Pitavastatin Calcium

精彩内容近日，信立泰公告称，公司引进的创新基因编辑药物YOLT-101注射液获批临床，用于治疗杂合子型家族性高胆固醇血症（HeFH）。米内网数据显示，近年来中国三大终端六大市场（统计范围详见本文末）血脂调节剂销售额均超过200亿元。YOLT-101注射液是一款靶向PCSK9碱基编辑药物，拟开发的适应症包括家族性高胆固醇血症等。与现有的PCSK9抗体、siRNA药物等治疗方法相比，YOLT-101可在DNA水平编辑PCSK9基因的单个碱基，降低靶蛋白表达。2024年8月，信立泰公告称，拟与尧唐生物签订协议，获得YOLT-101在中国大陆区域的独家许可权益，总交易金额近10.35亿元；2025年4月，YOLT-101注射液的临床申请获得CDE承办受理，同年7月获批临床，用于治疗杂合子型家族性高胆固醇血症（HeFH）。目前国内常用的血脂调节剂主要包括他汀类药物、贝特类药物、胆固醇吸收抑制剂、PCSK9抑制剂及其他降脂药。米内网数据显示，近年来中国三大终端六大市场血脂调节剂（化药+生物药）销售额均超过200亿元，且呈逐年上涨态势。近年来中国三大终端六大市场血脂调节剂（化药+生物药）销售情况（单位：万元）来源：米内网格局数据库在2025年第一季度血脂调节剂（化药+生物药）TOP5产品中，阿托伐他汀钙片、瑞舒伐他汀钙片、普伐他汀钠片3款他汀类药物分别位列第一、第二、第五；排位第三的依洛尤单抗注射液是一款PCSK9抑制剂，目前暂无生物类似药获批；排位第四的依折麦布片属于胆固醇吸收抑制剂，2025年第一季度同比增长接近20%。2025Q1中国三大终端六大市场血脂调节剂（化药+生物药）TOP5产品来源：米内网格局数据库在降血脂领域，目前信立泰仅拥有1款产品的生产批文，为匹伐他汀钙片；在研1类新药中，重组全人源抗PCSK9单抗注射液（SAL003）进展最快，高胆固醇血症和混合型高脂血症适应症已步入III期临床。信立泰国内部分在研的降血脂新药来源：米内网综合数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月15日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

Presentations Address Frailty, Inflammation, Asymptomatic Heart Muscle Damage, and Mental FunctionLOS ANGELES, March 12, 2025 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today presented findings from the REPRIEVE trial about the use of statins among people living with HIV with frailty and the relationship between major adverse cardiovascular events (MACE) and measurements of inflammation and asymptomatic heart muscle damage. These results were shared in two oral abstracts: “Frailty is Associated with Higher MACE Incidence but Does Not Appear to Modify Pitavastatin Effects” and “Plaque, Inflammation, Subclinical Myocardial Injury and MACE in the REPRIEVE Mechanistic Substudy” at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, California. REPRIEVE (The Randomized Trial to Prevent Vascular Events in HIV) was the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease among people living with HIV. It found that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of MACE by 36 percent compared with those receiving a placebo over a median duration of five years of follow up. “We are eager to share data from REPRIEVE at CROI about the relationship between frailty and major cardiovascular events, the importance of inflammation and asymptomatic heart muscle damage, and the impact of statin therapy on neurocognition (mental function) and heart failure risk,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “REPRIEVE was a groundbreaking study that has informed a multitude of international guidelines, which now recommend statins to prevent cardiovascular disease in many people living with HIV and we expect that it will continue to generate meaningful findings that improve the care of people living with HIV.” Frailty is Associated with Higher MACE Incidence but Does Not Appear to Modify Pitavastatin EffectsToday’s presentation examined whether frailty is associated with MACE among people living with HIV and whether statins may prevent MACE across a spectrum of frailty. Researchers found that higher levels of frailty were associated with increased risk of MACE among participants. They also determined that while adults living with HIV and frailty were routinely under-prescribed key preventive therapies such as statins, frailty status did not appear to modify the protective effects of pitavastatin that were seen in the primary trial. While further research is needed, the study concluded that incorporating frailty assessments such as the frailty index may help identify people living with HIV who are at risk of MACE. “The strong association in this analysis between the age-related syndrome of frailty and major adverse cardiovascular events may suggest similar underlying mechanisms and, further, that screening for frailty can help identify the participants at highest risk for cardiovascular events,” said Presenting Author Kristine Erlandson, M.D., University of Colorado Anschutz Medical Campus. “While providers and patients may question the added benefit of statins in patients with numerous comorbidities, the data presented today support the use of pitavastatin among adults living with HIV and frailty.” Plaque, Inflammation, Subclinical Myocardial Injury and MACE in the REPRIEVE Mechanistic SubstudyThis secondary analysis presented today assessed for the first time the relationship between coronary plaque and measurements of inflammation and asymptomatic heart muscle damage with MACE. Today’s presentation demonstrated that among participants in REPRIEVE’s mechanistic substudy, individuals with noncalcified coronary plaque (buildup of plaque in the arteries that can cause a heart attack) and higher blood levels of inflammation and heart muscle injury at study entry were at higher risk of having a cardiovascular event over six years of follow up even though they did not have symptoms. In exploratory analyses, plaque and biomarker (blood proteins associated with cardiovascular disease) combinations further improved the accuracy of predicting the risk of MACE beyond traditional risk scores. The data also suggested that the benefit of pitavastatin to prevent MACE may be greater among individuals who have noncalcified coronary plaque and evidence of low-grade myocardial damage, which may precede symptoms. Additional investigation is necessary to determine how pitavastatin can be most effective for these individuals. “These data suggest that key plaque, inflammatory, and asymptomatic heart muscle damage markers are strongly related to MACE, even among people living with HIV who are not experiencing cardiac-related symptoms,” said Presenting Author and Study Chair Steven Grinspoon, M.D, Harvard Medical School and Massachusetts General Hospital. “These data highlight the need for additional studies to identify people living with HIV who might benefit most from statin therapy and to identify new mechanistic pathways to target,” said REPRIEVE Mechanistic Substudy Protocol Chair and Lead Author Michael Lu, M.D., M.P.H., Harvard Medical School and Massachusetts General Hospital. ACTG also presented two posters at CROI reporting on additional REPRIEVE findings: No Evidence of a Detrimental Effect of Pitavastatin on Neurocognitive Function Among People with HIV found no evidence to suggest that pitavastatin impacted neurocognitive function among people living with HIV at low to moderate cardiovascular disease risk, even among those who entered the study with some existing level of impairment.“Concerns about potential detrimental cognitive effects of statins are often raised when considering statin therapy,” said Presenting Author Dr. Erlandson. “The results from this randomized, blinded study, which show no relationship between statin therapy and change in neurocognitive function, should provide reassurance to patients and providers.” Heart Failure Risk and Events In People with HIV: The Randomized Trial To Prevent Vascular Events In HIV (REPRIEVE)” (Gerald Bloomfield, et al.) found that the number of heart failure events among people living with HIV in REPRIEVE was consistent with the low estimated PREVENT (Predicting Risk of Cardiovascular Disease Events) heart failure risk rates. Participants who were Black, female, lived in sub-Saharan Africa, had pre-existing hypertension, and/or elevated body mass were more likely to experience heart failure. REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest NIH institutes, and ACTG (AI068636). It received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (providers of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare. The study is led by Dr. Grinspoon and Pamela S. Douglas, M.D., Duke University School of Medicine (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D., Harvard School of Public Health (Lead Statistician) and Dr. Lu, who led the Data Coordinating Center. ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice-Chair). To learn more, please visit www.reprievetrial.org. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Rachel Reiss, ACTGRLReiss@mednet.ucla.edu