更新于：2024-11-04
Evocalcet
依伏卡塞
更新于：2024-11-04
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2018-03-23), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C24H26N2O2 |
InChIKeyRZNUIYPHQFXBAN-XLIONFOSSA-N |
CAS号870964-67-3 |
关联
29
项与 依伏卡塞 相关的临床试验依伏卡塞片的生物等效性试验
依伏卡塞片人体生物等效性试验
中国健康受试者空腹及餐后状态下单次口服依伏卡塞片（规格：2mg）的一项单中心、随机、开放、两制剂、两序列、两周期交叉生物等效性试验
100 项与 依伏卡塞 相关的临床结果
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100 项与 依伏卡塞 相关的转化医学
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100 项与 依伏卡塞 相关的专利（医药）
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47
项与 依伏卡塞 相关的文献（医药）2024-10-01EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
Effects of active vitamin D analogs and calcimimetic agents on PTH and bone mineral biomarkers in hemodialysis patients with SHPT: a network meta-analysis
Article
作者: Mei, Ziwei ; Xie, Xun ; Liu, Xing ; Liu, Yichen ; Li, Zhouzhou ; Chen, Peipei ; Zheng, Peimin ; Yang, Rui ; Jin, Lie ; Zhou, Limei
OBJECTIVE:
Active vitamin D analogs and calcimimetic agents are primary drugs for patients with secondary hyperparathyroidism. Due to the different pharmacological mechanisms, they have different effects on the level of parathyroid hormone, serum calcium, phosphorus, and bone turnover biomarkers. This study aimed to evaluate the active vitamin D analogs and calcimimetic agents in hemodialysis patients with secondary hyperparathyroidism.
METHODS:
We included randomized clinical trials of hemodialysis patients with secondary hyperparathyroidism, comparing active vitamin D analogs to calcimimetic agents or placebo/control. The primary outcome was the change of PTH level from baseline to end-up. The secondary outcome was the change in serum calcium, phosphorus, calcium-phosphorus product, and bone turnover biomarkers. A network meta-analysis method was applied to complete this study. The forest plots reflected statistical differences in the outcomes between active vitamin D analogs and calcimimetic agents. The SUCRA result presented the ranking of impact on the outcomes.
RESULTS:
Twenty-one randomized clinical trials with 4653 patients were included in this network meta-analysis. Global and splitting-node inconsistencies provided no evidence of inconsistency in this study. There was no statistical difference between two active vitamin D analogs and three calcimimetic agents in the PTH, and phosphorus levels changed. Considering serum calcium level, compared with placebo, calcitriol (9.73, 3.09 to 16.38) and paricalcitol (9.74, 3.87 to 15.60) increase serum calcium. However, cinacalcet (- 1.94, - 3.72 to - 0.15) and etelcalcetide (- 7.80, - 11.80 to - 3.80) reduced the serum calcium, even a joint use of cinacalcet with active vitamin D analogs (- 5.83, - 9.73 to - 1.93). Three calcimimetic agents decreased calcium levels much more than calcitriol and paricalcitol. The same type of drugs was not distinct, with each one affecting the change in calcium level. Cinacalcet reduced calcium-phosphorus product much more than paricalcitol (- 3.66, - 6.72 to - 0.60). Evocalcet decreased calcium-phosphorus product more than cinacalcet (- 5.64, - 8.91 to - 2.37), calcitriol (- 9.36, - 14.81 to - 3.92), and paricalcitol (- 9.30, - 13.78 to - 4.82). Compared with paricalcitol, cinacalcet significantly increases the level of ALP (24.50, 23.05 to 25.95) and bALP (0.67, 0.03 to 1.31). The incidence of gastrointestinal disorders in cinacacet (29.35, 1.71 to 504.98) and etelcalcetide (20.92, 1.20 to 365.68) was notably higher than in paricalcitol. Etelcalcetide (0.71, 0.53 to 0.96) and evocalcet (0.46, 0.33 to 0.64) presented a lower rate of gastrointestinal disorders than cinacalcet. Cinacalcet ranked first in adverse gastrointestinal, nervous, and respiratory reactions.
CONCLUSION:
The same kinds of agents perform similar efficacy on the level of PTH, serum calcium, phosphorus, and calcium-phosphorus product. Paricalcitol did not lead to more hypercalcemia than calcitriol. The calcium decrease induced by cinacalcet was not settled even by associating it with active vitamin D analogs. Cinacalcet and evocalcet were superior to calcitriol and paricacitol in reducing calcium-phosphorus product. Calcimimetics induced more gastrointestinal disorders than active vitamin D analogs, especially cinacalcet.
2024-08-01Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy
Calcimimetics treatment strategy for serum calcium and phosphate management in patients with secondary hyperparathyroidism undergoing dialysis: A systematic review and meta‐analysis of randomized studies
Review
作者: Nakai, Kentaro ; Taniguchi, Masatomo ; Fukagawa, Masafumi ; Kono, Keiji ; Yamada, Shunsuke ; Hamano, Takayuki
Abstract:
Introduction:
Several calcimimetics, other than cinacalcet, are commercially available; however, their effects on calcium and phosphate levels have not yet been fully studied. We conducted a systematic review and meta‐analysis of randomized controlled trials to evaluate the impact of calcimimetics on the management of serum calcium and phosphate levels in patients with secondary hyperparathyroidism undergoing dialysis.
Methods:
A systematic literature search through October 2023 and a meta‐analysis were conducted on the effects of upacicalcet, etelcalcetide, evocalcet, and cinacalcet on serum calcium and phosphate levels in patients with secondary hyperparathyroidism undergoing dialysis; we searched PubMed, Ovid MEDLINE, and the Cochrane Central Register of Controlled Trials, and 21 studies comprising 6371 patients undergoing dialysis were included.
Results:
Participants treated with calcimimetics had lower serum calcium and phosphate levels than placebo.
Conclusion:
Calcimimetics significantly reduced serum calcium and phosphate levels compared to placebo in patients with secondary hyperparathyroidism undergoing dialysis, independent of therapeutic strategy or concomitant vitamin D treatment.
2024-07-24JCEM Case Reports
Sporadic Parathyroid Carcinoma Treated With Lenvatinib, Exhibiting a Novel Somatic MEN1 Mutation
Article
作者: Yabe, Daisuke ; Kato, Takehiro ; Ito, Yu ; Imaizumi, Toshinori ; Daido, Hisashi
Abstract:
Parathyroid carcinoma (PC) is extremely rare and is primarily treated surgically. Chemotherapy is an option for advanced stages, but no standard regimen exists. Emerging research suggests the efficacy of multitarget tyrosine kinase inhibitors (MTKIs) for PC, targeting vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR). A 61-year-old Japanese woman presented with a neck mass, diagnosed as PC with pleural and lumbar metastases. After parathyroidectomy and radiation for lumbar metastasis, immunohistochemistry showed VEGFR overexpression, leading to targeted therapy with MTKIs. Despite no actionable mutations on cancer genomic panel test, a novel MEN1 somatic mutation (NM_130801: exon2: c.332delG: p.G111fs*8) was identified, which may affect VEGFR2 expression and tumor epigenetics. Although severe hand-foot syndrome necessitated dose reductions and treatment interruptions, sorafenib treatment managed hypercalcemia with evocalcet and denosumab. Lenvatinib, as second-line therapy, was effective against pleural metastases but caused thrombocytopenia and hematuria, leading to discontinuation and uncontrolled recurrence and metastasis progression. Our case highlights the need for further research on genomic profiling, molecular targets, and therapy response in PC.
100 项与 依伏卡塞 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| 高钙血症 | 日本 | 2019-12-20 | |
| 原发性甲状旁腺功能亢进症 | 日本 | 2019-12-20 | |
| 甲状旁腺肿瘤 | 日本 | 2019-12-20 | |
| 继发性甲状旁腺功能亢进症 | 日本 | 2018-03-23 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 继发性甲状旁腺功能亢进症 iPTH level | - | 顧廠衊糧醖簾憲鹹範製(製壓製鑰願構廠艱獵顧) = 膚鏇醖壓選膚鹽蓋蓋膚 齋積製願選餘壓鏇簾顧 (積膚選築構積遞選醖齋 ) 更多 | 积极 | 2022-11-03 | ||
顧廠衊糧醖簾憲鹹範製(製壓製鑰願構廠艱獵顧) = 顧窪蓋艱遞壓壓艱艱鹽 齋積製願選餘壓鏇簾顧 (積膚選築構積遞選醖齋 ) 更多 | |||||||
N/A | - | 糧顧窪範艱廠膚獵衊鬱(顧壓網醖糧窪廠壓選鹹) = 網壓衊壓蓋醖積醖簾鹹 鹽鹽積艱繭餘顧襯壓鏇 (餘鑰繭艱範齋壓衊窪壓 ) 更多 | 积极 | 2022-11-03 | |||
糧顧窪範艱廠膚獵衊鬱(顧壓網醖糧窪廠壓選鹹) = 鏇憲膚糧餘餘築觸憲廠 鹽鹽積艱繭餘顧襯壓鏇 (餘鑰繭艱範齋壓衊窪壓 ) 更多 | |||||||
临床3期 | 634 | 淵齋積願襯遞憲築膚壓(構夢願醖觸繭憲壓積壓) = demonstrated similar trends 廠顧顧醖艱觸餘衊壓繭 (繭鏇鬱構餘襯築艱構衊 ) 更多 | - | 2022-01-01 | |||
临床3期 | 18 | 壓選蓋願鹽積衊簾鹽積(築蓋範齋壓獵蓋襯蓋獵) = 糧遞夢遞顧淵觸構膚鑰 積網遞構蓋衊艱膚艱範 (繭選網繭餘壓窪膚獵製, 鑰積築夢淵鹹簾襯範築 ~ 繭夢顧餘築鬱齋鑰夢網) 更多 | - | 2021-05-27 | |||
临床3期 | 18 | 顧顧遞窪網遞餘憲顧鏇(餘鹹獵蓋夢築憲衊淵選) = 積構憲製顧窪範製夢簾 繭遞憲顧窪衊範衊簾餘 (選淵糧廠製構鹹鏇鏇積, 52.4 ~ 93.6) 更多 | 积极 | 2020-09-01 | |||
N/A | - | 34 | 製簾繭簾獵構壓鬱網築(膚鹹憲蓋遞選觸願餘壓) = occurred in 2 patients 鑰膚選夢觸觸廠艱遞網 (築鬱鹽鏇繭窪壓簾襯艱 ) 更多 | 积极 | 2020-06-06 | ||
临床3期 | - | 39 | 衊遞鹹築窪觸遞觸艱窪(壓顧窪簾餘顧網鹹鏇鬱) = Adverse drug reactions occurred in 46.2% (18/39) of patients, with most being of mild-to-moderate severity including GI-related events 糧遞襯構淵餘鬱憲鏇構 (蓋繭夢鏇窪夢築繭襯網 ) | 积极 | 2019-06-01 | ||
临床3期 | 634 | 憲選餘鏇鏇選襯淵鏇糧(憲餘觸壓淵願獵醖築鑰) = 鑰齋製壓遞鑰夢簾顧鹹 遞範製鹽鬱鹽鹹選願壓 (遞廠觸夢窪鬱範餘選醖 ) 更多 | 非优 | 2018-10-01 | |||
憲選餘鏇鏇選襯淵鏇糧(憲餘觸壓淵願獵醖築鑰) = 顧鹹範簾遞齋艱醖築鑰 遞範製鹽鬱鹽鹹選願壓 (遞廠觸夢窪鬱範餘選醖 ) 更多 |
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