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Achieving Risk-Specific Absolute LDL-C Threshold with PCSK9 Inhibitors: A Real-World, Single-Center Analysis Cover

Achieving Risk-Specific Absolute LDL-C Threshold with PCSK9 Inhibitors: A Real-World, Single-Center Analysis

Romanian Journal of Internal Medicine
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Open Access
|Oct 2026
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References

  1. BLUMENTHAL RS., MORRIS PB., GAUDINO M., JOHNSON HM., ANDERSON TS., BITTNER VA., et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2026;87(19):2624–757.
    Search in Google ScholarBack to article
  2. World Health Organization. Cardiovascular diseases (CVDs) [Internet]. Geneva: World Health Organization; [cited 2026 Jul 27]. Available from: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
    Search in Google ScholarBack to article
  3. BALLENA-CAICEDO J., ZUZUNAGA-MONTOYA FE., LOAYZA-CASTRO JA., VÁSQUEZ-ROMERO LEM., TAPIA-LIMONCHI R., DE CARRILLO CIG., et al. Global prevalence of dyslipidemias in the general adult population: a systematic review and meta-analysis. J Health Popul Nutr. 2025;44(1):308.
    Search in Google ScholarBack to article
  4. DU H., SHI Q., SONG P., PAN XF., YANG X., CHEN L., et al. Global Burden Attributable to High Low-Density Lipoprotein-Cholesterol From 1990 to 2019. Front Cardiovasc Med. 2022;9:903126.
    Search in Google ScholarBack to article
  5. XU Z., YANG H., WANG Q., CHEN H., MA C., GAO Y., et al. Global, regional, and national high LDL-cholesterol-related disease burden: an updated analysis of the global burden of disease study 2021. Nutr Metab Cardiovasc Dis. 2026:104861.
    Search in Google ScholarBack to article
  6. ANDERSSON NW., CORN G., DOHLMANN TL., MELBYE M., WOHLFAHRT J., LUND M. LDL-C Reduction With Lipid-Lowering Therapy for Primary Prevention of Major Vascular Events Among Older Individuals. J Am Coll Cardiol. 2023;82(14):1381–91.
    Search in Google ScholarBack to article
  7. MACH F., KOSKINAS KC., ROETERS VAN LENNEP JE., TOKGÖZOĞLU L., BADIMON L., BAIGENT C., et al. 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias. Atherosclerosis. 2025;409:120479.
    Search in Google ScholarBack to article
  8. ABDULJABBAR MH. PCSK9 Inhibitors: Focus on Evolocumab and Its Impact on Atherosclerosis Progression. Pharmaceuticals (Basel). 2024;17(12):1581.
    Search in Google ScholarBack to article
  9. MHAIMEED O., BURNEY ZA., SCHOTT SL., KOHLI P., MARVEL FA., MARTIN SS. The importance of LDL-C lowering in atherosclerotic cardiovascular disease prevention: Lower for longer is better. Am J Prev Cardiol. 2024;18:100649.
    Search in Google ScholarBack to article
  10. DI GIROLAMO FG., PELLIN L., RONI C., BIOLO G., SINAGRA G., FABRIS E. Optimizing PCSK9 inhibitor therapy: Understanding and managing suboptimal LDL-C response in clinical practice. Eur J Intern Med. 2025;140:106442.
    Search in Google ScholarBack to article
  11. SCHWARTZ GG., STEG PG., SZAREK M., BHATT DL., BITTNER VA., DIAZ R., et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018;379(22):2097–107.
    Search in Google ScholarBack to article
  12. GUIDOTTI G., LIBERATI V., SORRENTINO A., LOTTI E., CRUDELE F., ROGOLINO A., et al. Monoclonal Anti-PCSK9 Antibodies: Real-World Data. J Clin Med. 2024;13(15):4543.
    Search in Google ScholarBack to article
  13. MCCLINTICK DJ., O’DONOGHUE ML., DE FERRARI GM., FERREIRA J., RAN X., IM K., et al. Long-Term Efficacy of Evolocumab in Patients With or Without Multivessel Coronary Disease. J Am Coll Cardiol. 2024;83(6):652–64.
    Search in Google ScholarBack to article
  14. MACHANAHALLI BALAKRISHNA A., KAUSHIK S., TANDALAM PALANIVELU S., MONTHER N., PONAMGI SP., ALLA VM., et al. Safety and Efficacy of Achieving Very Low LDL Cholesterol Concentrations with PCSK9 Inhibitors. J Clin Med. 2025;14(13):4562.
    Search in Google ScholarBack to article
  15. WRIGHT RS., RAY KK., LANDMESSER U., KOENIG W., RAAL FJ., LEITER LA., et al. Effects of Inclisiran in Patients With Atherosclerotic Cardiovascular Disease: A Pooled Analysis of the ORION-10 and ORION-11 Randomized Trials. Mayo Clin Proc. 2024;99(8):1222–35.
    Search in Google ScholarBack to article
  16. RAY KK., TROQUAY RPT., VISSEREN FLJ., LEITER LA., WRIGHT RS., VIKARUNNESSA S., 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.
    Search in Google ScholarBack to article
  17. MALIHA M., SATISH V., KUMAR SS., CHI KY., SHAMA N., KHARAWALA A., et al. The Safety Profile of Inclisiran in Patients with Dyslipidemia: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2025;13(2):141.
    Search in Google ScholarBack to article
  18. KAFOL J., FRAS Z., NOVAKOVIC M., SPERLING LS., CEVC M., KREVEL B., et al. Real-world effectiveness and cardiovascular outcomes of PCSK9 inhibitor therapy: a prospective registry study. Lipids Health Dis. 2026;25:106.
    Search in Google ScholarBack to article
  19. GHASEMPOUR G., ZAMANI-GARMSIRI F., SHAIKHNIA F., SOLEIMANI AA., HOSSEINI FARD SR., LEILA J., et al. Efficacy and Safety of Alirocumab and Evolocumab as Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitors in Familial Hypercholesterolemia: A Systematic Review and Meta-Analysis. Curr Med Chem. 2024;31(2):223–41.
    Search in Google ScholarBack to article
  20. CAMPUZANO R., MOSTAZA JM., BARRIOS V., EGOCHEAGA-CABELLO I., GÓMEZ-CEREZO JF., PALLARÉS-CARRATALÁ V., et al. Assessing LDL-C Levels and Lipid-Modifying Therapies in a Real-World Cohort of Patients with Atherosclerotic Cardiovascular Disease: The REALITY Study. J Clin Med. 2025;14(7):2340.
    Search in Google ScholarBack to article
  21. LIBERATI V., GUIDOTTI G., SORRENTINO A., SLANZI M., LOTTI E., CRUDELE F., et al. PCSK9-Targeting Drugs and Gender: Are There Any Differences? J Clin Med. 2025;14(13):4469.
    Search in Google ScholarBack to article
  22. ALAÍZ ÁR., GUDINO LC., DE LA ISLA LP., PARDO HG., CALLE DG., MIRAMONTES-GONZÁLEZ JP. Inclisiran: Efficacy in Real World—Systematic Review and Meta-Analysis. J Clin Med. 2025;14(12):4163.
    Search in Google ScholarBack to article
  23. VRABLIK M., SEIFERT B., PARKHOMENKO A., BANACH M., JÓŹWIAK JJ., KISS RG., et al. Lipid-lowering therapy use in primary and secondary care in Central and Eastern Europe: DA VINCI observational study. Atherosclerosis. 2021;334:66–75.
    Search in Google ScholarBack to article
  24. D’ANDREA D., CAPONE V., BELLIS A., CASTALDO R., FRANZESE M., CARPINELLA G., et al. PCSK9 Inhibitors “Fast Track” Use Versus “Stepwise” Lipid-Lowering Therapy in Patients with Acute Coronary Syndrome: A Retrospective Single-Center Study in a “Real-World” Population. J Clin Med. 2025;14(9):2992.
    Search in Google ScholarBack to article
  25. LEHRKE M., VOGT A., SCHETTLER V., GIRNDT M., FRAASS U., TABBERT-ZITZLER A., et al. Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice: The HEYMANS Study. Adv Ther. 2024;41(3):1184–200.
    Search in Google ScholarBack to article
  26. MACH F., BAIGENT C., CATAPANO AL., KOSKINAS KC., CASULA M., BADIMON L., et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk: The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J. 2020;41(1):111–88.
    Search in Google ScholarBack to article
  27. American Diabetes Association. Standards of Medical Care in Diabetes-2020 Abridged for Primary Care Providers. Clin Diabetes. 2020;38(1):10–38.
    Search in Google ScholarBack to article
  28. BONAITI F., CASULA M., OLMASTRONI E., AVERNA M., ARCA M., CATAPANO AL. Diagnosis Of Familial Hypercholesterolemia In The Clinical Practice: Performance Of Dutch Lipid Clinic Network Score. Atherosclerosis. 2019;287:e69.
    Search in Google ScholarBack to article
  29. SAMPSON M., WOLSKA A., COLE J., ZUBIRÁN R., OTVOS JD., MEEUSEN JW., et al. Accuracy and Clinical Impact of Estimating Low-Density Lipoprotein-Cholesterol at High and Low Levels by Different Equations. Biomedicines. 2022;10(12):3156.
    Search in Google ScholarBack to article
  30. BANACH M. Statin Intolerance—We Know Everything, We Know Nothing. J Clin Med. 2022;11(17):5250.
    Search in Google ScholarBack to article
  31. VISSEREN FLJ., MACH F., SMULDERS YM., CARBALLO D., KOSKINAS KC., BÄCK M., et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021;42(34):3227–337.
    Search in Google ScholarBack to article
  32. SABATINE MS., GIUGLIANO RP., KEECH AC., HONARPOUR N., WIVIOTT SD., MURPHY SA., et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017;376(18):1713–22.
    Search in Google ScholarBack to article
  33. TSE HF., CHANG HY., COLQUHOUN D., KIM JS., POH KK., KOSTNER K., et al. Asia–Pacific Real-World Evolocumab Use, LDL-C Reduction, Physician Goals, and Patient Perceptions: HALES Observational Study. Cardiol Ther. 2024;13(4):737–60.
    Search in Google ScholarBack to article
  34. ORMAN Z., KOH JW., TRIN C., ADEMI Z., ZOMER E., GREEN S., et al. Discontinuation of lipid-modifying agents and failure to achieve target LDL cholesterol levels across cardiovascular risk groups. J Clin Lipidol. 2025;19(4):835–43.
    Search in Google ScholarBack to article
  35. MAKHMUDOVA U., SCHATZ U., PERAKAKIS N., KASSNER U., SCHUMANN F., AXTHELM C., et al. High interindividual variability in LDL-cholesterol reductions after inclisiran administration in a real-world multicenter setting in Germany. Clin Res Cardiol. 2023;112(11):1639–49.
    Search in Google ScholarBack to article
  36. KASTELEIN JJP., KEREIAKES DJ., CANNON CP., BAYS HE., MININI P., LEE LV., et al. Effect of alirocumab dose increase on LDL lowering and lipid goal attainment in patients with dyslipidemia. Coron Artery Dis. 2017;28(3):190–7.
    Search in Google ScholarBack to article
  37. ROBINSON JG., FARNIER M., KASTELEIN JJP., ROTH EM., TASKINEN MR., COLHOUN HM., et al. Relationship between alirocumab, PCSK9, and LDL-C levels in four phase 3 ODYSSEY trials using 75 and 150 mg doses. J Clin Lipidol. 2019;13(6):979–88.e10.
    Search in Google ScholarBack to article
  38. ELIS A., MELZER COHEN C., CHODICK G. Real-World Use of Alirocumab: Experience from a Large Healthcare Provider. J Clin Med. 2023;12(3):1084.
    Search in Google ScholarBack to article
  39. CALAPAI F., MANNUCCI C., CURRÒ M., CARDIA L., ESPOSITO E., CALAPAI G., et al. Adverse Reactions to Evolocumab: Analysis of Real-World Data from EudraVigilance. Pharmaceuticals (Basel). 2024;17(3):364.
    Search in Google ScholarBack to article
  40. GONZÁLEZ-LLEÓ AM., SÁNCHEZ-HERNÁNDEZ RM., PLANA N., IBARRETXE D., REHUES P., RIBALTA J., et al. Impact of PCSK9 inhibitors in glycaemic control and new-onset diabetes. Cardiovasc Diabetol. 2024;23(1):4.
    Search in Google ScholarBack to article
  41. GOODMAN SG., STEG PG., POULOUIN Y., BHATT DL., BITTNER VA., DIAZ R., et al. Long-Term Efficacy, Safety, and Tolerability of Alirocumab in 8242 Patients Eligible for 3 to 5 Years of Placebo-Controlled Observation in the ODYSSEY OUTCOMES Trial. J Am Heart Assoc. 2023;12(18):e029216.
    Search in Google ScholarBack to article
  42. LIN JL., HSU C., LO SW., NIGAM N., SHENOI M., TU YF., et al. Lower Risk of Type 2 Diabetes Mellitus With PCSK9 Inhibitors Compared With Other Lipid-Lowering Agents Among Patients With Hyperlipidaemia. Diabetes Metab Res Rev. 2026;42(5):e70188.
    Search in Google ScholarBack to article
  43. GAUDET D., LÓPEZ-SENDÓN JL., AVERNA M., BIGOT G., BANACH M., LETIERCE A., et al. Safety and efficacy of alirocumab in a real-life setting: the ODYSSEY APPRISE study. Eur J Prev Cardiol. 2021;28(17):1864–72.
    Search in Google ScholarBack to article
  44. LEITER LA., HEGELE RA., BROWN V., BERGERON J., MACKINNON ES., MANCINI GBJ. Review of Evolocumab for the Reduction of LDL Cholesterol and Secondary Prevention of Atherosclerotic Cardiovascular Disease. Rev Cardiovasc Med. 2024;25(5):190.
    Search in Google ScholarBack to article
DOI: https://doi.org/10.2478/rjim-2026-0025 | Journal eISSN: 2501-062X (formerly 1220-4749) | Journal ISSN: 1220-4749
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Language: English, Romanian
Submitted on: Sep 4, 2026
Published on: Oct 26, 2026
Published by: N.G. Lupu Internal Medicine Foundation
In partnership with: Paradigm Publishing Services
Keywords:
Hypercholesterolemia,
PCSK9 Inhibitors,
Cholesterol,
LDL,
Cardiovascular Diseases,
Treatment Outcome
Related subjects:
Medicine,
Clinical medicine,
Internal medicine,
Internal medicine, other,
Cardiology,
Gastroenterology,
Rheumatology

© 2026 Dana Mihaela Ciobanu, Antonia Berchișan, Cosmina Mălan, Adriana Rusu, Anca-Elena Crăciun, Georgeta Inceu, Diana-Maria Tholvay, Cornelia Bala, published by N.G. Lupu Internal Medicine Foundation
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

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