ABC | Volume 111, Nº1, July 2018

Viewpoint Behr et al PCSK9 in patients at cardiovascular risk Arq Bras Cardiol. 2018; 111(1):104-108 1. Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004; 364(9438):937-52. 2. Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017;38(32):2459-72. 3. Khera AV, Won HH, Peloso GM, Lawson KS, BartzTM,Deng X, et al.Diagnostic Yield and Clinical Utility of Sequencing Familial HypercholesterolemiaGenes inPatientsWithSevereHypercholesterolemia. J Am Coll Cardiol.2016;67(22):2578-89. 4. Ridker PM, Mora S, Rose L; JUPITER Trial Study Group. Percent reduction in LDL cholesterol following high-intensity statin therapy: potential implications for guidelines and for the prescription of emerging lipid- lowering agents. Eur Heart J.2016;37(17):1373-9. 5. Kathiresan S. Developing medicines that mimic the natural successes of the humangenome: lessons fromNPC1L1,HMGCR,PCSK9,APOC3,andCETP. J Am Coll Cardiol. 2015;65(15):1562-6. 6. Urban D, Pöss J, Böhm M, Laufs U. Targeting the proprotein convertase subtilisin/kexin type 9 for the treatment of dyslipidemia and atherosclerosis. J Am Coll Cardiol.2013;62(16):1401-8. 7. Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, et al.ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015;36(43):2996-3003. 8. Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L, et al. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled Trial. Lancet. 2015;385(9965):331–40. 9. Sabatine MS, Giugliano RP, Keech AC,Honarpour N, Wiviott SD, Murohy AS, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376(18):1713–22. 10. GiuglianoRP.MachF,ZavitzK,KurtzC,ImH,KanevskyEetal.CognitiveFunction inaRandomizedTrialofEvolocumab.NEnglJMed.2017;377(7):633-43. 11. Ridker PM, Revkin J, Amerenco P, Brunell R, Curto M, Civeira F, et al. Cardiovascular efficacy and safety of bococizumab in high-risk patients. N Engl J Med. 2017;376(16):1527–39. 12. Schwartz GG, Szarek M, Bhatt DL, Bittner V, Diaz R, Steg G, et al. “The ODYSSEY OUTCOMES Trial: Topline results Alirocumab in patients after acute coronary syndrome”. In: 67th Scientific Session of American College Cardiology; 2018 March 10. Orlando(Flórida);2018. [Cited in 2018 April 10]. Available from :https://clinicaltrials.gov/ct2/show/NCT01663402?con d=NCT01663402&rank=1. 13. Faludi AA, Izar MCO, Saraiva JFK, Chacra APM, Bianco HT, Afiune Neto A et al. Atualização da Diretriz Brasileira de Dislipidemias e Prevenção da Aterosclerose – 2017. Arq Bras Cardiol 2017; 109(2Supl.1):1-76. 14. Lloyd-DM,Morris PB, Ballantyne CM, Birtcher KK, Daly DD, DePalma SM, et al. 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 Clinical Expert Consensus. J Am Coll Cardiol. 2016;68(1):92–125. 15. Cook RJ, SackettDL.The number needed to treat: a clinically useful measure of treatment effect. BMJ.1995;310(6977):452-4. 16. Robinson JG, Huijgen R, Ray K, Persons J, Kastelein JJ, Pencina MJ. Determining when to add nonstatin therapy: a quantitative approach. J Am Coll Cardiol.2016;68(22):2412-21. 17. LaufsU,DescampsOS,CatapanoAL,PackardCJ.Understanding IMPROVE- IT and the cardinal role of LDL-C lowering in CVD prevention. Eur Heart J. 2014;35:1996-2000. 18. Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, 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; 376(9753):1670-81. 19. Van der Leeuw J, Oemrawsingh RM, van der Graaf Y, BrugtsJJ, Deckers JW, et al. Prediction of absolute risk reduction of cardiovascular events with perindopril for individual patients with stable coronary artery disease — Results from EUROPA. Int J Cardiol. 2015;182:194-9. 20. Steel N.Thresholds for taking antihypertensive drugs in different professional and lay groups: questionnaire survey. BMJ. 2000;320(7247):1446–7. References Conclusion This position statement of the Atherosclerosis Department of the Rio Grande do Sul Society of Cardiology identifies patients who can derive the greatest secondary clinical benefit from PCSK9 inhibition. Those patients have higher CV risk associated with the highest probability of achieving a significant LDL-C reduction. In addition, this document takes into account the financial limitations of the healthcare system and the current economic scenario. It is worth emphasizing that the use of antibodies against PCSK9 for individuals who do not meet the criteria presented in this document is not contraindicated, because the therapeutic decision involves clinical judgement and consensus between physicians and patients. Author contributions Conception and design of the research, Acquisition of data, Analysis and interpretation of the data, Writing of the manuscript and Critical revision of the manuscript for intellectual content: Behr PEB, Moriguchi EH, Castro I, Bodanese LC, Dutra OP, Leães PE, Pimentel Filho P. Potential Conflict of Interest Paulo Eduardo Ballvé Behr, MD, received lecture fees in continuing medical education programs from Amgen. EmilioHideyuki Moriguchi received lecture fees in continuing medical education programs from Amgen and Sanofi. Luiz Carlos Bodanese, MD, participated as an investigator for the Odyssey and Rourier studies. Oscar Pereira Dutra, MD, participated as an investigator for the Rourier study. Paulo Ernesto Leães, MD, participated as an investigator for the Odyssey and Rourier studies. Pedro Pimentel Filho, MD, participated as an investigator for the Odyssey and Rourier studies. Sources of Funding There were no external funding sources for this study. Study Association This study is not associatedwith any thesis or dissertationwork. 107

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