The purpose of this study is to assess the bioequivalence between ASP1585 granules and ASP1585 capsules after repeated oral administration of ASP1585 granules or ASP1585 capsules under open-label conditions in non-elderly healthy male subjects. In addition, the safety of these products is assessed.

开始日期2014-08-01

申办/合作机构

Astellas Pharma, Inc.

JPRN-UMIN000013147

/ RecruitingN/AIIT

Bixalomer versus calcium carbonate on coronary artery calcification in hemodialysis patients with hyperphosphatemia: a randomized study. - BICOLOR STUDY

开始日期2014-02-13

申办/合作机构-

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100 项与比沙洛姆相关的专利（医药）

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项与比沙洛姆相关的文献（医药）

2025-05-01·Clinical Journal of the American Society of Nephrology

Efficacy and Safety of Phosphate-Lowering Agents for Adult Patients with CKD Requiring Dialysis

Article

作者: Noma, Hisashi ; Hamano, Takayuki ; Mizukami, Aya ; Kimura, Hiroshi ; Yamada, Shunsuke ; Hasegawa, Takeshi ; Fukagawa, Masafumi ; Nishimoto, Masatoshi ; Taniguchi, Masatomo ; Nishiwaki, Hiroki ; Murashima, Miho ; Saito, Hirotaka

Key Points:

Sevelamer was associated with lower all-cause mortality compared with calcium-based agents.Sucroferric oxyhydroxide and tenapanor were estimated to rank high in lowering all-cause mortality compared with other phosphate-lowering agents.Sucroferric oxyhydroxide and lanthanum were associated with slower progression of coronary artery calcium score compared with calcium-based agents.

Background:

It is necessary to update the evidence of each phosphate-lowering agent on dialysis patients.

Methods:

From the CENTRAL, MEDLINE, Embase, and ClinicalTrial.gov databases, randomized controlled trials using oral phosphate-lowering agents on adult patients requiring maintenance dialysis were extracted. The treatment period was required for 8 or more weeks, and the risk of bias was assessed according to the Cochrane Collaboration method. The outcomes were all-cause mortality, cardiovascular mortality, gastrointestinal events, fracture, coronary artery calcium score (CACS), serum calcium, phosphate, intact parathyroid hormone, and bicarbonate levels. A network meta-analyses using multivariate random-effects models were performed for assessing the comparative effectiveness. The ranking of the phosphate-lowering agents was assessed using a surface under the cumulative ranking curve.

Results:

A total of 70 randomized controlled trials involving 15,551 participants were included. Eleven phosphate-lowering agents including calcium-based agents, sevelamer, bixalomer, lanthanum, sucroferric oxyhydroxide, ferric citrate, tenapanor, magnesium, nicotinamide, aluminum, and sucralfate were assessed. Sevelamer was significantly associated with lower all-cause mortality compared with calcium-based agents (risk ratio [95% confidence interval]: 0.59 [0.37 to 0.94]), and sucroferric oxyhydroxide and tenapanor were estimated to rank high in lowering all-cause mortality on the basis of the surface under the cumulative ranking curve. The risk of gastrointestinal events was the highest with nicotinamide, followed by sucroferric oxyhydroxide. Compared with calcium-based agents, CACS was significantly lower among those on lanthanum and sucroferric oxyhydroxide (standardized mean difference [95% confidence interval]: −0.26 [−0.52 to −0.01] and −0.50 [−0.95 to−0.06], respectively). Serum calcium levels were higher, and serum intact parathyroid hormone levels were lower in patients treated with calcium-based agents. Except for sevelamer, serum bicarbonate levels for all other agents were higher compared with placebo.

Conclusions:

Compared with calcium-based agents, sevelamer was associated with lower all-cause mortality, and sucroferric oxyhydroxide and lanthanum were associated with slower progression of CACS. Potential benefits and harms should be considered when selecting phosphate-lowering agents (International prospective register of systematic reviews: CRD42022328388).

2023-01-01·Blood purification

Comparative Efficacy and Acceptability of 12 Phosphorus-Lowering Drugs in Adults with Hyperphosphatemia and Chronic Kidney Disease: A Systematic Review and Network Meta-Analysis

Review

作者: Li, Yunming ; Zhang, Yanbiao ; Huang, Xi ; Xiao, Hualin ; You, Shuang ; Luo, Houli ; Li, Lingfan ; Feng, Jian ; Li, Xianhui ; Chen, Xin ; Huang, Bo ; Ai, Xiang ; Xue, Gang ; Li, Juncheng ; Dong, Hongfei

Background: Hyperphosphatemia is associated with cardiovascular morbidity and mortality in adults with chronic kidney disease (CKD). Drug therapy has an irreplaceable role in the management of hyperphosphatemia. Objectives: We aimed to compare and rank phosphorus-lowering drugs, including phosphate binder and nonphosphate binder, in hyperphosphatemia adults with CKD. Methods: We did a systematic review and frequentist random-effect network meta-analysis. We searched in PubMed, Cochrane Library, Web of Science, and Embase from inception to February 1, 2023, for randomized controlled trials of 12 phosphorus-lowering drugs in adults with hyperphosphatemia and CKD. Primary outcomes were efficacy (changes in serum phosphorus) and acceptability (treatment withdrawals due to any cause). We ranked each drug according to the value of surface under the cumulative ranking curve. We applied the Confidence in Network Meta-Analysis frameworks to rate the certainty of evidence. This study was registered with PROSPERO, number CRD42022322270. Results: We identified 2,174 citations, and of these, we included 94 trials comprising 14,459 participants and comparing 13 drugs or placebo. In terms of efficacy, except for niacinamide, all drugs lowered the level of serum phosphorus compared with placebo, with mean difference ranging between −1.61 (95% credible interval [CrI], −2.60 to −0.62) mg/dL for magnesium carbonate and −0.85 (−1.66 to −0.05) mg/dL for bixalomer. Only ferric citrate with odds ratios 0.56 (95% CrI: 0.36–0.89) was significantly associated with fewer dropouts for acceptability. Of the 94 trials, 43 (46%), 7 (7%), and 44 (47%) trials were rated as high, moderate, and low risk of bias, respectively, the certainty of the evidence was moderate to very low. Conclusions: Magnesium carbonate has the best phosphorus-lowering effect in hyperphosphatemia adults with CKD; considering efficacy and acceptability, ferric citrate shows evidence to be the most appropriate drug with or without dialysis.

2022-07-03·Expert opinion on drug safety3区 · 医学

An update on phosphate binders for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis: a review of safety profiles

3区 · 医学

Review

作者: Ito, Hidetoshi ; Ogata, Hiroaki ; Takeshima, Akiko

INTRODUCTION:

Hyperphosphatemia is an inevitable complication for patients undergoing dialysis, as is the resulting need for treatment with phosphate binders. Currently, various phosphate binders are clinically available. In addition to their phosphate-lowering activity, individual phosphate binders have differing safety profiles and off-target actions.

AREAS COVERED:

This paper reviews the safety of phosphate binders and issues to be resolved.

EXPERT OPINION:

Calcium-based phosphate binders are well tolerated but may increase calcium overload risk. Sevelamer reduces serum cholesterol levels and exerts anti-inflammatory effects. Compared to sevelamer, bixalomer is associated with fewer gastrointestinal symptoms. Aluminum-containing binders, lanthanum carbonate, and sucroferric oxyhydroxide exhibit strong phosphate-lowering activity. Although ferric citrate reduces erythropoiesis-stimulating agents and intravenous iron doses, its use requires monitoring of iron metabolic markers to avoid overload. Occasionally, combined use of multiple phosphate binders can offer the advantages of each phosphate binder while minimizing their drawbacks; thus, this may be desirable according to individual patients' conditions and comorbidities. However, increased pill burden and nonadherence to phosphate binders emerge as new problems. We expect that novel therapeutic strategies will be developed to resolve these issues.

项与比沙洛姆相关的新闻（医药）

2022-06-22

·生物制药小编

2022QbD | 分论坛一：抗体药物论坛议程首发！

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抗体疫苗合作细胞疗法基因疗法

100 项与比沙洛姆相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09586	-	B	DB15200

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
高磷血症	日本	Astellas Pharma, Inc.	2012-03-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性肾病	临床3期	日本	Astellas Pharma, Inc.	2009-05-01
尿毒症	临床3期	日本	Astellas Pharma, Inc.	2009-05-01
终末期肾脏病	临床2期	-	Amgen, Inc.	2008-03-01
高磷酸盐家族性肿瘤钙质沉着症	临床2期	-	Amgen, Inc.	2008-03-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01742611 (Pubmed) 人工标引	临床3期	高磷血症 \| 慢性肾病	105	Bixalomer	窪構壓夢遞糧餘襯醖齋(憲糧壓蓋獵遞廠夢築蓋) = 憲蓋淵蓋網餘衊襯鬱積遞製襯鬱蓋願鏇窪壓鹹 (積艱積網壓壓鹽範繭顧 ) 更多	积极	2017-04-01
ASN2013	N/A	-	114	Bixalomer	鏇憲齋鹽衊製襯壓築蓋(醖範壓獵繭繭艱衊糧構) = 衊築膚膚繭艱範醖築襯顧窪選壓網觸窪衊製顧 (艱範淵齋艱選夢蓋遞簾 ) 更多	积极	2013-11-05
ASN2013	N/A	-	114	Sevelamer hydrochloride	鏇憲齋鹽衊製襯壓築蓋(醖範壓獵繭繭艱衊糧構) = 鏇築壓襯鏇糧壓選餘餘顧窪選壓網觸窪衊製顧 (艱範淵齋艱選夢蓋遞簾 ) 更多	积极	2013-11-05