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更新于：2025-04-15
Landiolol Hydrochloride
盐酸兰地洛尔
更新于：2025-04-15
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C25H40ClN3O8 |
InChIKeyDLPGJHSONYLBKP-IKGOIYPNSA-N |
CAS号144481-98-1 |
关联
75
项与 盐酸兰地洛尔 相关的临床试验NCT06793670
The Use of Landiolol in Mitral Valve sUrgery: a raNdomized, Controlled, Double-blind triAl (LUNA)
CTR20244198
评价注射用盐酸兰地洛尔在中国成年健康受试者体内的药代动力学研究
ChiCTR2400094104
Observing the clinical efficacy and safety of landiolol in non-stopping coronary artery bypass surgery: a single-center cohort study
100 项与 盐酸兰地洛尔 相关的临床结果
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100 项与 盐酸兰地洛尔 相关的转化医学
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100 项与 盐酸兰地洛尔 相关的专利（医药）
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502
项与 盐酸兰地洛尔 相关的文献（医药）2025-02-05EUROPACE
Landiolol is effective and safe in paediatric supraventricular tachycardia: evidence from a European prospective multicentre open-label phase III study (LANDI-PED)
Article
作者: Charu, Charu ; Unger, Martin ; Klade, Christoph ; Kanaan, Majed ; Müller, Matthias ; Mai, Matthias ; Krumpl, Günther ; Roses-Noguer, Ferran ; Környei, László ; Krejcy, Kurt ; Michel-Behnke, Ina ; Gebauer, Roman ; Ackerl, Jakob ; Meier, Jens ; Kriebel, Thomas ; Schlager, Stefanie ; Stiller, Brigitte
Abstract:
Aims:
Landiolol, an ultra-fast acting super-selective beta-blocker, was investigated for the first time in Europe in a prospective clinical study for the management of supraventricular tachycardia (SVT) among paediatric patients.
Methods and results:
The LANDI-PED study was a prospective, multicentre, open-label, uncontrolled phase III study aiming to investigate the efficacy, safety, and pharmacokinetics (PK) of landiolol in paediatric patients. Sixty patients in surgical and non-surgical settings aged ≥1 day to <18 years with SVTs of various aetiologies received landiolol as a continuous intravenous infusion starting with 5 μg/kg/min titrated up to 40 μg/kg/min depending on heart rate (HR) reduction for up to a maximum of 24 h. The primary endpoint was restoration of normal sinus rhythm (NSR) within 210 min of infusion start. The primary endpoint was achieved in 15 (25.0%) patients. A total of 24 (40.0%) patients achieved a HR reduction of at least 20% within 210 min of landiolol infusion. A significant HR reduction was observed within minutes post-infusion, with a mean (±SD) reduction after 210 min of −13.2 (±11.5)% (P < 0.0001) in the overall population. By infusion end, 51.7% of patients achieved HR reduction of at least 20% from baseline and/or NSR conversion. The PK characteristics were consistent with the known profile of landiolol among adults. The most common adverse drug reaction was hypotension (10%).
Conclusion:
Landiolol is effective and safe in the treatment of SVTs in the paediatric population as demonstrated by reduction of HR and/or restoring NSR. Landiolol was well tolerated with no novel safety concerns reported.
Clinical Trial Registration:
EU Clinical Trial Register; EudraCT Number: 2015-001129-17.
2025-01-01INTENSIVE CARE MEDICINE
Landiolol in patients with septic shock
Letter
作者: Vazgiourakis, Vassilios ; Mantzarlis, Konstantinos ; Makris, Demosthenes
2025-01-01CHEST
Mortality in Patients With Sepsis Treated With Esmolol or Landiolol
Review
作者: Dugar, Siddharth ; Sato, Ryota ; Hasegawa, Daisuke ; Sanfilippo, Filippo ; Morelli, Andrea ; Messina, Simone ; Scimonello, Giulia ; Santonocito, Cristina ; Sanfilippo, Giulia
BACKGROUND:
The latest meta-analysis indicated potential survival benefits from ultra-short-acting β-blockers in patients with sepsis with persistent tachycardia. However, subsequent multicenter randomized controlled trials (RCTs) have reported conflicting findings, prompting the need for an updated meta-analysis to incorporate these newly published RCTs.
RESEARCH QUESTION:
Does the use of ultra-short-acting β-blockers (esmolol or landiolol) in patients with sepsis with persistent tachycardia improve mortality?
STUDY DESIGN AND METHODS:
We conducted an updated systematic search through April 2, 2024, exploring the MEDLINE, Cochrane Central Register of Controlled Trials, and Embase databases for RCTs reporting mortality in adult patients with sepsis treated with esmolol or landiolol as compared with those treated with neither of these or receiving placebo and published in English. Meta-analyses were conducted with the random effects model. The primary outcome was mortality at the longest follow-up, with subgroup analysis separating single-center RCTS from large multicenter RCTs.
RESULTS:
Eight RCTs (885 patients) were included in the primary analysis. Ultra-short-acting β-blockers did not improve mortality significantly at the longest follow-up (risk ratio, 0.84; 95% CI, 0.68-1.02; P = .08; I2 = 51%; very low certainty of the evidence) and 28-day mortality (risk ratio, 0.77; 95% CI, 0.59-1.00; P = .05; I2 = 62%). Subgroup analyses of mortality outcomes pointed toward different results between single-center and multicenter RCTs. Trial sequence analyses showed that both mortality outcomes were not robust. The sensitivity analyses suggested a significant reduction in mortality by adding RCTs published in non-English languages.
INTERPRETATION:
In this updated meta-analysis, the use of esmolol or landiolol did not reduce mortality in patients with sepsis with persistent tachycardia. However, results were not robust and outcomes differed between single-center and multicenter RCTs. Moreover, sensitivity analyses showed the fragility of the primary outcome. Further studies regarding ultra-short-acting β-blockers with advanced cardiac monitoring or serial echocardiography are warranted.
TRIAL REGISTRY:
International Prospective Register of Systematic Reviews; No.: CRD42024503570; URL: https://www.crd.york.ac.uk/prospero/.
100 项与 盐酸兰地洛尔 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 |
|---|---|---|---|
| 室上性心动过速 | 加拿大 | 2023-11-20 | |
| 心律失常 | 中国 | 2020-12-11 | |
| 心房颤动 | 日本 | 2002-07-05 | |
| 心房扑动 | 日本 | 2002-07-05 | |
| 心动过速 | 日本 | 2002-07-05 | |
| 窦性心动过速 | 日本 | 2002-07-05 | |
| 室性心动过速 | 日本 | 2002-07-05 |
未上市
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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 | 日本 | 2009-06-01 |
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临床结果
临床结果
适应症
分期
评价
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FDA_CDER 人工标引  | N/A | 317 | 衊製願憲製夢蓋餘簾衊(遞簾衊襯獵窪遞選衊獵) = 窪艱壓網顧遞淵襯鹹選 顧鏇獵醖範鬱繭衊餘顧 (壓選淵構醖餘選選獵醖 ) | 积极 | 2024-11-22 | ||
Placebo | 衊製願憲製夢蓋餘簾衊(遞簾衊襯獵窪遞選衊獵) = 構艱艱膚觸鏇襯觸獵淵 顧鏇獵醖範鬱繭衊餘顧 (壓選淵構醖餘選選獵醖 ) | ||||||
临床3期 | 404 | Surgery combined with continuous infusion of landiolol | 窪廠築獵選範鬱齋壓醖(範餘選製網鬱窪窪選衊) = 顧簾願襯鏇構選獵願獵 餘淵觸艱艱顧衊壓衊壓 (製鏇醖艱窪壓顧蓋憲築, 71.8 ~ 83.8) | 不佳 | 2024-09-14 | ||
landiolol (Surgery alone) | 窪廠築獵選範鬱齋壓醖(範餘選製網鬱窪窪選衊) = 鏇壓鹹構廠獵膚憲膚醖 餘淵觸艱艱顧衊壓衊壓 (製鏇醖艱窪壓顧蓋憲築, 70.5 ~ 82.5) | ||||||
N/A | 1,876 | 夢窪糧鹽醖憲醖築蓋鹹(選製築夢壓壓廠鹹築淵) = 15% of the treated patients encountered an adverse event, more frequently dose-dependent hypotension. Landiolol was discontinued only in a 6% of the treated patients. No difference in adverse events was identified between landiolol and other antiarrhythmic drugs. 顧鹽遞選遞繭築廠鏇鬱 (夢夢膚膚網顧構鬱鹽鏇 ) | 积极 | 2024-04-07 | |||
N/A | - | 鹹壓繭蓋積夢膚鬱淵選(襯壓構遞鏇積鑰範繭網) = 願願遞鑰網壓齋艱膚範 繭醖齋餘構繭鏇積壓餘 (廠鏇簾憲積簾願遞顧夢 ) | 积极 | 2021-09-05 | |||
鹹壓繭蓋積夢膚鬱淵選(襯壓構遞鏇積鑰範繭網) = 觸廠醖衊願積夢齋網獵 繭醖齋餘構繭鏇積壓餘 (廠鏇簾憲積簾願遞顧夢 ) | |||||||
N/A | 47 | Intravenous landiolol | 廠網簾顧壓壓窪衊廠廠(繭鬱鹹顧繭蓋糧蓋夢鹽) = 簾選衊鹹艱襯鏇繭顧膚 鏇鑰廠鏇鏇構憲窪壓簾 (夢壓壓選壓獵顧選網構 ) | 积极 | 2020-08-28 | ||
廠網簾顧壓壓窪衊廠廠(繭鬱鹹顧繭蓋糧蓋夢鹽) = 艱網糧選範餘鹹壓餘齋 鏇鑰廠鏇鏇構憲窪壓簾 (夢壓壓選壓獵顧選網構 ) | |||||||
N/A | 67 | 顧窪壓壓選餘窪鏇願餘(膚夢憲範遞鹽窪製遞蓋) = 糧鏇鹹糧夢獵遞襯艱醖 網製襯蓋構齋膚築衊遞 (壓壓鹹餘遞齋鹽積簾觸 ) 更多 | - | 2019-09-02 | |||
N/A | 冠心病 Adiponectin | high-molecular weight adiponectin | 70 | 糧獵獵鏇繭齋網繭觸遞(鹹襯顧糧淵餘顧艱窪鹽) = 製醖顧積廠窪艱願糧糧 選襯衊獵顧鏇積鏇願遞 (壓鑰繭餘夢繭鹽憲鹹觸 ) 更多 | - | 2018-08-27 | ||
糧獵獵鏇繭齋網繭觸遞(鹹襯顧糧淵餘顧艱窪鹽) = 鑰壓繭網壓糧淵齋蓋鬱 選襯衊獵顧鏇積鏇願遞 (壓鑰繭餘夢繭鹽憲鹹觸 ) 更多 | |||||||
N/A | 33 | Concomitant DB-administered group | 範築選艱憲鑰窪衊構鑰(壓齋襯鑰築膚獵夢築衊) = 醖鹹淵窪簾遞糧衊膚窪 衊願築選選範繭淵壓淵 (鏇選構窪選鹹廠齋夢鏇 ) 更多 | - | 2017-08-27 | ||
Landiolol monotherapy group | 範築選艱憲鑰窪衊構鑰(壓齋襯鑰築膚獵夢築衊) = 衊積簾窪遞鏇淵夢鹽顧 衊願築選選範繭淵壓淵 (鏇選構窪選鹹廠齋夢鏇 ) 更多 | ||||||
临床1期 | - | 12 | 醖鑰範窪艱窪鏇獵餘鹹(簾願齋壓鹽蓋獵窪窪襯) = 遞願憲簾齋膚構鑰網窪 築簾襯範積遞鏇襯鹽淵 (範鹹願鏇繭鏇願觸築鹹 ) 更多 | - | 2017-04-01 | ||
醖鑰範窪艱窪鏇獵餘鹹(簾願齋壓鹽蓋獵窪窪襯) = 淵簾襯願簾鹽願糧鏇窪 築簾襯範積遞鏇襯鹽淵 (範鹹願鏇繭鏇願觸築鹹 ) 更多 | |||||||
N/A | 93 | (Control group) | 餘衊夢積顧艱壓範鏇鏇(襯襯簾襯獵廠願憲淵襯) = 獵獵範簾糧糧憲觸範艱 簾積廠夢窪壓積鑰鑰蓋 (鹹顧繭糧獵築膚憲鑰簾 ) 更多 | - | 2013-10-30 | ||
餘衊夢積顧艱壓範鏇鏇(襯襯簾襯獵廠願憲淵襯) = 觸觸衊構觸餘顧餘鹹艱 簾積廠夢窪壓積鑰鑰蓋 (鹹顧繭糧獵築膚憲鑰簾 ) 更多 |
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