: 27660454; PubMed Central PMCID: PMCPMC5019477.
   PubMed Web of Science ®Google Scholar
• Blom DJ, Dent R, Castro RC, et al. PCSK9 inhibition in the management of hyperlipidemia: focus on evolocumab. Vasc Health Risk Manag. 2016;12:185–197. PubMed PMID: 27274264; PubMed Central PMCID: PMCPMC4868869.
   PubMed Web of Science ®Google Scholar
• Blom DJ, Hala T, Bolognese M, et al. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014 May 8;370(19):1809–1819. PubMed PMID: 24678979.
   PubMed Web of Science ®Google Scholar
• Sattar N, Preiss D, Robinson JG, et al. Lipid-lowering efficacy of the PCSK9 inhibitor evolocumab (AMG 145) in patients with type 2 diabetes: a meta-analysis of individual patient data. Lancet Diabetes Endocrinol. 2016 May;4(5):403–410. PubMed PMID: 26868195.
   PubMed Web of Science ®Google Scholar
• Sabatine MS, Giugliano RP, Wiviott SD, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500–1509. PubMed PMID: 25773607.
   PubMed Web of Science ®Google Scholar
• Giugliano RP, Mach F, Zavitz K, et al. Cognitive function in a randomized trial of evolocumab. N Engl J Med. 2017 Aug 17;377(7):633–643. . PubMed PMID: 28813214.
   PubMed Web of Science ®Google Scholar
• Sattar N, Toth PP, Blom DJ, et al. Effect of the proprotein convertase subtilisin/kexin type 9 inhibitor evolocumab on glycemia, body weight, and new-onset diabetes mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521–1527. PubMed PMID: 28844508; eng.
   PubMed Web of Science ®Google Scholar
• Descamps OS, Fraass U, Dent R, et al. Anti-PCSK9 antibodies for hypercholesterolaemia: overview of clinical data and implications for primary care. Int J Clin Pract. 2017 Aug;71(8). DOI:10.1111/ijcp.12979. PubMed PMID: 28750477; PubMed Central PMCID: PMCPMC5601297.
   PubMed Web of Science ®Google Scholar
• Catapano AL, Pirillo A, Norata GD. Anti-PCSK9 antibodies for the treatment of heterozygous familial hypercholesterolemia: patient selection and perspectives. Vasc Health Risk Manag. 2017;13:343–351. PubMed PMID: 28919772; PubMed Central PMCID: PMCPMC5590683.
   PubMed Web of Science ®Google Scholar
• Moriarty PM, Thompson PD, Cannon CP, et al. Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: the ODYSSEY ALTERNATIVE randomized trial. J Clin Lipidol. 2015 Nov-Dec;9(6):758–769. PubMed PMID: 26687696.
   PubMed Web of Science ®Google Scholar
• Roth EM, Moriarty PM, Bergeron J, et al. A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I. Atherosclerosis. 2016 Nov;254:254–262. . PubMed PMID: 27639753.
   PubMed Web of Science ®Google Scholar
• Stroes E, Guyton JR, Lepor N, et al. Efficacy and safety of alirocumab 150 mg every 4 weeks in patients with hypercholesterolemia not on statin therapy: the ODYSSEY CHOICE II study. J Am Heart Assoc. 2016 Sep 13;5(9). PubMed PMID: 27625344; PubMed Central PMCID: PMCPMC5079013.
   Web of Science ®Google Scholar
• Kereiakes DJ, Robinson JG, Cannon CP, et al. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: the ODYSSEY COMBO I study. Am Heart J. 2015 Jun;169(6):906–915 e13. PubMed PMID: 26027630.
   PubMed Web of Science ®Google Scholar
• CP C, Cariou B, Blom D, et al. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J. 2015 May 14;36(19):1186–1194. . PubMed PMID: 25687353; PubMed Central PMCID: PMCPMC4430683.
   PubMed Web of Science ®Google Scholar
• Bays H, Gaudet D, Weiss R, et al. Alirocumab as add-on to atorvastatin versus other lipid treatment strategies: ODYSSEY OPTIONS I randomized trial. J Clin Endocrinol Metab. 2015 Aug;100(8):3140–3148. 10.1210/jc.2015-1520. PubMed PMID: 26030325; PubMed Central PMCID: PMCPMC4524987.
   PubMed Web of Science ®Google Scholar
• Farnier M, Gaudet D, Valcheva V, et al. Efficacy of alirocumab in high cardiovascular risk populations with or without heterozygous familial hypercholesterolemia: pooled analysis of eight ODYSSEY Phase 3 clinical program trials. Int J Cardiol. 2016 Nov 15;223:750–757. . PubMed PMID: 27573600.
   PubMed Web of Science ®Google Scholar
• McCullough PA, Ballantyne CM, Sanganalmath SK, et al. Efficacy and safety of alirocumab in high-risk patients with clinical atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia (from 5 Placebo-Controlled ODYSSEY Trials). Am J Cardiol. 2018 Apr 15;121(8):940–948. PubMed PMID: 29472008.
   PubMed Web of Science ®Google Scholar
• Leiter LA, Cariou B, Muller-Wieland D, et al. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: the ODYSSEY DM-INSULIN randomized trial. Diabetes Obes Metab. 2017 Dec;19(12):1781–1792. PubMed PMID: 28905478; PubMed Central PMCID: PMCPMC5698740.
   PubMed Web of Science ®Google Scholar
• Leiter LA, Zamorano JL, Bujas-Bobanovic M, et al. Lipid-lowering efficacy and safety of alirocumab in patients with or without diabetes: A sub-analysis of ODYSSEY COMBO II. Diabetes Obes Metab. 2017 Jul;19(7):989–996. PubMed PMID: 28206704; PubMed Central PMCID: PMCPMC5485164.
   PubMed Web of Science ®Google Scholar
• Ray KK, Leiter LA, Muller-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 Jun;20(6):1479–1489. PubMed PMID: 29436756; PubMed Central PMCID: PMCPMC5969299.
   PubMed Web of Science ®Google Scholar
• Leiter LA, Muller-Wieland D, Baccara-Dinet MT, et al. Efficacy and safety of alirocumab in people with prediabetes vs those with normoglycaemia at baseline: a pooled analysis of 10 phase III ODYSSEY clinical trials. Diabet Med. 2018 Jan;35(1):121–130. PubMed PMID: 28799203; PubMed Central PMCID: PMCPMC5763418.
   PubMed Web of Science ®Google Scholar
• Jones PH, Bays HE, Chaudhari U, et al. Safety of alirocumab (A PCSK9 Monoclonal Antibody) from 14 randomized trials. Am J Cardiol. 2016 Dec 15;118(12):1805–1811. PubMed PMID: 27729106.
   PubMed Web of Science ®Google Scholar
• Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489–1499. PubMed PMID: 25773378.
   PubMed Web of Science ®Google Scholar
• Harvey PD, Sabbagh MN, Harrison JE, et al. No evidence of neurocognitive adverse events associated with alirocumab treatment in 3340 patients from 14 randomized Phase 2 and 3 controlled trials: a meta-analysis of individual patient data. Eur Heart J. 2018 Feb 1;39(5):374–381. PubMed PMID: 29186504; PubMed Central PMCID: PMCPMC5837381.
   PubMed Web of Science ®Google Scholar
• Colhoun HM, Ginsberg HN, Robinson JG, et al. No effect of PCSK9 inhibitor alirocumab on the incidence of diabetes in a pooled analysis from 10 ODYSSEY Phase 3 studies. Eur Heart J. 2016 Oct 14;37(39):2981–2989. PubMed PMID: 27460890; PubMed Central PMCID: PMCPMC5081037.
   PubMed Web of Science ®Google Scholar
• Ridker PM, Revkin J, Amarenco P, et al. Cardiovascular efficacy and safety of bococizumab in high-risk patients. N Engl J Med. 2017 Apr 20;376(16):1527–1539. PubMed PMID: 28304242.
   PubMed Web of Science ®Google Scholar
• 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 Jan 23;137(4):338–350. . PubMed PMID: 29133605.
   PubMed Web of Science ®Google Scholar
• 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 Dec;5(12):941–950. . PubMed PMID: 28927706; eng.
   PubMed Web of Science ®Google Scholar
• Sabatine MS, De Ferrari GM, Giugliano RP, et al. Clinical benefit of evolocumab by severity and extent of coronary artery disease: an analysis from FOURIER. Circulation. 2018 Apr 6. DOI:10.1161/circulationaha.118.034309. PubMed PMID: 29626068; eng.
   Web of Science ®Google Scholar
• Nicholls SJ, Puri R, Anderson T, et al. Effect of evolocumab on progression of coronary disease in statin-treated patients: the GLAGOV randomized clinical trial. JAMA. 2016 Dec 13;316(22):2373–2384. . PubMed PMID: 27846344.
   PubMed Web of Science ®Google Scholar
• Schmidt AF, Pearce LS, Wilkins JT, et al. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017 Apr 28;4:CD011748. . PubMed PMID: 28453187.
   PubMed Web of Science ®Google Scholar
• Zhu Y, Shen X, Jiang Q, et al. Effects of monoclonal antibodies against PCSK9 on clinical cardiovascular events: A meta-analysis of randomized controlled trials. Herz. 2017 Nov 7. DOI:10.1007/s00059-017-4640-8. PubMed PMID: 29116337.
   Web of Science ®Google Scholar
• Karatasakis A, Danek BA, Karacsonyi J, et al. Effect of PCSK9 inhibitors on clinical outcomes in patients with hypercholesterolemia: a meta-analysis of 35 randomized controlled trials. J Am Heart Assoc. 2017 Dec 9;6(12). PubMed PMID: 29223954; PubMed Central PMCID: PMCPMC5779013.
   PubMed Web of Science ®Google Scholar
• Bai J, Gong LL, Li QF, et al. Long-term efficacy and safety of proprotein convertase subtilisin/kexin 9 monoclonal antibodies: A meta-analysis of 11 randomized controlled trials. J Clin Lipidol. 2018 Mar - Apr;12(2):277–291 e3. PubMed PMID: 29428832.
   PubMed Web of Science ®Google Scholar
• Khan SU, Talluri S, Riaz H, et al. A Bayesian network meta-analysis of PCSK9 inhibitors, statins and ezetimibe with or without statins for cardiovascular outcomes. Eur J Prev Cardiol. 2018 May;25(8):844–853. PubMed PMID: 29569492.
   PubMed Web of Science ®Google Scholar
• Bajaj NS, Patel N, Kalra R, et al. Neurological effects of proprotein convertase subtilisin/kexin type 9 inhibitors: direct comparisons. Eur Heart J Qual Care Clin Outcomes. 2018 Apr 1;4(2):132–141. PubMed PMID: 29121222; PubMed Central PMCID: PMCPMC5884103.
   PubMed Web of Science ®Google Scholar
• Di Angelantonio E, Sarwar N, Perry P, et al. Major lipids, apolipoproteins, and risk of vascular disease. Jama. 2009 Nov 11;302(18):1993–2000. PubMed PMID: 19903920; PubMed Central PMCID: PMCPMC3284229. eng.
   PubMed Web of Science ®Google Scholar
• Stamler J, Wentworth D, Neaton JD. Is relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? Findings in 356,222 primary screenees of the Multiple Risk Factor Intervention Trial (MRFIT). Jama. 1986 Nov 28;256(20):2823–2828. PubMed PMID: 3773199; eng.
   PubMed Web of Science ®Google Scholar
• Soran H, Dent R, Durrington P. Evidence-based goals in LDL-C reduction. Clin Res Cardiol. 2017 Apr;106(4):237–248. doi:10.1007/s00392-016-1069-7. PubMed PMID: 28124099; PubMed Central PMCID: PMCPMC5360845. eng.
   PubMed Web of Science ®Google Scholar
• Robinson JG, Stone NJ. The 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk: a new paradigm supported by more evidence. Eur Heart J. 2015 Aug 14;36(31):2110–2118. PubMed PMID: 25994746.
   PubMed Web of Science ®Google Scholar
• Cannon CP, Steinberg BA, Murphy SA, et al. Meta-analysis of cardiovascular outcomes trials comparing intensive versus moderate statin therapy. J Am Coll Cardiol. 2006 Aug 1;48(3):438–445. PubMed PMID: 16875966; eng.
   PubMed Web of Science ®Google Scholar
• Schwartz GG, Olsson AG, Ezekowitz MD, et al. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. Jama. 2001 Apr 4;285(13):1711–1718. PubMed PMID: 11277825; eng.
   PubMed Web of Science ®Google Scholar
• Schwartz GG, Fayyad R, Szarek M, et al. Early, intensive statin treatment reduces ‘hard’ cardiovascular outcomes after acute coronary syndrome. Eur J Prev Cardiol. 2017 Aug;24(12):1294–1296. PubMed PMID: 28504565; eng.
   PubMed Web of Science ®Google Scholar
• Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495–1504. PubMed PMID: 15007110; eng.
   PubMed Web of Science ®Google Scholar
• Zhong P, Wu D, Ye X, et al. Secondary prevention of major cerebrovascular events with seven different statins: a multi-treatment meta-analysis. Drug Des Devel Ther. 2017;11:2517–2526. PubMed PMID: 28919704; PubMed Central PMCID: PMCPMC5587089. eng.
   PubMed Web of Science ®Google Scholar
• Amarenco P, Labreuche J. Lipid management in the prevention of stroke: review and updated meta-analysis of statins for stroke prevention. Lancet Neurol. 2009 May;8(5):453–463. PubMed PMID: 19375663; eng.
   PubMed Web of Science ®Google Scholar
• Amarenco P, Bogousslavsky J, Callahan A 3rd, et al. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006 Aug 10;355(6):549–559. . PubMed PMID: 16899775; eng.
   PubMed Web of Science ®Google Scholar
• Collins R, Armitage J, Parish S, et al. Effects of cholesterol-lowering with simvastatin on stroke and other major vascular events in 20536 people with cerebrovascular disease or other high-risk conditions. Lancet. 2004 Mar 6;363(9411):757–767. PubMed PMID: 15016485; eng.
   PubMed Web of Science ®Google Scholar
• Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509–1526. . PubMed PMID: 25908725.
   PubMed Web of Science ®Google Scholar
• Criqui MH, Langer RD, Fronek A, et al. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992 Feb 6;326(6):381–386. PubMed PMID: 1729621; eng.
   PubMed Web of Science ®Google Scholar
• Heart Protection Study Collaborative G. Randomized trial of the effects of cholesterol-lowering with simvastatin on peripheral vascular and other major vascular outcomes in 20,536 people with peripheral arterial disease and other high-risk conditions. J Vasc Surg. 2007 Apr;45(4):645–654; discussion 653–4. PubMed PMID: 17398372.
   Web of Science ®Google Scholar
• Foley TR, Singh GD, Kokkinidis DG, et al. High-intensity statin therapy is associated with improved survival in patients with peripheral artery disease. J Am Heart Assoc. 2017 Jul 15;6(7). PubMed PMID: 28711864; PubMed Central PMCID: PMCPMC5586293.
   PubMed Web of Science ®Google Scholar
• Kearney PM, Blackwell L, Collins R, et al. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008 Jan 12;371(9607):117–125. PubMed PMID: 18191683; eng.
   PubMed Web of Science ®Google Scholar
• de Vries FM, Kolthof J, Postma MJ, et al. Efficacy of standard and intensive statin treatment for the secondary prevention of cardiovascular and cerebrovascular events in diabetes patients: a meta-analysis. PLoS One. 2014;9(11):e111247. PubMed PMID: 25372483; PubMed Central PMCID: PMCPMC4220992. eng.
   PubMed Web of Science ®Google Scholar
• Hong N, Lee YH, Tsujita K, et al. Comparison of the effects of ezetimibe-statin combination therapy on major adverse cardiovascular events in patients with and without diabetes: a meta-analysis. Endocrinol Metab (Seoul). 2018 May 4;33(2):219–227. PubMed PMID: 29766679; eng.
   Google Scholar
• Giugliano RP, Cannon CP, Blazing MA, et al. Benefit of adding ezetimibe to statin therapy on cardiovascular outcomes and safety in patients with versus without diabetes mellitus: results from IMPROVE-IT (Improved reduction of outcomes: vytorin efficacy international trial). Circulation. 2018 Apr 10;137(15):1571–1582. PubMed PMID: 29263150; eng.
   PubMed Web of Science ®Google Scholar
• Navarese EP, Robinson JG, Kowalewski M, et al. Association between baseline LDL-C level and total and cardiovascular mortality after LDL-C lowering: a systematic review and meta-analysis. Jama. 2018 Apr 17;319(15):1566–1579. PubMed PMID: 29677301; PubMed Central PMCID: PMCPMC5933331. eng.
   PubMed Web of Science ®Google Scholar
• Giraldez RR, Giugliano RP, Mohanavelu S, et al. Baseline low-density lipoprotein cholesterol is an important predictor of the benefit of intensive lipid-lowering therapy: a PROVE IT-TIMI 22 (Pravastatin or atorvastatin evaluation and infection therapy-thrombolysis in myocardial infarction 22) analysis. J Am Coll Cardiol. 2008 Sep 9;52(11):914–920. PubMed PMID: 18772061; eng.
   PubMed Web of Science ®Google Scholar
• Korman M, Wisloff T. Modelling the cost-effectiveness of PCSK9 inhibitors vs. ezetimibe through LDL-C reductions in a Norwegian setting. Eur Heart J Cardiovasc Pharmacother. 2018 Jan 1;4(1):15–22. PubMed PMID: 28444187; PubMed Central PMCID: PMCPMC5843101.
   PubMed Web of Science ®Google Scholar
• Stam-Slob MC, van der Graaf Y, de Boer A, et al. Cost-effectiveness of PCSK9 inhibition in addition to standard lipid-lowering therapy in patients at high risk for vascular disease. Int J Cardiol. 2018 Feb 15;253:148–154. PubMed PMID: 29306457; eng.
   PubMed Web of Science ®Google Scholar
• Villa G, Lothgren M, Kutikova L, et al. Cost-effectiveness of evolocumab in patients with high cardiovascular risk in Spain. Clin Ther. 2017 Apr;39(4):771–786.e3. PubMed PMID: 28366593; eng.
   PubMed Web of Science ®Google Scholar
• Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia: technology appraisal guidance: National Institute for Health and Care Excellence; 2016. [ cited 2019 June 6]. Available from: http://www.nice.org.uk/guidance/ta393
   Google Scholar
• Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia: technology apprasial guidance: National Institute for Health and Care Excellence; 2016. [ cited 2019 June 6]. Available from: http://www.nice.org.uk/guidance/ta394
   Google Scholar
• Institute for Q, Efficiency in Health C. IQWiG dossier assessment extracts. Evolocumab – benefit assessment according to section sign35a social code book V. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG)Copyright (c) 2015 by the Institute for Quality and Efficiency in Healthcare (IQWiG); 2015.
   Google Scholar
• Institute for Q, Efficiency in Health C. IQWiG dossier assessment extracts. Alirocumab – benefit assessment according to section sign35a social code book V. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG)Copyright (c) 2016 by the Institute for Quality and Efficiency in Healthcare (IQWiG); 2016.
   Google Scholar
• Institute for Q, Efficiency in Health C. IQWiG dossier assessment extracts. Alirocumab – addendum to commission A15-47. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG)Copyright (c) 2016 by the Institute for Quality and Efficiency in Healthcare (IQWiG); 2016.
   Google Scholar
• Landmesser U, Chapman MJ, Stock JK, et al. 2017 update of ESC/EAS task force on practical clinical guidance for proprotein convertase subtilisin/kexin type 9 inhibition in patients with atherosclerotic cardiovascular disease or in familial hypercholesterolaemia. Eur Heart J. 2018 Apr 7;39(14):1131–1143. . PubMed PMID: 29045644.
   PubMed Web of Science ®Google Scholar
• Grundy SM, Stone NJ, Bailey AL, et al. AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Circulation. 2018 Nov 10:Cir0000000000000625. DOI: 10.1161/cir.0000000000000625. PubMed PMID: 30586774; eng.
   Google Scholar
• Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the American college of cardiology/American heart association task force on clinical practice guidelines. J Am Coll Cardiol. 2019 Mar 17. DOI:10.1016/j.jacc.2019.03.010. [ PubMed PMID: 30894318; eng].
   Google Scholar
• Gencer B, Koskinas KC, Raber L, et al. Eligibility for PCSK9 inhibitors according to American College of Cardiology (ACC) and European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines after acute coronary syndromes. J Am Heart Assoc. 2017 Nov 9;6(11). PubMed PMID: 29122809; PubMed Central PMCID: PMCPMC5721754.
   PubMed Web of Science ®Google Scholar
• Zamora A, Masana L, Comas-Cufi M, et al. Number of patients eligible for PCSK9 inhibitors based on real-world data from 2.5 million patients. Rev Esp Cardiol (Engl Ed). 2018 Mar 29. DOI:10.1016/j.rec.2018.03.003. PubMed PMID: 29606363; eng spa.
   Web of Science ®Google Scholar
• Julius U, Tselmin S, Schatz U, et al. Lipoprotein(a) and proprotein convertase subtilisin/kexin type 9 inhibitors. Clin Res Cardiol Suppl. 2019 Apr;14(Suppl 1):45–50. 10.1007/s11789-019-00099-z. PubMed PMID: 30838555; eng.
   PubMedGoogle Scholar
• Steg PG, Szarek M, Bhatt DL, et al. Effect of alirocumab on mortality after acute coronary syndromes. Circulation. 2019;140(2):103–112.
   PubMed Web of Science ®Google Scholar