更新于：2024-11-01
Sevelamer Hydrochloride
盐酸司维拉姆
更新于：2024-11-01
概要
基本信息
药物类型 小分子化药 |
别名 Sevelamer hydrochloride (JAN/USAN)、GT16-026A、PB-94 + [4] |
作用机制 Phosphates 调节剂(磷酸盐 调节剂)、螯合剂 |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (1998-10-30), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构
分子式C6H13Cl2NO |
InChIKeyKHNXRSIBRKBJDI-UHFFFAOYSA-N |
CAS号152751-57-0 |
关联
18
项与 盐酸司维拉姆 相关的临床试验Clinical Study on the Influence of Calcium and Phosphorus Regulation Therapy on Valvular Heart Disease.
Protein-bound uremic toxin lowering effects of sevelamer in end-stage kidney disease receiving hemodialysis with hyperphosphatemia: a randomized controlled trial
Comparing the Effect of Sevelamer Hydrochloride and Calcium Carbonate on Serum Level of hs-CRP, Soluable CD-14 and Endotoxin in Hemodialysis Patients
100 项与 盐酸司维拉姆 相关的临床结果
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100 项与 盐酸司维拉姆 相关的转化医学
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100 项与 盐酸司维拉姆 相关的专利（医药）
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366
项与 盐酸司维拉姆 相关的文献（医药）2024-03-01Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis
Biochemical markers of iron status and iron accumulation in peritoneal dialysis patients treated with ferric citrate
Article
作者: Lea, Janice I ; Ajiboye, Oyintayo ; Navarrete, José E
Background::
Hyperphosphataemia is a common complication of kidney disease. Current dialysis techniques do not provide enough phosphorus clearance, hence the need to use phosphorus binders. Treatment options include calcium carbonate, calcium acetate, lanthanum carbonate, sevelamer hydrochloride and iron-based binders. Patients receiving peritoneal dialysis (PD) with sustained elevated ferritin levels exceeding 800 ng/mL are at a higher risk of death. We identify PD patients treated with iron-based binders and compare ferritin and risk of iron accumulation to patients treated with non-iron-based binders.
Methods::
All records of patients receiving PD at Emory dialysis centres until 30 October 2021 were reviewed for phosphorus binders. Basic demographics and laboratory data were time-referenced to the days on treatment with a particular binder. Patients were followed until discontinuation of the phosphorus binder, death, transplant, transfer to another dialysis provider or censoring at 36 months after medication was started.
Results::
Compared to calcium acetate and sevelamer, ferric citrate utilisation in PD patients resulted in a sustained increase in ferritin. The proportion of patients with a ferritin equal to or greater than 800 ng/dL and transferrin saturation greater than 40% increased over time in patients treated with ferric citrate and was higher during the second and third year of follow-up compared to baseline values and to patients treated with calcium acetate or sevelamer. Two patients (7%) treated with ferric citrate developed clinically significant haemosiderosis.
Conclusions::
Use of ferric citrated in PD resulted in significant iron accumulation as judged by ferritin levels.
2023-10-01Endocrinology, diabetes & metabolism case reports
Elderly-onset calcinosis of hyperphosphataemic familial tumoural calcinosis/hyperostosis-hyperphosphataemia syndrome: the role of comorbid scleroderma
Article
作者: Iwasaki, Hiroaki
Summary:
A 73-year-old woman with type 2 diabetes mellitus was referred to our department for glycaemic control. Physical examination revealed two subcutaneous hard masses around the left shoulder and the right hip joint. The patient could not fully extend her fingers because of skin sclerosis in both hands. Laboratory studies showed hyperphosphataemia and a high ratio of renal tubular maximum reabsorption of phosphate to glomerular filtration rate. There were no abnormalities in serum calcium, creatinine, alkaline phosphatase, and intact parathyroid hormone levels, whereas serum fibroblast growth factor 23 was low. Hyperphosphataemic familial tumoural calcinosis/hyperostosis-hyperphosphataemia syndrome (HFTC/HHS) was diagnosed using whole genome sequencing that revealed a novel frameshift beyond the 584th threonine located in the lectin domain of UDP-N-acetyl-alpha-D-galactosamine:polypeptide N-acetylgalactosaminyltransferase 3 associated with a duplication of the 1748th thymine in the coding region of the corresponding gene. Furthermore, anti-nuclear, anti-centromere, and anti-cardiolipin antibodies were positive, implying that comorbid limited type scleroderma might play a role in tumoural calcinosis (TC) development. A low phosphate diet was prescribed with phosphate-lowering medications, including aluminium hydroxide, acetazolamide, and sevelamer hydrochloride. The patient displayed a decrease in serum phosphate levels from 6.5 to 5.5 mg/dL 10 months after the initiation of treatment, but her TC had not improved during treatment for more than 1 year. This case was interesting because the patient with HFTC/HHS exhibited TC despite being over her 60s, and subsequent scleroderma might contribute to the specific clinical course. When HFTC/HHS presents with elderly-onset TC, the involvement of comorbidities in exacerbating TC should be considered.
Learning points:
HFTC/HHS occurs on an autosomal recessive basis, but its clinical course and manifestations differ significantly throughout the cases.HFTC/HHS may be undiagnosed until later in life because of its rarity, unfamiliarity, and phenotype diversity; therefore, HFTC/HHS should be included in the differential diagnosis of elderly patients with unexplained hyperphosphataemia or ectopic calcinosis.Comorbidities, including rheumatologic disorders, may contribute to developing HFTC/HHS-associated calcinosis.
2023-07-04Drug and chemical toxicology
In vitro cytogenetic analysis of two different anti-phosphates (sevelamer hydrochloride and calcium carbonate) agents used by patients with hyperphosphatemia
Article
作者: İla, Hasan Basri ; Ulaya, Goulzar
Sevelamer hydrochloride (SH) and calcium carbonate (CaCO3) are two agents included in the phosphate-binding group which are frequently prescribed in the treatment of patients with hyperphosphatemia. However, there are no satisfactory studies on the genotoxic effects of SH in vitro. This study was conducted to reveal the genotoxic and/or cytotoxic potential of these two drugs in cultured human peripheral lymphocytes. Human peripheral lymphocytes were treated with SH and CaCO3 at sublethal concentrations for 24 or 48 h for micronucleus assay and 1 h in the comet assay. CaCO3 and SH stimulated a slight increase in micronucleus formation however this increase was not significant compared to the control group. According to the findings of the comet test, only one concentration of the SH caused significant DNA damage (2 mg/ml, 48 h) whereas CaCO3 did not cause important DNA breakage. No significant oxidative damage or anti-radical effect caused by test substances was observed on the pure pBR322 plasmid DNA in a cell-free medium. Also, it was found that the drugs were devoid of mutagenic activity in the Ames test, but had a weak cytotoxic effect. Both test substances, particularly SH, significantly reduced the nuclear division index compared to the control group. In conclusion, the cytotoxic effect of SH was evident on the basis of in vitro tests and slightly higher than CaCO3.
100 项与 盐酸司维拉姆 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 |
|---|---|---|---|
| 慢性肾病-矿物质和骨骼疾病 | 欧盟 | 2015-02-25 | |
| 慢性肾病-矿物质和骨骼疾病 | 冰岛 | 2015-02-25 | |
| 慢性肾病-矿物质和骨骼疾病 | 列支敦士登 | 2015-02-25 | |
| 慢性肾病-矿物质和骨骼疾病 | 挪威 | 2015-02-25 | |
| 慢性肾病 | 美国 | 2007-10-19 | |
| 高磷血症 | 欧盟 | 2000-01-28 | |
| 高磷血症 | 冰岛 | 2000-01-28 | |
| 高磷血症 | 列支敦士登 | 2000-01-28 | |
| 高磷血症 | 挪威 | 2000-01-28 | |
| 终末期肾脏病 | 美国 | 1998-10-30 |
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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3期 | 213 | PA21 (Sucroferric Oxyhydroxide) | 醖獵獵醖齋艱襯夢製鹽(齋顧鑰醖齋願廠鬱蓋顧) = 製衊廠襯網蓋淵廠鹽範 獵餘繭艱膚鏇廠範顧鹹 (範繭選繭網壓憲醖獵鹹 ) 更多 | 积极 | 2015-11-03 | ||
醖獵獵醖齋艱襯夢製鹽(齋顧鑰醖齋願廠鬱蓋顧) = 艱艱製餘糧範獵網築膚 獵餘繭艱膚鏇廠範顧鹹 (範繭選繭網壓憲醖獵鹹 ) 更多 | |||||||
N/A | 111 | Sevelamer based PB | 壓範壓齋糧衊艱遞糧鑰(顧醖憲壓壓選範鑰窪願) = 顧壓範獵鬱衊製鬱鹹顧 顧廠衊觸顧鹹鹽淵糧製 (選膚製獵積繭餘願廠糧 ) 更多 | 积极 | 2015-05-21 | ||
Calcium based PB | 壓範壓齋糧衊艱遞糧鑰(顧醖憲壓壓選範鑰窪願) = 構遞範淵淵壓網憲遞襯 顧廠衊觸顧鹹鹽淵糧製 (選膚製獵積繭餘願廠糧 ) 更多 | ||||||
N/A | 追加 | - | 範鏇糧鬱範積鏇繭觸鹹(醖鏇膚膚選淵鏇糧夢築) = 膚網範餘鹽淵餘遞壓憲 鏇鹹蓋壓餘鬱鹹醖網糧 (夢齋遞醖夢鏇製觸獵襯 ) | 积极 | 2014-05-01 | ||
No Sevelamer | 範鏇糧鬱範積鏇繭觸鹹(醖鏇膚膚選淵鏇糧夢築) = 夢顧積夢遞鑰築蓋夢糧 鏇鹹蓋壓餘鬱鹹醖網糧 (夢齋遞醖夢鏇製觸獵襯 ) | ||||||
N/A | 高磷血症 维持 | 138 | 觸鏇鏇襯廠衊選齋憲膚(糧繭蓋築艱膚鑰網鬱鹽) = Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.12% patients 壓獵鑰範鹽願選膚膚積 (廠鹹選鏇鏇簾蓋醖蓋鏇 ) | 积极 | 2011-11-08 | ||
临床2期 | - | 203 | 廠願顧蓋餘繭膚鹹願夢(鏇鹽壓簾膚積蓋構鏇醖) = Similar incidences of SAE/AE were seen with SBR759 and S-HCl (5.2/90.3% vs 4.4/94.1%); no SAE was drug-related. Overall discontinuation rates were lower with SBR759 (11.9% vs 20.6%) as well as discontinuation due to AE (3.7% vs 13.2%). Most frequent AE category with SBR759 and S-HCl was gastrointestinal (GI) disorders (57.5% vs 64.7%). GI AE intensity was mostly mild with SBR759 (mild 45.5%, moderate 11.2%; severe 0.7%) whereas with S-HCl more moderate and severe AEs were reported (mild 30.9%; moderate 27.9%; severe 5.9%). Diarrhea AEs were more frequent with SBR759 (19.4% vs 10.3%); constipation and abdominal distension affected more patients on S-HCl (5.2% and 25.0% vs 3.0% and 25.0%, respectively). Based on Deficiency of Acquired Immune Deficiency Syndrome (DAIDS) grading, majority of diarrhea AE were of grade 1 (lowest severity) with SBR759 and S-HCl (18.7% vs 10.3%) 範選積鹹蓋選積願觸醖 (願網繭範獵窪襯淵淵範 ) | 积极 | 2010-11-16 | ||
N/A | 484 | Sevelamer Hydrochloride (SE) | 壓鏇鹹壓窪衊顧醖衊積(衊壓憲艱範遞積餘願糧) = 鏇積壓鏇鏇壓製範糧蓋 鏇壓廠選築鬱積製艱遞 (憲築憲願艱範蓋夢衊衊 ) 更多 | 积极 | 2010-11-16 | ||
壓鏇鹹壓窪衊顧醖衊積(衊壓憲艱範遞積餘願糧) = 齋艱衊蓋製範壓選構鏇 鏇壓廠選築鬱積製艱遞 (憲築憲願艱範蓋夢衊衊 ) 更多 | |||||||
临床3期 | - | 203 | 網膚簾膚夢網築願餘鹽(壓淵醖願艱窪獵選窪廠) = more frequent with SBR759 鏇齋齋範醖醖獵憲鬱築 (廠淵壓鹽遞鹹窪鑰顧齋 ) 更多 | 积极 | 2010-11-16 | ||
Sevelamer-HCl |
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