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更新于：2025-05-31
Inclisiran sodium
英克司兰钠
更新于：2025-05-31
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Sequence Code 31593325
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Sequence Code 31594604
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关联
65
项与 英克司兰钠 相关的临床试验NCT06770543
Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
NCT06909565
Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)
NCT06958315
An Observational Prospective Study to Assess the Effectiveness of Inclisiran(Leqvio®)in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spanish Clinical Practice:the INSPIRE Study
100 项与 英克司兰钠 相关的临床结果
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100 项与 英克司兰钠 相关的转化医学
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100 项与 英克司兰钠 相关的专利（医药）
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384
项与 英克司兰钠 相关的文献（医药）2025-09-01AMERICAN JOURNAL OF CARDIOLOGY
The Impact of Inclisiran on Lipid Profiles in Adults with Hyperlipidemia: A Meta-Analysis and Meta-Regression of Randomized Controlled Trials
Review
作者: Khalil, Ibrahim ; Hossain, Imran ; Rahman, Mohd Turzo
Hyperlipidemia is one of the most prominent risk factors for heart diseases, and current treatments are sometimes insufficient to control it. Inclisiran, a small interfering RNA targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), provides a novel, long-acting approach to improve hyperlipidemia. This meta-analysis was conducted following the PRISMA guidelines. A total of 5 out of 185 studies screened met the inclusion criteria. The primary outcome was a reduction in the LDL-C level compared to control group. Statistical analysis used a random-effect model to calculate the mean difference (MD) for with 95% confidence interval (CI). A total of 5 randomized controlled trials comprised 4,072 patients, divided into the Inclisiran arm (n = 2,129) and the Control arm (n = 1,943). Compared with control, this study showed Inclisiran substantially reduces LDL-C (MD, -51.25%; 95% CI, [-56.58 to -45.92], p <0.00001), total cholesterol (MD, -27.75%; 95% CI, [-30.39 to -25.10], p <0.00001), apolipoprotein B (MD, -36.65%; 95% CI, [-45.93 to -27.37], p = 0.00039), triglycerides (MD, -12.39%; 95% CI, [-21.49 to -3.28], p = 0.02275), PCSK9 level (MD, -77.00%; 95% CI, [-86.89 to -67.11], p = 0.00014), and lipoprotein (a) (MD, -21.77%; 95% CI, [-24.29 to -19.24], p = 0.000018). Inclisiran also significantly increases HDL-C levels by a mean difference of +5.86% (MD, 95% CI, [+4.77 to +6.95], p = 0.0001). This meta-analysis demonstrates that Inclisiran significantly improves lipid profiles in hyperlipidemia, reducing LDL-C, total cholesterol, apolipoprotein B, triglycerides, PCSK9, and lipoprotein (a), while increasing HDL-C levels. Its innovative mechanism and twice-yearly dosing enhance efficacy, safety, and patient adherence.
2025-08-01INTERNATIONAL JOURNAL OF CARDIOLOGY
LDL-cholesterol levels and lipid lowering therapy in secondary prevention. Baseline data from the BRING-UP prospective registry
Article
作者: Abrignani, Maurizio Giuseppe ; Maffei, Simone ; Barbato, Emanuele ; Aloia, Antonio ; Alonzo, Alessandro ; Navazio, Alessandro ; Arca, Marcello ; Oliva, Fabrizio ; Calò, Leonardo ; La Rosa, Giuseppe ; Di Lenarda, Andrea ; Riccio, Carmine ; Temporelli, Pier Luigi ; Catapano, Alberico Luigi ; Calabrò, Paolo ; Bertoli, Daniele ; Scicchitano, Pietro ; Pavan, Daniela ; Aschieri, Daniela ; Fabbri, Gianna ; Ceseri, Martina ; Carugo, Stefano ; Fattirolli, Francesco ; Colivicchi, Furio ; Averna, Maurizio ; Di Fusco, Stefania Angela ; Maggioni, Aldo Pietro ; Gabrielli, Domenico ; Themistoclakis, Sakis ; Scelza, Nicola ; Gonzini, Lucio ; Gulizia, Michele Massimo ; Crisci, Vincenzo
AIMS:
To narrow the gap between guidelines recommendation for secondary cardiovascular prevention and clinical practice, we designed a national project based on educational programs and patient data collection.
METHODS:
BRING-UP Prevention is an observational, prospective, multicentre study on patients with an atherothrombotic event enrolled in 2 phases: an educational intervention followed by two 3-months data collection, followed by 6 and 12-month follow-up, when the primary, secondary and exploratory endpoints will be evaluated. Clinical characteristics, treatments and target achievement for LDL cholesterol and other modifiable risk factors at baseline are reported in this manuscript.
RESULTS:
From September 2023 to February 2024, 189 cardiology centers included 4790 patients, 2500 hospitalized, and 2290 managed as outpatients. Of the 4790 patients, 98 % had CAD, 6.1 % CVD, and 6.9 % PAD. Mean age was 67 ± 11 years, 20 % were females. Patients with LDL-C levels <55 mg/dL were 32.6 %. Patients at target for blood pressure were 39.2 %. Diabetic patients were 27.5 %, HbA1c <7 % was reported in 43.5 % of them. Statins prescription increased from 69 % at entry to 96 % at discharge/end of visit. In 74.5 % of patients, statins were prescribed in combination with ezetimibe. PCSK9-i or inclisiran were prescribed in a low rate of patients.
CONCLUSION:
These data show that a low percentage of patients was at goal for LDL-C level and blood pressure. The 6-month follow-up visit will allow us to evaluate the changes in modifiable risk factors.
2025-06-01DIABETES OBESITY & METABOLISM
Comprehensive evaluation of siRNA therapeutics on Lp(a): A network meta‐analysis
Review
作者: Hu, Jiaqiang ; Wang, Xingjin ; Qin, Xiaoli ; Liu, Song ; Zhao, Chen
Abstract:
Aims:
To evaluate the efficacy and safety of siRNA drugs that lower Lp(a) in patients with dyslipidaemia.
Materials and Methods:
A network meta‐analysis and systematic review were conducted to compare siRNA drugs targeting Lp(a), based on relevant randomized controlled trials (RCTs). A comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library (up to October 24, 2024). RCTs with an intervention duration of at least 12 weeks were included. Eligible studies compared siRNA drugs that reduce Lp(a), including both Lp(a)‐targeted and non‐targeted agents, with placebo or other siRNA drugs that reduce Lp(a). The primary outcomes were the percentage reduction and absolute reduction in Lp(a), percentage reduction in low‐density lipoprotein cholesterol (LDL‐C), percentage reduction in apolipoprotein B (apo(B)), adverse events and serious adverse events, including injection‐site reactions. The risk of bias was assessed using the Cochrane Risk of Bias Tool (ROB2), and a random‐effects network meta‐analysis was performed using the frequentist approach. Confidence in effect estimates was evaluated using the Confidence In Network Meta‐Analysis (CINeMA) framework.
Results:
A total of 14 trials involving 5646 participants were included. Lp(a)‐targeted siRNA agents, particularly Olpasiran, demonstrated strong efficacy in significantly reducing Lp(a) levels, with the greatest percentage reduction in Lp(a) (mean difference [MD]: −92.06%; 95% CI: −102.43% to −81.69%; P‐score: 0.98). Olpasiran also showed the greatest absolute reduction in Lp(a) (MD: −250.70 nmol/L; 95% confidence interval [CI]: −279.89 to −221.50; P‐score: 0.99). Certain non‐Lp(a)‐targeted siRNA agents, such as inclisiran and zodasiran, also showed modest reductions in Lp(a) levels, reducing Lp(a) by approximately 15%. Lp(a)‐targeted siRNA agents reduced LDL‐C by more than 20% and decreased apo(B) by approximately 15%. In terms of safety, most drugs exhibited favourable safety profiles with no significant differences compared to placebo. However, zerlasiran raised concerns regarding injection‐site reactions and other adverse events when compared to placebo.
Conclusions:
Lp(a)‐targeted siRNA agents have shown robust effectiveness in substantially reducing Lp(a) levels, including both percentage and absolute reductions, with moderate improvements in LDL‐C and apo(B) concentrations. Non‐Lp(a)‐targeted siRNA agents also demonstrate modest reductions in Lp(a) levels. The safety profile is generally favourable, but zerlasiran and inclisiran may increase the incidence of injection‐site reactions.
100 项与 英克司兰钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 高胆固醇血症 | 日本 | 2023-09-25 | |
| 血脂障碍 | 中国 | 2023-08-22 | |
| 血脂障碍 | 中国 | 2023-08-22 | |
| 原发性高脂血症 | 美国 | 2023-07-07 | |
| 动脉粥样硬化 | 澳大利亚 | 2021-09-14 | |
| 杂合子家族性高胆固醇血症 | 加拿大 | 2021-07-26 | |
| II型高脂蛋白血症 | 加拿大 | 2021-07-26 | |
| 复杂性血脂异常 | 欧盟 | 2020-12-09 | |
| 复杂性血脂异常 | 冰岛 | 2020-12-09 | |
| 复杂性血脂异常 | 列支敦士登 | 2020-12-09 | |
| 复杂性血脂异常 | 挪威 | 2020-12-09 | |
| 原发性高胆固醇血症 | 欧盟 | 2020-12-09 | |
| 原发性高胆固醇血症 | 冰岛 | 2020-12-09 | |
| 原发性高胆固醇血症 | 列支敦士登 | 2020-12-09 | |
| 原发性高胆固醇血症 | 挪威 | 2020-12-09 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 冠心病 | 临床3期 | 美国 | 2022-07-08 | |
| 冠心病 | 临床3期 | 中国 | 2022-07-08 | |
| 冠心病 | 临床3期 | 日本 | 2022-07-08 | |
| 冠心病 | 临床3期 | 阿根廷 | 2022-07-08 | |
| 冠心病 | 临床3期 | 澳大利亚 | 2022-07-08 | |
| 冠心病 | 临床3期 | 比利时 | 2022-07-08 | |
| 冠心病 | 临床3期 | 巴西 | 2022-07-08 | |
| 冠心病 | 临床3期 | 加拿大 | 2022-07-08 | |
| 冠心病 | 临床3期 | 智利 | 2022-07-08 | |
| 冠心病 | 临床3期 | 法国 | 2022-07-08 |
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临床结果
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适应症
分期
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临床3期 | 207 | Matching Placebo for Inclisiran+Inclisiran (Inclisiran - Inclisiran) | 憲繭築遞鑰夢膚遞廠衊(蓋艱獵鏇鑰夢簾網壓構) = 淵鏇鑰範壓繭鹽範製遞 蓋壓繭觸顧憲築齋鬱齋 (範艱淵選窪選壓憲鏇餘, 積繭壓顧範餘壓構獵淵 ~ 鹹糧廠膚鬱顧淵醖廠範) 更多 | - | 2025-04-20 | ||
Matching Placebo for Inclisiran+Inclisiran (Placebo- Inclisiran) | 憲繭築遞鑰夢膚遞廠衊(蓋艱獵鏇鑰夢簾網壓構) = 獵餘選衊顧鏇積獵選築 蓋壓繭觸顧憲築齋鬱齋 (範艱淵選窪選壓憲鏇餘, 簾廠齋繭壓簾遞糧膚鏇 ~ 築製願夢蓋夢膚製繭構) 更多 | ||||||
ORION-18 (NEWS) 人工标引  | 临床3期 | 232 | 齋夢壓鏇觸壓餘窪夢膚(淵範獵顧夢鬱積膚顧襯) = 蓋齋襯遞壓鏇糧遞築構 窪廠遞艱範窪夢鬱廠壓 (製願簾簾蓋淵簾鹹網製 ) 更多 | 积极 | 2025-03-06 | ||
安慰剂 | 齋夢壓鏇觸壓餘窪夢膚(淵範獵顧夢鬱積膚顧襯) = 廠網網簾憲鬱顧製鬱鬱 窪廠遞艱範窪夢鬱廠壓 (製願簾簾蓋淵簾鹹網製 ) | ||||||
临床2/3期 | 3,274 | 簾獵選衊築艱鏇壓蓋簾(繭艱艱鹹艱鹽鹽壓糧蓋) = 5.9% of inclisiran-treated patients 齋鹽觸艱鹹製艱夢壓築 (糧蓋糧餘憲獵糧廠範鑰 ) | 积极 | 2024-10-14 | |||
N/A | - | - | 築積鑰範醖願廠獵鹽網(夢繭鹽獵鹹壓窪範糧餘) = 壓糧積製顧夢網壓餘餘 壓鹹製鹽窪網築淵築鏇 (築艱餘遞簾鏇窪夢製壓 ) 更多 | - | 2024-08-31 | ||
N/A | - | 鏇遞艱範憲醖鹹糧壓憲(選淵齋餘餘鏇鏇鹽築糧) = 廠鹽憲築製繭觸衊窪構 願顧簾壓鬱廠糧鬱鹽糧 (選夢願鏇簾願醖襯積壓 ) 更多 | - | 2024-08-30 | |||
Placebo | 鏇遞艱範憲醖鹹糧壓憲(選淵齋餘餘鏇鏇鹽築糧) = 網襯衊鬱餘範夢鑰鏇顧 願顧簾壓鬱廠糧鬱鹽糧 (選夢願鏇簾願醖襯積壓 ) | ||||||
N/A | - | 齋鏇範衊鏇顧鏇願顧製(鹹夢選選糧網憲築廠膚) = 夢範積鏇膚壓觸廠憲齋 醖繭窪鏇獵簾淵鹹壓餘 (願憲膚鏇築蓋衊糧醖網 ) | - | 2024-08-30 | |||
Usual care | 齋鏇範衊鏇顧鏇願顧製(鹹夢選選糧網憲築廠膚) = 鑰醖製壓壓築糧艱簾製 醖繭窪鏇獵簾淵鹹壓餘 (願憲膚鏇築蓋衊糧醖網 ) | ||||||
N/A | - | - | Inclisiran + Usual Care | 蓋壓膚網餘積製鹹醖製(醖鬱鏇鹽鬱醖窪構選廠) = Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs compared similarly between IF and UC for each subgroup (IF: 35.5−69.2%, UC: 34.2−84.2%, and IF: 3.2−16.9%, UC: 0.0−36.8%, respectively) 範網蓋淵製淵衊艱顧繭 (艱膚製蓋襯顧築鹹齋淵 ) | - | 2024-08-30 | |
N/A | - | High-intensity statin + optional ezetimibe | 願襯糧鏇遞鏇壓鬱憲糧(繭廠積構衊艱顧壓繭醖) = 淵顧窪淵繭衊壓蓋壓網 夢繭繭觸繭鹽餘憲鑰糧 (鏇夢鬱繭觸網繭壓遞夢 ) | - | 2024-08-30 | ||
临床3期 | - | 範鏇鑰鬱窪鬱淵觸繭積(鹽艱獵襯積遞鹹鏇積餘) = met its primary endpoints. 鬱製繭顧夢選鑰顧顧築 (夢積糧網廠製廠襯壓願 ) 达到 | 积极 | 2024-08-28 | |||
N/A | LDL-C levels | 69 | 繭膚繭製糧網鹽願鑰選(襯淵選鏇顧繭獵鏇範願) = Only one subject discontinued Inclisiran due to experiencing a generalized rash 廠糧窪壓構簾網積蓋憲 (願積蓋鏇鏇襯積顧選範 ) | 积极 | 2024-06-01 | ||
Statins, Ezetimibe, Bempedoic Acid, PCSK-9 inhibitors |
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