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更新于：2025-05-31
Landiolol Hydrochloride
盐酸兰地洛尔
更新于：2025-05-31
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
73
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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512
项与 盐酸兰地洛尔 相关的文献（医药）2025-05-23CIRCULATION JOURNAL
Post-Marketing Surveillance of the Safety of Landiolol in Patients With Recurrent Hemodynamically Unstable Ventricular Tachyarrhythmias
Article
作者: Matsumoto, Ryoji ; Shiozaki, Masato ; Fukui, Masato ; Shiga, Tsuyoshi ; Takahashi, Rika
BACKGROUND:
Landiolol is a short-acting, intravenously administered β1-adrenergic receptor blocker that can rapidly control heart rate in refractory and urgent fatal arrhythmias (ventricular fibrillation [VF] and hemodynamically unstable ventricular tachyarrhythmia [VT]). This indication was approved in Japan in 2019 based on results of the J-Land II clinical trial. We conducted post-marketing surveillance (PMS) to assess the safety and effectiveness of landiolol in real-world settings in Japan.
METHODS AND RESULTS:
This PMS examined the safety, focusing on adverse drug reactions (ADRs) related to the safety specifications (SS), namely hypotension-decreased blood pressureSS, bradycardiaSS, and heart failureSS, and effectiveness (physician-rated) in patients treated with landiolol for the target indication. Among 253 registered patients, 13.0% experienced ADRs related to the safety specifications: bradycardiaSS(7.1%), hypotension-decreased blood pressureSS(6.7%), and heart failureSS(1.2%). Serious ADRs related to the safety specifications occurred in 6.7% of patients, including those related to bradycardiaSS(3.2%), hypotension-decreased blood pressureSS(3.2%), and heart failureSS(1.2%). The effectiveness of landiolol within 48 h after starting treatment was rated as effective (52.4%), slightly effective (27.0%), not effective (18.7%), and indeterminate (2.0%).
CONCLUSIONS:
The safety profile of landiolol in this PMS was similar to that observed in a prior clinical trial, and no new safety signals were identified. Landiolol is an option for treating refractory and potentially fatal VF or hemodynamically unstable VT.
2025-05-09Circulation reports
Landiolol-Induced Severe Vasospastic Angina Leading to Total Coronary Occlusion During Coronary Computed Tomography Angiography
Article
作者: Hachinohe, Daisuke ; Fujita, Tsutomu ; Kuramitsu, Shoichi ; Kashima, Yoshifumi ; Shimizu, Takuya
2025-05-01Radiography
Calculating the heart rate cutoff that avoids motion artifacts with and without beta-blockers during 64-row coronary artery CT angiography
Article
作者: Arao, S ; Funama, Y ; Miyata, J ; Masuda, T ; Sugimoto, K ; Arao, K ; Nakaura, T ; Awai, K ; Ono, A ; Sato, T
INTRODUCTION:
This study evaluates the establishment of specific heart rate (HR) cutoff values for coronary computed tomography angiography (CCTA) images obtained with and without the use of beta-blockers in a 64-row scanner.
METHODS:
The study included 399 patients, of whom 269 received beta-blockers and 130 did not. Patients with an HR exceeding 65 bpm were administered an additional dose of landiolol hydrochloride (CoreBeta; Ono, Osaka, Japan). HR was continuously monitored using a noninvasive cardiac output monitor (Aesculon mini; Ospyka Medical, Berlin, Germany). A total of 1197 randomized curved maximum intensity projection images were independently reviewed by observers for the presence or absence of motion artifacts in the CCTA images. Receiver operating characteristic (ROC) analysis was used to calculate the area under the curve (AUC) and determine the optimal HR thresholds that maximized the sum of sensitivity and specificity for detecting motion artifacts.
RESULTS:
The optimal HR cutoff values were 76.6 bpm (AUC = 0.88, sensitivity = 83.0 %, specificity = 78.0 %) with beta-blockers, and 64.3 bpm (AUC = 0.91, sensitivity = 93.0 %, specificity = 86.0 %) without beta-blockers.
CONCLUSION:
This study determined the optimal HR cut-off values for CCTA using a 64-row CT scanner, with and without beta-blockers, respectively. Future research should explore how evolving imaging technology and techniques influence optimal HR thresholds and image quality.
IMPLICATIONS FOR PRACTICE:
Patients whose HR exceed 64.3 bpm during a CCTA scan, should be administered beta-blockers to lower HR to the level (≤64.3) that optimises image quality.
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
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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 | 遞獵繭鏇齋鹹淵遞夢鏇(網鹽淵願鹽願鏇獵膚鏇) = 遞獵艱鑰淵鹹遞窪衊製 鑰鹹築鹹膚獵餘艱窪蓋 (獵選簾憲窪範壓淵範網 ) | 积极 | 2024-11-22 | ||
Placebo | 遞獵繭鏇齋鹹淵遞夢鏇(網鹽淵願鹽願鏇獵膚鏇) = 鏇艱製繭繭壓餘簾積築 鑰鹹築鹹膚獵餘艱窪蓋 (獵選簾憲窪範壓淵範網 ) | ||||||
临床3期 | 404 | Surgery combined with continuous infusion of landiolol | 鑰蓋襯鑰齋範廠網鬱糧(夢糧鏇衊顧醖鬱淵鹹遞) = 齋鹽糧網窪觸夢窪齋鹽 鏇鹽網簾簾繭鑰糧糧夢 (鏇廠鬱壓構觸繭積襯鏇, 71.8 ~ 83.8) | 不佳 | 2024-09-14 | ||
landiolol (Surgery alone) | 鑰蓋襯鑰齋範廠網鬱糧(夢糧鏇衊顧醖鬱淵鹹遞) = 醖範夢獵廠膚醖願醖網 鏇鹽網簾簾繭鑰糧糧夢 (鏇廠鬱壓構觸繭積襯鏇, 70.5 ~ 82.5) | ||||||
N/A | 1,876 | 鹽簾蓋簾鏇齋鏇膚壓衊(淵壓顧艱齋餘範窪憲淵) = 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. 願夢壓餘膚鬱鏇繭獵鹽 (衊窪衊願衊範願遞選築 ) | 积极 | 2024-04-07 | |||
N/A | - | 醖積壓醖鑰廠淵築窪簾(鏇簾顧築餘壓積構網憲) = 壓窪鹹積襯範蓋築鹽醖 蓋選網膚襯艱觸簾觸築 (壓醖壓觸範製範遞蓋築 ) | 积极 | 2021-09-05 | |||
醖積壓醖鑰廠淵築窪簾(鏇簾顧築餘壓積構網憲) = 壓蓋構簾鬱構鹽壓淵網 蓋選網膚襯艱觸簾觸築 (壓醖壓觸範製範遞蓋築 ) | |||||||
N/A | 47 | Intravenous landiolol | 獵選壓獵遞鏇簾製範範(選網鬱製醖艱選廠醖遞) = 願鏇鬱鹹顧鏇衊鏇夢醖 艱觸膚製鹽鹽襯獵衊醖 (衊鏇鑰鹽觸夢獵網獵蓋 ) | 积极 | 2020-08-28 | ||
獵選壓獵遞鏇簾製範範(選網鬱製醖艱選廠醖遞) = 鏇範餘膚繭齋糧衊顧獵 艱觸膚製鹽鹽襯獵衊醖 (衊鏇鑰鹽觸夢獵網獵蓋 ) | |||||||
N/A | 67 | 齋選蓋製糧襯鏇範蓋艱(構衊壓醖醖網餘鏇膚範) = 願鹽齋夢簾齋糧繭襯衊 蓋築鹹築顧醖願鏇製餘 (鏇鬱鏇築獵淵鹹築鏇壓 ) 更多 | - | 2019-09-02 | |||
N/A | 冠心病 Adiponectin | high-molecular weight adiponectin | 70 | 製憲鏇醖鏇鏇構鬱願蓋(淵憲鬱憲蓋範範繭鏇繭) = 糧淵淵觸鏇鹹廠齋構選 鏇淵願鏇繭願網構廠範 (選窪膚繭鏇餘憲願窪夢 ) 更多 | - | 2018-08-27 | ||
製憲鏇醖鏇鏇構鬱願蓋(淵憲鬱憲蓋範範繭鏇繭) = 繭顧構構鏇壓範廠顧顧 鏇淵願鏇繭願網構廠範 (選窪膚繭鏇餘憲願窪夢 ) 更多 | |||||||
N/A | 33 | Concomitant DB-administered group | 蓋廠觸鹹製鏇網淵網廠(膚選襯顧願築鬱觸廠餘) = 鏇糧製選構鏇廠鑰憲膚 願糧醖範積鏇糧醖鑰夢 (顧簾衊築遞蓋艱醖鹹繭 ) 更多 | - | 2017-08-27 | ||
Landiolol monotherapy group | 蓋廠觸鹹製鏇網淵網廠(膚選襯顧願築鬱觸廠餘) = 壓願構廠膚鑰鏇廠糧願 願糧醖範積鏇糧醖鑰夢 (顧簾衊築遞蓋艱醖鹹繭 ) 更多 | ||||||
N/A | 93 | (Control group) | 獵獵選鏇糧鹹選鹽衊範(膚糧鏇襯衊網簾廠窪蓋) = 餘選繭鹽鏇艱遞蓋製窪 鹹網獵繭鏇襯鹹顧構繭 (顧糧構築醖憲艱壓網窪 ) 更多 | - | 2013-10-30 | ||
獵獵選鏇糧鹹選鹽衊範(膚糧鏇襯衊網簾廠窪蓋) = 夢蓋願夢簾餘鏇積築糧 鹹網獵繭鏇襯鹹顧構繭 (顧糧構築醖憲艱壓網窪 ) 更多 | |||||||
临床2期 | 183 | Landiolol hydrochloride 0.06-mg/kg | 衊鬱網遞憲顧顧醖觸夢(積淵顧網範鑰選網壓鏇) = No adverse events or reactions occurred at an incidence of 5 % or greater, confirming the safety of landiolol hydrochloride 鹹顧獵積憲觸鹹夢網鬱 (淵廠製膚積蓋鑰窪蓋網 ) | - | 2013-06-01 | ||
Landiolol hydrochloride 0.125-mg/kg |
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