{"id":15240206,"date":"2026-08-03T22:28:41","date_gmt":"2026-08-04T02:28:41","guid":{"rendered":"https:\/\/www.inthacity.com\/news\/how-lipfendra-inclisiran-and-new-guidelines-are-changing-cholesterol-management\/"},"modified":"2026-08-03T22:33:21","modified_gmt":"2026-08-04T02:33:21","slug":"how-lipfendra-inclisiran-and-new-guidelines-are-changing-cholesterol-management","status":"publish","type":"post","link":"https:\/\/www.inthacity.com\/news\/how-lipfendra-inclisiran-and-new-guidelines-are-changing-cholesterol-management\/","title":{"rendered":"How Lipfendra, Inclisiran, and New Guidelines Are Changing Cholesterol Management"},"content":{"rendered":"<figure class=\"wp-block-image size-full\"><img decoding=\"async\" loading=\"lazy\" width=\"1296\" height=\"728\" src=\"https:\/\/media.post.rvohealth.io\/wp-content\/uploads\/2026\/08\/getty_2151967080_header_1296x728.jpg\" alt=\"Middle aged male speaking with a healthcare professional in a clinical setting\" class=\"wp-image-4885383\" \/><figcaption>With more than half of U.S. adults now eligible for statins, the face of cholesterol treatment may be changing with drugs like Lipfendra and Inclisiran. FatCamera \u00b7 E+\/Getty<\/figcaption><\/figure>\n<ul>\n<li><strong>A new analysis found that the twice-yearly cholesterol medication inclisiran reduced LDL cholesterol by 49% more than placebo.<\/strong><\/li>\n<li><strong>The FDA approved Lipfendra, the first oral PCSK9 inhibitor for adults with high LDL cholesterol.<\/strong><\/li>\n<li><strong>Updated cholesterol guidelines suggest more than half of U.S. adults may now be eligible for statin therapy.<\/strong><\/li>\n<\/ul>\n<p>New medications and updated guidelines are changing how high cholesterol is treated.<\/p>\n<p>A systematic review and meta-analysis published in <a href=\"https:\/\/www.jacc.org\/doi\/10.1016\/j.jacadv.2026.102932\" target=\"_blank\" rel=\"noreferrer noopener\">JACC: Advances<\/a> on July 22 found that a new twice-yearly therapy may substantially reduce <a href=\"https:\/\/www.healthline.com\/health\/ldl-cholesterol\">LDL cholesterol<\/a> levels.&nbsp;<\/p>\n<p>The <a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-approves-first-oral-therapy-inhibits-proprotein-convertase-subtilisinkexin-type-9-pcsk9-lower\" target=\"_blank\" rel=\"noreferrer noopener\">Food and Drug Administration (FDA)<\/a> also approved the groundbreaking cholesterol medication Lipfendra on July 16. This new drug helped lower people\u2019s LDL cholesterol by nearly 60%.&nbsp;<\/p>\n<p>The American Heart Association (AHA), American College of Cardiology (ACC), and several other medical organizations introduced <a href=\"https:\/\/www.jacc.org\/doi\/epdf\/10.1016\/j.jacc.2026.02.4872\" target=\"_blank\" rel=\"noreferrer noopener\">new guidelines<\/a> for the management and screening of high cholesterol earlier in 2026. <a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2851792\" target=\"_blank\" rel=\"noreferrer noopener\">Studies<\/a> on the impacts of these guidelines found that over 50% of adults in the United States may now be eligible for <a href=\"https:\/\/www.healthline.com\/health\/high-cholesterol\/statins-uses-side-effects\">statins<\/a>.\u00a0<\/p>\n<p>Here&#8217;s a closer look at what these developments could mean for cholesterol care.<\/p>\n<h2>New twice-yearly drug shows promise in reducing LDL levels<\/h2>\n<p>A new systematic review and meta-analysis found that inclisiran led to a 49% greater reduction in LDL cholesterol compared with placebo.<\/p>\n<p>The analysis examined nine randomized controlled trials and found consistent reductions in LDL cholesterol among people receiving different background lipid-lowering therapies, including statins.<\/p>\n<p>Inclisiran is a synthetic drug that targets the synthesis of certain proteins that can increase LDL levels. It is <a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-approves-add-therapy-lower-cholesterol-among-certain-high-risk-adults\">FDA approved<\/a> to lower LDL cholesterol, and the agency recently updated its label to allow the drug to be used either alone or in combination with statin therapy, in addition to diet and exercise, for people with hypercholesterolemia.<\/p>\n<p>Statins remain the first-line treatment for high cholesterol. However, some people do not achieve guideline-recommended LDL levels because of intolerance, an inadequate response, or high residual cardiovascular risk.<\/p>\n<p>Because inclisiran is administered only twice a year, it may also offer an alternative for people who have difficulty adhering to daily oral medications.<\/p>\n<p>\u201cThe data is important because while there are mixed responses depending on which trial is considered, the overall trend is reassuring that the drug\u2019s impact on LDL concentrations is consistent,\u201d <a href=\"https:\/\/www.memorialcare.org\/providers\/kevin-s-shah\" target=\"_blank\" rel=\"noreferrer noopener\">Kevin Shah<\/a>, MD, board certified cardiologist and Program Director of Heart Failure Outreach at MemorialCare Heart &amp; Vascular Institute at Long Beach Medical Center in Long Beach, CA, told Healthline. Shah was not involved in the study.&nbsp;<\/p>\n<p>\u201cThe cardiology community is excited about this therapeutic option, but we do continue to await outcomes trials, which would confirm that the degree of LDL lowering also lowers risk of heart attack and stroke,\u201d he said.&nbsp;<\/p>\n<div class=\"wp-block-healthline-standout\">\n<h3 class=\"standout--heading\">Key points<\/h3>\n<ul>\n<li>A systematic review and meta-analysis of the impact of inclisiran found that the drug may lead to a 49% greater reduction in LDL cholesterol levels.&nbsp;<\/li>\n<li>Inclisiran is a twice-yearly medication that can be used alone or alongside other lipid-lowering therapies, like statins.&nbsp;<\/li>\n<li>It may help more adults with high cholesterol meet the guideline-recommended LDL levels.<\/li>\n<\/ul>\n<\/div>\n<h2>The FDA approved Lipfendra to help reduce cholesterol levels<\/h2>\n<p>On July 16, the FDA approved Lipfendra (enlicitide), the first oral <a href=\"https:\/\/www.healthline.com\/health\/pcsk9-inhibitors-what-you-need-to-know\">PCSK9 inhibitor<\/a> for adults with high LDL cholesterol. The once-daily pill can be used in addition to or instead of statins.<\/p>\n<p>In the two clinical trials supporting the approval, Lipfendra lowered LDL cholesterol by about 56% after 24 weeks in one study and 59% in the other.<\/p>\n<p>While the trials evaluated Lipfendra&#8217;s ability to lower LDL cholesterol, they did not examine whether the drug reduces the risk of <a href=\"\/health\/heart-attack\/signs-of-stroke-or-heart-attack\">heart attack or stroke<\/a>. However, the FDA previously told Healthline that it accepts reductions in LDL cholesterol as a validated surrogate marker for lower <a href=\"\/health\/heart-disease\/causes-risks\">cardiovascular risk<\/a>.<\/p>\n<p>In an earlier interview with Healthline, <a href=\"https:\/\/www.memorialcare.org\/providers\/yu-ming-ni\" target=\"_blank\" rel=\"noreferrer noopener\">Yu-Ming Ni<\/a>, MD, a cardiologist and lipidologist at MemorialCare Heart and Vascular Institute at Orange Coast Medical Center in Fountain Valley, CA, pointed to decades of research supporting LDL cholesterol as a meaningful marker of cardiovascular risk.<\/p>\n<p>\u201cWe have tons of data showing that the lower the cholesterol you go, the lower your risk for heart disease,\u201d he said.&nbsp;<\/p>\n<div class=\"wp-block-healthline-standout\">\n<h3 class=\"standout--heading\">Key Points<\/h3>\n<ul>\n<li>The FDA approved Lipfendra, the first oral PCSK9 inhibitor, for adults with high LDL cholesterol. <\/li>\n<li>In clinical trials, the once-daily pill lowered LDL cholesterol by 56% to 59%. <\/li>\n<li>Lipfendra can be used alone or alongside statins to help lower LDL cholesterol.<\/li>\n<\/ul>\n<p><a href=\"\/health-news\/fda-approves-new-cholesterol-pill-lipfendra\">Read the full article here.<\/a>&nbsp;<\/p>\n<\/div>\n<h2>More than 50% of U.S. adults are eligible for statins<\/h2>\n<p>Earlier this year, the American Heart Association (AHA), American College of Cardiology (ACC), and several other medical organizations released <a href=\"\/health-news\/aha-updated-cholesterol-guidelines-early-intervention\" target=\"_blank\" rel=\"noreferrer noopener\">updated cholesterol guidelines<\/a> that recommend treating high cholesterol earlier, measuring <a href=\"\/health\/lipoprotein-a\">lipoprotein(a)<\/a> at least once to help identify inherited heart disease risk, and using a newer risk calculator to better estimate cardiovascular risk.<\/p>\n<p>The guidelines also set lower LDL (&#8220;bad&#8221;) cholesterol targets for people at higher risk of heart disease and encourage treatment decisions based on individual risk factors and imaging when appropriate.<\/p>\n<p>Three recent studies examined the impact of those recommendations.<\/p>\n<p>One study, published in <a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2851798\" target=\"_blank\" rel=\"noreferrer noopener\">JAMA<\/a>, found that approximately 56.6% of U.S. adults ages 30 to 79\u2014about 87.5 million people\u2014are now eligible for statin therapy under the updated guidelines. That includes 21.5 million adults who would not have qualified under the previous 2018 recommendations.<\/p>\n<p>Another <a href=\"https:\/\/jamanetwork.com\/journals\/jama\/article-abstract\/2851792\">study<\/a> found substantial gaps in cholesterol treatment, with more than three-quarters of high-risk adults without cardiovascular disease and one-third of those with existing heart disease not receiving recommended therapy.<\/p>\n<p>A third <a href=\"https:\/\/jamanetwork.com\/journals\/jama\/article-abstract\/2851797\">study<\/a> found that the updated PREVENT risk calculator reclassified about 21.5% of adults into different cardiovascular risk categories. About two-thirds moved into lower-risk categories, while one-third moved into higher-risk categories.<\/p>\n<div class=\"wp-block-healthline-standout\">\n<h3 class=\"standout--heading\">Key points<\/h3>\n<ul>\n<li>Updated cholesterol guidelines recommend earlier treatment and more personalized cardiovascular risk assessment.<\/li>\n<li>New research suggests more than half of U.S. adults may now qualify for statin therapy under the recommendations.<\/li>\n<li>Additional studies found gaps in cholesterol treatment and changes in cardiovascular risk classification under the new guidelines.<\/li>\n<\/ul>\n<p><a href=\"\/health-news\/many-adults-eligible-statin-therapy-new-guidelines\">Read the full article here.<\/a><\/p>\n<\/div>\n<p class=\"inmi-source\">Source: <a href=\"https:\/\/www.healthline.com\/health-news\/cholesterol-management-changing-new-drugs-lipfrenda-inclisiran\" target=\"_blank\" rel=\"noopener nofollow\">News \u2013 World \u2013 Canada \u2013 rss.app #1 \u2192 manual entry<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>With more than half of U.S. adults now eligible for statins, the face of cholesterol treatment may be changing with drugs like Lipfendra and Inclisiran. FatCamera \u00b7 E+\/Getty<\/p>\n<p>A new analysis found that the twice-yearly cholesterol medication inclisiran reduced LDL cholesterol\u2026<\/p>\n","protected":false},"author":1,"featured_media":15240208,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[103],"tags":[],"class_list":["post-15240206","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-canada"],"featured_image_urls":{"full":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728.avif",1296,728,false],"thumbnail":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-300x169.avif",300,169,true],"medium":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-620x348.avif",620,348,true],"medium_large":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-768x431.avif",768,431,true],"large":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-940x528.avif",940,528,true],"1536x1536":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728.avif",1296,728,false],"2048x2048":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728.avif",1296,728,false],"post-thumbnail":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-998x665.avif",998,665,true],"ignition_item":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-670x446.avif",670,446,true],"ignition_item_lg":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728.avif",1296,728,false],"ignition_article_media":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-510x510.avif",510,510,true],"ignition_minicart_item":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-160x160.avif",160,160,true],"profile_24":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-24x24.avif",24,24,true],"profile_48":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-48x48.avif",48,48,true],"profile_96":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-96x96.avif",96,96,true],"profile_150":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-150x150.avif",150,150,true],"profile_300":["https:\/\/www.inthacity.com\/news\/wp-content\/uploads\/2026\/08\/15240206-getty_2151967080_header_1296x728-300x300.avif",300,300,true]},"author_info":{"display_name":"news.iNthacity","author_link":"https:\/\/www.inthacity.com\/news\/author\/atombo\/"},"category_info":"<a href=\"https:\/\/www.inthacity.com\/news\/articles\/news\/canada\/\" rel=\"category tag\">Canada<\/a>","tag_info":"Canada","comment_count":"0","_links":{"self":[{"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/posts\/15240206","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/comments?post=15240206"}],"version-history":[{"count":1,"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/posts\/15240206\/revisions"}],"predecessor-version":[{"id":15240207,"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/posts\/15240206\/revisions\/15240207"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/media\/15240208"}],"wp:attachment":[{"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/media?parent=15240206"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/categories?post=15240206"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inthacity.com\/news\/wp-json\/wp\/v2\/tags?post=15240206"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}