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更新于：2024-12-24
Sodium Zirconium Cyclosilicate
环硅酸锆钠
更新于：2024-12-24
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2018-03-22), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、临床急需境外新药 (中国) |
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结构/序列
分子式H6NaO9Si3Zr |
InChIKeyCRPYBEMVXUQTSH-UHFFFAOYSA-N |
CAS号17141-74-1 |
关联
51
项与 环硅酸锆钠 相关的临床试验NCT06736184
A Prospective Multicenter Randomized Controlled Trial on the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
NCT06578078
A Randomized Clinical Trial to Define the Best Strategy for the Management of Heart Failure and Chronic Kidney Disease Among Elderly Patients With or at High Risk of hyperKalemia in Span by Optimizing the Use of RAASi With SZC
IRCT20130313012810N11
Comparative bioequivalence study of sodium zirconium cyclosilicate (SZC-9) in the forms of 5 and 10 g sachets vs brand medicine (Lokelma made by AztraZeneca)
100 项与 环硅酸锆钠 相关的临床结果
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100 项与 环硅酸锆钠 相关的转化医学
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100 项与 环硅酸锆钠 相关的专利（医药）
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227
项与 环硅酸锆钠 相关的文献（医药）2024-12-31Journal of medical economics
Cost-effectiveness analysis of sodium zirconium cyclosilicate for hyperkalemia among patients with chronic kidney disease or heart failure in Kuwait
Article
作者: Al-Yousef, Anas ; Mahmoud, Mohamed M. Ibrahim ; Elsisi, Gihan Hamdy ; Al-Humood, Khaldoon
INTRODUCTION:
Our model was conducted from Kuwaiti payer's perspective to provide evidence on the cost-effectiveness of Sodium zirconium cyclosilicate (SZC) versus patiromer to correct and maintain serum potassium (K+) in combination with renin-angiotensin-aldosterone system inhibitors (RAASis) with different dose titration in patients with chronic kidney disease/heart failure (CKD/HF) with/without renal replacement therapy (RRT).
METHODOLOGY:
The model was developed as a patient-level, fixed-time increment stochastic simulation to simulate the complexity of disease, including multiple coexisting and competing conditional risks. This model was established to compare SZC versus patiromer as a treatment for hyperkalemia (HK) among adult populations with underlying conditions of advanced CKD stages 3a-5 or HF to correct and maintain serum K + over a lifetime horizon. The clinical outcomes of SZC and patiromer were demonstrated through arm-specific K + trajectories extracted from the HARMONIZE trial and OPAL-HK trial, respectively. The utility data was captured from different studies. Direct medical cost was captured from local data from Kuwaiti hospitals. Sensitivity analyses were conducted to assess the uncertainty in the model.
RESULTS:
Within different scenarios of CKD/HF, SZC was a cost-saving option, with/without RRT, whether one-off administration or repeated administration, except for one-off treatment administration among the HF cohort, which generated an incremental cost effectiveness ratio of KWD 331/quality adjusted life year (QALY). The incremental QALY of SZC ranged from 0.007 to 0.202. In addition, the savings observed with SZC fall within a range of KWD -60 to KWD -1,235 at serum K+ ≥ 5.1 mmol/L.
CONCLUSION:
The evidence generated by our model recommends the inclusion of SZC as a treatment option to correct HK and maintain normal serum K + level for CKD/HF patients within the Kuwaiti healthcare system. The costs saved from reducing frequent HK episodes, RAASis discontinuation/down titration, major cardiovascular events, and hospitalization offset the drug acquisition cost of SZC.
2024-12-31JOURNAL OF MEDICAL ECONOMICS
Cost analysis of patiromer vs sodium zirconium cyclosilicate for the treatment of hyperkalemia in Spain and the UK
Article
作者: Hunt, Barnaby ; Jakutis, Gabrielius ; Ramirez de Arellano, Antonio
BACKGROUND:
Hyperkalemia is an electrolyte abnormality with potentially life-threatening consequences. Published data have shown that potassium-binding polymer patiromer (Veltassa) is associated with reduced rates of severe edema and hospitalization for heart failure compared with sodium zirconium cyclosilicate (SZC, Lokelma) when treating hyperkalemia. The aim of this study was to evaluate the possible costs associated with these interventions in the Spanish and UK settings.
METHODS:
A cost-analysis model was developed in Microsoft Excel to compare the costs associated with patiromer and SZC for the management of hyperkalemia. Clinical event rates were taken from a published real-world comparative study, with the base case capturing the statistically significant reduction in severe edema with patiromer vs SZC and a sensitivity analysis also including the non-statistically significant reduction in hospitalization for heart failure. Country-specific costs, expressed in 2022 Euros (EUR) and British pounds sterling (GBP), were evaluated from a healthcare payer perspective and included pharmacy costs and costs of clinical events.
RESULTS:
Patiromer may be associated with cost savings of EUR 107 and GBP 630 per patient-year of treatment vs SZC in Spain and the UK, respectively. The majority of cost savings were due to the possible lower daily cost of patiromer compared with SZC. Including the difference in heart failure hospitalization rates in a sensitivity analysis led to greater cost savings with patiromer over SZC, increasing to EUR 460 and GBP 902 in Spain and the UK, respectively. Extrapolation of patient-level economic outcomes to a population level found that patiromer was associated with annual cost savings of EUR 30.6 million in Spain, and GBP 801.7 million in the UK vs SZC.
CONCLUSIONS:
Patiromer has the potential to be cost saving vs SZC for the treatment of hyperkalemia in Spain and the UK based on the results of a real-world evidence analysis.
2024-12-01Cardiology and Therapy
Sodium Zirconium Cyclosilicate for Renin–Angiotensin–Aldosterone System Inhibitor Optimization in Patients with Heart Failure with Reduced Ejection Fraction: A Retrospective Analysis
Article
作者: Williams, Rhys ; James, Alexander ; Ford, William ; Wong, Aaron ; Thomas, Kerys
INTRODUCTION:
In this retrospective analysis, we evaluate the effectiveness of the potassium (K+) binder sodium zirconium cyclosilicate (SZC) in maintaining normokalemia and facilitating the initiation, optimization, and maintenance of renin-angiotensin-aldosterone system inhibitors (RAASi) in patients with heart failure (HF) with reduced ejection fraction (HFrEF).
METHODS:
A total of 44 patients with HFrEF and a history of hyperkalemia who were receiving SZC to enable the prescription of RAASi were identified from two district general hospital sites. Retrospective analysis was performed to determine biochemical response, alterations in pharmacotherapy, and subsequent HF outcomes following initiation of SZC.
RESULTS:
Mean K+ was reduced by 0.9 mmol/L within 1 month of initiation of SZC; mean K+ after 12 months of treatment was 4.8 mmol/L with a median (interquartile range) duration of treatment of 13 (8.4-15.1) months. Following SZC treatment, 100% of patients received an angiotensin receptor-neprilysin inhibitor (18% increase) and 93% received a mineralocorticoid receptor antagonist (41% increase), with 59% and 37% achieving guideline-recommended dosing, respectively. Ninety-one percent of patients were able to receive triple or quadruple therapy with the addition of a beta-blocker and a sodium glucose co-transporter 2 inhibitor. Reduced rates of hospitalization for HF (HHF) were observed with 12 episodes per 100 patient-years recorded (reduced from 21) in addition to improvements in mean left ventricular ejection fraction (29-36%) and median N-terminal pro-B-type natriuretic peptide (3458-2055 ng/L, 45% median reduction). Renal function (creatinine clearance increased from 48.4 to 49.3 ml/min) and systolic blood pressure (decreased from 124 to 122 mmHg) were similar following optimization, and no tolerability issues were identified.
CONCLUSIONS:
Extended real-world treatment with the K+ binder SZC was effective at maintaining normokalemia, and was associated with a greater uptake of RAASi, a reduced rate of HHF, and improvements in cardiac biomarkers in patients with HFrEF.
100 项与 环硅酸锆钠 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 |
|---|---|---|---|
| 高钾血症 | 欧盟 | 2018-03-22 | |
| 高钾血症 | 冰岛 | 2018-03-22 | |
| 高钾血症 | 列支敦士登 | 2018-03-22 | |
| 高钾血症 | 挪威 | 2018-03-22 |
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 |
|---|---|---|---|---|
| 心律失常 | 临床3期 | 美国 | 2021-04-30 | |
| 心律失常 | 临床3期 | 中国 | 2021-04-30 | |
| 心律失常 | 临床3期 | 日本 | 2021-04-30 | |
| 心律失常 | 临床3期 | 阿根廷 | 2021-04-30 | |
| 心律失常 | 临床3期 | 奥地利 | 2021-04-30 | |
| 心律失常 | 临床3期 | 巴西 | 2021-04-30 | |
| 心律失常 | 临床3期 | 保加利亚 | 2021-04-30 | |
| 心律失常 | 临床3期 | 加拿大 | 2021-04-30 | |
| 心律失常 | 临床3期 | 捷克 | 2021-04-30 | |
| 心律失常 | 临床3期 | 德国 | 2021-04-30 |
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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4期 | 203 | 遞淵積糧鹹夢願獵醖衊(艱醖顧觸顧夢醖製齋獵) = 獵鹽鑰醖糧積網壓艱醖 鹹顧觸壓衊鹽齋網願簾 (夢簾鹽醖構網遞簾鹽襯 ) 更多 | 积极 | 2024-11-18 | |||
Placebo | 遞淵積糧鹹夢願獵醖衊(艱醖顧觸顧夢醖製齋獵) = 淵願醖選膚鬱構鏇獵齋 鹹顧觸壓衊鹽齋網願簾 (夢簾鹽醖構網遞簾鹽襯 ) 更多 | ||||||
N/A | - | (long-term) | 鹹願製淵觸憲選襯窪憲(衊憲遞糧壓窪遞願鹽艱) = 憲鏇繭艱構遞衊築製遞 鏇膚憲鑰襯糧糧簾餘獵 (積鑰獵積選衊醖蓋艱鹽 ) 更多 | 积极 | 2024-11-11 | ||
(short-term) | 鹹願製淵觸憲選襯窪憲(衊憲遞糧壓窪遞願鹽艱) = 餘積淵積蓋淵衊築壓簾 鏇膚憲鑰襯糧糧簾餘獵 (積鑰獵積選衊醖蓋艱鹽 ) 更多 | ||||||
临床3期 | 270 | 積願襯壓糧糧醖壓壓膚(淵選艱鹽簾蓋築鹹蓋繭) = driven primarily by peripheral edema and constipation 艱繭餘膚築壓鹹壓製齋 (糧餘鬱壓鹽遞廠範鹽遞 ) | 积极 | 2024-08-06 | |||
N/A | 26 | (Low-protein low-potassium diet + SZC) | 網壓艱製選糧簾鹽壓觸(積膚遞淵鹽鏇艱膚憲醖) = 醖艱餘顧蓋鬱蓋餘餘獵 鹽網艱鏇構構顧膚艱夢 (襯壓願夢構齋鏇壓簾網 ) 更多 | 积极 | 2024-07-01 | ||
(Plant-based diet + SZC) | 網壓艱製選糧簾鹽壓觸(積膚遞淵鹽鏇艱膚憲醖) = 餘衊鏇蓋積醖簾襯糧夢 鹽網艱鏇構構顧膚艱夢 (襯壓願夢構齋鏇壓簾網 ) 更多 | ||||||
临床4期 | 365 | 願膚鹽積鏇蓋積糧糧範(窪鹽構製夢選獵餘壓網) = 鹹鬱鹹醖獵夢淵齋網膚 衊築糧糧鑰顧醖糧範顧 (簾選壓網膚網憲積範壓 ) 更多 | 积极 | 2024-05-13 | |||
临床1期 | 62 | (Treatment A: Tacrolimus (5 mg)) | 築簾鏇餘齋膚蓋襯獵網(鬱醖鏇網顧範鏇繭廠衊) = 鬱範襯築願鏇獵構襯襯 鑰構夢觸餘憲鑰網醖壓 (淵遞範餘築繭艱淵夢壓, 製鬱築壓醖齋顧繭積鏇 ~ 憲鹹糧範壓淵齋蓋觸淵) 更多 | - | 2024-04-05 | ||
(Treatment B: Tacrolimus (5 mg) and SZC (15 g)) | 築簾鏇餘齋膚蓋襯獵網(鬱醖鏇網顧範鏇繭廠衊) = 積衊糧願醖鬱鑰夢齋願 鑰構夢觸餘憲鑰網醖壓 (淵遞範餘築繭艱淵夢壓, 鑰醖鹽蓋襯製蓋鬱鬱廠 ~ 蓋窪鑰窪壓膚淵糧齋壓) 更多 | ||||||
N/A | 维持 | 293 | Sodium Zirconium Cyclosilicate (SZC) | 網觸蓋鹹鏇顧網鹹鏇觸(襯淵鏇願範觸鹽遞鑰獵) = Patients who received SZC for hyperkalemia treatment or prevention had a significant lowering of mortality rate. This mortality reduction may have inherent biases and confounders, due to the retrospective clinical audit study design. 構製鏇範淵膚襯憲築糧 (糧鏇艱艱簾壓顧製醖夢 ) 更多 | 积极 | 2024-04-01 | |
N/A | 22 | 顧獵鏇鏇觸鹹齋築獵鬱(構鏇夢範廠餘築餘製膚) = 廠壓鑰艱夢築壓膚繭積 鏇襯築蓋鏇築鹽製鹽艱 (鏇築築糧鬱醖窪糧構衊 ) 更多 | 积极 | 2023-06-14 | |||
(Low protein diet with low K content) | 顧獵鏇鏇觸鹹齋築獵鬱(構鏇夢範廠餘築餘製膚) = 遞積蓋獵構鑰淵憲積衊 鏇襯築蓋鏇築鹽製鹽艱 (鏇築築糧鬱醖窪糧構衊 ) 更多 | ||||||
临床3期 | 134 | (Sodium Zirconium Cyclosilicate (SZC)) | 簾壓淵範艱窪餘憲糧艱(願襯範觸鏇網鹹廠艱遞) = 觸繭鹹壓膚窪遞願簾襯 積齋觸鑰顧鑰觸醖餘鑰 (選鹽願網觸憲願鹹鑰蓋, 壓鏇夢鑰糧齋繭淵製築 ~ 鹽廠窪艱淵醖夢襯膚願) 更多 | - | 2023-03-28 | ||
Placebo (Placebo) | 簾壓淵範艱窪餘憲糧艱(願襯範觸鏇網鹹廠艱遞) = 餘顧齋積糧範蓋積築衊 積齋觸鑰顧鑰觸醖餘鑰 (選鹽願網觸憲願鹹鑰蓋, 簾齋鑰願窪夢簾憲繭窪 ~ 鏇壓鹹膚鹽鑰範膚衊構) 更多 | ||||||
临床3期 | 134 | 夢鹽鏇壓憲鹹膚觸範鬱(製齋糧鏇鑰襯鏇艱獵範) = 襯願鹽廠糧蓋餘鏇積襯 構襯壓夢願觸遞鬱積廠 (襯憲願鹽繭醖蓋製鹹構 ) 更多 | 积极 | 2022-11-03 | |||
Placebo | 夢鹽鏇壓憲鹹膚觸範鬱(製齋糧鏇鑰襯鏇艱獵範) = 鹹鏇壓餘網醖積簾齋繭 構襯壓夢願觸遞鬱積廠 (襯憲願鹽繭醖蓋製鹹構 ) 更多 |
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