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[PMID]:29311459
[Au] Autor:Mitsuboshi S; Yamada H; Nagai K; Okajima H
[Ad] Endereço:Department of Pharmacy, Kaetsu Hospital.
[Ti] Título:[Low Continuity Rate of Sucroferric Oxyhydroxide among Japanese Hemodialysis Patients with High Phosphate Binder Pill Burden].
[So] Source:Yakugaku Zasshi;138(1):135-139, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:This prospective observational study was conducted to evaluate the continuity, efficacy, and tolerability of sucroferric oxyhydroxide (SO) among hemodialysis (HD) patients who switched to SO from sevelamer hydrochloride (SH) or bixalomer (BX). Participants were 9 HD patients in Kaetsu Hospital who had been receiving more than 9 tablets/d of SH or BX and were switched to SO 750 mg/d. All the participants were men. Over a 6-month observational period, 6 of the 9 patients (67%) discontinued SO because of adverse events, including diarrhea, atheroma, and polycythemia. Although the diarrhea and atheroma were mild, the affected patients did not wish to restart SO. On the other hand, 3 of the 9 patients (33%) continued taking SO throughout the observation period. These patients tended to have increased levels of serum calcium, hematocrit, and serum ferritin; a decreased number of phosphate binder tablets (from 21 tablets/d to 8 tablets/d); and a decreased dosage of erythropoiesis-stimulating agents. Serum phosphate levels tended to decrease in continuers, but tended to increase in discontinuers. It may be preferable to increase the SO dosage gradually rather than switching from SH or BX all at once, and patients who switch to SO should be carefully monitored.
[Mh] Termos MeSH primário: Quelantes/administração & dosagem
Esquema de Medicação
Substituição de Medicamentos/métodos
Compostos Férricos/administração & dosagem
Poliaminas
Diálise Renal
Sevelamer
Sacarose/administração & dosagem
[Mh] Termos MeSH secundário: Idoso
Grupo com Ancestrais do Continente Asiático
Quelantes/efeitos adversos
Combinação de Medicamentos
Compostos Férricos/efeitos adversos
Seres Humanos
Masculino
Meia-Idade
Fosfatos/sangue
Estudos Prospectivos
Sacarose/efeitos adversos
Comprimidos
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Chelating Agents); 0 (Drug Combinations); 0 (Ferric Compounds); 0 (Phosphates); 0 (Polyamines); 0 (Tablets); 0 (sucroferric oxyhydroxide); 3160WY51LV (bixalomer); 57-50-1 (Sucrose); 9YCX42I8IU (Sevelamer)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180110
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00180


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[PMID]:27772629
[Au] Autor:Airy M; Winkelmayer WC; Navaneethan SD
[Ad] Endereço:Baylor College of Medicine, Houston, Texas.
[Ti] Título:Phosphate Binders: The Evidence Gap Persists.
[So] Source:Am J Kidney Dis;68(5):667-670, 2016 11.
[Is] ISSN:1523-6838
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Hiperfosfatemia
Sevelamer
[Mh] Termos MeSH secundário: Quelantes
Seres Humanos
Falência Renal Crônica
Fosfatos
Diálise Renal
[Pt] Tipo de publicação:EDITORIAL; COMMENT
[Nm] Nome de substância:
0 (Chelating Agents); 0 (Phosphates); 9YCX42I8IU (Sevelamer)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171129
[Lr] Data última revisão:
171129
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE


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[PMID]:28704404
[Au] Autor:Yaguchi A; Tatemichi S; Takeda H; Kobayashi M
[Ad] Endereço:Pharmacology Research Laboratory, R&D., Kissei Pharmaceutical Co., Ltd., Azumino-City, Nagano-Pref., Japan.
[Ti] Título:PA21, a novel phosphate binder, improves renal osteodystrophy in rats with chronic renal failure.
[So] Source:PLoS One;12(7):e0180430, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The effects of PA21, a novel iron-based and non-calcium-based phosphate binder, on hyperphosphatemia and its accompanying bone abnormality in chronic kidney disease-mineral and bone disorder (CKD-MBD) were evaluated. Rats with adenine-induced chronic renal failure (CRF) were prepared by feeding them an adenine-containing diet for four weeks. They were also freely fed a diet that contained PA21 (0.5, 1.5, and 5%), sevelamer hydrochloride (0.6 and 2%) or lanthanum carbonate hydrate (0.6 and 2%) for four weeks. Blood biochemical parameters were measured and bone histomorphometry was performed for femurs, which were isolated after drug treatment. Serum phosphorus and parathyroid hormone (PTH) levels were higher in the CRF rats. Administration of phosphate binders for four weeks decreased serum phosphorus and PTH levels in a dose-dependent manner and there were significant decreases in the AUC0-28 day of these parameters in 5% PA21, 2% sevelamer hydrochloride, and 2% lanthanum carbonate hydrate groups compared with that in the CRF control group. Moreover, osteoid volume improved significantly in 5% of the PA21 group, and fibrosis volume and cortical porosity were ameliorated in 5% PA21, 2% sevelamer hydrochloride, and 2% lanthanum carbonate hydrate groups. These results suggest that PA21 is effective against hyperphosphatemia, secondary hyperparathyroidism, and bone abnormalities in CKD-MBD as sevelamer hydrochloride and lanthanum carbonate hydrate are, and that PA21 is a new potential alternative to phosphate binders.
[Mh] Termos MeSH primário: Distúrbio Mineral e Ósseo na Doença Renal Crônica/dietoterapia
Compostos Férricos/administração & dosagem
Falência Renal Crônica/induzido quimicamente
Lantânio/administração & dosagem
Sevelamer/administração & dosagem
[Mh] Termos MeSH secundário: Adenina/efeitos adversos
Animais
Distúrbio Mineral e Ósseo na Doença Renal Crônica/metabolismo
Modelos Animais de Doenças
Relação Dose-Resposta a Droga
Compostos Férricos/farmacologia
Falência Renal Crônica/complicações
Falência Renal Crônica/metabolismo
Lantânio/farmacologia
Masculino
Hormônio Paratireóideo/sangue
Fósforo/sangue
Ratos
Sevelamer/farmacologia
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Ferric Compounds); 0 (PA21 compound); 0 (Parathyroid Hormone); 27YLU75U4W (Phosphorus); 490D9F069T (lanthanum carbonate); 6I3K30563S (Lanthanum); 9YCX42I8IU (Sevelamer); JAC85A2161 (Adenine)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170921
[Lr] Data última revisão:
170921
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170714
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0180430


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[PMID]:28584909
[Au] Autor:Peter WLS; Wazny LD; Weinhandl E; Cardone KE; Hudson JQ
[Ad] Endereço:Department of Pharmaceutical Care and Health Systems, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA. stpet002@umn.edu.
[Ti] Título:A Review of Phosphate Binders in Chronic Kidney Disease: Incremental Progress or Just Higher Costs?
[So] Source:Drugs;77(11):1155-1186, 2017 07.
[Is] ISSN:1179-1950
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:As kidney disease progresses, phosphorus retention also increases, and phosphate binders are used to treat hyperphosphatemia. Clinicians prescribe phosphate binders thinking that reducing total body burden of phosphorus may decrease risks of mineral and bone disorder, fractures, cardiovascular disease, progression of kidney disease, and mortality. Recent meta-analyses suggest that sevelamer use results in lower mortality than use of calcium-containing phosphate binders. However, studies included in meta-analyses show significant heterogeneity, and exclusion or inclusion of specific studies alters results. Since no long-term studies have been conducted to determine whether treatment with any phosphate binder is better than placebo on any hard clinical endpoint (including mortality), it is unclear whether possible benefit with sevelamer represents net benefit of sevelamer, net harm with calcium-containing phosphate binders, or both. Although one meta-analysis suggested that calcium acetate may be more efficacious gram for gram than calcium carbonate as a binder, calcium acetate did not reduce hypercalcemia, and gastrointestinal intolerance was higher. Data are insufficient to determine whether calcium acetate provides lower risk of vascular calcification than calcium carbonate. Fears of lanthanum accumulation in the central nervous system or bone with long-term treatment do not appear to be warranted. Newer iron-containing phosphate binders have potential benefits, such as lower pill burden (sucroferric oxyhydroxide) and improved iron parameters (ferric citrate). The biggest challenge to phosphate binder efficacy is non-adherence. This article reviews the current knowledge regarding safety, effectiveness, and adherence with currently marketed phosphate binders and those in development.
[Mh] Termos MeSH primário: Quelantes/uso terapêutico
Hiperfosfatemia/tratamento farmacológico
Lantânio/uso terapêutico
Fosfatos/metabolismo
Insuficiência Renal Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Compostos de Cálcio/efeitos adversos
Compostos de Cálcio/metabolismo
Compostos de Cálcio/uso terapêutico
Quelantes/efeitos adversos
Quelantes/economia
Quelantes/farmacologia
Custos de Medicamentos
Compostos Férricos/efeitos adversos
Compostos Férricos/metabolismo
Compostos Férricos/uso terapêutico
Seres Humanos
Hiperfosfatemia/etiologia
Lantânio/metabolismo
Lantânio/farmacologia
Metanálise como Assunto
Fosfatos/sangue
Insuficiência Renal Crônica/complicações
Sevelamer/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Calcium Compounds); 0 (Chelating Agents); 0 (Ferric Compounds); 0 (Phosphates); 490D9F069T (lanthanum carbonate); 6I3K30563S (Lanthanum); 9YCX42I8IU (Sevelamer)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170808
[Lr] Data última revisão:
170808
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170607
[St] Status:MEDLINE
[do] DOI:10.1007/s40265-017-0758-5


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[PMID]:28169559
[Au] Autor:Gonzalez RS; Lagana SM; Szeto O; Arnold CA
[Ti] Título:Challenges in Diagnosing Medication Resins in Surgical Pathology Specimens: A Crystal-Clear Review Guide.
[So] Source:Arch Pathol Lab Med;141(9):1276-1282, 2017 Sep.
[Is] ISSN:1543-2165
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:CONTEXT: - Medication resins, including Kayexalate, sevelamer, and bile acid sequestrants, can be encountered in gastrointestinal tract specimens. Their classic histologic appearances have been well documented, but pathologist recognition of the resins is 75%, patient history is not always available, and atypical morphologic findings are sometimes present. OBJECTIVE: - To offer a succinct overview of resins in the gastrointestinal tract, including typical and atypical appearances, in order to serve as a quick reference guide. DATA SOURCES: - The study comprises published literature, survey data, and our personal experiences. CONCLUSIONS: - Classic morphology is the benchmark for identifying these resins, but color, location, and fish scale pattern can deviate from the norm, making proper identification a challenge. Patient history should be sought whenever possible, and ancillary staining is an option when necessary. Additionally, the presence of resins should prompt the pathologist to search for potentially related diagnoses (namely, causes of diarrhea in patients on bile acid sequestrants and diagnoses associated with renal failure in patients on Kayexalate or sevelamer).
[Mh] Termos MeSH primário: Resinas de Troca de Cátion/efeitos adversos
Trato Gastrointestinal/patologia
[Mh] Termos MeSH secundário: Seres Humanos
Patologia Cirúrgica/métodos
Poliestirenos/efeitos adversos
Sequestrantes/efeitos adversos
Sevelamer/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Cation Exchange Resins); 0 (Polystyrenes); 0 (Sequestering Agents); 70KO0R01RY (polystyrene sulfonic acid); 9YCX42I8IU (Sevelamer)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171002
[Lr] Data última revisão:
171002
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170208
[St] Status:MEDLINE
[do] DOI:10.5858/arpa.2016-0587-RA


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[PMID]:27651467
[Au] Autor:Habbous S; Przech S; Acedillo R; Sarma S; Garg AX; Martin J
[Ad] Endereço:Department of Epidemiology & Biostatistics, Western University, London, ON, Canada.
[Ti] Título:The efficacy and safety of sevelamer and lanthanum versus calcium-containing and iron-based binders in treating hyperphosphatemia in patients with chronic kidney disease: a systematic review and meta-analysis.
[So] Source:Nephrol Dial Transplant;32(1):111-125, 2017 01 01.
[Is] ISSN:1460-2385
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Background: It remains unclear which phosphate binders should be preferred for hyperphosphatemia management in chronic kidney disease (CKD). Methods: We performed a systematic review and meta-analysis of randomized trials comparing sevelamer or lanthanum with other phosphate binders in CKD. Results: Fifty-one trials (8829 patients) were reviewed. Compared with calcium-based binders, all-cause mortality was nonsignificantly lower with sevelamer {risk ratio [RR] 0.62 [95% confidence interval (CI) 0.35-1.08]} and lanthanum [RR 0.73 (95% CI 0.18-3.00)], but risk of bias was concerning. Compared with calcium-based binders, sevelamer reduced the risk of hypercalcemia [RR 0.27 (95% CI 0.17-0.42)], as did lanthanum [RR 0.12 (95% CI 0.05-0.32)]. Sevelamer reduced hospitalizations [RR 0.50 (95% CI 0.31-0.81)], but not lanthanum [RR 0.80 (95% CI 0.34-1.93)]. The presence/absence of other clinically relevant outcomes was infrequently reported. Compared with calcium-based binders, sevelamer reduced serum calcium, low-density lipoprotein and coronary artery calcification, but increased intact parathyroid hormone. The clinical relevance of these changes is unknown since corresponding clinical outcomes were not reported. Lanthanum had less favorable impact on biochemical parameters. Sevelamer hydrochloride and sevelamer carbonate were similar in three studies. Sevelamer was similar to lanthanum (three studies) and iron-based binders (three studies). Conclusion: Sevelamer was associated with a nonsignificant reduction in mortality and significantly lower hospitalization rates and hypercalcemia compared with calcium-based binders. However, differences in important outcomes, such as cardiac events, fractures, calciphylaxis, hyperchloremic acidosis and health-related quality of life remain understudied. Lanthanum and iron-based binders did not show superiority for any clinically relevant outcomes. Future studies that fail to measure clinically important outcomes (the reason why phosphate binders are prescribed in the first place) will be wasteful.
[Mh] Termos MeSH primário: Compostos de Cálcio/uso terapêutico
Quelantes/uso terapêutico
Hiperfosfatemia/tratamento farmacológico
Lantânio/uso terapêutico
Fosfatos/sangue
Insuficiência Renal Crônica/complicações
Sevelamer/uso terapêutico
[Mh] Termos MeSH secundário: Biomarcadores/sangue
Seres Humanos
Hiperfosfatemia/etiologia
Segurança
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Biomarkers); 0 (Calcium Compounds); 0 (Chelating Agents); 0 (Phosphates); 6I3K30563S (Lanthanum); 9YCX42I8IU (Sevelamer)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170926
[Lr] Data última revisão:
170926
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160922
[St] Status:MEDLINE
[do] DOI:10.1093/ndt/gfw312


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[PMID]:27496336
[Au] Autor:Koiwa F; Yokoyama K; Fukagawa M; Terao A; Akizawa T
[Ad] Endereço:Division of Nephrology, Department of Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.
[Ti] Título:Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open-label, multicentre, 12-week phase III study.
[So] Source:Nephrology (Carlton);22(4):293-300, 2017 Apr.
[Is] ISSN:1440-1797
[Cp] País de publicação:Australia
[La] Idioma:eng
[Ab] Resumo:AIM: We aimed to investigate the non-inferiority of PA21 (sucroferric oxyhydroxide) to sevelamer hydrochloride (sevelamer) in terms of efficacy and safety in Japanese haemodialysis patients with hyperphosphataemia. METHODS: In this Phase III, open-label, multicentre study, 213 haemodialysis patients with hyperphosphataemia were randomized to PA21 or sevelamer treatment for 12 weeks. The primary outcome was adjusted serum phosphorus concentration at the end of treatment; the non-inferiority of PA21 was confirmed if the upper limit of the two-sided 95% confidence interval (CI) is ≤0.32 mmol/L. Secondary outcomes were corrected serum calcium and intact-parathyroid hormone concentrations. Adverse events (AEs) and adverse drug reactions (ADRs) were evaluated. RESULTS: The adjusted mean serum phosphorus concentration at the end of treatment confirmed the non-inferiority of PA21 for lowering serum phosphorus compared with sevelamer (1.62 vs 1.72 mmol/L; difference, -0.11 mmol/L; 95% CI, -0.20 to -0.02 mmol/L). The mean daily tablet intake was 5.6 ± 2.6 and 18.7 ± 7.1 tablets in the PA21 and sevelamer groups, respectively. The incidences of AEs and ADRs were not significantly different between the two groups. CONCLUSION: The non-inferiority of PA21 to sevelamer was confirmed for the treatment of Japanese haemodialysis patients with hyperphosphataemia. PA21 was effective, safe, and well tolerated, while having a considerably lower pill burden than sevelamer.
[Mh] Termos MeSH primário: Quelantes/uso terapêutico
Compostos Férricos/uso terapêutico
Hiperfosfatemia/tratamento farmacológico
Fósforo/sangue
Diálise Renal
Insuficiência Renal Crônica/terapia
Sevelamer/uso terapêutico
Sacarose/uso terapêutico
[Mh] Termos MeSH secundário: Administração Oral
Idoso
Biomarcadores/sangue
Cálcio/sangue
Quelantes/administração & dosagem
Quelantes/efeitos adversos
Esquema de Medicação
Combinação de Medicamentos
Feminino
Compostos Férricos/administração & dosagem
Compostos Férricos/efeitos adversos
Seres Humanos
Hiperfosfatemia/sangue
Hiperfosfatemia/diagnóstico
Hiperfosfatemia/etiologia
Japão
Masculino
Meia-Idade
Hormônio Paratireóideo/sangue
Diálise Renal/efeitos adversos
Insuficiência Renal Crônica/complicações
Insuficiência Renal Crônica/diagnóstico
Sevelamer/administração & dosagem
Sevelamer/efeitos adversos
Sacarose/administração & dosagem
Sacarose/efeitos adversos
Comprimidos
Fatores de Tempo
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Biomarkers); 0 (Chelating Agents); 0 (Drug Combinations); 0 (Ferric Compounds); 0 (PTH protein, human); 0 (Parathyroid Hormone); 0 (Tablets); 0 (sucroferric oxyhydroxide); 27YLU75U4W (Phosphorus); 57-50-1 (Sucrose); 9YCX42I8IU (Sevelamer); SY7Q814VUP (Calcium)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170324
[Lr] Data última revisão:
170324
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160807
[St] Status:MEDLINE
[do] DOI:10.1111/nep.12891


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[PMID]:27965186
[Au] Autor:Ikee R; Toyoyama T; Endo T; Tsunoda M; Hashimoto N
[Ad] Endereço:Department of Nephrology and Dialysis, H. N. Medic Kitahiroshima, 5-6-1, Kyoeicho, Kitahiroshima 061-1113, Hokkaido, Japan.
[Ti] Título:Impact of sevelamer hydrochloride on serum magnesium concentrations in hemodialysis patients.
[So] Source:Magnes Res;29(4):184-190, 2016 Apr 01.
[Is] ISSN:1952-4021
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Serum Mg levels are elevated in patients with renal insufficiency: harmful effects of hypomagnesemia have been reported in patients receiving hemodialysis (HD). In this cross-sectional study, which included 86 HD patients (male : female = 56:30, age 68 ± 12 years), we examined the clinical factors associated with serum Mg levels, with a focus on sevelamer, a phosphate binder widely used to control the hyperphosphatemia of HD patients. The mean serum Mg concentration among our patients was 2.48 ± 0.37 mg/dL (1.02 ± 0.15 mmol/L). Sevelamer was administered to 67 patients (77.9%) at a mean dose of 1.98 ± 1.64 g/day. Sex, diabetes mellitus, cardiovascular disease, anuria, and drugs other than sevelamer were not associated with serum Mg levels. HD duration, serum calcium, albumin, high-density lipoprotein cholesterol, normalized protein catabolic rate (nPCR), creatinine generation rate, and sevelamer dose correlated positively with serum Mg levels, whereas a negative correlation was observed for age and high-sensitivity C-reactive protein. A stepwise multiple regression analysis revealed that age, nPCR, and the dose of sevelamer were independently associated with serum Mg levels. Sevelamer and Mg have been reported to exhibit similar effects, such as an anti-inflammatory effect, inhibition of cardiovascular calcification, and decreased mortality. Therefore, the pleiotropic effects of sevelamer may be partly attributable to the increase in serum Mg levels caused by the drug itself.
[Mh] Termos MeSH primário: Magnésio/sangue
Diálise Renal
Sevelamer/farmacologia
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Feminino
Seres Humanos
Masculino
Meia-Idade
Sevelamer/administração & dosagem
[Pt] Tipo de publicação:CLINICAL TRIAL; JOURNAL ARTICLE
[Nm] Nome de substância:
9YCX42I8IU (Sevelamer); I38ZP9992A (Magnesium)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170420
[Lr] Data última revisão:
170420
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161215
[St] Status:MEDLINE
[do] DOI:10.1684/mrh.2016.0410


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[PMID]:27751671
[Au] Autor:Yang L; Chuen Tan S; Chen C; Wang X; Li X; Yang X
[Ad] Endereço:Peking University Health Science Centre, Beijing, China. Electronic address: lyang@bjmu.edu.cn.
[Ti] Título:Economic Evaluation of Sevelamer versus Calcium-based Binders in Treating Hyperphosphatemia among Patients with End-stage Renal Disease in China.
[So] Source:Clin Ther;38(11):2459-2467.e1, 2016 Nov.
[Is] ISSN:1879-114X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To conduct a cost-effectiveness analysis study of sevelamer versus calcium-based binders (CBBs) in treating hyperphosphatemia among patients with end-stage renal disease (ESRD) in China. METHODS: A decision-analytic model of a lifetime horizon was used for base case analysis from the payers' perspective. The transition probabilities between different health states were derived from survival analysis. The overall survival of CBBs was derived from the Dialysis Clinical Outcomes Revisited study for up to 44 months and a Weibull regression model was used to extrapolate the overall survival to a lifetime horizon. A hazard ratio (0.54; 95% CI, 0.32-0.93) of the overall survival for sevelamer versus CBBs was used to calculate the survival of the sevelamer group. Clinical and cost data were derived from literature and health care system in the local setting. Incremental life year and quality-adjusted life year (QALY) were the primary outcomes. One-way and probabilistic sensitivity analyses were conducted to assess the uncertainty of the model assumptions and parameters. The results were reported in 2015 Chinese Renminbi. FINDINGS: The incremental cost per life year and per QALY gained of sevelamer versus CBBs was ¥44,475 and ¥57,910, respectively. The incremental cost per QALY gained was below the World Health Organization's recommended cost-effectiveness threshold (¥151,070), which is 3 times the gross domestic product per capita of 2015 in China. The incremental cost-effectiveness ratio was most sensitive to the hazard ratio of overall survival with sevelamer versus CBBs in the 1-way sensitivity analysis. The cost-effectiveness acceptability curve indicated that sevelamer had a 89.6% likelihood of cost-effectiveness at the ¥151,070 threshold. IMPLICATIONS: Sevelamer is likely to be a cost-effective option in treating hyperphosphatemia among patients with ESRD compared with CBBs in the local context of China.
[Mh] Termos MeSH primário: Cálcio/uso terapêutico
Hiperfosfatemia/tratamento farmacológico
Falência Renal Crônica/terapia
Sevelamer/uso terapêutico
[Mh] Termos MeSH secundário: Quelantes/uso terapêutico
China
Análise Custo-Benefício
Seres Humanos
Masculino
Anos de Vida Ajustados por Qualidade de Vida
Análise de Sobrevida
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Chelating Agents); 9YCX42I8IU (Sevelamer); SY7Q814VUP (Calcium)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170922
[Lr] Data última revisão:
170922
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161019
[St] Status:MEDLINE


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[PMID]:27605663
[Au] Autor:McGettigan BM; McMahan RH; Luo Y; Wang XX; Orlicky DJ; Porsche C; Levi M; Rosen HR
[Ad] Endereço:From the Departments of Gastroenterology and Hepatology.
[Ti] Título:Sevelamer Improves Steatohepatitis, Inhibits Liver and Intestinal Farnesoid X Receptor (FXR), and Reverses Innate Immune Dysregulation in a Mouse Model of Non-alcoholic Fatty Liver Disease.
[So] Source:J Biol Chem;291(44):23058-23067, 2016 10 28.
[Is] ISSN:1083-351X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Bile acid sequestrants are synthetic polymers that bind bile acids in the gut and are used to treat dyslipidemia and hyperphosphatemia. Recently, these agents have been reported to lower blood glucose and increase insulin sensitivity by altering bile acid signaling pathways. In this study, we assessed the efficacy of sevelamer in treating mice with non-alcoholic fatty liver disease (NAFLD). We also analyzed how sevelamer alters inflammation and bile acid signaling in NAFLD livers. Mice were fed a low-fat or Western diet for 12 weeks followed by a diet-plus-sevelamer regimen for 2 or 12 weeks. At the end of treatment, disease severity was assessed, hepatic leukocyte populations were examined, and expression of genes involved in farnesoid X receptor (FXR) signaling in the liver and intestine was analyzed. Sevelamer treatment significantly reduced liver steatosis and lobular inflammation. Sevelamer-treated NAFLD livers had notably fewer pro-inflammatory infiltrating macrophages and a significantly greater fraction of alternatively activated Kupffer cells compared with controls. Expression of genes involved in FXR signaling in the liver and intestine was significantly altered in mice with NAFLD as well as in those treated with sevelamer. In a mouse model of NAFLD, sevelamer improved disease and counteracted innate immune cell dysregulation in the liver. This study also revealed a dysregulation of FXR signaling in the liver and intestine of NAFLD mice that was counteracted by sevelamer treatment.
[Mh] Termos MeSH primário: Anti-Inflamatórios/administração & dosagem
Imunidade Inata/efeitos dos fármacos
Intestinos/efeitos dos fármacos
Fígado/efeitos dos fármacos
Hepatopatia Gordurosa não Alcoólica/tratamento farmacológico
Receptores Citoplasmáticos e Nucleares/metabolismo
Sevelamer/administração & dosagem
[Mh] Termos MeSH secundário: Animais
Modelos Animais de Doenças
Seres Humanos
Intestinos/metabolismo
Fígado/metabolismo
Macrófagos/efeitos dos fármacos
Macrófagos/imunologia
Masculino
Camundongos
Camundongos Endogâmicos C57BL
Hepatopatia Gordurosa não Alcoólica/genética
Hepatopatia Gordurosa não Alcoólica/imunologia
Hepatopatia Gordurosa não Alcoólica/metabolismo
Receptores Citoplasmáticos e Nucleares/genética
Transdução de Sinais/efeitos dos fármacos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, U.S. GOV'T, NON-P.H.S.
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents); 0 (Receptors, Cytoplasmic and Nuclear); 0 (farnesoid X-activated receptor); 9YCX42I8IU (Sevelamer)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171107
[Lr] Data última revisão:
171107
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160909
[St] Status:MEDLINE



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