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更新于：2026-09-08
Patiromer sorbitex calcium
帕替罗姆
更新于：2026-09-08
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 美国 (2015-10-21), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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关联
35
项与 帕替罗姆 相关的临床试验JPRN-jRCT2031250353
Veltassa 8.4 g powder for suspension post-marketing surveillance study (Veltassa post-marketingnsurveillance study)
NCT06858280
Impact of Patiromer Treatment on Dietary Potassium Intake Restriction and Health-related Quality of Life and Nutrition in Patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled, Pilot Trial
NCT05766839
A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children Under 12 Years of Age With Hyperkalaemia (EMERALD2)
100 项与 帕替罗姆 相关的临床结果
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100 项与 帕替罗姆 相关的转化医学
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100 项与 帕替罗姆 相关的专利（医药）
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255
项与 帕替罗姆 相关的文献（医药）2026-07-01Kidney360
Efficacy and Tolerability of Sodium Zirconium Cyclosilicate or Patiromer in Managing Hyperkalemia
Review
作者: Jaturapisanukul, Solos ; Thongprayoon, Charat ; Cheungpasitporn, Wisit ; Wathanavasin, Wannasit
Key Points:
Both sodium zirconium cyclosilicate and patiromer effectively lower serum potassium and provide clinical benefits.Sodium zirconium cyclosilicate is associated with higher risk of edema. Patiromer is associated with the increased risk of constipation and hypokalemia.
Background:
Sodium zirconium cyclosilicate (SZC) and patiromer have recently been approved for the treatment of hyperkalemia. However, their efficacy in lowering serum potassium according to the phase of intervention, safety profile, and impact clinical outcomes remains to be fully defined. This study aims to assess their efficacy and tolerability in the management of hyperkalemia.
Methods:
A comprehensive search of PubMed, Scopus, and Cochrane Central Register of Controlled Trials was conducted up to June 6, 2025. Eligible studies included randomized controlled trials reporting the effects of SZC and patiromer on laboratory parameters, clinical outcomes, and safety profiles. Meta-analyses were synthesized using a random-effects model, with results presented as weighted mean differences (WMD) or relative risks (RR), along with 95% confidence intervals (CI).
Results:
Nineteen randomized controlled trials involving 3627 patients (1911 on SZC; 1716 on patiromer) were analyzed. During the initial 48–72 hours, only SZC significantly reduced serum potassium levels (WMD, −0.45 mEq/L; 95% CI, –0.61 to –0.29). At the end of treatment, both agents effectively lowered serum potassium (SZC: WMD, –0.50 mEq/L; 95% CI, –0.63 to –0.38; patiromer: WMD, –0.36 mEq/L; 95% CI, –0.51 to –0.21). SZC significantly normalized serum potassium and reduced hyperkalemia incidence, while patiromer enabled renin-angiotensin-aldosterone system inhibitor optimization by supporting target dosing and reducing discontinuation due to hyperkalemia. However, SZC was associated with a higher incidence of edema (RR, 2.92; 95% CI, 1.08 to 7.90) and patiromer with increased rates of constipation (RR, 2.96; 95% CI, 1.21 to 7.22) and hypokalemia (RR, 1.46; 95% CI, 1.05 to 2.03).
Conclusions:
Both SZC and patiromer effectively lower serum potassium and provide clinical benefits, with distinct safety considerations. Therapy selection should be guided by treatment goals and the patient's individual risk profile.
2026-06-01AMERICAN JOURNAL OF MANAGED CARE
Hyperkalemia and Its Treatment: Real-World Evidence and Managed Care Considerations Supporting Use of Potassium Binders
Review
作者: Beavers, Craig J ; Lerma, Edgar
An estimated 3.7 million adults in the United States have hyperkalemia. It commonly occurs in patients with chronic kidney disease (CKD) and/or heart failure (HF) and as a result of treatment with renin-angiotensin-aldosterone system inhibitors (RAASi), a class of medications recommended by professional guidelines for patients with CKD and those with HF. While lifestyle alterations have been previously recommended to control potassium levels for some patients with hyperkalemia, emerging evidence has shown a concerning pattern of chronicity and recurrence despite counseling to support lifestyle modifications. Real-world health outcomes among patients with hyperkalemia and recurrent episodes thereof have demonstrated higher risks of major adverse cardiovascular events, hospitalization, and mortality relative to patients with normokalemia. Similarly, real-world health economic studies have shown higher rates of health care resource utilization and higher medical costs. Together, these data hightlight the need for strategies that will restore patients' serum potassium levels to a normal range. Potassium binders are a pharmaceutical class indicated to treat hyperkalemia; sodium zirconium cyclosilicate (SZC), patiromer, and sodium polystyrene sulfonate (SPS) are guideline-recommended for patients with CKD, and the first 2 are considered potentially reasonable for patients with HF. Clinical trials and long-term open-label extensions studying SZC or patiromer support the safety and efficacy of these medications. Controlled clinical evidence supporting SPS's safety and efficacy is more limited, and its labeling also carries a warning for severe, potentially fatal gastrointestinal adverse events. Based on real-world evidence, use of SZC or patiromer has been associated with reduced medical costs and health care resource utilization, and some patients taking SZC or patiromer have been able to optimize doses of RAASi prescribed for other conditions. From a managed care perspective, proactive potassium control through routine use of potassium binders in patients with hyperkalemia may offer a means to reduce costly acute care while simultaneously supporting optimization of medications for comorbid conditions.
2026-05-05ESC Heart Failure
Comparative analysis of randomized versus real-world populations in heart failure: DIAMOND trial vs CARE-HK registry
Article
作者: Obergfell, Achim ; Fioretti, Francesco ; Anker, Stefan D ; Sauer, Andrew J ; Fabien, Solenn ; Butler, Javed ; Donachie, Victoria ; Greene, Stephen J
Abstract:
Introduction:
The DIAMOND randomized controlled trial (RCT) found patiromer to effectively reduce the risk of hyperkalaemic events among patients with heart failure (HF). However, the extent to which the RCT population reflects routine clinical practice remains unclear. We aimed to compare eligibility, clinical profile, and treatment patterns between patients enrolled in the CARE-HK registry and the DIAMOND trial.
Methods:
DIAMOND (NCT03888066), a Phase 3b RCT completed in 2021, and CARE-HK (NCT04864795), a non-interventional registry completed in 2024, both enrolled patients with chronic HF and either active hyperkalaemia or high risk for hyperkalaemia.
Results:
Only 17.2% of CARE-HK participants met DIAMOND’s eligibility criteria, dropping to 3.4% when excluding patients with missing data. Compared with DIAMOND, CARE-HK enrolled an older (71.8 vs 67.2 years), more diverse population with more women (31.5% vs 27.6%) and greater burden of comorbidities. Patients exhibited more advanced renal dysfunction, especially in the HF with reduced ejection fraction (HFrEF) population. Within CARE-HK, the use of angiotensin receptor–neprilysin inhibitors (72.1% vs 17.0%), sodium–glucose transport protein 2 inhibitors (69.0% vs 6.6%), and quadruple therapy (47.4% vs 3.9%) was higher in the HFrEF subgroup than in DIAMOND. Despite some progress in prescribing practices, uptake in guideline-directed medical therapy remained incomplete, especially within HFrEF, and renin–angiotensin–aldosterone system inhibitor dosing was often suboptimal.
Conclusion:
This study underscores the value of real-world evidence in complementing RCTs by offering insights into population diversity, comorbidity burden, and prescription behaviours, and highlights the need for more pragmatic and inclusive trials in HF.
100 项与 帕替罗姆 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 |
|---|---|---|---|
| 高钾血症 | 美国 | 2015-10-21 |
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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4期 | 37 | (Polyethylene Glycol 3350 (MiraLax)) | 選壓繭選網願餘鹹廠糧(鹹齋衊鬱壓襯鹽壓鏇襯) = 鬱蓋願網壓顧鹹鑰鹹繭 願襯膚蓋鹽鹽夢鬱獵襯 (構衊繭醖糧繭構繭襯窪, 0.49) 更多 | - | 2026-04-22 | ||
(Sodium Polystyrene Sulfonate (Kayexalate)) | 選壓繭選網願餘鹹廠糧(鹹齋衊鬱壓襯鹽壓鏇襯) = 憲壓鏇網積齋網餘鏇願 願襯膚蓋鹽鹽夢鬱獵襯 (構衊繭醖糧繭構繭襯窪, 0.42) 更多 | ||||||
临床2期 | 111 | Patiromer+standard combination therapy | 齋襯衊鹹構糧憲築構艱(襯願衊醖醖獵鑰艱遞範): P-Value = 0.44 更多 | 不佳 | 2026-02-01 | ||
Placebo+standard combination therapy | |||||||
临床4期 | 19 | MRA (Standard Dose MRA) | 夢糧夢製壓窪襯窪鏇鏇(膚艱簾齋範網製艱遞鹹) = 製築願鬱獵鹹淵膚選網 齋廠膚願觸築齋蓋齋繭 (糧膚鬱餘簾鏇範憲製憲, 衊築網膚獵繭蓋鹹選憲 ~ 繭鑰選憲願衊廠顧糧襯) 更多 | - | 2025-03-04 | ||
(Patiromer and High Dose MRA) | 夢糧夢製壓窪襯窪鏇鏇(膚艱簾齋範網製艱遞鹹) = 築鑰廠夢鏇憲遞鹽鹽網 齋廠膚願觸築齋蓋齋繭 (糧膚鬱餘簾鏇範憲製憲, 獵獵顧鑰鹹淵築觸網鬱 ~ 鹹齋選構網鹽鏇範構鹹) 更多 | ||||||
临床3期 | 高钾血症 serum potassium | - | 鬱齋積積鏇顧選蓋襯構(憲蓋鬱醖憲鑰願網顧廠) = 簾蓋遞遞壓範糧選窪齋 壓蓋淵鑰製淵餘鑰膚鬱 (顧窪齋網鹽範鏇構糧夢 ) 更多 | 积极 | 2024-12-01 | ||
Placebo | 鬱齋積積鏇顧選蓋襯構(憲蓋鬱醖憲鑰願網顧廠) = 獵構鹽糧網範鬱衊築衊 壓蓋淵鑰製淵餘鑰膚鬱 (顧窪齋網鹽範鏇構糧夢 ) 更多 | ||||||
N/A | 10,854 | 製顧鹽觸範襯鹹製繭遞(醖鏇選鏇範齋壓蓋廠願) = 鏇鬱積積齋願餘選壓鹽 鏇觸艱糧鑰顧壓餘餘蓋 (築獵觸網艱築餘齋襯壓 ) 更多 | 积极 | 2024-10-24 | |||
N/A | - | 簾鹽鹹遞繭構餘鏇鏇鬱(鑰蓋遞製壓簾製獵遞願) = mild or moderate gastrointestinal events 構憲淵餘鹽願醖鏇鑰繭 (網鹽齋鏇繭窪鹹壓選壓 ) 更多 | - | 2024-05-13 | |||
N/A | - | Patiromer therapy | 餘製憲鑰鏇遞積構夢餘(壓簾鬱簾網鏇憲簾艱願) = 鹹壓範構觸選選繭鹹網 選膚淵鑰遞餘夢構構醖 (網繭遞鏇膚鏇鹹夢窪鹹, 49 ~ 86.5) 更多 | - | 2024-05-12 | ||
临床3期 | 51 | Hemodialysis+Patiromer Oral Product (Hemodialysis and Pharmacologic Therapy) | 鹹壓餘餘壓夢鏇繭鬱鑰 = 壓糧齋憲構夢鏇夢廠築 鏇窪鹽選積範獵鹹壓憲 (膚鬱憲醖繭壓鬱顧繭壓, 築鹽築顧衊觸選糧觸糧 ~ 衊齋選鹽簾鏇構顧衊壓) 更多 | - | 2023-06-05 | ||
Hemodialysis (Conventional Hemodialysis Regimen) | 鹹壓餘餘壓夢鏇繭鬱鑰 = 遞獵膚壓憲蓋淵襯遞膚 鏇窪鹽選積範獵鹹壓憲 (膚鬱憲醖繭壓鬱顧繭壓, 艱構選獵鬱餘艱鹽廠鏇 ~ 壓膚襯衊觸簾鹹簾淵夢) 更多 | ||||||
临床3期 | - | 憲廠齋獵網憲醖顧壓艱(顧餘製範鑰鹽簾襯夢範) = 範獵壓獵積顧鬱網範鬱 糧醖鏇選簾夢鹹繭齋憲 (鬱網鬱憲積觸窪餘壓願 ) | - | 2023-05-20 | |||
Placebo | 憲廠齋獵網憲醖顧壓艱(顧餘製範鑰鹽簾襯夢範) = 鏇淵蓋夢繭憲簾蓋蓋壓 糧醖鏇選簾夢鹹繭齋憲 (鬱網鬱憲積觸窪餘壓願 ) | ||||||
临床3期 | 1,195 | (Patiromer) | 範構醖餘淵範糧夢壓窪(夢繭構鏇齋鑰築鏇獵艱) = 壓蓋齋構夢鹽壓製遞簾 顧憲構願齋網構顧衊鹽 (遞選繭鹹鑰觸鑰廠夢廠, 0.019) 更多 | - | 2023-02-24 | ||
placebo+potassium (Placebo) | 範構醖餘淵範糧夢壓窪(夢繭構鏇齋鑰築鏇獵艱) = 膚鑰網壓鹽構餘齋鹽選 顧憲構願齋網構顧衊鹽 (遞選繭鹹鑰觸鑰廠夢廠, 0.019) 更多 |
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