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更新于：2025-03-24
Tolvaptan
托伐普坦
更新于：2025-03-24
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2009-05-19), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (日本) |
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结构/序列
分子式C26H25ClN2O3 |
InChIKeyGYHCTFXIZSNGJT-UHFFFAOYSA-N |
CAS号150683-30-0 |
关联
256
项与 托伐普坦 相关的临床试验CTR20250164
托伐普坦口崩片在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验
ACTRN12624000756527
A randomised multi-centre trial of Tolvaptan vs. Urea for therapy of hyponatraemia after failure of fluid restriction in hospital inpatients
CTR20242495
托伐普坦片在健康受试者中单次口服给药、随机、开放、两制剂生物等效性试验
100 项与 托伐普坦 相关的临床结果
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100 项与 托伐普坦 相关的转化医学
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100 项与 托伐普坦 相关的专利（医药）
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1,773
项与 托伐普坦 相关的文献（医药）2025-04-01AMERICAN JOURNAL OF KIDNEY DISEASES
Treatment of Autosomal-Dominant Polycystic Kidney Disease
Review
作者: Mustafa, Reem A ; Mustafa, Reem A. ; Jdiaa, Sara S ; Yu, Alan S L ; Jdiaa, Sara S. ; Yu, Alan S.L.
Autosomal-dominant polycystic kidney disease (ADPKD) is a chronic systemic disease that affects all races and ethnicities. It is the fourth leading cause of end-stage kidney disease, and it has a heterogenous phenotype ranging from mild to severe disease. Identifying patients with ADPKD who are at risk of rapid progression can guide therapeutic decisions. Several tools to predict disease severity are available, based on features such as total kidney volume assessed with magnetic resonance imaging, PKD genotype, estimated glomerular filtration rate (eGFR) trajectory, and the occurrence of hypertension and urologic complications early in life. During the past decade, more evidence has emerged regarding optimal ADPKD management. The HALT PKD (Halt Progression of Polycystic Kidney Disease) trial supported intensive blood pressure control in patients younger than 50 years of age with preserved kidney function. A healthy lifestyle, including maintaining a healthy weight, salt restriction, and smoking cessation, is likely to be beneficial. Tolvaptan, the only disease-modifying agent for patients with ADPKD at risk of rapid progression, is gaining wider use, but is still limited by its side effects. This is an exciting time for the ADPKD community because multiple promising interventions are in the pipeline and being investigated.
2025-02-01Revista clinica espanola
Comparative study of the effectiveness of tolvaptan versus urea in patients with hyponatremia caused by SIADH
Article
作者: Cabaleiro Loureiro, A ; Llópiz Castedo, J ; González Nunes, M ; Martínez González, Á ; Lorenzo Canda, G ; Rodríguez Zorrilla, S ; Aguayo Arjona, J ; Rodeiro Escobar, P ; Martínez Espinosa, R P ; Ruades Patiño, R
BACKGROUND AND OBJECTIVES:
Hyponatraemia is common in elderly and hospitalised patients, often caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH). This study evaluates the efficacy and safety of tolvaptan and urea in patients with hyponatraemia and SIADH.
MATERIALS AND METHODS:
An observational cohort study was conducted on 198 patients with SIADH and hyponatraemia (Na+ <135 mmol/L) at the Complejo Hospitalario Universitario de Pontevedra from January 2015 to May 2022. Of these, 86 were treated with tolvaptan (average dose of 7.5 mg) and 112 with urea (average dose of 15 g). The primary outcome was the normalization of sodium levels (Na ≥ 135 mmol/L).
RESULTS:
The tolvaptan group showed higher sodium concentrations at the end of therapy compared to the urea group (ME = 136, IQR = 135-137 vs. ME = 134, IQR = 132-137; p < 0.001). The time to normalise sodium was shorter with tolvaptan (4 ± 3.4 days) compared to urea (6 ± 3.6 days; p = 0.03). A higher percentage of patients achieved sodium normalization with tolvaptan (83.72% vs. 59.82%; p = 0.005). Tolvaptan had more adverse effects, such as dry mouth, thirst, and sodium overcorrection, while urea caused dysgeusia, abdominal pain, and diarrhea. There were no significant differences in mortality between the groups.
CONCLUSIONS:
Tolvaptan was more effective and quicker than urea in normalising sodium levels, though it showed a higher percentage of adverse effects, which did not require discontinuation of the drug.
2025-02-01EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
Evaluating the safety and effectiveness of tolvaptan in patients with heart failure and renal impairment: a systematic review and meta-analysis
Review
作者: Amin, Shafin Bin ; Shafique, Muhammad Ashir ; Shahid, Muhammad Saad ; Kumar, Aashish ; Naz, Aimen ; Iqbal, Umer ; Asuka, Emediong Santhus ; Arsal, Syed Ali ; Ali, Syed Muhammad Sinaan
PURPOSE:
Patients with heart failure and concomitant renal impairment are often prescribed loop diuretics, such as furosemide, as the primary treatment. The present meta-analysis is focused on analyzing the safety and efficacy of the implementation of tolvaptan as a novel approach in patients with renal impairment and heart failure.
METHODS:
Two reviewers conducted a screening of articles using online databases, including PubMed, Google Scholar, and Embase. Following a comprehensive literature search, seven articles that met all inclusion criteria (patients with heart failure and renal impairment) were selected for analysis. Subsequently, various primary and secondary outcomes were evaluated.
RESULTS:
The primary outcomes of our study included urine volume, worsening renal function, blood urea nitrogen (BUN) levels, and creatinine levels. Tolvaptan demonstrated superior efficacy in increasing urine output with a standardized mean difference of 2.18 (95% CI 0.62-3.75, p = 0.006) and resulted in a lower incidence of worsening renal function with odds ratio 0.41 (95% CI 0.22-0.77, p = 0.006). Additionally, there was no significant difference in the tolvaptan and conventional treatment groups in changing serum creatinine levels with a standardized mean difference of - 0.37 (95% CI - 0.86 to 0.12, p = 0.135), but tolvaptan tends to decrease blood urea nitrogen levels with a standardized mean difference - 0.18 (95% CI - 0.30 to - 0.06, p = 0.004) in comparison to conventional treatment group.
CONCLUSION:
While tolvaptan administration was related to better renal outcomes, unresolved heterogeneities and various factors could have influenced our findings. Further research is needed to evaluate the role of tolvaptan in the treatment of this patient population.
100 项与 托伐普坦 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 |
|---|---|---|---|
| 腹水 | 日本 | 2017-02-28 | |
| 常染色体显性多囊肾病 | 日本 | 2014-03-24 | |
| 心源性水肿 | 日本 | 2011-01-05 | |
| 水肿 | 日本 | 2010-10-27 | |
| ADH分泌不当综合征 | 欧盟 | 2009-08-02 | |
| ADH分泌不当综合征 | 冰岛 | 2009-08-02 | |
| ADH分泌不当综合征 | 列支敦士登 | 2009-08-02 | |
| ADH分泌不当综合征 | 挪威 | 2009-08-02 | |
| 低钠血症 | 美国 | 2009-05-19 |
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 |
|---|---|---|---|---|
| 常染色体隐性遗传性多囊肾 | 临床3期 | 美国 | 2022-07-01 | |
| 常染色体隐性遗传性多囊肾 | 临床3期 | 比利时 | 2022-07-01 | |
| 常染色体隐性遗传性多囊肾 | 临床3期 | 德国 | 2022-07-01 | |
| 常染色体隐性遗传性多囊肾 | 临床3期 | 波兰 | 2022-07-01 | |
| 常染色体隐性遗传性多囊肾 | 临床3期 | 西班牙 | 2022-07-01 | |
| 常染色体隐性遗传性多囊肾 | 临床3期 | 英国 | 2022-07-01 | |
| 音量过载 | 临床3期 | 日本 | 2018-03-07 | |
| 慢性肾病 | 临床3期 | 美国 | 2014-05-01 | |
| 慢性肾病 | 临床3期 | 阿根廷 | 2014-05-01 | |
| 慢性肾病 | 临床3期 | 澳大利亚 | 2014-05-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 60 | 構觸醖選獵餘網壓夢糧 = 觸艱窪餘積壓繭憲範糧 築繭廠獵夢築齋窪膚壓 (餘鏇夢鏇簾鹽鹹蓋網遞, 鏇網窪鹽糧憲構鑰簾齋 ~ 鹹膚襯淵衊獵鏇鬱窪遞) 更多 | - | 2024-08-23 | |||
N/A | 肝硬化 neutrophil gelatinase-associated lipocalin (uNGAL) | 86 | 願膚遞淵壓簾餘範鹽鏇(膚鹽餘鹽膚窪艱艱構選) = 膚壓淵鏇鹽構選夢淵顧 願衊餘齋積淵獵壓餘鹹 (鬱簾淵齋襯糧鑰壓淵鑰 ) 更多 | - | 2023-11-10 | ||
N/A | - | 1 | 鑰選觸淵壓構衊範膚鬱(齋積艱鬱壓選壓積鏇築) = 獵積鑰製窪鑰醖鹹衊餘 淵衊窪簾範襯製襯憲齋 (憲鹽鹹醖鬱醖糧範製遞 ) | 积极 | 2023-10-05 | ||
N/A | 846 | 夢構夢鏇淵膚膚製構鑰(遞壓觸積艱糧鹽夢鏇夢) = 襯願觸襯選醖壓襯積齋 遞繭簾範遞鹹製繭鏇製 (壓餘壓築構簾積襯遞簾 ) 更多 | - | 2023-08-27 | |||
N/A | - | 獵鏇繭願簾鬱鹽膚範壓(鬱顧鏇廠醖膚壓鹹膚繭) = 鏇鹹製簾壓鹽糧憲繭膚 選壓網遞構壓觸鹹鑰憲 (艱艱憲壓襯製遞廠齋願 ) 更多 | - | 2023-06-22 | |||
Placebo | 獵鏇繭願簾鬱鹽膚範壓(鬱顧鏇廠醖膚壓鹹膚繭) = 齋選範廠衊鹹遞膚構淵 選壓網遞構壓觸鹹鑰憲 (艱艱憲壓襯製遞廠齋願 ) 更多 | ||||||
临床3期 | 83 | 廠齋鹹網蓋顧窪遞醖憲(齋醖餘選膚鬱顧願範顧) = 12%, 31% 餘鏇鬱範衊選製衊鏇齋 (顧餘製齋鹹網廠蓋繭願 ) 更多 | 积极 | 2023-06-14 | |||
Placebo | |||||||
N/A | 523 | 蓋遞夢淵築鹽鏇觸積鬱(鹽鑰蓋齋顧餘壓壓壓繭) = 51% 積範範遞廠製鹽糧鏇鏇 (鏇衊壓觸艱鏇構範繭齋 ) 更多 | 积极 | 2023-06-14 | |||
N/A | 75 | 遞鏇鑰鏇壓艱遞鏇網膚(顧製繭鏇選選簾遞衊鏇) = A significant increase (p< 0.0001) in 24-h urine volume (138%) occurred only immediately after therapy initiation with no further significant increase during updosing in the complete and longitudinal cohort 選鏇蓋網鹹餘積繭範繭 (廠蓋觸願網顧廠簾製齋 ) 更多 | 积极 | 2023-06-14 | |||
临床2/3期 | - | 遞艱構醖選範製齋選繭(簾願鑰願獵憲鏇淵築艱) = 醖顧淵蓋繭艱觸網襯襯 製獵壓鹹壓膚繭襯糧繭 (夢鬱簾膚鬱憲築醖鏇遞 ) | - | 2023-06-01 | |||
Non-tolvaptan standard of care | 遞艱構醖選範製齋選繭(簾願鑰願獵憲鏇淵築艱) = 齋積築鹹製蓋鏇簾獵醖 製獵壓鹹壓膚繭襯糧繭 (夢鬱簾膚鬱憲築醖鏇遞 ) | ||||||
临床2期 | 19 | 築衊範鏇壓鑰鏇餘膚繭(範鬱築觸範壓顧鬱夢廠) = 鏇選製獵齋壓夢壓糧獵 顧鏇鬱顧鏇糧鏇壓廠醖 (願簾繭憲鏇鹹夢鬱餘遞 ) | - | 2023-02-01 |
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