Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 211
Filtrar
1.
Clin Ther ; 46(9): 702-710, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39112102

RESUMO

PURPOSE: Sodium zirconium cyclosilicate (SZC) is an oral potassium (K+)-lowering therapy for adults with hyperkalemia. HARMONIZE Asia (ClinicalTrials.gov identifier: NCT03528681) evaluated the efficacy and safety of SZC in Chinese patients with hyperkalemia. METHODS: This Phase III, randomized, double-blind, placebo-controlled study recruited patients with serum K+ (sK+) ≥5.1 mmol/L at 35 sites in China. Patients received SZC 10 g three times daily (TID) for 24 or 48 hours during an open-label initial phase (OLP). Those patients achieving normokalemia (sK+ 3.5-5.0 mmol/L inclusive) entered a 28-day randomized (2:2:1) treatment phase (RTP) and received SZC 5 g, SZC 10 g, or placebo once daily. The primary endpoint was mean sK+ during RTP Days 8 to 29. Secondary endpoints included mean change in sK+ during the OLP, the proportion of patients who achieved normokalemia at the end of the OLP, the proportion that maintained normokalemia during the RTP, and time to recurrence of hyperkalemia. FINDINGS: In total, 270 patients received SZC 10 g TID during the OLP; 256 (94.8%) completed the OLP. During the OLP, mean sK+ decreased by 1.1 mmol/L from baseline (5.9 mmol/L; P < 0.001) and 87.4% of patients achieved normokalemia. During the RTP, SZC 5 g and 10 g reduced mean sK+ versus placebo in a dose-dependent manner (each P < 0.001); least-squares means (95% confidence interval [CI]) sK+ were 4.9 mmol/L (4.7, 5.0), 4.4 mmol/L (4.3, 4.6), and 5.2 mmol/L (5.1, 5.4) for SZC 5 g, 10 g, and placebo, respectively. At RTP end, the proportions of patients who maintained normokalemia were 58.8% (SZC 5 g; odds ratio vs placebo, 2.5 [95% CI: 1.1, 6.1; P = 0.035]), 76.5% (SZC 10 g; odds ratio vs placebo, 6.3 [95% CI: 2.6, 15.3; P < 0.001]), and 36.8% for placebo. Risk of recurrent hyperkalemia was reduced by 61.0% and 84.0% with SZC 5 g and SZC 10 g, respectively, versus placebo (each P < 0.001). During the RTP, the incidence of adverse events was numerically higher with SZC 5 g (50.0% of patients) and 10 g (44.0%) versus placebo (36.0%); driven primarily by peripheral edema and constipation. IMPLICATIONS: Both SZC doses demonstrated clinically relevant and statistically significant, dose-dependent efficacy in managing sK+ levels in Chinese patients with hyperkalemia, compared with placebo. SZC tolerability was broadly aligned with the known safety profile of SZC.


Assuntos
Hiperpotassemia , Silicatos , Humanos , Hiperpotassemia/tratamento farmacológico , Silicatos/efeitos adversos , Silicatos/uso terapêutico , Silicatos/administração & dosagem , Masculino , Feminino , Pessoa de Meia-Idade , Método Duplo-Cego , China , Idoso , Adulto , Resultado do Tratamento , Potássio/sangue
2.
Transplant Proc ; 56(7): 1569-1573, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39174389

RESUMO

PURPOSE: Evaluate the safety/efficacy of novel potassium binders (patiromer, sodium zirconium cyclosilicate [SZ-9]) for early postoperative hyperkalemia following kidney transplantation. METHODS: Retrospective, single-center, cohort study of deceased-donor kidney recipients transplanted between 1/2018 and 12/2020. Potassium-binder use was evaluated from immediately posttransplant until discharge. Potassium binders were administered ≥2 hours before/after medications. RESULTS: A total of 179 patients were included, 24 (13%) of whom received potassium binders (16 [67%] patiromer, 7 [29%] SZ-9, 1 [4%] both) for a mean of 2.5 (±3.18) doses. Peak potassium levels were higher in the potassium-binder group (6.05 vs 5.35 mEq/L; P < .001). More patients on potassium binders transitioned to atovaquone than those on no binders (n = 21 [100%] vs n = 112 [75%], respectively; P = .005). Delayed graft function (DGF) was observed in 100 (56%) patients, with a higher proportion receiving potassium binders (18 [75%] vs 82 [53%], respectively; P = .042). There was no difference between groups in number of posttransplant dialysis sessions required in the general study population (P = .2), nor in the DGF group (P = .12). No difference was noted in the incidence of ileus (P = .2), or gastrointestinal symptoms (diarrhea, nausea, vomiting; P = .6). Of the 24 patients who received inpatient binders, 9 (37.5%) were discharged and remained on them for a mean of 46 (±49) days. CONCLUSION: Patiromer and SZ-9 appear safe in the early posttransplant period, but larger prospective trials are needed. Potassium-binder use does not appear to be associated with fewer dialysis sessions in DGF patients, however, they may be used as additional tools for lowering potassium in these patients.


Assuntos
Hiperpotassemia , Transplante de Rim , Polímeros , Complicações Pós-Operatórias , Potássio , Silicatos , Humanos , Hiperpotassemia/sangue , Hiperpotassemia/etiologia , Transplante de Rim/efeitos adversos , Estudos Retrospectivos , Masculino , Feminino , Pessoa de Meia-Idade , Potássio/sangue , Silicatos/uso terapêutico , Silicatos/efeitos adversos , Polímeros/uso terapêutico , Adulto , Função Retardada do Enxerto , Idoso
3.
Clin Nephrol ; 102(4): 223-231, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-38994592

RESUMO

BACKGROUND: Hyperkalemia is a common complication of chronic kidney disease (CKD). This study aims to investigate the efficacy and safety of sodium zirconium cyclosilicate and calcium polystyrene sulfonate in reducing potassium in patients with acute and severe hyperkalemia in CKD who are not undergoing dialysis. MATERIALS AND METHODS: A retrospective real-world study was conducted among 73 patients with non-dialysis chronic kidney disease who were hospitalized in the First Affiliated Hospital of Chengdu Medical College from June 2020 to June 2022. 33 patients treated with sodium zirconium cyclosilicate were categorized as SZC group, and the other 40 patients treated with calcium polystyrene sulfonate were categorized as CPS group. Serum potassium, serum sodium, magnesium, calcium, and phosphorus levels were examined. Adverse reactions were recorded during medication. RESULTS: Significantly decreased serum potassium was observed in both groups, whereas the potassium reduction was higher in the SZC group than in the CPS group at 2, 4, 24, and 48 hours after medication while there was no statistically significant difference in the serum potassium level between the two groups at 72 hours. For those people whose initial potassium exceeded 6 mmol/L, the potassium reduction was more obvious in the SZC group than in the CPS group at 2 and 4 hours after medication. The control rate of hyperkalemia in the SZC group was significantly higher than in the CPS group at 4, 24, and 48 hours. No distinct change was observed in serum sodium, calcium, magnesium, and phosphorus before and 72 hours after medication. No severe adverse reactions occurred. CONCLUSION: Sodium zirconium cyclosilicate has a more obvious effect on reducing potassium particularly for those patients with moderate to severe hyperkalemia who need rapid potassium reduction.


Assuntos
Hiperpotassemia , Poliestirenos , Potássio , Insuficiência Renal Crônica , Silicatos , Humanos , Hiperpotassemia/sangue , Hiperpotassemia/etiologia , Hiperpotassemia/tratamento farmacológico , Masculino , Feminino , Silicatos/uso terapêutico , Silicatos/efeitos adversos , Estudos Retrospectivos , Pessoa de Meia-Idade , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/terapia , Insuficiência Renal Crônica/sangue , Potássio/sangue , Idoso , Poliestirenos/uso terapêutico , Poliestirenos/efeitos adversos , Resultado do Tratamento , Índice de Gravidade de Doença , Adulto , Magnésio/sangue
4.
Clin Med (Lond) ; 24(4): 100222, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38871123

RESUMO

Inpatient treatment of hyperkalaemia with insulin and dextrose can be complicated by iatrogenic hypoglycaemia. We sought to assess the incidence of hypoglycaemia in hospitalised patients with renal disease and assess the impact of the introduction of a local guideline incorporating the use of sodium zirconium cyclosilicate (SZC) for patients with moderate hyperkalaemia. After establishing a significant burden of hypoglycaemia in the initial observation period, a requirement for hourly capillary blood glucose monitoring (for up to 6 h) following the administration of insulin for hyperkalaemia was incorporated into the guidelines. The two-fold introduction of SZC alongside changes in patient care after the administration of insulin/dextrose resulted in more appropriate use of insulin/dextrose, as well as a significant (73%) reduction in the iatrogenic burden of hypoglycaemia (P = 0.04).


Assuntos
Glucose , Hiperpotassemia , Hipoglicemia , Insulina , Silicatos , Humanos , Hiperpotassemia/tratamento farmacológico , Hiperpotassemia/induzido quimicamente , Insulina/efeitos adversos , Insulina/administração & dosagem , Insulina/uso terapêutico , Glucose/uso terapêutico , Glucose/administração & dosagem , Silicatos/uso terapêutico , Silicatos/efeitos adversos , Hipoglicemia/tratamento farmacológico , Hipoglicemia/induzido quimicamente , Masculino , Feminino , Idoso , Glicemia/análise , Glicemia/efeitos dos fármacos , Pessoa de Meia-Idade , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/uso terapêutico , Hipoglicemiantes/administração & dosagem , Doença Iatrogênica/prevenção & controle
6.
Nephrology (Carlton) ; 29(6): 311-324, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38403867

RESUMO

Hyperkalaemia is an electrolyte imbalance that impairs muscle function and myocardial excitability, and can potentially lead to fatal arrhythmias and sudden cardiac death. The prevalence of hyperkalaemia is estimated to be 6%-7% worldwide and 7%-10% in Asia. Hyperkalaemia frequently affects patients with chronic kidney disease, heart failure, and diabetes mellitus, particularly those receiving treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors. Both hyperkalaemia and interruption of RAAS inhibitor therapy are associated with increased risks for cardiovascular events, hospitalisations, and death, highlighting a clinical dilemma in high-risk patients. Conventional potassium-binding resins are widely used for the treatment of hyperkalaemia; however, caveats such as the unpalatable taste and the risk of gastrointestinal side effects limit their chronic use. Recent evidence suggests that, with a rapid onset of action and improved gastrointestinal tolerability, novel oral potassium binders (e.g., patiromer and sodium zirconium cyclosilicate) are alternative treatment options for both acute and chronic hyperkalaemia. To optimise the care for patients with hyperkalaemia in the Asia-Pacific region, a multidisciplinary expert panel was convened to review published literature, share clinical experiences, and ultimately formulate 25 consensus statements, covering three clinical areas: (i) risk factors of hyperkalaemia and risk stratification in susceptible patients; (ii) prevention of hyperkalaemia for at-risk individuals; and (iii) correction of hyperkalaemia for at-risk individuals with cardiorenal disease. These statements were expected to serve as useful guidance in the management of hyperkalaemia for health care providers in the region.


Assuntos
Consenso , Hiperpotassemia , Humanos , Hiperpotassemia/epidemiologia , Hiperpotassemia/terapia , Hiperpotassemia/diagnóstico , Ásia/epidemiologia , Fatores de Risco , Potássio/sangue , Silicatos/uso terapêutico , Silicatos/efeitos adversos
7.
J Nephrol ; 37(4): 961-972, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38236474

RESUMO

BACKGROUND: The pharmacological management of hyperkalemia traditionally considered calcium or sodium polystyrene sulfonate and, since recently, the novel binders patiromer and sodium zirconium cyclosilicate. We evaluated their patterns of use, duration of treatment and relative effectiveness/safety in Swedish routine care. METHODS: Observational study of adults initiating therapy with sodium polystyrene sulfonate or a novel binder (sodium zirconium cyclosilicate or patiromer) in Stockholm 2019-2021. We quantified treatment duration by repeated dispensations, compared mean achieved potassium concentration within 60 days, and potential adverse events between treatments. RESULTS: A total of 1879 adults started treatment with sodium polystyrene sulfonate, and 147 with novel binders (n = 41 patiromer and n = 106 sodium zirconium cyclosilicate). Potassium at baseline for all treatments was 5.7 mmol/L. Sodium polystyrene sulfonate patients stayed on treatment a mean of 61 days (14% filled ≥3 consecutive prescriptions) compared to 109 days on treatment (49% filled ≥3 prescriptions) for novel binders. After 15 days of treatment, potassium similarly decreased to 4.6 (SD 0.6) and 4.8 (SD 0.6) mmol/L in the sodium polystyrene sulfonate and novel binder groups, respectively, and was maintained over the 60 days post-treatment. In multivariable regression, the odds ratio for novel binders (vs sodium polystyrene sulfonate) in reaching potassium ≤ 5.0 mmol/L after 15 days was 0.65 (95% CI 0.38-1.10) and after 60 days 0.89 (95% CI 0.45-1.76). Hypocalcemia, hypokalemia, and initiation of anti-diarrheal/constipation medications were the most-commonly detected adverse events. In multivariable analyses, the OR for these events did not differ between groups. CONCLUSION: We observed similar short-term effectiveness and safety for all potassium binders. However, treatment duration was longer for novel binders than for sodium polystyrene sulfonate.


Assuntos
Hiperpotassemia , Polímeros , Poliestirenos , Potássio , Silicatos , Humanos , Hiperpotassemia/sangue , Hiperpotassemia/induzido quimicamente , Feminino , Masculino , Silicatos/uso terapêutico , Silicatos/efeitos adversos , Potássio/sangue , Poliestirenos/uso terapêutico , Poliestirenos/efeitos adversos , Pessoa de Meia-Idade , Idoso , Suécia , Polímeros/uso terapêutico , Creatinina/sangue , Fatores de Tempo , Quelantes/uso terapêutico , Quelantes/efeitos adversos , Idoso de 80 Anos ou mais
8.
Am J Ind Med ; 67(3): 179-199, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38265196

RESUMO

BACKGROUND: With increasing reports of accelerated and acute silicosis, PMF, and autoimmune disease among coal miners and silica-exposed countertop workers, we present previously incompletely-described pulmonary pathology of accelerated silicosis and correlations with mineralogy, radiography, and disease progression in 46 Texas oilfield pipe sandblasters who were biopsied between 1988 and 1995. METHODS: Worker examinations included pulmonary function tests, chest X-ray (CXR), high-resolution computed tomography (HRCT), and Gallium-67 scans. Quantitative mineralogic analysis of pulmonary parenchymal burden of silica, silicates, and metal particles used scanning electron microscopy with energy dispersive x-ray spectroscopy (SEM EDS). RESULTS: Workers had clinical deterioration after <10 years exposure in dusty workplaces. Although initial CXR was normal in 54%, Gallium-67 scans were positive in 68% of those with normal CXR, indicating pulmonary inflammation. The histology of accelerated silicosis is diffuse interstitial infiltration of macrophages filled with weakly birefringent particles with or without silicotic nodules or alveolar proteinosis. Lung silica concentrations were among the highest in our database, showing a dose-response relationship with CXR, HRCT, and pathologic changes (macrophages, fibrosis, and silicotic nodules). Radiographic scores and diffusing capacity worsened during observation. Silica exposure was intensified, patients presented younger, with shorter exposure, more severe clinical abnormalities, higher lung particle burdens, and more rapid progression in a subset of patients exposed to recycled blasting sand. CONCLUSIONS: Accelerated silicosis may present with a normal CXR despite significant histopathology. Multivariable analyses showed silica, and not other particles, is the driver of observed radiologic, physiologic, and histologic outcomes. Eliminating this preventable disease requires higher physician, public health, and societal awareness.


Assuntos
Radioisótopos de Gálio , Exposição Ocupacional , Silicose , Humanos , Silicose/diagnóstico por imagem , Silicose/epidemiologia , Silicose/etiologia , Pulmão/patologia , Dióxido de Silício/efeitos adversos , Silicatos/efeitos adversos , Exposição Ocupacional/efeitos adversos
9.
Pharmacotherapy ; 44(1): 13-21, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37475499

RESUMO

STUDY OBJECTIVE: To assess the efficacy of single-dose sodium zirconium cyclosilicate (SZC) compared to the FDA approved three times daily (TID) dosing and to single-dose sodium polystyrene sulfonate (SPS) for the management of asymptomatic hyperkalemia in hospitalized patients. DESIGN: Single-center retrospective chart review. SETTING: University of Florida Health Jacksonville, a 695-bed academic medical center in Jacksonville, FL, between June 15, 2018 and August 15, 2021. PATIENTS: Three hundred fifty-one adult patients who were admitted to any hospital unit in the specified timeframe and received one of three interventions for asymptomatic hyperkalemia (serum potassium ≥4.7 mmol/L) were included in this study. INTERVENTION: The interventions compared were single-dose SZC 10 g, SZC 10 g × 3 doses (30 g total) within 24 h, or SPS 15-30 g once. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the proportion of patients achieving normokalemia (K+ 3.3-4.6 mmol/L) within 12-30 h of the first study dose. Secondary outcomes included average change in potassium within 12-30 h and 3-54 h from the first dose. The primary outcome was met in 68 patients (58.1%) in the SZC 10 g group, 51 (43.6%) in the SZC 10 g × 3 doses group, and 81 (69.2%) in the SPS 15-30 g group (p < 0.01). The average reduction in potassium in 12-30 h was 0.70 mmol/L, 0.78 mmol/L, and 0.99 mmol/L in the SZC 10 g, SZC 10 g × 3 doses, and SPS 15-30 g groups, respectively (p < 0.01). CONCLUSIONS: SZC 10 g once resulted in more patients achieving normokalemia compared to SZC 10 g × 3 doses but less than SPS (p < 0.01). Single-dose SZC may be a reasonable option to manage asymptomatic hyperkalemia in the hospital setting, but achieving normokalemia with one dose may be less likely in patients with higher baseline potassium concentrations and impaired renal function.


Assuntos
Hiperpotassemia , Adulto , Humanos , Estudos Retrospectivos , Potássio , Silicatos/efeitos adversos
10.
Am J Health Syst Pharm ; 80(18): 1238-1246, 2023 09 07.
Artigo em Inglês | MEDLINE | ID: mdl-37335862

RESUMO

PURPOSE: Potassium binders are frequently utilized for the treatment of hyperkalemia in hospitalized patients; however, there is limited data directly comparing individual agents. The purpose of this study was to compare the effectiveness and safety of sodium polystyrene sulfonate (SPS) and sodium zirconium cyclosilicate (SZC) for hyperkalemia treatment in hospitalized patients. METHODS: This retrospective cohort study evaluated adult patients who were admitted within a 7-hospital health system and received SPS or SZC for a serum potassium level greater than 5.0 mEq/L. Patients receiving dialysis prior to SPS/SZC administration, those receiving other potassium-lowering medications within 6 hours prior to blood sampling for a repeat potassium level, and those started on kidney replacement therapy prior to sampling for a repeat potassium level were excluded. RESULTS: Following evaluation of 3,903 patients, the mean reduction in serum potassium 4 to 24 hours after binder administration was 0.96 mEq/L with SPS and 0.78 mEq/L with SZC (P < 0.0001). The median dose of SPS was 30 g (interquartile range [IQR], 15-30 g) while the median (IQR) dose of SZC was 10 g (10-10 g). Resolution of hyperkalemia within 24 hours was achieved in a higher percentage of patients with use of SPS (74.9%) versus SZC (68.8%) (P < 0.001). CONCLUSION: One of the largest comparisons of SPS and SZC conducted to date, this study demonstrated the effectiveness and safety of both agents. While a statistically greater reduction in serum potassium was observed with use of SPS, there was significant dosing variability among agents that limited the ability to directly compare specific doses. Further investigation is needed to determine the optimal dose of each agent for acute hyperkalemia management. This data will inform clinical decisions about the choice of potassium binder for acute hyperkalemia.


Assuntos
Hiperpotassemia , Adulto , Humanos , Hiperpotassemia/diagnóstico , Hiperpotassemia/tratamento farmacológico , Estudos Retrospectivos , Potássio , Silicatos/efeitos adversos
11.
J Appl Oral Sci ; 31: e20220444, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37132699

RESUMO

Few long-term studies assess the discoloration induced by hydraulic calcium silicate-based cement on dental structures. In addition, as far as we know, no long-term study has assessed the discoloration induced by these cement on composite resin. This in vitro study aimed to assess, during a period of two years, the discoloration potential of different hydraulic calcium silicate-based cements (hCSCs) on the enamel/dentin structure and composite resin restoration. A total of 40 enamel/dentin discs were obtained from bovine incisors, and 40 composite resin discs (10 mm in diameter × 2 mm thick) were fabricated. A 0.8 mm-deep cavity was made in the center of each disc and filled with the following hCSCs (n=10): Original MTA (Angelus); MTA Repair HP (Angelus); NeoMTA Plus (Avalon); and Biodentine (Septodont). An initial color measurement was performed (T0 - baseline). After 7, 15, 30, 45, 90, 300 days, and two years, new color measurements were performed to determine the color (ΔE00), lightness (ΔL'), chroma (ΔC'), hue differences (ΔH'), and whiteness index (WID). For enamel/dentin, the ΔE00 was significant among groups and periods (p<0.05). NeoMTA Plus had the greatest ΔE00. The NeoMTA Plus group had the greatest ΔE00 after two years for composite resin. Significant reduction in lightness was observed for all groups after two years (p<0.05). The most significant WID values were observed after 30 days for Biodentine (enamel/dentin) and MTA Repair HP groups (composite resin) (p<0.05). The hCSCs changed the colorimetric behavior of both substrates, leading to greater darkening over time. The Bi2O3 in the Original MTA seems relevant in the short periods of color change assessment.


Assuntos
Compostos de Cálcio , Resinas Compostas , Animais , Bovinos , Resinas Compostas/efeitos adversos , Resinas Compostas/química , Compostos de Cálcio/efeitos adversos , Silicatos/efeitos adversos , Cimentos Dentários/efeitos adversos , Óxidos , Combinação de Medicamentos , Teste de Materiais , Compostos de Alumínio/efeitos adversos , Cimentos de Resina/efeitos adversos
12.
Ann Pharmacother ; 57(9): 1044-1052, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-36637028

RESUMO

BACKGROUND: Sodium zirconium cyclosilicate (SZC) is an inorganic zirconium silicate compound that selectively exchanges potassium for hydrogen and sodium. "Once" doses of SZC (with option to redose) in patients with hyperkalemia in hospitalized settings have not been evaluated. We hypothesized that a once dose of SZC would be non-inferior to sodium polystyrene sulfonate (SPS) in reducing serum potassium. OBJECTIVE: The objective of our study is to evaluate the effect of a "once" dose of SZC when compared with SPS in reducing serum potassium levels. METHODS: This was a retrospective analysis of patients who received either a "once" dose of SZC or single or repeated doses of SPS for hyperkalemia. The primary endpoint was mean absolute reduction in the first serum potassium value at least 4 hours after administration. The secondary efficacy endpoints were the rate of additional potassium-lowering therapies and the rate of normokalemia within 48 hours. Safety endpoints were the incidence of electrolyte abnormalities, hypoglycemia, hypertension, hypotension, and colonic necrosis. RESULTS: A total of 260 patients were included in the analysis. The mean initial serum potassium was similar between groups (5.6 ± 0.4). The absolute serum potassium reduction was -0.88 ± 0.64 mEq/L and -0.75 ± 0.65 mEq/L with SZC and SPS, respectively. The "once" regimen of SZC demonstrated non-inferiority compared with SPS (P < 0.0001). The proportion of patients achieving normokalemia within 48 hours and the proportion of patients receiving additional potassium-lowering therapies did not differ between groups. CONCLUSION AND RELEVANCE: The "once" dose regimen (with redose option) of SZC was non-inferior to the "once" or repeated dosing regimen of SPS with regard to absolute potassium reduction. There were no significant differences in the rate of additional potassium-lowering therapies and the rate of normokalemia at 48 hours. The incidence of hypertension was less common among patients who received SZC.


Assuntos
Hiperpotassemia , Hipertensão , Humanos , Hiperpotassemia/tratamento farmacológico , Estudos Retrospectivos , Potássio , Silicatos/efeitos adversos , Hipertensão/tratamento farmacológico
13.
Expert Opin Pharmacother ; 24(3): 301-308, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36617700

RESUMO

INTRODUCTION: Hyperkalemia is a common complication of chronic kidney disease (CKD), diabetes mellitus (DM), and heart failure (HF) that can lead to severe arrhythmias and sudden death and is associated with a higher risk of mortality. Therefore, the prevention and treatment of hyperkalemia is important. Sodium zirconium cyclosilicate (SZC), a new oral potassium-lowering drug, has offered an additional treatment option for Chinese patients with hyperkalemia since its launch in China in late 2019, and some experience has been accumulated regarding its efficacy and safety. AREAS COVERED: In this review, the authors summarize the epidemiological features of hyperkalemia in China and review the clinical data regarding the use of sodium zirconium cyclosilicate in Chinese patients. EXPERT OPINION: The prevalence of hyperkalemia is particularly high in Chinese patients with chronic kidney disease and heart failure. In China, recent clinical studies have shown that SZC rapidly reduces serum potassium, maintains normal potassium concentration, and is well tolerated and safe. Two Chinese expert consensus statements have recommended the use of SZC for the acute correction and chronic maintenance of potassium concentration.


Assuntos
Insuficiência Cardíaca , Hiperpotassemia , Insuficiência Renal Crônica , Humanos , Hiperpotassemia/tratamento farmacológico , Hiperpotassemia/epidemiologia , Potássio , Silicatos/efeitos adversos , Insuficiência Renal Crônica/tratamento farmacológico , Insuficiência Cardíaca/induzido quimicamente , China/epidemiologia
14.
Clin Pharmacol Drug Dev ; 11(3): 348-357, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34997825

RESUMO

Sodium zirconium cyclosilicate (SZC) is an effective potassium binder for patients with hyperkalemia. This single-center, open-label, phase I study (NCT03283267) characterized the pharmacodynamics and safety of SZC in Chinese individuals. Twenty-two healthy Chinese adults (mean age, 33.5 years) randomized 1:1 received daily oral SZC 5 or 10 g for 4 days, following 4 days on a low-sodium, high-potassium diet (continued throughout the study). End points were mean change from baseline in 24-hour urinary potassium (primary) and sodium excretion, and serum potassium concentration. Urinary potassium excretion significantly decreased with SZC 5 g (mean change [mmol], -13.0; P < .001) and 10 g (-15.4; P < .001). Although urinary sodium excretion decreased significantly with SZC 5 g (-11.5; P = .030), there was no significant change with SZC 10 g (-5.1; P = .299). Serum potassium concentrations decreased significantly with SZC 5 g (-0.14; P = .031) and 10 g (-0.20; P = .002). All treatment-emergent adverse events were mild, and none were considered causally related to SZC. Over 4 days, the pharmacodynamics and safety of SZC were consistent in healthy Chinese adults with global studies and patients of Japanese ethnicity.


Assuntos
Hiperpotassemia , Silicatos , Adulto , China , Humanos , Hiperpotassemia/induzido quimicamente , Potássio , Silicatos/efeitos adversos
15.
Clin Oral Investig ; 26(1): 375-383, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34151389

RESUMO

OBJECTIVES: To assess tooth discoloration induced by different hydraulic calcium silicate-based cements (HCSCs), including effects of blood and placement method. MATERIALS AND METHODS: Eighty bovine teeth cut to a length of 18 mm (crown 8 mm, root 10 mm) were randomly assigned to 10 groups (n = 8), receiving orthograde apical plug treatment (APT). Apical plugs were 4 mm in length and made of ProRoot MTA (Dentsply), Medcem MTA (Medcem), TotalFill BC RRM Fast Set Putty (Brasseler), or Medcem Medical Portland Cement (Medcem) plus bismuth oxide (Bi2O3) with and without bovine blood. Further, orthograde (with or without preoperative adhesive coronal dentin sealing) and retrograde APT were compared. Teeth were obturated with gutta-percha and sealer, sealed with composite and stored in distilled water. Tooth color was measured on apical plug, gutta-percha/sealer, and crown surface before treatment versus 24 h, 1, 3, 6, 12, and 24 months after treatment by spectrophotometry. Color difference (ΔE) values were calculated and analyzed by Shapiro-Wilk test, ANOVA with post hoc tests, Friedman test, t test, and post hoc tests with Bonferroni correction (α = .05). RESULTS: Tooth discoloration occurred in all groups with no significant differences between HCSCs (p > .05). After 24 months, color changes were prominent on roots but insignificant on crowns. Blood contamination induced a significantly decreased luminescence (p < .05). Blood had a stronger impact on tooth color than Bi2O3. No relevant effects of retrograde placement (p > .05) or preoperative dentin sealing (p > .05) were detected. CONCLUSIONS: Apical plugs of the tested HCSCs cause discoloration of bovine roots, but not discoloration of bovine tooth crowns within a 24-month period. CLINICAL RELEVANCE: APT should be performed carefully while avoiding direct contact with the coronal dentin, and in that case no aesthetic impairments occur.


Assuntos
Materiais Restauradores do Canal Radicular , Descoloração de Dente , Animais , Compostos de Cálcio/efeitos adversos , Bovinos , Combinação de Medicamentos , Materiais Restauradores do Canal Radicular/efeitos adversos , Silicatos/efeitos adversos , Descoloração de Dente/induzido quimicamente
16.
Braz Dent J ; 32(3): 65-74, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34755791

RESUMO

This study investigated the effect of three commercial calcium silicate-based materials (CSBM) on cytotoxicity and pro-and anti-inflammatory cytokines production in cultured human periodontal ligament stem cells (hPDLSCs). Culture of hPDLSCs was established and characterized. Extracts of Bio-C Sealer (Angelus, Londrina, PR, Brazil), MTA Fillapex (Angelus, Londrina, PR, Brazil) and PBS Cimmo HP (Cimmo Soluções em Saúde, Pouso Alegre, MG, Brazil) were prepared by placing cement specimens (5 x 3 mm) in culture medium. Then, the extracts were serially two-fold diluted (1, 1:2, 1:4, 1:8, 1:16) and inserted into the cell-seeded wells for 24, 48 and 72 h for MTT assays. TNF-α and IL-10 cytokines were quantified by ELISA at 24h-cell supernatants. Data were analyzed by ANOVA and Tukey's test (α = 0.05). All CSBM exhibited some cytotoxicity that varied according to extract concentration and time of evaluation. MTA Fillapex presented the highest cytotoxic effects with significant reduction of metabolic activity/cell viability when compared to Bio-C Sealer and Cimmo HP®. TNF-α was significantly upregulated by the three tested cements (p < 0.05) while only MTA Fillapex significantly upregulated IL-10 in comparison to control. Taken collectively, the results showed that PBS Cimmo HP®, Bio-C Sealer and MTA Fillapex present mild and transient cytotoxicity and slightly induced TNF-α production. MTA Fillapex upregulated IL-10 release by hPDLSCs.


Assuntos
Compostos de Cálcio/efeitos adversos , Ligamento Periodontal , Materiais Restauradores do Canal Radicular/efeitos adversos , Silicatos/efeitos adversos , Células-Tronco/efeitos dos fármacos , Compostos de Alumínio , Citocinas/metabolismo , Humanos , Teste de Materiais , Óxidos , Ligamento Periodontal/citologia
17.
J Clin Pediatr Dent ; 45(5): 306-311, 2021 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-34740264

RESUMO

INTRODUCTION: Bioceramic materials, gray and white mineral trioxide aggregate (GMTA, WMTA), have been shown to have high rates of success in various endodontic applications. A major drawback is their tendency to discolor teeth compared to Biodentine (BD), that has been claimed not to discolor teeth. The aim of this study was to compare tooth discoloration after applying different pulpotomy base materials (BD, GMTA and WMTA). STUDY DESIGN: Forty human incisors teeth were used in this study. Coronal access was achieved by a Tungsten Carbide drill, and the pulp chambers were accessed and chemo-mechanically debrided. Each material was placed in the pulp chamber, up to the cervical sectioning level. All specimens were incubated at 37°C and 100% humidity for three months and have been evaluated before the study and weekly. Color was assessed according to the CIE L*a*b* color space system. RESULTS: ΔE of all experimental groups (GMTA, WMTA and BD) were significantly different from the control group at all time points (P<0.05). Color changes in the GMTA and WMTA groups, had no statistically significant differences, but showed higher discoloration compared to BD group in the cervical part of the crown, since week 1 (P<0.05). WMTA group showed significant discoloration in the cervical part as of week 1 (P<0.05), and gradually increased over time (Figure 2). BD group showed no significantly discoloration over time. GMTA group showed the significant discoloration at week 1 and week 14 (P<0.05). CONCLUSIONS: both GMTA and WMTA pulpotomy materials may discolor tooth structure over time in an extracted permanent anterior tooth model. When choosing bioceramic pulpotomy material, BD may be preferable in esthetic area.


Assuntos
Materiais Restauradores do Canal Radicular , Descoloração de Dente , Compostos de Alumínio/efeitos adversos , Compostos de Cálcio/efeitos adversos , Coroas , Combinação de Medicamentos , Humanos , Incisivo , Óxidos/efeitos adversos , Pulpotomia , Silicatos/efeitos adversos , Coroa do Dente , Descoloração de Dente/induzido quimicamente
18.
BMC Oral Health ; 21(1): 330, 2021 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-34215230

RESUMO

BACKGROUND: Variation in the composition of calcium silicate-based pulp capping materials could influence the discoloration potential of some of these materials, thus affecting the color and aesthetic appearance of the coronal tooth structure. Furthermore, contact with blood if hemostasis is not fully achieved may enhance this discoloration for some materials. Therefore the aim of this study was to evaluate in vitro the color change of coronal tooth structure after placing various calcium silicate-based materials in the pulp chamber in the presence or absence of blood. MEHTODS: Maxillary extracted premolars (n = 144) were sectioned and the crowns were separated from the roots. Pulp chambers were prepared to a standard size and then the tested materials (GMTA Angelus, ProRoot WMTA, Biodentine, TheraCal, and TotalFill) were placed with saline or with blood. Color change was assessed by spectrophotometry; prior to and after material placement at different time intervals of 24 h, 1 week, 1 month, 3 months, and 6 months. Color change (ΔE) values were calculated and statistically analyzed. RESULTS: In the saline groups, Biodentine caused the least color change, while GMTA and WMTA caused the highest color change which were significantly different from the others (p < 0.001), TotalFill and TheraCal caused moderate changes. Adding blood increased the ΔE overall the tested materials to various degrees. Biodentine was the most affected by the blood, while MTA groups were the least affected, followed by TotalFill and then TheraCal. The increase in ΔE was significant over time up to 3 months, after which the increase was not significant. CONCLUSIONS: Overall, WMTA and GMTA caused the most severe discoloration. In saline, Biodentine caused the least discoloration, but it was the most affected by the presence of blood, although it still caused the least discoloration similar to that observed with TotatFill. TheraCal caused moderate discoloration but more than that caused by Biodentine and TotalFill.


Assuntos
Descoloração de Dente , Compostos de Alumínio/efeitos adversos , Compostos de Cálcio/efeitos adversos , Capeamento da Polpa Dentária , Combinação de Medicamentos , Humanos , Óxidos/efeitos adversos , Silicatos/efeitos adversos , Descoloração de Dente/induzido quimicamente
19.
Clin Cardiol ; 44(9): 1272-1275, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34263946

RESUMO

BACKGROUND: Sodium zirconium cyclosilicate (SZC), a newly-developed selective potassium binder, has been clinically available to treat hyperkalemia. SZC might be a promising option to manage hyperkalemia, particularly in patients with heart failure, who often require potassium-sparing medications. However, the optimal initial dose of SZC therapy at a loading dose (30 g per day for the initial 2 days) versus a maintenance dose (5 g per day) remains unknown. METHODS: Consecutive patients with heart failure and hyperkalemia who received 2-day SZC therapy were retrospectively included. Safety and efficacy of SZC therapy were compared between the two strategies (maintenance versus loading). RESULTS: We had 16 patients (76 years old, 11 men) who received 2-day SZC therapy (4 maintenance dose group and 12 loading dose group). Serum potassium decreased 0.7 mEqL/L by 2-day maintenance dose therapy and 1.3 mEq/L by 2-day loading dose therapy. Following 2-day SZC therapy, 25% of patients had hypokalemia, which was defined as serum potassium <4.0 mEq/L. Baseline lower serum potassium level was associated with the post-SZC hypokalemia. CONCLUSIONS: SZC immediately decreases approximately 1.0 mEq/L of serum potassium in patients with heart failure and hyperkalemia. However, caution should be exercised when utilizing SZC at a loading dose specifically in those with mild hyperkalemia to prevent iatrogenic hypokalemia.


Assuntos
Insuficiência Cardíaca , Hiperpotassemia , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Hiperpotassemia/diagnóstico , Hiperpotassemia/tratamento farmacológico , Masculino , Estudos Retrospectivos , Silicatos/efeitos adversos
20.
Expert Rev Clin Pharmacol ; 14(9): 1055-1064, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34227913

RESUMO

INTRODUCTION: Hyperkalemia is a common finding in patients with advanced kidney disease for multiple reasons. Renin-Angiotensin-Aldosterone-System Inhibitors (RAASi) that are indicated for slowing down progression of kidney disease are often associated with hyperkalemia which becomes a limiting factor in their use and titration to the maximum dose. Having a safe, effective, tolerable, and affordable potassium binder can help optimize RAAS inhibition in the setting of kidney disease. AREAS COVERED: Although sodium polystyrene sulfonate has been a mainstay of acute management of hyperkalemia for decades, evidence regarding its efficacy is limited, and its chronic use is not routinely recommended for concerns regarding toxicity. The concern of gastrointestinal (GI) adverse effects with sodium polystyrene sulfonate has spurred the development of alternatives. Sodium zirconium cyclosilicate (SZC) is a promising agent that selectively binds potassium in the gut and eliminates it, while being safe for chronic use based on 1 year of data. Even though we do not have head-to-head studies among the three currently available binders, SZC stands out in rapidity of onset and efficacy. EXPERT OPINION: In this review, we summarize the general management of hyperkalemia, including new agents. We review the pre-clinical and clinical data relating to sodium zirconium cyclosilicate.


Assuntos
Hiperpotassemia/tratamento farmacológico , Insuficiência Renal Crônica/complicações , Silicatos/administração & dosagem , Doença Crônica , Progressão da Doença , Relação Dose-Resposta a Droga , Humanos , Hiperpotassemia/etiologia , Resinas de Troca Iônica/administração & dosagem , Resinas de Troca Iônica/efeitos adversos , Resinas de Troca Iônica/farmacologia , Insuficiência Renal Crônica/tratamento farmacológico , Sistema Renina-Angiotensina/efeitos dos fármacos , Silicatos/efeitos adversos , Silicatos/farmacologia
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA