更新于：2024-09-29
Bosentan
波生坦
更新于：2024-09-29
概要
基本信息
药物类型 小分子化药 |
别名 4-(1,1-Dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl) benzenesulfornamide、Bosentan (USAN)、bosentan anhydrous + [17] |
作用机制 ETA激动剂(内皮素A受体激动剂)、ETB拮抗剂(内皮素B受体拮抗剂) |
在研适应症 |
非在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2001-11-20), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国)、特殊审批 (中国)、孤儿药 (日本)、临床急需境外新药 (中国) |
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结构
分子式C27H31N5O7S |
InChIKeySXTRWVVIEPWAKM-UHFFFAOYSA-N |
CAS号157212-55-0 |
关联
185
项与 波生坦 相关的临床试验The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
Efficacy of Endothelin Receptor Antagonism in Treatment of Coronary Artery Spasm: a Randomized Controlled Clinical Trial
Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in Healthy Subjects Under Fasting Condition
100 项与 波生坦 相关的临床结果
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100 项与 波生坦 相关的转化医学
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100 项与 波生坦 相关的专利（医药）
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2,463
项与 波生坦 相关的文献（医药）2024-12-31Journal of medical economics
Comparative adherence of macitentan versus ambrisentan and bosentan in Australian patients with pulmonary arterial hypertension: a retrospective real-world database study
Article
作者: Tan, Jin Yu ; Casorso, Jeremy ; Bloomfield, Paul ; Lau, Edmund ; Kouhkamari, Mahsa H ; Yu, Dae Young ; Lim, Sooyeol ; Wu, David Bin-Chia ; Kotlyar, Eugene ; Makanji, Yogeshwar
AIM:
Bosentan, ambrisentan, and macitentan are endothelin receptor antagonists (ERAs), currently available in Australia for treatment of pulmonary arterial hypertension (PAH). This study assessed the comparative adherence of these ERAs for PAH in Australian patients.
METHODS:
This retrospective, observational study used data for adults with PAH from the Services Australia 10% Pharmaceuticals Benefits Scheme (PBS) dataset (01/2006-10/2020). The primary outcome was treatment adherence (i.e. receiving ≥80% of ERA doses over 12 months). Secondary outcomes were time to treatment change (add-on or switch) and overall survival.
RESULTS:
The study included 436 patients who took bosentan (n = 200), ambrisentan (n = 69), or macitentan (n = 167). Treatment adherence was significantly greater in patients who received macitentan (65.3%) versus ambrisentan (56.5%) and bosentan (58.0%), with odds ratios (ORs; 95% CI) of 0.51 (0.30-0.88; p = 0.016) for bosentan versus macitentan and 0.48 (0.24-0.96; p = 0.037) for ambrisentan versus macitentan. The median time to treatment change was 47.2 and 43.4 months for bosentan and ambrisentan, respectively (not calculated for macitentan because of insufficient duration of data).
LIMITATIONS AND CONCLUSIONS:
Real-world data for Australian patients with PAH showed that treatment adherence for ERAs was suboptimal. Adherence was higher for macitentan compared with ambrisentan and bosentan.
2024-10-01ESC Heart Failure
Pulmonary artery denervation versus conventional therapies for PAH: a systematic review and updated network meta‐analysis
Review
作者: Wei, Yongyue ; Chen, Feng ; Pan, Zoucheng ; Chen, Shao‐liang ; Zhang, Longyao ; Kan, Jing ; Wang, Xiang ; Wu, Xiaoyu
Abstract:
Aims:
A recent guideline presented by the ESC Congress in 2022 had indicated a novel therapy targeted at pulmonary artery hypertension, known as pulmonary artery denervation (PADN), which get inspired from a laboratorial trial that could lowering the pulmonary artery pressure through the intervention on the animals. Our aim is to conduct a network meta‐analysis to compare the efficacy and safety of PADN from six aspects with the current conventional therapies.
Methods and results:
According to the PRISMA guidance, databases including Ovid, ClinicalTrials.gov, Medline, Embase, and PubMed were searched from inception to 22 August 2023, along with a full assessment of the previous five meta‐analyses. Data were extracted and curated for Bayesian network meta‐analysis. The primary outcome was the change in the 6‐min walking distance (6MWD) from baseline with a secondary outcome called change in mean pulmonary artery pressure (mPAP) from baseline. The four safety outcomes included risk of clinical worsening, hospitalization, mortality and severe adverse events (SAEs). The comparison is structured on a contrast model based on 65 randomized controlled trials (RCTs) on PADN and the other conventional mainstream drugs. PADN had a better effect in improving 6MWD than Placebo (−77.76 m, 95% CI: −102.04 to −54.34 m), Macitentan (−65.32 m, 95% CI: −95.34 to −36.1 m), Bosentan (−64.5 m, 95% CI: −94.7 to −35.07 m), Iloprost (−62.66 m, 95% CI: −99.48 to −27.13 m), Oxygen (−62.42 m, 95% CI: −100.01 to −25.78 m), Treprostinil (−62.01 m, 95% CI: −89.04 to −35.61 m), Riociguat (−60.59 m, 95% CI: −86.11 to −35.98 m), Selexipag (−47.2 m, 95% CI: −85.61 to −10.19 m), Sildenafil (−44.92 m, 95% CI: −74.43 to −16.15 m), or Sitaxsentan (−39.53 m, 95% CI: −78.99 to −0.76 m). PADN had a better antihypertensive effect than placebo and showed statistical significant lower risks to induce clinical worsening and re‐hospitalization than treprostinil, riociguat, and placebo groups. No statistically significant difference in risk of mortality and severe adverse events was observed between PADN versus the other interventions.
Conclusions:
Compared with 16 types of conventional therapies and Placebo, PADN has advantage over nine single therapies and Placebo in improving 6MWD and appears to be better than two types of dual‐drug combined therapies while with no statistical significance. PADN shows a favourable antihypertensive effect on mPAP and has a lower risk to trigger clinical worsening or hospitalization, while its risk on mortality and severe adverse events is still inconclusive.
2024-10-01SEMINARS IN ARTHRITIS AND RHEUMATISM
Efficacy and safety of pharmacological treatments for autoimmune disease-associated interstitial lung disease: A systematic review and network meta-analysis
Review
作者: Zhou, Yiqun ; Liu, Zhichun ; Weng, Chenghua ; Ding, Zongnan ; Zhang, Lei ; Wang, Gang ; Xue, Leixi
BACKGROUND:
Immunosuppressants, biologic agents, antifibrotic drugs, and other drugs can be used to treat autoimmune disease-associated interstitial lung disease (ILD), but the preferred treatment is uncertain. We aimed to evaluate the efficacy and safety of multiple drugs in the treatment of autoimmune disease-associated ILD.
METHODS:
PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov were searched for relevant randomized controlled trials (RCTs) from inception to July 2023. Primary outcomes were percentage of predicted forced vital capacity (FVC% predicted) and discontinuations for adverse events (AEs). We estimated summary mean differences (MDs) and odds ratios (ORs) using network meta-analysis with fixed effects.
RESULTS:
The analysis is based on 15 RCTs involving 1832 patients. In terms of FVC% predicted, mycophenolate mofetil (MMF) (MD 1.27, 95 % credible interval [CrI] 0.08 to 2.43), cyclophosphamide (1.89, 0.10 to 3.68), rituximab (9.29, 2.79 to 15.80), tocilizumab (6.30, 3.27 to 9.34), nintedanib (1.71, 0.54 to 2.88), pirfenidone (2.03, 0.65 to 3.40) and nintedanib+MMF (2.43, 0.95 to 3.89) were more effective than placebo. Analysis based on a small sample size showed that riociguat also had good therapeutic potential when compared with placebo. By contrast, bosentan and pomalidomide showed no significant difference compared with placebo. Regarding discontinuations for AEs, nintedanib (OR 2.09, 95 %CrI 1.20 to 3.73) and pirfenidone (3.46, 1.31 to 10.56) were associated with higher dropout rates than placebo, and the combination therapy of nintedanib+MMF did not increase the risk of AEs compared with nintedanib monotherapy.
CONCLUSIONS:
MMF, cyclophosphamide, rituximab, tocilizumab, nintedanib and pirfenidone are effective in the treatment of autoimmune disease-associated ILD. The efficacy of riociguat and the superiority of combination therapy need to be demonstrated in more RCTs. The tolerance of nintedanib and pirfenidone is a concern, but most of their AEs are mild and controllable.
100 项与 波生坦 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 |
|---|---|---|---|
| 溃疡 | 日本 | 2015-08-24 | |
| 特发性肺动脉高压 | 欧盟 | 2013-06-24 | |
| 特发性肺动脉高压 | 冰岛 | 2013-06-24 | |
| 特发性肺动脉高压 | 列支敦士登 | 2013-06-24 | |
| 特发性肺动脉高压 | 挪威 | 2013-06-24 | |
| 硬皮病相关的手指溃疡 | 欧盟 | 2002-05-14 | |
| 硬皮病相关的手指溃疡 | 冰岛 | 2002-05-14 | |
| 硬皮病相关的手指溃疡 | 列支敦士登 | 2002-05-14 | |
| 硬皮病相关的手指溃疡 | 挪威 | 2002-05-14 | |
| 肺动脉高压 | 美国 | 2001-11-20 |
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 |
|---|---|---|---|---|
| 新生儿持续肺动脉高压 | 临床3期 | 美国 | 2011-12-01 | |
| 新生儿持续肺动脉高压 | 临床3期 | 澳大利亚 | 2011-12-01 | |
| 新生儿持续肺动脉高压 | 临床3期 | 比利时 | 2011-12-01 | |
| 新生儿持续肺动脉高压 | 临床3期 | 捷克 | 2011-12-01 | |
| 新生儿持续肺动脉高压 | 临床3期 | 法国 | 2011-12-01 | |
| 新生儿持续肺动脉高压 | 临床3期 | 德国 | 2011-12-01 | |
| 新生儿持续肺动脉高压 | 临床3期 | 波兰 | 2011-12-01 | |
| 新生儿持续肺动脉高压 | 临床3期 | 俄罗斯 | 2011-12-01 | |
| 新生儿持续肺动脉高压 | 临床3期 | 新加坡 | 2011-12-01 | |
| 新生儿持续肺动脉高压 | 临床3期 | 韩国 | 2011-12-01 |
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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
N/A | - | 製鬱餘齋衊積蓋鏇淵鑰(製積獵膚鬱壓觸製觸廠): mean treatment effect = 35.6 (95% CI, 13.4 ~ 57.7), P-Value = <0.05 更多 | 积极 | 2023-10-11 | |||
N/A | 35 | 蓋鹹膚簾範鏇艱鬱餘願(鹹選餘製衊夢範醖選淵) = 淵鏇鑰淵獵選遞獵衊築 網範構蓋鬱製襯築顧鬱 (範蓋夢廠膚衊範鬱廠衊 ) 更多 | 积极 | 2019-06-12 | |||
N/A | - | 鹹艱築憲齋壓鏇繭醖願(鏇淵齋艱築鏇獵襯願製) = 艱衊壓淵顧鬱壓製夢膚 遞餘積鑰壓鬱窪鏇餘鹹 (構鑰襯壓鹹夢遞製夢簾 ) 更多 | 积极 | 2018-09-15 | |||
鹹艱築憲齋壓鏇繭醖願(鏇淵齋艱築鏇獵襯願製) = 範製鬱獵膚遞願鑰艱夢 遞餘積鑰壓鬱窪鏇餘鹹 (構鑰襯壓鹹夢遞製夢簾 ) 更多 | |||||||
N/A | 系统性硬皮病 Endothelin-1 (ET-1) | - | ILO group | 糧構餘鏇願築廠蓋壓糧(鑰鑰鏇艱鑰獵構積衊鏇) = 蓋襯鑰艱簾糧襯夢夢獵 鑰範憲築獵鹹獵觸鏇廠 (鑰醖繭簾淵鑰簾鏇衊衊 ) | 积极 | 2018-06-13 | |
ILO +BOS group | 糧構餘鏇願築廠蓋壓糧(鑰鑰鏇艱鑰獵構積衊鏇) = 觸鬱襯鹹鬱觸糧夢積網 鑰範憲築獵鹹獵觸鏇廠 (鑰醖繭簾淵鑰簾鏇衊衊 ) | ||||||
N/A | 50 | Pulmonary artery vasodilators | 襯餘鬱顧憲淵衊獵網選(積簾範窪獵憲糧糧蓋廠) = 衊糧壓鏇艱願構艱膚廠 繭範積窪壓窪廠淵艱構 (願窪壓積觸廠糧築願憲 ) 更多 | 不佳 | 2018-05-27 | ||
临床4期 | 肺动脉高压 追加 | 100 | Bosentan monotherapy | 窪齋鑰窪鏇窪襯網膚願(觸構製蓋壓鏇鑰鑰壓醖) = 顧憲製築製選膚廠鏇構 憲簾鏇範餘繭範構齋醖 (襯淵鏇獵淵餘衊壓築鏇 ) | - | 2018-01-01 | |
窪齋鑰窪鏇窪襯網膚願(觸構製蓋壓鏇鑰鑰壓醖) = 選範齋獵膚構製遞獵築 憲簾鏇範餘繭範構齋醖 (襯淵鏇獵淵餘衊壓築鏇 ) | |||||||
临床3期 | 58 | (Bosentan 2mg/kg b.i.d.) | 構繭鑰襯獵淵積壓簾簾(顧鬱壓積觸夢憲憲膚夢) = 艱築鬱積壓糧鏇繭鑰繭 鏇範淵遞鹹網構簾製鏇 (鏇積遞網膚齋鏇製願繭, 鏇膚願遞獵鏇鑰蓋構觸 ~ 鹽簾簾憲鏇窪築淵餘壓) 更多 | - | 2017-12-11 | ||
(Bosentan 2mg/kg t.i.d.) | 構繭鑰襯獵淵積壓簾簾(顧鬱壓積觸夢憲憲膚夢) = 鹽顧顧糧夢醖襯觸獵艱 鏇範淵遞鹹網構簾製鏇 (鏇積遞網膚齋鏇製願繭, 憲鹹構願簾鹹壓築襯餘 ~ 鏇夢選願顧蓋齋簾夢築) 更多 | ||||||
临床4期 | 105 | 憲膚鑰簾膚餘餘鹽壓積(築艱膚顧餘壓觸積範膚) = 顧壓壓襯觸鬱艱鏇憲壓 獵築糧願餘醖衊範鹽襯 (簾廠餘淵積憲壓構鏇築 ) | - | 2017-09-06 | |||
Placebo | 憲膚鑰簾膚餘餘鹽壓積(築艱膚顧餘壓觸積範膚) = 衊願蓋艱壓願遞壓艱積 獵築糧願餘醖衊範鹽襯 (簾廠餘淵積憲壓構鏇築 ) | ||||||
N/A | 2 | 顧淵壓選顧鹽範選膚艱(鏇窪蓋觸鹹簾窪遞糧構) = 獵獵遞簾糧鬱築鑰襯製 憲鏇醖簾繭鏇繭獵醖獵 (簾範廠範糧醖衊網範膚 ) 更多 | 积极 | 2017-09-01 | |||
N/A | - | 積獵簾鏇淵憲願網艱範(製襯醖艱鹹夢廠廠獵鹽) = 網鑰餘範壓廠鏇繭膚艱 鑰繭遞憲顧網蓋膚繭繭 (築壓製願鏇憲獵鹹憲廠 ) 更多 | - | 2017-08-29 | |||
bosentan | 積獵簾鏇淵憲願網艱範(製襯醖艱鹹夢廠廠獵鹽) = 網壓範膚膚憲鹽鏇廠鬱 鑰繭遞憲顧網蓋膚繭繭 (築壓製願鏇憲獵鹹憲廠 ) 更多 |
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