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1.
Front Immunol ; 12: 760708, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34777374

RESUMO

Objective: To characterize the incidence, type, and risk factors of severe infections (SI) in patients with autoimmune kidney diseases treated with rituximab (RTX). Methods: We conducted a multicenter retrospective cohort study of adult patients with immune-related kidney diseases treated with at least one course of RTX between 2015 and 2019. As a part of the ABCDE Registry, detailed data on RTX application and SI were collected. SI were defined by Common Terminology Criteria for Adverse Events v5.0 as infectious complications grade 3 and above. Patients were dichotomized between "nephrotic" and "nephritic" indications. The primary outcome was the incidence of SI within 12 months after the first RTX application. Results: A total of 144 patients were included. Twenty-five patients (17.4%) presented with SI, mostly within the first 3 months after RTX administration. Most patients in the nephritic group had ANCA-associated vasculitis, while membranous nephropathy was the leading entity in the nephrotic group. Respiratory infections were the leading SI (n= 10, 40%), followed by urinary tract (n=3, 12%) and gastrointestinal infections (n=2, 8%). On multivariable analysis, body mass index (BMI, 24.6 kg/m2 versus 26.9 kg/m2, HR: 0.88; 95%CI: 0.79-0.99; p=0.039) and baseline creatinine (HR: 1.25; 95%CI: 1.04-1.49; p=0.017) were significantly associated with SI. All patients in the nephritic group (n=19; 100%) who experienced a SI received oral glucocorticoid (GC) treatment at the time of infection. Hypogammaglobulinemia was frequent (58.5%) but not associated with SI. Conclusions: After RTX administration, impaired kidney function and lower BMI are independent risk factors for SI. Patients with nephritic glomerular diseases having concomitant GC treatment might be at higher risk of developing SI.

2.
Front Oncol ; 11: 655355, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34123810

RESUMO

Lipegfilgrastim is a long-acting glycopegylated granulocyte-colony stimulating factor (G-CSF) approved for the management of chemotherapy-induced neutropenia. In general, there is little information on the use of any G-CSFs specifically in patients with urological malignancies receiving chemotherapy. This report combines information from two prospective non-interventional studies on the prophylactic use of lipegfilgrastim in urological cancer patients receiving chemotherapy in the real-world setting. Data were derived from two phase IV studies (NADIR and LEOS) with similar protocols conducted in nine European countries. Analysis included 228 patients (142 prostate, 50 testicular, 27 bladder, and 9 other urological cancers). Chemotherapy-induced febrile neutropenia risk was classified as high (43.0%), intermediate (49.1%), or low (7.5%). Lipegfilgrastim was administered as primary (n=180, 78.9%) or secondary (n=29, 12.7%) prophylaxis. The incidence of febrile neutropenia over all chemotherapy cycles (n=998) and first cycles (n=228) for which lipegfilgrastim was administered for prophylaxis was 2.6% and 1.3%, respectively. Corresponding results for Grade 3/4 neutropenia were 2.2% and 0.9%, respectively. Adverse drug reactions occurred in 24 patients (10.5%): those in more than one patient were bone pain (n=6, 2.6%) and pyrexia (n=3, 1.3%). The use of lipegfilgrastim for the prophylaxis of chemotherapy-induced neutropenia was effective and well tolerated in patients with urological malignancies in the real-world setting.

3.
Sci Rep ; 10(1): 1788, 2020 02 04.
Artigo em Inglês | MEDLINE | ID: mdl-32019947

RESUMO

The preferable route for treatment of peritoneal dialysis related peritonitis remains the intraperitoneal administration of antibiotics admixed to peritoneal dialysis fluids. It is important to know whether the administered drug is compatible with the PD fluids and its container. In the present study the compatibility of aztreonam with four commercial PDFs at storing temperatures and duration representative for storing conditions in the clinical settings was investigated. Aztreonam concentrations were determined using high-performance liquid chromatography. The antimicrobial activity of aztreonam was evaluated using an E. coli diffusion disk inhibition assay and P. aeruginosa time-kill curves. In Extraneal evaluated at 6 °C, 25 °C and 37 °C aztreonam was stable over the whole study period of 14 days and 24 hours, respectively. In Physioneal and Nutrineal aztreonam was stable at 6 °C for up to 14 days. Antimicrobial activity was retained in all PD fluids over the whole study period. Aztreonam remained stable and was compatible with the PD fluids, particularly with Extraneal or Nutrineal, and no compensatory dose adjustment is needed when stored for up to 14 days at refrigeration temperature before use.


Assuntos
Antibacterianos/uso terapêutico , Aztreonam/uso terapêutico , Soluções para Diálise/química , Diálise Peritoneal/efeitos adversos , Peritonite/tratamento farmacológico , Antibacterianos/administração & dosagem , Antibacterianos/análise , Aztreonam/administração & dosagem , Aztreonam/análise , Vias de Administração de Medicamentos , Humanos , Diálise Peritoneal/métodos , Peritonite/etiologia
4.
Eur J Cancer ; 127: 12-20, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31962198

RESUMO

PURPOSE: To investigate long-term results of patients with hormonal receptor-positive breast cancer treated with breast-conserving surgery (BCS) and consecutive endocrine therapy (ET) with or without whole breast irradiation (WBI). METHODS AND MATERIALS: Within the 8 A trial of the Austrian Breast and Colorectal Cancer Study Group, a total of 869 patients received ET after BCS which was randomly followed by WBI (n = 439, group 1) or observation (n = 430, group 2). WBI was applied up to a mean total dosage of 50 Gy (+/- 10 Gy boost) in conventional fractionation. RESULTS: After a median follow-up of 9.89 years, 10 in-breast recurrences (IBRs) were observed in group 1 and 31 in group 2, resulting in a 10-year local recurrence-free survival (LRFS) of 97.5% and 92.4%, respectively (p = 0.004). This translated into significantly higher rates for disease-free survival (DFS): 94.5% group 1 vs 88.4% group 2, p = 0.0156. For distant metastases-free survival (DMFS) and overall survival (OS), respective 10-year rates amounted 96.7% and 86.6% for group 1 versus 96.4% and 87.6%, for group 2 (ns). WBI (hazard ratio [HR]: 0.27, p < 0.01) and tumour grading (HR: 3.76, p = 0.03) were found as significant predictors for IBR in multiple cox regression analysis. CONCLUSIONS: After a median follow-up of 10 years, WBI resulted in a better local control and DFS compared with ET alone. The omission of WBI and tumour grading, respectively, were the only negative predictors for LRFS.


Assuntos
Antineoplásicos Hormonais/uso terapêutico , Braquiterapia/mortalidade , Neoplasias da Mama/tratamento farmacológico , Mastectomia Segmentar/mortalidade , Recidiva Local de Neoplasia/tratamento farmacológico , Idoso , Neoplasias da Mama/patologia , Neoplasias da Mama/radioterapia , Terapia Combinada , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Metástase Neoplásica , Recidiva Local de Neoplasia/patologia , Recidiva Local de Neoplasia/radioterapia , Prognóstico , Taxa de Sobrevida
5.
Sci Rep ; 9(1): 6512, 2019 04 24.
Artigo em Inglês | MEDLINE | ID: mdl-31019280

RESUMO

Intraperitoneal administration of antibiotics together with peritoneal dialysis fluids (PDFs) remains the preferable route for treatment of peritoneal dialysis-related peritonitis. For home based therapy, antibiotic-containing PDFs are stored for up to two weeks and warmed up to body-temperature before administration. The present study investigated the compatibility of ciprofloxacin with five commercial PDFs at refrigeration-temperature, room-temperature and body-temperature. Ciprofloxacin concentrations were determined using high-performance liquid chromatography. Drug-diluent stability was evaluated by measurement of pH-values and visual inspection at each sampling point. The antimicrobial activity of ciprofloxacin was assessed by an E. coli disk diffusion method. Ciprofloxacin was stable at refrigeration-temperature and body-temperature in all PDFs evaluated over the whole study period of 14 days and 24 hours, respectively. At room-temperature, in contrast, ciprofloxacin demonstrated only limited stability in particular when tested in mixed Physioneal. Except for Physioneal 1.36%, no relevant drug adsorption was observed and the antimicrobial activity of ciprofloxacin was found to be preserved in each PDF at each storage condition investigated. Intraperitoneal ciprofloxacin might be used for inpatient and home based therapy of peritoneal dialysis-related peritonitis and no compensatory dose adjustment is needed when stored for up to two weeks at refrigeration-temperature before use.


Assuntos
Materiais Biocompatíveis/uso terapêutico , Ciprofloxacina/uso terapêutico , Soluções para Diálise/uso terapêutico , Diálise Peritoneal/métodos , Peritonite/tratamento farmacológico , Antibacterianos/química , Antibacterianos/uso terapêutico , Materiais Biocompatíveis/química , Cromatografia Líquida de Alta Pressão , Ciprofloxacina/química , Soluções para Diálise/química , Estabilidade de Medicamentos , Escherichia coli/efeitos dos fármacos , Humanos , Concentração de Íons de Hidrogênio , Diálise Peritoneal/efeitos adversos , Peritonite/etiologia , Temperatura
6.
Kidney Int ; 94(6): 1227-1237, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30360960

RESUMO

In early clinical testing, acute addition of alanyl-glutamine (AlaGln) to glucose-based peritoneal dialysis (PD) fluids restored peritoneal cellular stress responses and leukocyte function. This study was designed to test the effect of extended treatment with AlaGln-supplemented PD fluid on biomarkers of peritoneal health. In a double-blinded, randomized crossover design, stable PD patients were treated with AlaGln (8 mM) or placebo added to PD fluid for eight weeks. As primary outcome measures, dialysate cancer-antigen 125 (CA-125) appearance rate and ex vivo stimulated interleukin-6 (IL-6) release were assessed in peritoneal equilibration tests. In 8 Austrian centers, 54 patients were screened, 50 randomized, and 41 included in the full analysis set. AlaGln supplementation significantly increased CA-125 appearance rate and ex vivo stimulated IL-6 release. AlaGln supplementation also reduced peritoneal protein loss, increased ex vivo stimulated tumor necrosis factor (TNF)-α release, and reduced systemic IL-8 levels. No adverse safety signals were observed. All 4 peritonitis episodes occurred during standard PD fluid treatment. A novel AlaGln-supplemented PD fluid improves biomarkers of peritoneal membrane integrity, immune competence, and systemic inflammation compared to unsupplemented PD fluid with neutral pH and low-glucose degradation. A phase 3 trial is needed to determine the impact of AlaGln supplementation on hard clinical outcomes.


Assuntos
Soluções para Diálise/química , Dipeptídeos/administração & dosagem , Falência Renal Crônica/terapia , Diálise Peritoneal/efeitos adversos , Peritonite/prevenção & controle , Idoso , Áustria , Biomarcadores/análise , Estudos Cross-Over , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Peritônio/efeitos dos fármacos , Peritônio/patologia , Peritonite/diagnóstico , Peritonite/etiologia , Estudo de Prova de Conceito , Estudos Prospectivos , Resultado do Tratamento
7.
Am J Health Syst Pharm ; 75(19): 1467-1477, 2018 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-30257843

RESUMO

PURPOSE: Results of a compatibility and stability study of linezolid admixed in commercial peritoneal dialysis (PD) solutions stored at various temperatures are reported. METHODS: Test samples were prepared by adding linezolid i.v. injection (2 mg/mL) to infusion bags of 4 PD solutions (Extraneal, Nutrineal, Physioneal 40 Glucose 1.36%, and Physioneal 40 Glucose 2.27%, all from Baxter Healthcare Corporation). Assessments were conducted at various time points during storage of test samples at refrigeration temperature (6 °C) or room temperature (25 °C) for 14 days and at body temperature (37 °C) for 24 hours. Linezolid concentrations over time were determined by high-performance liquid chromatography, physical compatibility was determined by pH measurement and visual inspection, and antimicrobial activity was monitored by a disk diffusion method. The influence of solution warming by heating plate on drug stability was investigated. RESULTS: Linezolid was stable in all tested solutions for 14 days at refrigeration and room temperatures and for 24 hours at body temperature. No linezolid adsorption to container material was detected. There were only minor variations in pH values, and visual inspection revealed no diluent abnormalities. With 1 exception, antimicrobial activity of >90% was retained in all PD solution samples for the duration of the study under all temperature conditions. CONCLUSION: Linezolid injection 2 mg/mL remained stable and was compatible with the PD solutions studied for up to 2 weeks at refrigeration or room temperature and up to 24 hours at body temperature.


Assuntos
Anti-Infecciosos/química , Soluções para Diálise/química , Linezolida/química , Anti-Infecciosos/farmacologia , Bacillus subtilis/efeitos dos fármacos , Cromatografia Líquida de Alta Pressão , Incompatibilidade de Medicamentos , Estabilidade de Medicamentos , Armazenamento de Medicamentos , Concentração de Íons de Hidrogênio , Linezolida/farmacologia , Testes de Sensibilidade Microbiana , Diálise Peritoneal , Refrigeração
8.
Eur J Clin Microbiol Infect Dis ; 37(6): 1091-1098, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29546637

RESUMO

Peritonitis is still the main infectious complication among patients on peritoneal dialysis. For treatment of peritoneal dialysis-related peritonitis, the intraperitoneal administration of antibiotics admixed to peritoneal dialysis fluids (PDFs) should be preferred. However, the influence of diverse PDFs on the activity of frequently used antibiotics has been investigated insufficiently. Thus, the present study set out to investigate the in vitro activity of fosfomycin against Escherichia coli, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Staphylococcus aureus in commercially available PDFs. Time-kill curves in four different PDFs (Dianeal®, Extraneal®, Nutrineal®, and Physioneal®) were performed over 24 h with two different concentrations of fosfomycin (150 and 400 mg/L) and without antibiotics as control. Cation-adjusted Mueller Hinton broth (CA-MHB) was used as a comparator solution. In blank PDFs, bacterial growth of each organism evaluated was reduced when compared to CA-MHB. For S. aureus in blank Physioneal®, a reduction under the limit of detection was observed within 24 h. The activity of fosfomycin was reduced in all PDFs when compared to CA-MHB except for P. aeruginosa in Nutrineal® where the activity of fosfomycin was increased when investigated at 400 mg/L. Against E.coli, bactericidal activity was demonstrated in Extraneal®, Nutrineal®, and Physioneal®. Fosfomycin resistance (MIC > 1024 mg/L) was observed for P. aeruginosa in CA-MHB at both concentrations and in Nutrineal® at 150 mg/L. Fosfomycin is active in PDFs particularly against the frequently isolated enterobacterium E. coli. The choice of the respective PDF considerably influences the microbiological outcome in vitro. Further studies are warranted to investigate the clinical relevance of these findings.


Assuntos
Soluções para Diálise/farmacologia , Escherichia coli/efeitos dos fármacos , Fosfomicina/farmacologia , Pseudomonas aeruginosa/efeitos dos fármacos , Staphylococcus aureus/efeitos dos fármacos , Staphylococcus epidermidis/efeitos dos fármacos , Antibacterianos/farmacologia , Soluções para Diálise/efeitos adversos , Soluções para Diálise/análise , Soluções para Diálise/química , Escherichia coli/crescimento & desenvolvimento , Humanos , Testes de Sensibilidade Microbiana , Diálise Peritoneal/efeitos adversos , Peritonite/tratamento farmacológico , Peritonite/etiologia , Peritonite/microbiologia , Pseudomonas aeruginosa/crescimento & desenvolvimento , Infecções Estafilocócicas/tratamento farmacológico , Infecções Estafilocócicas/etiologia , Staphylococcus aureus/crescimento & desenvolvimento , Staphylococcus epidermidis/crescimento & desenvolvimento
9.
Perit Dial Int ; 37(1): 51-55, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-27605684

RESUMO

♦ BACKGROUND: Intraperitoneal administration of antimicrobial agents is recommended for the treatment of peritoneal dialysis (PD)-related peritonitis. For home-based antimicrobial therapy it is common to supply patients with PD fluid bags with admixed antibiotic. Thus, the compatibility of meropenem with different PD fluids (PDFs), namely Extraneal, Physioneal 1.36% and Physioneal 2.27% (all Baxter Healthcare Corp., Deerfield, IL, USA), was investigated under varying storage conditions. ♦ METHODS: Meropenem (Venus Pharma, Werne, Germany) was stored at 6°C and 25°C over 14 days and at 37°C over 24 hours. Drug concentration over time was determined using high performance liquid chromatography, drug activity by a diffusion disk method, diluent stability by visual inspection and drug adsorption was calculated. Blank PD fluids and deionized water were used as comparator solutions. ♦ RESULTS: Compared to water, the stability of meropenem was minimally lower in Extraneal but markedly reduced in both Physioneal solutions. No significant drug adsorption was detected for any PDF investigated. ♦ CONCLUSIONS: Meropenem is stable and compatible with Extraneal and might be stored for up to a week at refrigeration temperature (6°C). A loss of ~20% of meropenem after 2 days at room temperature should be considered. Mixed Physioneal appears not suitable for storage at any temperature after meropenem has been admixed. A considerable drug degradation due to the warming up to body temperature through heating plates should further be taken into account in clinical practice.


Assuntos
Antibacterianos/química , Soluções para Diálise/química , Estabilidade de Medicamentos , Peritonite/tratamento farmacológico , Tienamicinas/química , Antibacterianos/farmacologia , Incompatibilidade de Medicamentos , Armazenamento de Medicamentos , Humanos , Meropeném , Diálise Peritoneal/efeitos adversos , Diálise Peritoneal/métodos , Peritonite/etiologia , Sensibilidade e Especificidade , Tienamicinas/farmacologia
10.
Perit Dial Int ; 36(6): 662-668, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27680756

RESUMO

♦ BACKGROUND: Peritonitis is a major problem among patients on peritoneal dialysis (PD). The influence of diverse PD fluids on the activity of frequently used antibiotics has been insufficiently investigated. Thus, the present study set out to investigate the impact of different PD fluids on the activity of cefepime, ciprofloxacin, ertapenem, meropenem, and tobramycin against Escherichia coli. ♦ METHODS: Time-kill curves in 4 different PD fluids (Dianeal PDG4, Extraneal, Nutrineal PD4 and Physioneal 40, all Baxter Healthcare Corp., Deerfield, IL, USA) were performed over 24 hours with 4 different concentrations (1 × minimum inhibitory concentration [MIC], 4 × MIC, 8 × MIC, 30 × MIC) of each antibiotic evaluated and without antibiotics as control. Cation-adjusted Mueller Hinton broth (CA-MHB) was used as comparator solution. ♦ RESULTS: In all PD fluids investigated, bacterial growth and antimicrobial activity of all antibiotics tested was significantly reduced compared with the CA-MHB comparator solution. Except at high concentrations of 30 × MIC, cefepime, ertapenem and meropenem demonstrated a strongly reduced activity in all PD fluids investigated. Ciprofloxacin and tobramycin were highly active and bactericidal in all PD fluids and demonstrated dose-dependent activity. ♦ CONCLUSION: The antimicrobial activity of cefepime, ertapenem and meropenem is limited or even nullified in certain PD fluids in vitro, whereas ciprofloxacin and tobramycin show excellent activity. The choice of PD fluids can impact the activity of antimicrobial agents and might influence microbiological outcome. Further studies are required to verify the clinical relevance of our findings.


Assuntos
Antibacterianos/farmacologia , Soluções para Diálise/farmacologia , Escherichia coli/efeitos dos fármacos , Diálise Peritoneal/efeitos adversos , Peritonite/tratamento farmacológico , Cefepima , Cefalosporinas/farmacologia , Ciprofloxacina/farmacologia , Soluções para Diálise/efeitos adversos , Ertapenem , Escherichia coli/isolamento & purificação , Humanos , Técnicas In Vitro , Meropeném , Testes de Sensibilidade Microbiana , Diálise Peritoneal/métodos , Peritonite/etiologia , Sensibilidade e Especificidade , Tienamicinas/farmacologia , Tobramicina/farmacologia , beta-Lactamas/farmacologia
11.
Antimicrob Agents Chemother ; 60(5): 2790-7, 2016 05.
Artigo em Inglês | MEDLINE | ID: mdl-26902765

RESUMO

The objective of this study was to determine the pharmacokinetic profile of meropenem in automated peritoneal dialysis (APD) patients. In 6 patients without peritonitis, a single dose of 0.5 g of meropenem was applied intraperitoneally (i.p.) or intravenously (i.v.) and concentrations in serum and dialysate were measured at specified intervals over 24 h with high-performance liquid chromatography-mass spectrometry. The mean maximum concentrations of meropenem in serum (Cmax) were 27.2 mg/liter (standard deviation [SD], ±6.9) and 10.1 mg/liter (SD, ±2.5) and in dialysate were 3.6 mg/liter (SD, ±2.3) and 185.8 mg/liter (SD, ±18.7) after i.v. and i.p. administrations, respectively. The mean areas under the curve from 0 to 24 (AUC0-24) of meropenem in serum were 173.5 mg · h/liter (SD, ±29.7) and 141.4 mg · h/liter (SD, ±37.5) (P = 0.046) and in dialysate were 42.6 mg · h/liter (SD, ±20.0) and 623.4 mg · h/liter (SD, ±84.1) (P = 0.028) after i.v. and i.p. administrations, respectively. The ratios for dialysate exposure over plasma exposure after i.v. and i.p. treatments were 0.2 (SD, ±0.1) and 4.6 (SD, ±0.9), respectively (P = 0.031). A mean target value of 40% T>MIC (time for which the free meropenem concentration exceeds the MIC) for clinically relevant pathogens with EUCAST susceptibility breakpoints of 2 mg/liter was reached in serum after i.p. and i.v. administrations and in dialysate after i.p. but not after i.v. administration. The present data indicate that low i.p. exposure limits the i.v. use of meropenem for PD-associated peritonitis. In contrast, i.p. administration not only results in superior concentrations in dialysate but also might be used to treat systemic infections.


Assuntos
Antibacterianos/farmacocinética , Diálise Peritoneal , Tienamicinas/farmacocinética , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Antibacterianos/sangue , Cromatografia Líquida de Alta Pressão , Estudos Cross-Over , Feminino , Taxa de Filtração Glomerular/fisiologia , Humanos , Infusões Intravenosas , Masculino , Espectrometria de Massas , Meropeném , Pessoa de Meia-Idade , Tienamicinas/administração & dosagem , Tienamicinas/sangue , Adulto Jovem
12.
Clin Ther ; 38(2): 276-287.e4, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26708119

RESUMO

PURPOSE: The European Medicines Agency recommends limiting the hemoglobin (Hb) concentration to 10 to 12 g/dL in adults with chronic kidney disease (CKD) receiving erythropoiesis-stimulating agents such as epoetin theta. This postauthorization study assessed the incidence and intensity of cardiovascular events, including ischemic stroke, in patients receiving epoetin theta for anemia associated with CKD. A secondary end point was adverse drug reactions, including pure red cell aplasia. METHODS: In this prospective, noninterventional, multinational cohort study, consecutive patients with advanced or end-stage renal disease and receiving epoetin theta were followed up for 6 months. Data on reportable adverse events (RAEs) (cardiac disorders, cardiac failure, myocardial infarction, and ischemic stroke and respective subterms), epoetin theta dosage, and Hb concentrations were collected. A post hoc exploratory analysis assessed the incidences of RAEs according to tertiles for individual mean Hb concentration (≤10.7, >10.7-11.47, and >11.47 g/dL for low, intermediate, and high, respectively) and mean weekly epoetin theta dosage (≤62, >62-125, and >125 IU/kg/wk for low, intermediate, and high). FINDINGS: Data from 1039 patients were included (577 men, 462 women; mean age, 68.7 years). A total of 101 RAEs were documented in 89 patients (8.6%), for an event rate of 0.1985/person-year. Sixty-four patients (6.1%) died; none of the deaths was considered related to epoetin theta use. The incidence of RAEs was lowest at intermediate Hb concentrations (6.2%) compared with low (11.3%) and high (7.8%) Hb concentrations. The incidence of ischemic stroke was 1.5% at high Hb concentrations versus 0.6% at both the low and intermediate Hb concentrations. The incidence of any RAE was greater in the high-dose group (10.1%) than in the intermediate-dose (8.0%) and low-dose (7.6%) groups. The risk for any cardiovascular RAE or ischemic stroke was greatest in the high-dose/high-Hb group (13.3%), followed by high dose/low Hb (12.6%) and low dose/low Hb (12.1%). The risks for RAEs were lowest at high dose/intermediate Hb (3.8%) and low dose/intermediate Hb (5.3%). The event rate of adverse drug reactions other than the predefined RAEs was 0.0161/person-year. No cases of pure red cell aplasia were reported. IMPLICATIONS: The findings from the present study suggest that, for maintaining the optimal target Hb concentration (10-12 g/dL according to the current summary of product characteristics for epoetin theta; 10-11.5 g/dL according to the current guideline from Kidney Disease Improving Global Outcomes) in anemic adults with CKD, the lowest approved, effective dose epoetin theta should be used.


Assuntos
Anemia/tratamento farmacológico , Eritropoetina/administração & dosagem , Aplasia Pura de Série Vermelha/epidemiologia , Insuficiência Renal Crônica/complicações , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Eritropoetina/efeitos adversos , Feminino , Insuficiência Cardíaca/epidemiologia , Hematínicos/administração & dosagem , Humanos , Falência Renal Crônica/complicações , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Estudos Prospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Adulto Jovem
13.
PLoS One ; 8(7): e67836, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23844107

RESUMO

Peritonitis is a major complication of peritoneal dialysis (PD) being associated with hospitalization, catheter loss, technique failure, and increased mortality. Data on incidence rates and risk factors for peritonitis episodes vary between centers. In seven Austrian PD units clinical and laboratory data on each peritonitis episode were collected from all patients (n = 726) who performed PD between January 2000 and December 2009. The peritonitis incidence rate was 0.32 episodes/patient-year. In a multivariate analysis the risk of peritonitis was decreased by 57% in patients treated with oral active vitamin D (HR 0.43; 95% CI 0.28-0.64). Renal disease classified as "other or unknown" (HR 1.65; 95% CI 1.08-2.53) and serum albumin <3500 mg/dl (HR 1.49; 95% CI 1.04-2.15) were also associated with an increased risk of peritonitis. Albumin levels <3500 mg/dl (HR 1.89; 95% CI 1.13-3.17), age (HR 1.06 per year; 95% CI 1.03-1.09), and cardiomyopathy (HR 3.01; 95% CI 1.62-5.59) were associated with increased mortality, whereas treatment with oral active vitamin D was associated with a significantly lower risk of death (HR 0.46; 95% CI 0.27-0.81). In this retrospective multi-center study we identified several factors being related to increased risk of peritonitis in PD patients. Treatment with oral active vitamin D was identified as being independently associated with decreased risk of peritonitis, and decreased all-cause mortality in PD patients.


Assuntos
Nefropatias/terapia , Diálise Peritoneal/métodos , Peritonite/prevenção & controle , Vitamina D/uso terapêutico , Administração Oral , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Austrália/epidemiologia , Cardiomiopatias/complicações , Feminino , Humanos , Incidência , Nefropatias/mortalidade , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Diálise Peritoneal/mortalidade , Peritonite/epidemiologia , Peritonite/etiologia , Estudos Retrospectivos , Fatores de Risco , Albumina Sérica/metabolismo , Taxa de Sobrevida , Vitamina D/administração & dosagem , Vitaminas/administração & dosagem , Vitaminas/uso terapêutico , Adulto Jovem
14.
Wien Med Wochenschr ; 163(11-12): 280-7, 2013 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-23797681

RESUMO

The number of elderly patients with end stage renal disease is constantly increasing. Conventional hämodiaylsis as the mainstay of renal replacement therapy is often poorly tolerated by frail eldery patients with multiple comorbidities. Although many of these patients would prefer a home based dialysis treatment, the number of elderly patients using peritoneal dialysis (PD) is still low. Impaired physical and cognitive function often generates insurmountable barriers for self care peritoneal dialysis. Assisted peritoneal dialysis can overcome many of these barriers and give elderly patients the ability of a renal replacement therapy in their own homes respecting their needs.


Assuntos
Idoso Fragilizado , Serviços de Assistência Domiciliar , Falência Renal Crônica/terapia , Diálise Peritoneal Ambulatorial Contínua/métodos , Idoso , Áustria , Cateteres de Demora , Comorbidade , Estudos Transversais , Avaliação da Deficiência , Hemodiálise no Domicílio/métodos , Humanos , Falência Renal Crônica/epidemiologia , Preferência do Paciente , Seleção de Pacientes
15.
Wien Klin Wochenschr ; 125(3-4): 71-82, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23299452

RESUMO

BACKGROUND: Dialysis patients, receiving erythropoiesis stimulating agents, typically show signs of hemoglobin variability as a consequence of their dosing patterns, bleeding, infection, etc., which is commonly managed adjusting the dose regimen of the erythropoiesis stimulating agent. However, information on dosing strategies used in daily clinical practice and their outcomes in relation to hemoglobin variability is limited. OBJECTIVES: To investigate clinical practice in Austria in relation with the management of hemoglobin variability, defined as a decrease of ³ 1 g/dL within 4 weeks from ³ 11 g/dL to £ 11 g/dL during maintenance therapy with darbepoetin alfa. The nature and incidence of clinical events related to the hemoglobin drop were also assessed. RESEARCH DESIGN AND METHODS: The MAINTAIN non-interventional study was conducted in hemodialysis patients, receiving darbepoetin alfa in accordance to the label approved in the European Union at that time. Patient data were documented retrospectively for the 3 months prior to the hemoglobin drop. Data for the 6 months post hemoglobin drop were collected retrospectively or prospectively, depending on the time of patient inclusion respective to the Hb drop. RESULTS: A hundred thirty six of 154 patients fulfilled all inclusion/exclusion criteria and had prospective documentation of 6 months. The main causes for the hemoglobin drop included surgical and medical procedures (36.1 %), and infections or infestations (24.4 %). The median treatment period was 273 days. The mean hemoglobin drop was - 1.74 g/dL (95 % confidence interval (CI): - 1.60 to - 1.87). Consequently, 81 % of the patients had their dose of darbepoetin alfa increased within a median Kaplan-Meier time to dose increase of 12.5 days (95 % CI: 6-22). The geometric mean weekly darbepoetin alfa dose increased by a factor of 1.1 from 29.1 mg (95 % CI: 24.6-34.4) in the 3 months before hemoglobin drop to 32.4 (95 % CI: 27.2-38.6) in months 4-6 post hemoglobin drop. Three patients had red blood cell transfusions before hemoglobin drop and nine patients after hemoglobin drop. The mean hemoglobin increase was 0.43 g/dL (95 % CI: 0.24-0.62) from immediately prior to 2 weeks after dose increase. The median Kaplan-Meier time to achieve a hemoglobin ³ 11 g/dL after hemoglobin drop was 36 days (95 % CI: 32-45). Frequent darbepoetin alfa dose adjustments were necessary to sustain maintenance levels. No drug-related adverse events were reported. CONCLUSIONS: This observational study describes physicians' reactions to a drop in hemoglobin in clinical practice. Using darbepoetin alfa, the drop was generally compensated without leading to overcorrection.


Assuntos
Anemia/tratamento farmacológico , Anemia/epidemiologia , Índices de Eritrócitos/efeitos dos fármacos , Eritropoetina/análogos & derivados , Falência Renal Crônica/epidemiologia , Falência Renal Crônica/prevenção & controle , Diálise Renal/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia/prevenção & controle , Áustria/epidemiologia , Comorbidade , Darbepoetina alfa , Eritropoetina/administração & dosagem , Feminino , Hematínicos/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Resultado do Tratamento , Adulto Jovem
16.
Perit Dial Int ; 29(3): 330-9, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19458307

RESUMO

BACKGROUND: Catheter-associated infections markedly contribute to treatment failure in peritoneal dialysis (PD) patients. There is much controversy surrounding prophylactic strategies to prevent these infections. METHODS: In this nationwide multicenter study we analyzed strategies to prevent catheter-associated infections as performed in Austrian PD centers in 2006. A questionnaire was sent to all 23 PD centers in Austria. RESULTS: Ten different catheter models were used in the 332 patients being treated in the 23 Austrian PD centers. Systemic antibiotics prior to catheter placement were given by 17 of the 23 PD centers (glycopeptides, n = 7; cephalosporins, n = 10). Nasal swabs were taken preoperatively by 17 PD centers; nasal Staphylococcus aureus carriers were treated prophylactically with mupirocin cream in 15 of these centers. Dressing change was routinely performed in 318 of 332 chronic PD patients (nonocclusive film dressing, n = 58; gauze dressing, n = 260). Disinfectants for chronic exit-site care included povidone iodine (n = 155), sodium hypochlorite (n = 31), povidone iodine + sodium hypochlorite together (n = 102), and octenidine dihydrochloride/phenoxyethanol (n = 17). Water + non-disinfectant soap or 0.9% sodium chloride was administered as a cleansing agent to the exit site by 27 patients. Routine S. aureus screening (nasal and/or exit-site swabs) in chronic PD patients was performed in 12 PD centers; carriers were treated with mupirocin cream in 11 of these centers. Dialysis staff members were screened for S. aureus in 8 PD centers and spouses were screened for S. aureus in 5 PD centers. The overall exit-site infection rate was 1 episode/43.9 patient-months, tunnel infection rate was 1 episode/88.9 patient-months, and peritonitis rate was 1 episode/51.0 patient-months. Patients of centers that have installed a prophylaxis protocol for treating S. aureus carriers had lower mean infection rates compared with those not using such a protocol. CONCLUSION: Various individual prophylactic strategies are used to prevent catheter-associated infections in Austrian PD centers. Infection rates are within the range reported in the literature. There is still scope for improvement in some centers (e.g., by establishing a prophylaxis protocol).


Assuntos
Infecções Relacionadas a Cateter/prevenção & controle , Cateteres de Demora/efeitos adversos , Infecções por Bactérias Gram-Negativas/prevenção & controle , Infecções por Bactérias Gram-Positivas/prevenção & controle , Diálise Peritoneal/efeitos adversos , Diálise Peritoneal/instrumentação , Adolescente , Adulto , Idoso , Antibacterianos/uso terapêutico , Áustria , Infecções Relacionadas a Cateter/diagnóstico , Infecções Relacionadas a Cateter/epidemiologia , Remoção de Dispositivo , Feminino , Infecções por Bactérias Gram-Negativas/diagnóstico , Infecções por Bactérias Gram-Negativas/epidemiologia , Infecções por Bactérias Gram-Positivas/diagnóstico , Infecções por Bactérias Gram-Positivas/epidemiologia , Pesquisas sobre Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Educação de Pacientes como Assunto , Padrões de Prática Médica , Adulto Jovem
17.
Wien Klin Wochenschr ; 117 Suppl 6: 46-53, 2005.
Artigo em Alemão | MEDLINE | ID: mdl-16437333

RESUMO

The number of patients suffering from end-stage renal disease (ESRD) throughout the world continues to increase. The unacceptably high mortality in this population has led to current efforts to optimize dialysis treatment and has focused attention on comorbidities and their interaction with dialysis treatment. Cardiovascular morbidity is the most important cause of death in patients with ESRD. The advantages of hemodynamic stability and volume regulation offered by peritoneal dialysis (PD), compared with hemodialysis (HD), have made PD preferable for patients with cardiovascular comorbidity. However, recent studies on PD have shown a higher mortality in patients with coronary artery disease or congestive heart failure than in similar patients receiving HD. Nevertheless, the validity of the studies is limited by their retrospective study design and, furthermore, at the time of data collection, new dialysis solutions were not available and the percentage of patients on automated PD was low. Little is known about the frequency of chronic obstructive pulmonary disease (COPD) in the ESRD population, but COPD data on the general population without kidney disease suggest that significant underestimation of both prevalence and mortality of this disease can be supposed in the ESRD population. Data currently available do not suggest that PD is contraindicated in patients with cardiac diseases. However, consequent diagnostic and therapeutic interventions of cardiac comorbidities and corresponding risk factors are required. Patients suffering from mild COPD should not be generally excluded from PD as renal replacement therapy, although individually tailored modifications of dialysate volume and frequency of exchanges are often required.


Assuntos
Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Falência Renal Crônica/mortalidade , Falência Renal Crônica/terapia , Diálise Peritoneal/mortalidade , Doença Pulmonar Obstrutiva Crônica/mortalidade , Doença Pulmonar Obstrutiva Crônica/prevenção & controle , Áustria/epidemiologia , Comorbidade , Humanos , Diálise Peritoneal/métodos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica , Prognóstico , Medição de Risco , Fatores de Risco , Taxa de Sobrevida , Resultado do Tratamento
18.
J Am Soc Nephrol ; 15(5): 1323-9, 2004 May.
Artigo em Inglês | MEDLINE | ID: mdl-15100373

RESUMO

Anderson-Fabry disease is possibly underdiagnosed in patients with end-stage renal disease. Nationwide screening was therefore undertaken for Anderson-Fabry disease among dialysis patients in Austria. Screening for alpha-galactosidase A (AGAL) deficiency was performed by a blood spot test. In patients with a positive screening test, AGAL activity in leukocytes was determined. Individuals with decreased leukocyte AGAL activity were subjected to mutation testing in the GLA gene. Fifty (90.9%) of 55 Austrian hemodialysis centers participated in this study; 2480 dialysis patients (80.1% of the Austrian dialysis population) were screened. In 85 patients, the screening test was positive (85 of 2480, 3.42%; women, 3.32%; men, 3.50%). Among these 85 patients, 4 men (in 3 of whom Anderson-Fabry disease was already known before screening) had a severely decreased and 11 subjects had a borderline low AGAL activity. Genetic testing revealed mutations associated with Fabry disease in all four men with severely decreased AGAL activity resulting in a prevalence of 0.161% for the entire study population. A nationwide screening of dialysis patients permitted detection of a hitherto unknown man with Anderson-Fabry disease. The overall prevalence among dialysis patients was at least ten times higher as compared with recent registry data. Screening programs among patients with end-stage renal disease, especially men, should be put in place to identify families with Anderson-Fabry disease who probably may benefit from specific clinical care, and perhaps from enzyme replacement therapy. In dialysis patients, however, there is no evidence to support enzyme replacement therapy at present.


Assuntos
Doença de Fabry/diagnóstico , Doença de Fabry/genética , Testes Genéticos , Falência Renal Crônica/complicações , alfa-Galactosidase/genética , Idoso , Áustria , Doença de Fabry/complicações , Feminino , Humanos , Falência Renal Crônica/terapia , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Diálise Renal
19.
J Ren Nutr ; 13(3): 174-85, 2003 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-12874741

RESUMO

Malnutrition is a relevant risk factor for mortality for patients on maintenance hemodialysis treatment. In a retrospective study including 377 patients who began hemodialysis treatment between 1986 and 2001, we assessed the prevalence of different statuses of nutrition and the impact of the initial status of nutrition on the change in body weight and patient survival. We found an inverse relationship between body mass index (BMI, kg/m2) and the gain in body weight and BMI within 12 months of hemodialysis treatment. Underweight and normal weight patients had a substantial increase in these parameters, greatest in underweight subjects, whereas overweight and obese patients showed only a moderate increase or none (P =.0019, P =.00036). Adjusted mortality rates showed an inverse correlation with the initial BMI (P <.0001). There was a statistically significant difference in the mortality between patients with normal weight and overweight or obesity, respectively, showing a more favorable prognosis in overweight and obese patients (P =.0007; P =.022; log-rank, normal versus overweight, P =.012). Weight loss was the greatest independent risk factor for mortality in general. Adjusted hazard ratio of death was highest in underweight patients (3.999; CI, 2.708 to 5.905; P <.0001) and decreased to 2.251 (CI, 1.795 to 2.822; P <.0001) in normal weight, 1.927 (CI, 1.390 to 2.670; P <.0001) in overweight, and 1.651 (CI, 0.841 to 3.236; P =.1439) in obese subjects when patients with weight loss were compared with patients who preserved their initial weight or gained weight. Overall, the initial BMI has an influence on the change in body weight as well as on patient survival in general and in the case of weight loss in particular.


Assuntos
Índice de Massa Corporal , Falência Renal Crônica/mortalidade , Desnutrição/etiologia , Obesidade/mortalidade , Diálise Renal/efeitos adversos , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Diabetes Mellitus Tipo 2/complicações , Nefropatias Diabéticas/complicações , Nefropatias Diabéticas/mortalidade , Feminino , Humanos , Falência Renal Crônica/complicações , Falência Renal Crônica/terapia , Masculino , Desnutrição/epidemiologia , Desnutrição/mortalidade , Pessoa de Meia-Idade , Razão de Chances , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de Risco , Análise de Sobrevida , Fatores de Tempo , Ganho de Peso/fisiologia , Perda de Peso/fisiologia
20.
Kidney Int Suppl ; (84): S113-6, 2003 May.
Artigo em Inglês | MEDLINE | ID: mdl-12694323

RESUMO

BACKGROUND: Dyslipidemic factors obviously contribute to the high cardiovascular risk in dialysis patients but are often an underestimated problem. Therefore, we determined the prevalence of dyslipidemic factors in a large group of unselected hemodialysis (N = 564) and CAPD (N = 168) patients. METHODS: We used the recently published recommendations of the Medical Experts Group concerning cardiovascular risk factors for the categorization of dyslipidemic factors. These were total cholesterol>200 mg/dL, low-density lipoprotein (LDL) cholesterol>100 mg/dL, high-density lipoprotein (HDL) cholesterol <40 mg/dL, triglycerides>180 mg/dL, and Lp(a)>30 mg/dL. RESULTS: CAPD patients had, in sum, a markedly worse lipid profile when compared with HD patients. They had higher frequencies of elevated total cholesterol (67% vs. 34%), triglycerides (47% vs. 28%), and Lp(a) concentrations (37% vs. 30%) when compared with HD patients. In both patient groups, about two thirds of the patients had LDL cholesterol above 100 mg/dL and HDL cholesterol below 40 mg/dL. When we analyzed the total frequency of dyslipidemic factors, we observed that the CAPD group included a markedly higher number of patients with three or four concurrent dyslipidemic factors than HD patients (P < 0.001). Furthermore, we analyzed apolipoprotein A-IV (apoA-IV), which was recently shown to be associated with cardiovascular disease, and which was about twice as high in both patient groups when compared with controls (P < 0.001). CONCLUSIONS: Dyslipidemic risk factors are highly prevalent in dialysis patients, and the concomitant occurrence of several risk factors in a given patient is more often observed in CAPD than HD patients.


Assuntos
Hiperlipidemias/epidemiologia , Falência Renal Crônica/epidemiologia , Diálise Peritoneal Ambulatorial Contínua/estatística & dados numéricos , Diálise Renal/estatística & dados numéricos , Adulto , Idoso , Apolipoproteínas A/sangue , HDL-Colesterol/sangue , LDL-Colesterol/sangue , Feminino , Humanos , Hiperlipidemias/sangue , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Triglicerídeos/sangue
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