{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T18:21:24Z","timestamp":1793298084657,"version":"4.5.0"},"reference-count":30,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T00:00:00Z","timestamp":1720742400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Medicina"],"abstract":"<jats:p>Background and Objectives: Lowering low-density lipoprotein (LDL-C) levels is critical for preventing atherosclerotic cardiovascular disease, yet some patients fail to reach the LDL-C targets despite available intensive lipid-lowering therapies. This study assessed the effectiveness and safety profile of alirocumab, evolocumab, and inclisiran in lipid reduction. Materials and Methods: A cohort of 51 patients (median (Q1\u2013Q3) age: 49.0 (39.5\u201357.5) years) was analyzed. Eligibility included an LDL-C level &gt; 2.5 mmol\/L while on the maximum tolerated dose of statin and ezetimibe, a diagnosis of familial hypercholesterolemia, or a very high risk of cardiovascular diseases following myocardial infarction within 12 months prior to the study. Follow-ups and lab assessments were conducted at baseline (51 patients), 3 months (51 patients), and 15 months (26 patients) after the treatment initiation. Results: Median initial LDL-C levels 4.1 (2.9\u20135.0) mmol\/L, decreasing significantly to 1.1 (0.9\u20131.6) mmol\/L at 3 months and 1.0 (0.7\u20131.8) mmol\/L at 15 months (p &lt; 0.001). Total cholesterol also reduced significantly compared to baseline at both intervals (p &lt; 0.001). No substantial differences in LDL-C or total cholesterol levels were observed between 3- and 15-month observations (p &gt; 0.05). No statistically significant differences were noted in cholesterol reduction among the alirocumab, evolocumab, and inclisiran groups at 3 months. The safety profile was favorable, with no reported adverse cardiovascular events or significant changes in alanine transaminase, creatinine, or creatine kinase levels. Conclusions: Alirocumab, evolocumab, and inclisiran notably decreased LDL-C and total cholesterol levels without significant adverse effects, underscoring their potential as effective treatments in patients who do not achieve lipid targets with conventional therapies.<\/jats:p>","DOI":"10.3390\/medicina60071124","type":"journal-article","created":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T08:47:41Z","timestamp":1720774061000},"page":"1124","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Efficacy of Alirocumab, Evolocumab, and Inclisiran in Patients with Hypercholesterolemia at Increased Cardiovascular Risk"],"prefix":"10.3390","volume":"60","author":[{"given":"Renata","family":"Rajtar-Salwa","sequence":"first","affiliation":[{"name":"Clinical Department of Cardiology and Cardiovascular Interventions, University Hospital, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beata","family":"Bobrowska","sequence":"additional","affiliation":[{"name":"Clinical Department of Cardiology and Cardiovascular Interventions, University Hospital, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylwia","family":"Socha","sequence":"additional","affiliation":[{"name":"Clinical Department of Cardiology and Cardiovascular Interventions, University Hospital, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2100-5076","authenticated-orcid":false,"given":"Artur","family":"Dziewierz","sequence":"additional","affiliation":[{"name":"Clinical Department of Cardiology and Cardiovascular Interventions, University Hospital, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland"},{"name":"2nd Department of Cardiology, Jagiellonian University Medical College, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8033-3977","authenticated-orcid":false,"given":"Zbigniew","family":"Siudak","sequence":"additional","affiliation":[{"name":"Collegium Medicum, Jan Kochanowski University in Kielce, 25-369 Kielce, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5329-5856","authenticated-orcid":false,"given":"Jakub","family":"Batko","sequence":"additional","affiliation":[{"name":"Department of Anatomy, Jagiellonian University Medical College, 12 Kopernika Street, 31-034 Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4508-3551","authenticated-orcid":false,"given":"Stanis\u0142aw","family":"Bartu\u015b","sequence":"additional","affiliation":[{"name":"Clinical Department of Cardiology and Cardiovascular Interventions, University Hospital, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland"},{"name":"2nd Department of Cardiology, Jagiellonian University Medical College, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7691-8174","authenticated-orcid":false,"given":"Agata","family":"Krawczyk-O\u017c\u00f3g","sequence":"additional","affiliation":[{"name":"Clinical Department of Cardiology and Cardiovascular Interventions, University Hospital, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland"},{"name":"Department of Anatomy, Jagiellonian University Medical College, 12 Kopernika Street, 31-034 Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,7,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"74","DOI":"10.4103\/HEARTVIEWS.HEARTVIEWS_59_19","article-title":"PCSK 9 Inhibitors: A Short History and a New Era of Lipid-lowering Therapy","volume":"20","author":"Hajar","year":"2019","journal-title":"Heart Views"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Wo\u0142owiec, \u0141., Osiak, J., Wo\u0142owiec, A., Wijata, A., Grze\u015bk, E., Kozakiewicz, M., Banach, J., Nowaczyk, A., Nowaczyk, J., and Grze\u015bk, G. (2023). Inclisiran\u2014Safety and Effectiveness of Small Interfering RNA in Inhibition of PCSK-9. Pharmaceutics, 15.","DOI":"10.3390\/pharmaceutics15020323"},{"key":"ref_3","first-page":"162","article-title":"Effectiveness and safety of proprotein convertase subtilisin\/kexin type 9 inhibitors in patients with familial hypercholesterolemia. Our experience in implementing the drug program of the Polish National Health Fund","volume":"18","author":"Bobrowska","year":"2022","journal-title":"Adv. Interv. Cardiol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"387","DOI":"10.1097\/MOL.0000000000000114","article-title":"PCSK9 and LDLR degradation: Regulatory mechanisms in circulation and in cells","volume":"25","author":"Lagace","year":"2014","journal-title":"Curr. Opin. Lipidol."},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Guo, Q., Feng, X., and Zhou, Y. (2020). PCSK9 Variants in Familial Hypercholesterolemia: A Comprehensive Synopsis. Front. Genet., 11.","DOI":"10.3389\/fgene.2020.01020"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"e016461","DOI":"10.1136\/bmjopen-2017-016461","article-title":"Estimating the prevalence of heterozygous familial hypercholesterolaemia: A systematic review and meta-analysis","volume":"7","author":"Akioyamen","year":"2017","journal-title":"BMJ Open"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1093\/eurheartj\/ehz455","article-title":"2019 ESC\/EAS Guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular riskThe Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS)","volume":"41","author":"Mach","year":"2020","journal-title":"Eur. Heart J."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"558","DOI":"10.5551\/jat.CR005","article-title":"Guidelines for the Diagnosis and Treatment of Adult Familial Hypercholesterolemia 2022","volume":"30","author":"Arai","year":"2023","journal-title":"J. Atheroscler. Thromb."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"3227","DOI":"10.1093\/eurheartj\/ehab484","article-title":"2021 ESC Guidelines on cardiovascular disease prevention in clinical practice","volume":"42","author":"Visseren","year":"2021","journal-title":"Eur. Heart J."},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Rajtar-Salwa, R., Bobrowska, B., Batko, J., Bartu\u015b, S., Petkow-Dimitrow, P., and Krawczyk-O\u017c\u00f3g, A. (2023). Lipid-Lowering Therapy after Acute Coronary Syndrome in Outpatient Practice\u2014How to Achieve Goal. J. Clin. Med., 12.","DOI":"10.3390\/jcm12206579"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"2666","DOI":"10.1016\/j.ajpc.2023.100472","article-title":"The importance of low-density lipoprotein cholesterol measurement and control as performance measures: A joint clinical perspective from the National Lipid Association and the American Society for Preventive Cardiology","volume":"13","author":"Virani","year":"2023","journal-title":"Am. J. Prev. Cardiol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1006","DOI":"10.1373\/clinchem.2018.287037","article-title":"Quantifying Atherogenic Lipoproteins: Current and Future Challenges in the Era of Personalized Medicine and Very Low Concentrations of LDL Cholesterol. A Consensus Statement from EAS and EFLM","volume":"64","author":"Langlois","year":"2018","journal-title":"Clin. Chem."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"2313","DOI":"10.1093\/eurheartj\/ehz962","article-title":"Low-density lipoproteins cause atherosclerotic cardiovascular disease: Pathophysiological, genetic, and therapeutic insights: A consensus statement from the European Atherosclerosis Society Consensus Panel","volume":"41","author":"Krauss","year":"2020","journal-title":"Eur. Heart J."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1007\/s40265-021-01473-6","article-title":"Inclisiran: First Approval","volume":"81","author":"Lamb","year":"2021","journal-title":"Drugs"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1713","DOI":"10.1056\/NEJMoa1615664","article-title":"Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease","volume":"376","author":"Sabatine","year":"2017","journal-title":"N. Engl. J. Med."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1870","DOI":"10.1001\/jama.2014.4030","article-title":"Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: The LAPLACE-2 randomized clinical trial","volume":"311","author":"Robinson","year":"2014","journal-title":"JAMA"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1016\/S0140-6736(14)61399-4","article-title":"PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): A randomised, double-blind, placebo-controlled trial","volume":"385","author":"Raal","year":"2015","journal-title":"Lancet"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"2373","DOI":"10.1001\/jama.2016.16951","article-title":"Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial","volume":"316","author":"Nicholls","year":"2016","journal-title":"JAMA"},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Huang, Y.T., Ho, L.T., Hsu, H.Y., Tu, Y.K., and Chien, K.L. (2022). Efficacy and Safety of Proprotein Convertase Subtilisin\/Kexin Type 9 Inhibitors as Adjuvant Treatments for Patients with Hypercholesterolemia Treated with Statin: A Systematic Review and Network Meta-analysis. Front. Pharmacol., 13.","DOI":"10.3389\/fphar.2022.832614"},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"Imran, T.F., Khan, A.A., Has, P., Jacobson, A., Bogin, S., Khalid, M., Khan, A., Kim, S., Erqou, S., and Choudhary, G. (2023). Proprotein convertase subtilisn\/kexin type 9 inhibitors and small interfering RNA therapy for cardiovascular risk reduction: A systematic review and meta-analysis. PLoS ONE, 18.","DOI":"10.1371\/journal.pone.0295359"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"2097","DOI":"10.1056\/NEJMoa1801174","article-title":"Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome","volume":"379","author":"Schwartz","year":"2018","journal-title":"N. Engl. J. Med."},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Elis, A., Melzer Cohen, C., and Chodick, G. (2023). Real-World Use of Alirocumab: Experience from a Large Healthcare Provider. J. Clin. Med., 12.","DOI":"10.3390\/jcm12031084"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"834","DOI":"10.1253\/circj.CJ-22-0445","article-title":"Safety and Effectiveness of Alirocumab, a Proprotein Convertase Subtilisin\/Kexin Type 9 (PCSK9) Inhibitor, in Patients With Familial or Non-Familial Hypercholesterolemia\u2014A Post-Marketing Survey (J-POSSIBLE)","volume":"87","author":"Kiyosue","year":"2023","journal-title":"Circ. J."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"285","DOI":"10.5114\/aoms\/143476","article-title":"Treatment adherence and effect of concurrent statin intensity on the efficacy and safety of alirocumab in a real-life setting: Results from ODYSSEY APPRISE","volume":"18","author":"Banach","year":"2022","journal-title":"Arch. Med. Sci."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"421","DOI":"10.2147\/VHRM.S338424","article-title":"Inclisiran: A New Strategy for LDL-C Lowering and Prevention of Atherosclerotic Cardiovascular Disease","volume":"19","author":"Albosta","year":"2023","journal-title":"Vasc. Health Risk Manag."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1430","DOI":"10.1056\/NEJMoa1615758","article-title":"Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol","volume":"376","author":"Ray","year":"2017","journal-title":"N. Engl. J. Med."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1067","DOI":"10.1001\/jamacardio.2019.3502","article-title":"Effect of 1 or 2 Doses of Inclisiran on Low-Density Lipoprotein Cholesterol Levels: One-Year Follow-up of the ORION-1 Randomized Clinical Trial","volume":"4","author":"Ray","year":"2019","journal-title":"JAMA Cardiol."},{"key":"ref_28","doi-asserted-by":"crossref","unstructured":"Katsiki, N., Vrablik, M., Banach, M., and Gouni-Berthold, I. (2023). Inclisiran, Low-Density Lipoprotein Cholesterol and Lipoprotein (a). Pharmaceuticals, 16.","DOI":"10.3390\/ph16040577"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"e025551","DOI":"10.1161\/JAHA.122.025551","article-title":"Network Meta-Analysis of Randomized Trials Evaluating the Comparative Efficacy of Lipid-Lowering Therapies Added to Maximally Tolerated Statins for the Reduction of Low-Density Lipoprotein Cholesterol","volume":"11","author":"Toth","year":"2022","journal-title":"J. Am. Heart Assoc."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"420","DOI":"10.1016\/j.tem.2018.03.013","article-title":"Beyond LDL: What Role for PCSK9 in Triglyceride-Rich Lipoprotein Metabolism?","volume":"29","author":"Dijk","year":"2018","journal-title":"Trends Endocrinol. Metab."}],"container-title":["Medicina"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1648-9144\/60\/7\/1124\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T15:15:42Z","timestamp":1760109342000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1648-9144\/60\/7\/1124"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,12]]},"references-count":30,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2024,7]]}},"alternative-id":["medicina60071124"],"URL":"https:\/\/doi.org\/10.3390\/medicina60071124","relation":{},"ISSN":["1648-9144"],"issn-type":[{"value":"1648-9144","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,12]]}}}