New medication given every 1-3 months may slash stubborn high cholesterol

13 Nov 2023
www.sciencedaily.com
Drug ApprovalAHAClinical Result
While currently available PCSK9 inhibitor medications to lower cholesterol must be administered every few weeks by injection, a new, investigational PCSK9 inhibitor called recaticimab safely lowered bad cholesterol more than 50% when injected every 1-3 months, depending on dose. A new PCSK9 inhibitor (recaticimab) injected every one to three months may work safely and provide more flexible dosing to lower cholesterol, according to late-breaking science presented today at the American Heart Association's Scientific Sessions 2023. The meeting, Nov. 11-13, in Philadelphia, is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science. "Previous studies found that 30% to 40% of people discontinued their current PCSK9 therapies, given every two to four weeks, during or after six months of beginning treatment. More flexible dosing with recaticimab, given up to every 12 weeks, might increase the proportion of people with high levels of bad cholesterol to stick with their recommended treatment to lower bad cholesterol levels and reduce risk of heart disease," said lead study author Xin Du, Ph.D., a professor of cardiology at Beijing Anzhen Hospital and the Capital Medical University in Beijing, China. The current study, Recaticimab Add-On Therapy in Patients With Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia or REMAIN-2, examines the safety of a new PCSK9 inhibitor, recaticimab, and its ability to lower bad cholesterol when given at different doses and intervals to people with non-genetic forms of high cholesterol. American Heart Association guidelines indicate a cholesterol target of less than 100 mg/dl in most adults and less than 70 mg/dl in high-risk people who have already had a heart attack, or stroke or have genetic forms of high cholesterol. When cholesterol-lowering statin medications and other treatments are not effective in reducing bad cholesterol to target levels, physicians may often add a PCSK9 inhibitor. The medication binds to and inactivates a protein on cells found in the liver to lower bad cholesterol. Current FDA approved PCSK9 inhibitors include alirocumab and evolocumab, which are injected every 2-4 weeks. This multicenter study in China involved 689 participants with abnormally high levels of bad cholesterol despite ongoing moderate or high intensity statin therapy. Participants were divided into three groups: one received either 150 mg of recaticimab or a placebo injection every 4 weeks; one group received 300 mg of recaticimab or placebo injection every 8 weeks; and one group was given 450 mg of recaticimab or placebo injection every 12 weeks. The study found: "Since all the doses and frequencies had similar effectiveness and safety, this may someday provide patients and physicians with more flexible options," Du said. In the study's secondary findings, other types of lipids associated with atherosclerotic heart disease were also reduced significantly in the recaticimab groups compared to the placebo groups, including: "Recaticimab reduced these key lipid parameters by a similar magnitude to other PCSK9 inhibitors, providing further evidence of profound benefits with the treatment despite less frequent dosing," Du said. Trial background and details: Although there are several statin medications, all participants in this study were taking either atorvastatin or rosuvastatin, so the impact of adding recaticimab to other statins may differ, researchers note. In addition, because the study was conducted in China, where a higher proportion of people often have increased rates of reactions and intolerance to statin treatment, more of the participants were on moderate rather than high intensity statin therapy, and the results may not be generalizable to other populations. In addition, changes in laboratory measures in this study suggest but do not demonstrate that recaticimab add-on treatment may lower rates of heart attack and stroke, Du said. "Further studies will be conducted to explore the possible benefits of recaticimab in reducing cardiovascular risk," Du said. In addition, a separate trial, REMAIN-3, is being completed to determine whether recaticimab reduces bad cholesterol in people who have one gene for familial hypercholesterolemia, a genetic disorder that causes high low-density-lipoprotein cholesterol and increases the risk for developing heart disease or having a heart attack at a younger age. Co-authors, disclosures and funding sources are listed in the abstract. The study was funded by Jiangsu Hengrui Pharmaceuticals. Statements and conclusions of studies that are presented at the American Heart Association's scientific meetings are solely those of the study authors and do not necessarily reflect the Association's policy or position. The Association makes no representation or guarantee as to their accuracy or reliability. Abstracts presented at the Association's scientific meetings are not peer-reviewed, rather, they are curated by independent review panels and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting. The findings are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal. The Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific Association programs and events. The Association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and biotech companies, device manufacturers and health insurance providers and the Association's overall financial information are available here.
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