[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-113568-en":3,"doc-seo-113568-105":31,"detail-sidebar-cat-0-en-105":93},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":4,"category_id":11,"category_name":12,"doc_title":13,"doc_description":14,"doc_content":15,"file_id":16,"file_url":17,"file_type":18,"file_size":19,"view_count":20,"is_deleted":4,"is_public":21,"is_downloadable":21,"audit_status":21,"page_count":22,"language":23,"language_code":24,"site_id":25,"html_lang":24,"table_of_contents":26,"faqs":27,"seo_title":28,"seo_description":14,"update_tm":29,"read_time":30},113568,7971461741311,"Ophelia","https://ap-avatar.wpscdn.com/avatar/74000253aff267980c6?x-image-process=image/resize,m_fixed,w_180,h_180&k=1779345379180704826",7,"Healthcare","Inclisiran - A Review in Hypercholesterolemia","Inclisiran (Leqvio®) is a first-in-class, subcutaneously administered small interfering RNA (siRNA) that blocks hepatic synthesis of PCSK9, reducing circulating LDL-C. In the EU, it is indicated for adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet, including patients unable to achieve LDL-C goals on maximally tolerated statins. Twice-yearly injections (after initial doses at days 1 and 90) approximately halved LDL-C in patients with, or at high risk for, ASCVD. Safety resembled placebo, with more transient, mild-to-moderate injection-site reactions. Pending CV outcome confirmation, its infrequent dosing offers convenience versus other non-statin LLTs.","American Journal of Cardiovascular Drugs (2023) 23:219–230  \n[https://doi.org/10.1007/s40256-023-00568-7](https://doi.org/10.1007/s40256-023-00568-7)  \nInclisiran: A Review in Hypercholesterolemia  \nJames E. Frampton1  \nAccepted: 11 January 2023 / Published online: 4 March 2023 © Springer Nature Switzerland AG 2023  \nAbstract  \nInclisiran (Leqvio®) is a first-in-class, subcutaneously administered, small interfering RNA (siRNA) that prevents hepatic synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9), thereby decreasing circulating low-density lipoprotein cholesterol (LDL-C). In the EU, inclisiran is indicated in adults with primary hypercholesterolemia or mixed dyslipidemia, asan adjunct to diet. It is intended for use in patients unable to reach LDL-C goals on maximally tolerated statin therapy, with or without other lipid-lowering therapies (LLTs). In patients who are statin intolerant or for whom a statin is contraindicated, it can be used with or without other LLTs. In clinical trials, twice-yearly injections of inclisiran (after initial doses at days 1 and 90) approximately halved LDL-C levels in patients with, or at high risk of developing, atherosclerotic cardiovascular disease (ASCVD) who had hypercholesterolemia, irrespective of whether or not their existing treatment included a statin. The safety and tolerability profile of the drug was similar to placebo, although mild to moderate, transient injection-site adverse reactions were more frequent with inclisiran. Pending confirmation of the expected reduction in cardiovascular (CV) events with inclisiran, it is a valuable additional/alternative antihyperlipidemic agent to a statin, as its infrequent maintenance dosing regimen confers a convenience advantage over other non-statin LLTs.  \nPlain Language Summary  \nAtherosclerotic cardiovascular disease (ASCVD) is a leading cause of death and disability.‘Statins’ are the drugs of choice for reducing elevated levels of low-density lipoprotein cholesterol (LDL-C) in patients with, or at risk of developing, ASCVD. However, due to multiple factors, including adverse events and/or poor adherence, many patients don’t achieve their guideline target LDL-C level on conventional (statin-based) therapy and novel, non-statin lipid-lowering therapies (LLTs) are needed. Inclisiran (Leqvio®) is a small interfering RNA (siRNA) drug that works as an LLT by stopping the liver from making an enzyme [proprotein convertase subtilisin/kexin type 9 (PCSK9)] that otherwise reduces its ability to remove LDL-C from the blood. Subcutaneously injecting inclisiran every 6 months (after initial doses at days 1 and 90) was generally well tolerated and approximately halved LDL-C levels in patients with, or at high risk of developing, ASCVD who had hypercholesterolemia, regardless of whether or not their conventional therapy included a statin. Inclisiran is a potentially valuable additional/alternative antihyperlipidemic agent to a statin because of its infrequent, and therefore more convenient, dosing schedule versus other non-statin LLTs, including anti-PCSK9 monoclonal antibodies.  \nDigital Features for this Adis Drug Evaluation can be found at [https://doi.org/10.6084/m9.figshare.21862563](https://doi.org/10.6084/m9.figshare.21862563) .  \n* James E. Frampton [demail@springer.com](demail@springer.com)  \n1 Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand  \n1 Introduction  \nAtherosclerotic cardiovascular disease (ASCVD) continues tobe the leading cause of mortality and a major cause of morbidity worldwide [1, 2]. Elevated low-density lipoprotein cholesterol (LDL-C) levels are one of the most important modifiable risk factors related to the development of ASCVD [3] . Accordingly, lowering LDL-C levels is a key therapeutic strategy in the primary and secondary prevention of major adverse cardiovascular events (MACEs) in patients with ASCVD or at risk of ASCVD, with benefits proportionally related to greater absolut","cbCairZJQLtyE6bb","https://ap.wps.com/l/cbCairZJQLtyE6bb","pdf",1020914,6,1,12,"English","en",105,"# Abstract\n## Drug mechanism and indication\n## Efficacy and safety overview\n## Background: ASCVD and LDL-C risk\n## Limitations of statins and need for non-statin LLTs\n## Non-statin lipid-lowering options and PCSK9 targeting","[{\"question\":\"What is inclisiran and how does it work?\",\"answer\":\"Inclisiran is a small interfering RNA (siRNA) given by subcutaneous injection. It prevents hepatic synthesis of PCSK9, decreasing circulating LDL-C by limiting PCSK9-driven effects on LDL-C clearance.\"},{\"question\":\"Who is inclisiran indicated for, according to the abstract?\",\"answer\":\"In the EU, inclisiran is indicated for adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet—especially for patients who cannot reach LDL-C goals on maximally tolerated statins, or who are statin intolerant or have statin contraindications.\"},{\"question\":\"How effective and tolerable is inclisiran in clinical trials?\",\"answer\":\"In trials, twice-yearly injections (after doses on day 1 and day 90) approximately halved LDL-C levels in patients with, or at high risk for, ASCVD. The safety profile was similar to placebo, while mild-to-moderate, transient injection-site adverse reactions were more frequent.\"}]","Inclisiran - A Review in Hypercholesterolemia | PDF",1784705742,30,{"code":4,"msg":32,"data":33},"ok",{"site_id":25,"language":24,"slug":34,"title":13,"keywords":35,"description":14,"schema_data":36,"social_meta":88,"head_meta":90,"extra_data":92,"updated_unix":29},"inclisiran-a-review-in-hypercholesterolemia","",{"@graph":37,"@context":87},[38,55,70],{"@type":39,"itemListElement":40},"BreadcrumbList",[41,45,49,52],{"item":42,"name":43,"@type":44,"position":21},"https://docshare.wps.com","Home","ListItem",{"item":46,"name":47,"@type":44,"position":48},"https://docshare.wps.com/document/","Document",2,{"item":50,"name":12,"@type":44,"position":51},"https://docshare.wps.com/document/healthcare/",3,{"item":53,"name":13,"@type":44,"position":54},"https://docshare.wps.com/document/inclisiran-a-review-in-hypercholesterolemia/113568/",4,{"url":53,"name":13,"@type":56,"author":57,"headline":13,"publisher":59,"fileFormat":62,"inLanguage":24,"description":14,"dateModified":63,"datePublished":64,"encodingFormat":62,"isAccessibleForFree":65,"interactionStatistic":66},"DigitalDocument",{"name":9,"@type":58},"Person",{"url":42,"name":60,"@type":61},"DocShare","Organization","application/pdf","2026-07-29","2026-07-22",true,{"@type":67,"interactionType":68,"userInteractionCount":20},"InteractionCounter",{"@type":69},"ViewAction",{"@type":71,"mainEntity":72},"FAQPage",[73,79,83],{"name":74,"@type":75,"acceptedAnswer":76},"What is inclisiran and how does it work?","Question",{"text":77,"@type":78},"Inclisiran is a small interfering RNA (siRNA) given by subcutaneous injection. It prevents hepatic synthesis of PCSK9, decreasing circulating LDL-C by limiting PCSK9-driven effects on LDL-C clearance.","Answer",{"name":80,"@type":75,"acceptedAnswer":81},"Who is inclisiran indicated for, according to the abstract?",{"text":82,"@type":78},"In the EU, inclisiran is indicated for adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet—especially for patients who cannot reach LDL-C goals on maximally tolerated statins, or who are statin intolerant or have statin contraindications.",{"name":84,"@type":75,"acceptedAnswer":85},"How effective and tolerable is inclisiran in clinical trials?",{"text":86,"@type":78},"In trials, twice-yearly injections (after doses on day 1 and day 90) approximately halved LDL-C levels in patients with, or at high risk for, ASCVD. The safety profile was similar to placebo, while mild-to-moderate, transient injection-site adverse reactions were more frequent.","https://schema.org",{"og:url":53,"og:type":89,"og:title":13,"og:site_name":60,"og:description":14},"article",{"robots":91,"canonical":53},"index,follow",{"doc_id":7,"site_id":25},{"code":4,"msg":5,"data":94},[95,99,103,107,112,116,119,123,128,131,135],{"id":21,"doc_module":4,"doc_module_name":47,"category_name":96,"show_sort_weight":97,"slug":98},"Story & Novel",90,"story-novel",{"id":48,"doc_module":4,"doc_module_name":47,"category_name":100,"show_sort_weight":101,"slug":102},"Literature",80,"literature",{"id":54,"doc_module":4,"doc_module_name":47,"category_name":104,"show_sort_weight":105,"slug":106},"Exam",70,"exam",{"id":108,"doc_module":4,"doc_module_name":47,"category_name":109,"show_sort_weight":110,"slug":111},5,"Comic",60,"comic",{"id":20,"doc_module":4,"doc_module_name":47,"category_name":113,"show_sort_weight":114,"slug":115},"Technology",50,"technology",{"id":11,"doc_module":4,"doc_module_name":47,"category_name":12,"show_sort_weight":117,"slug":118},40,"healthcare",{"id":120,"doc_module":4,"doc_module_name":47,"category_name":121,"show_sort_weight":30,"slug":122},8,"Research & Report","research-report",{"id":124,"doc_module":4,"doc_module_name":47,"category_name":125,"show_sort_weight":126,"slug":127},9,"Religion & Spirituality",20,"religion-spirituality",{"id":126,"doc_module":4,"doc_module_name":47,"category_name":129,"show_sort_weight":126,"slug":130},"World Cup","world-cup",{"id":132,"doc_module":4,"doc_module_name":47,"category_name":133,"show_sort_weight":132,"slug":134},10,"Lifestyle","lifestyle",{"id":136,"doc_module":4,"doc_module_name":47,"category_name":137,"show_sort_weight":108,"slug":138},19,"General","general"]