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Unmet Need in
Cardiovascular Disease

Today, statin therapy remains the standard of care for elevated low-density
lipoprotein cholesterol (LDL-C) levels and reducing risk for cardiovascular
disease (CVD). However, for many patients at a high risk for a future
cardiovascular event, treatment with statins alone is inadequate for reaching
their LDL-C–lowering goals.1-4

Statins have been shown to elevate Lp(a) levels, an additional risk factor for
CVD,8-10 and are associated with an increased risk of type 2 diabetes,
especially with high-intensity statins, contributing to greater risk compared
with low- and medium-intensity statins.11

IN ONE STUDY OF

24 million

patients with atherosclerotic cardiovascular disease (ASCVD) in the United States, only 12% achieved their LDL-C goals, despite more than half of the patients taking a moderate- or high-intensity statin.2

UP TO

30%

of patients are also either statin intolerant or partially statin intolerant, contributing to lack of persistence and poor adherence.5-7

A close-up of blood cellsA close-up of blood cells
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Limitations of Nonstatin LLTs

Nonstatin lipid-lowering therapies (LLTs) are recommended as add-ons to statin therapy in
patients not meeting their lipid-lowering goals. However, these therapies have their own
limitations, including efficacy, safety, and tolerability issues, as well as dosing and
administration challenges.12-21

Due to these shortcomings, an unmet need exists for novel, oral LLTs that can help
patients achieve their LDL-C goals, while also addressing other risk factors.22

LEARN ABOUT CETP AND
CARDIOVASCULAR DISEASE

1. Lloyd-Jones DM, Morris PB, Ballantyne CM; Writing Committee, et al. 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022;80(14):1366-1418. doi:10.1016/j.jacc.2022.07.006 2. Gu J, Sanchez R, Chauhan A, Fazio S, Wong N. Lipid treatment status and goal attainment among patients with atherosclerotic cardiovascular disease in the United States: a 2019 update. Am J Prev Cardiol. 2022;10:100336. doi:10.1016/j.ajpc.2022 3. ASCVD patients face barriers reaching guideline-recommended cholesterol goals. News release. American College of Cardiology; November 13, 2019. Accessed March 5, 2024. https://www.acc.org/about-acc/press-releases/2019/11/13/15/38/ascvd-patients-face-barriers-reaching-guideline-recommended-cholesterol-goals 4. Ray KK, Molemans B, Schoonen WM, et al. EU-wide cross-sectional observational study of lipid-modifying therapy use in secondary and primary care: the DA VINCI study. Eur J Prev Cardiol. 2021;28(11):1279-1289. doi:10.1093/eurjpc/zwaa047 5. Cheeley MK, Saseen JJ, Agarwala A, et al. NLA scientific statement on statin intolerance: a new definition and key considerations for ASCVD risk reduction in the statin intolerant patient. J Clin Lipidol. 2022;16(4):361-375. doi:10.1016/j.jacl.2022.05.068 6. Toth PP, Patti AM, Giglio RV, et al. Management of statin intolerance in 2018: still more questions than answers. Am J Cardiovasc Drugs. 2018;18(3):157-173. doi:10.1007/s40256-017-0259-7 7. Bytyçi I, Penson PE, Mikhailidis DP, et al. Prevalence of statin intolerance: a meta-analysis. Eur Heart J. 2022;43(34):3213-3223. doi:10.1093/eurheartj/ehac015 8. Lampsas S, Xenou M, Oikonomou E, et al. Lipoprotein(a) in atherosclerotic diseases: from pathophysiology to diagnosis and treatment. Molecules. 2023;28(3):969. doi:10.3390/molecules28030969 9. Tsimikas S, Gordts PLSM, Nora C, Yeang C, Witztum JL. Statin therapy increases lipoprotein(a) levels. Eur Heart J. 2020;41(24):2275-2284. doi:10.1093/eurheartj/ehz310 10. Wang L, Liu L, Zhao Y, Chu M, Teng J. Lipoprotein(a) and residual vascular risk in statin-treated patients with first acute ischemic stroke: a prospective cohort study. Front Neurol. 2022;13:1004264. doi:10.3389/fneur.2022.1004264 11. Laakso M, Silva LF. Statins and risk of type 2 diabetes: mechanism and clinical implications. Front Endocrinol (Lausanne). 2023;14:1239335. doi:10.3389/fendo.2023.1239335 12. Lloyd-Jones DM, Morris PB, Ballantyne CM; Writing Committee, et al. 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022;80(14):1366-1418. doi:10.1016/j.jacc.2022.07.006 13. Gagné C, Bays HE, Weiss SR, et al. Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia. Am J Cardiol. 2002;90(10):1084-1091. doi:10.1016/s0002-9149(02)02774-1 14. 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: the CLEAR Wisdom randomized clinical trial. JAMA. 2019;322(18):1780-1788. doi:10.1001/jama.2019.16585 15. Jacomelli I, Monzo L, Panattoni G, Lanzillo C, Rebecchi M, Calò L. Bempedoic acid: what prospective uses? Eur Heart J Suppl. 2023;25(suppl C):C109-C111. doi:10.1093/eurheartjsupp/suad012 16. Blom DJ, Hala T, Bolognese M; DESCARTES Investigators, et al. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014;370(19):1809-1819. doi:10.1056/NEJMoa1316222 17. 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;169(6):906-915.e13. doi:10.1016/j.ahj.2015.03.004 18. Ray KK, Wright RS, Kallend D; ORION-10 and ORION-11 Investigators, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 19. Hao Q, Aertgeerts B, Guyatt G, et al. PCSK9 inhibitors and ezetimibe for the reduction of cardiovascular events: a clinical practice guideline with risk-stratified recommendations. BMJ. 2022;377:e069066. doi:10.1136/bmj-2021-069066 20. Chiou TT, Tomasi K, Taub PR, Wilkinson MJ. Inclisiran creates unique opportunities and challenges for patient access to therapy: early experience in a United States lipid clinic. J Clin Lipidol. 2023;17(1):73-77. doi:10.1016/j.jacl.2022.10.009 21. Annemans L, Stock JK, Chapman MJ. PCSK9 inhibition, atherosclerotic cardiovascular disease, and health economics: challenges at the crossroads. J Clin Lipidol. 2019;13(5):714-720. doi:10.1016/j.jacl.2019.07.005 22. Kosmas CE, Sourlas A, Silverio D, Montan PD, Guzman E. Novel lipid-modifying therapies addressing unmet needs in cardiovascular disease. World J Cardiol. 2019;11(11):256-265. doi:10.4330/wjc.v11.i11.256