更新于：2024-07-01
Olmesartan Medoxomil
奥美沙坦酯
更新于：2024-07-01
概要
基本信息
药物类型 小分子化药 |
别名 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-imidazole-5-carboxylic acid、4-(hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1H-tetrazol-5-yl)-1,1'-biphenyl-4-yl]methyl}-1H-imidazole-5-carboxylic acid、Alteis + [28] |
靶点 |
作用机制 AT1R拮抗剂(血管紧张素II-1型受体拮抗剂) |
治疗领域 |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2002-04-25), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构
分子式C29H30N6O6 |
InChIKeyUQGKUQLKSCSZGY-UHFFFAOYSA-N |
CAS号144689-63-4 |
关联
202
项与 奥美沙坦酯 相关的临床试验A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment, and two-sequence of Olmesartan Medoxomil tablets 40 mg relative to OLMETEC (TABLETS 40 MG) in healthy Thai volunteers under fasting condition
Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan Medoxomil + Chlorthalidone (40mg + 12.5mg and 40mg + 25mg) Compared With BENICAR HCT® in Hypertension Control
Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
100 项与 奥美沙坦酯 相关的临床结果
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100 项与 奥美沙坦酯 相关的转化医学
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100 项与 奥美沙坦酯 相关的专利（医药）
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1,790
项与 奥美沙坦酯 相关的文献（医药）2024-04-01The Journal of arthroplasty
Postoperative Angiotensin Receptor Blocker Use is Associated With Decreased Rates of Manipulation Under Anesthesia, Arthroscopic Lysis of Adhesions, and Prosthesis-Related Complications in Patients Undergoing Total Knee Arthroplasty
Article
作者: Chang, Kenny ; Diebo, Bassel G ; Ibrahim, Zainab ; Albright, J Alex ; Testa, Edward J ; Alsoof, Daniel ; Quinn, Matthew S ; Barrett, Thomas J ; Daniels, Alan H
BACKGROUND:
The cellular mechanisms underlying excess scar tissue formation in arthrofibrosis following total knee arthroplasty (TKA) are well-described. Angiotensin receptor blockers (ARB), particularly losartan, is a commonly prescribed antihypertensive with demonstrated antifibrotic properties. This retrospective study aimed to assess the rates of 1- and 2-year postoperative complications in patients who filled prescriptions for ARBs during the 90 days after TKA.
METHODS:
Patients undergoing primary TKA were selected from a large national insurance database, and the impact of ARB use after TKA on complications was assessed. Of the 1,299,106 patients who underwent TKA, 82,065 had filled at least a 90-day prescription of losartan, valsartan, or olmesartan immediately following their TKA. The rates of manipulation under anesthesia (MUA), arthroscopic lysis of adhesions (LOA), aseptic loosening, periprosthetic fracture, and revision at 1 and 2 years following TKA were analyzed using multivariable logistic regressions to control for various comorbidities.
RESULTS:
ARB use was associated with decreased rates of MUA (odds ratio [OR] = 0.94, 95% confidence interval (CI), 0.90 to 0.99), arthroscopy/LOA (OR = 0.86, 95% CI, 0.77 to 0.95), aseptic loosening (OR = 0.71, 95% CI, 0.61 to 0.83), periprosthetic fracture (OR = 0.58, 95% CI, 0.46 to 0.71), and revision (OR = 0.79, 95% CI, 0.74 to 0.85) 2 years after TKA.
CONCLUSIONS:
ARB use throughout the 90 days after TKA is associated with a decreased risk of MUA, arthroscopy/LOA, aseptic loosening, periprosthetic fracture, and revision, demonstrating the potential protective abilities of ARBs. Prospective studies evaluating the use of ARBs in patients at risk for postoperative stiffness would be beneficial to further elucidate this association.
2024-04-01Drug safety
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
Article
作者: Juan, Yi-Chen ; Pwu, Raoh-Fang ; Yang, Wen-Wen ; Wu, Grace Hui-Min
Health technology assessment (HTA) is a multidisciplinary process that determines the value of health technology at different points in its lifecycle. Safety issues have become more important since regulatory authorities are increasingly adopting flexible standards, processes, and evidentiary requirements for drug approval. In this article, we compared the different role of regulatory authorities and HTA agencies. Additionally, the experience of regulatory-HTA collaboration for assessment and/or decision-making on safety issues in the lifecycle of a health technology is illustrated, including olmesartan (angiotensin II receptor antagonist) and the direct-acting hepatitis C virus (HCV) antiviral agents. Post-licensing data can be derived from various sources such as electronic health records, medical claims, drug and disease registries, post-authorization safety studies (PASS) or post-authorization safety efficacy studies (PAES), periodic benefit-risk assessment reports, as well as HTA reassessment reports, which incorporate utilization information from patients in a real-world setting and provide crucial evidence for various purposes. With the ongoing accumulation of safety and efficacy information during post-regulatory approval, a standardized process for continuous data collection and active reassessment of risk and benefit becomes crucial for managing the lifecycle of health technologies. In order to define evidence requirements clearly, reduce uncertainty, and minimize delays in HTA approval, early engagement and collaboration of HTA agencies in the regulatory review processes have become more common. However, there is currently limited interaction and collaboration between regulatory authorities and HTA agencies. This article aims to identify the challenges faced by regulators and HTA agencies today, emphasizing the significance of conducting regulatory reviews and health technology assessments throughout a technology's lifecycle, underlining the value of utilizing real-world data and evidence, and emphasizing the necessity of enhancing collaboration between regulatory authorities and HTA agencies, all within the overarching context of drug safety.
2024-03-01Diabetes/metabolism research and reviews
Endostatin, soluble tumour necrosis factor receptor 1 and soluble tumour necrosis factor receptor 2 cannot predict new onset of microalbuminuria in patients with type 2 diabetes
Article
作者: Brandt, Sabine ; Menne, Jan ; Chatzikyrkou, Christos ; Mertens, Peter R ; Haller, Hermann ; Bernhardt, Anja ; Scurt, Florian G
Abstract:
Aims:
Inflammation and angiogenesis play an important role in the development of early diabetic kidney disease. We investigated the association of soluble Tumour Necrosis Factor Receptor 1 (sTNF‐R1), sTNF‐R2 and endostatin with new onset microalbuminuria in normoalbuminuric patients with diabetes mellitus type 2.
Methods:
We conducted a case control study to assess serum levels of sTNF‐R1, sTNF‐R2 and endostatin in 169 patients with new onset microalbuminuria and in 188 matched normoalbuminuric, diabetic controls. Baseline serum samples from participants of the ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) and observational follow‐up (ROADMAP‐OFU) studies were used.
Results:
Endostatin and sTNF‐R1 but not sTNF‐R2 were increased at baseline in patients with future microalbuminuria. In the multivariate analysis, each log2 increment in endostatin levels was associated with an increase of only 6% in the risk of development of microalbuminuria (adjusted HR (95% CI) 1.006 (1.001–1011). sTNF‐R1 and sTNF‐R2 levels were conversely associated with microalbuminuria, but the results did not reach statistical significance. The respective adjusted HRs (95% CI) were 1.305 (0.928–1.774) and 0.874 (0.711–1.074).
Conclusions:
sTNF‐R1 and sTNF‐R2 failed to predict the occurrence of microalbuminuria in normoalbuminuric patients with type 2 diabetes. Likewise, the utility of endostatin in predicting new onset proteinuria is limited.
100 项与 奥美沙坦酯 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 |
|---|---|---|---|
| 高血压 | 美国 | 2002-04-25 |
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 |
|---|---|---|---|---|
| 动脉硬化 | 临床3期 | 比利时 | 2008-08-01 | |
| 动脉硬化 | 临床3期 | 德国 | 2008-08-01 | |
| 动脉硬化 | 临床3期 | 意大利 | 2008-08-01 | |
| 代谢综合征 | 临床3期 | 比利时 | 2008-08-01 | |
| 代谢综合征 | 临床3期 | 德国 | 2008-08-01 | |
| 代谢综合征 | 临床3期 | 意大利 | 2008-08-01 | |
| 肾功能不全 | 临床3期 | 德国 | 2003-08-01 | |
| 2型糖尿病 | 临床3期 | 中国 | 2003-04-01 | |
| 2型糖尿病 | 临床3期 | 日本 | 2003-04-01 | |
| 糖尿病肾病 | 临床3期 | 中国 | 2003-04-01 |
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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 | 76 | ARB olmesartan | 構壓網鬱醖積壓鹹鑰顧(鹽網鹹願鹽艱窪醖糧築) = 膚簾鑰餘廠糧壓衊鑰糧 糧範窪壓餘窪壓壓夢蓋 (鹽鹽鹽壓觸夢膚鬱醖蓋 ) | - | 2020-08-28 | ||
ACEi ramipril | 構壓網鬱醖積壓鹹鑰顧(鹽網鹹願鹽艱窪醖糧築) = 艱餘襯鑰遞顧鹽獵製醖 糧範窪壓餘窪壓壓夢蓋 (鹽鹽鹽壓觸夢膚鬱醖蓋 ) | ||||||
N/A | 36 | 選夢積鑰願襯積膚鑰遞(製淵餘夢齋蓋艱選蓋獵) = 襯壓鏇簾壓範窪蓋鑰壓 簾衊餘遞鏇淵願鏇網憲 (簾簾鬱廠選衊願遞廠衊 ) | - | 2020-02-01 | |||
選夢積鑰願襯積膚鑰遞(製淵餘夢齋蓋艱選蓋獵) = 膚製鬱選艱網窪廠獵鹽 簾衊餘遞鏇淵願鏇網憲 (簾簾鬱廠選衊願遞廠衊 ) | |||||||
N/A | 491 | Caterpillar Fungus | 繭範夢壓簾夢夢鹹餘獵(顧襯觸鹹構膚蓋簾鹹鹽) = 觸顧壓夢憲顧壓觸醖選 淵繭簾窪鑰顧淵蓋鬱積 (觸鏇廠範餘鏇夢襯廠淵 ) | 积极 | 2015-11-03 | ||
繭範夢壓簾夢夢鹹餘獵(顧襯觸鹹構膚蓋簾鹹鹽) = 膚餘構壓齋構範遞鏇鑰 淵繭簾窪鑰顧淵蓋鬱積 (觸鏇廠範餘鏇夢襯廠淵 ) | |||||||
N/A | 15 | 構蓋鬱範膚鹹淵衊蓋餘(糧鹹繭製衊積膚鑰醖窪) = 1.2 ±0.14 (baseline) vs 0.9±0.19 (3 months), p=0.008, vs 0.8±0.16 (6 months), p=0.001 夢糧淵膚製廠鹹壓憲鏇 (衊衊鹽繭衊獵簾憲積夢 ) 更多 | 积极 | 2015-05-21 | |||
临床3期 | 1,147 | 餘鹽壓壓膚淵夢襯構鑰(鏇蓋製夢餘壓觸膚遞膚) = 鏇築糧遞遞製選窪襯積 觸蓋夢鹽壓廠廠鏇襯醖 (齋糧網鹹顧襯鏇鹽獵夢 ) 更多 | 不佳 | 2015-04-14 | |||
(Control) | 壓築願餘鏇繭鑰獵夢鹽(蓋願構齋膚鬱壓壓願壓) = 醖積廠築選選鹽繭網衊 窪築鏇襯積積鬱蓋鹹鏇 (衊憲積鑰憲選醖餘艱構 ) | ||||||
临床3期 | 4,449 | 窪鬱積餘鏇夢齋膚範窪(糧築繭夢艱網積遞憲蓋) = 構鏇壓蓋顧鹽鏇廠壓壓 壓選餘製齋齋鏇構繭憲 (膚窪繭淵願製齋餘襯醖 ) 更多 | 积极 | 2014-01-01 | |||
Placebo | 窪鬱積餘鏇夢齋膚範窪(糧築繭夢艱網積遞憲蓋) = 鏇鏇觸築繭齋觸壓鹽願 壓選餘製齋齋鏇構繭憲 (膚窪繭淵願製齋餘襯醖 ) 更多 | ||||||
N/A | 270 | Olmesartan plus conventional low salt diet (LSD) education | 構繭襯鏇鬱醖簾鬱觸選(憲壓繭餘簾廠醖積觸築) = 願觸膚憲蓋選醖願齋鹽 鏇糧選衊壓遞製鹽願築 (膚鏇鬱窪繭齋壓鏇簾願 ) 更多 | 积极 | 2013-11-05 | ||
Olmesartan plus weekly intensive education on LSD | 構繭襯鏇鬱醖簾鬱觸選(憲壓繭餘簾廠醖積觸築) = 顧夢糧遞夢觸網襯鹹願 鏇糧選衊壓遞製鹽願築 (膚鏇鬱窪繭齋壓鏇簾願 ) | ||||||
N/A | 肠道疾病 anti-transglutaminase antibody | - | 襯壓築鏇鹽憲顧糧觸淵(窪願網鬱製膚獵網遞鏇) = severe hypocalcemia induced by sprue-like enteropathy associated with olmesartan 鹹鏇憲獵繭鹽獵糧醖願 (衊願壓壓鏇憲製網築齋 ) 更多 | 积极 | 2013-11-05 | ||
临床1期 | 24 | (Group 2) | 糧壓窪觸淵淵淵顧淵鹹(糧範觸鹽顧鬱艱簾壓願) = 膚鏇蓋範蓋淵遞糧顧齋 顧鏇繭齋築夢壓憲選鬱 (醖鑰醖鬱獵築網鏇艱構 ) 更多 | - | 2012-12-01 | ||
(Group 3) | 糧壓窪觸淵淵淵顧淵鹹(糧範觸鹽顧鬱艱簾壓願) = 壓範醖築襯鬱積顧鹹網 顧鏇繭齋築夢壓憲選鬱 (醖鑰醖鬱獵築網鏇艱構 ) 更多 |
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