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End-stage renal disease (ESRD) is increasing worldwide as a consequence of population aging and increasing chronic illness. Treatment consists mostly of dialysis and kidney transplantation (KTx), and KTx offers advantages for life expectancy and long-term cost reductions compared with dialysis. This study uses the administrative database of the Lombardy Region to analyze the costs of a cohort of patients with ESRD receiving KTx, covering a time period of 24 months before transplant to 12 months after. During 2011, 276 patients underwent kidney transplantation (8.7% preemptive and 91.3% non-preemptive). In the period before transplantation, the main cost driver was dialysis (66.6% for the period from -24 to -12 months and 73.8% for the period from -12 to 0 months), while in the 12 months after KTx, the most relevant cost was surgery. The total cost -24 to -12 months pre-KTx was 35 049.2; the cost -12 to 0 months was 36 745.9; and the cost 12 months after KTx was 43 805.8. Non-preemptive patients showed much higher costs both pre- and post-KTx than preemptive patients. This study highlights how KTx modifies the resource consumption and costs composition of patients with ESRD vs those undergoing dialysis treatment and how KTx may be economically beneficial, especially preemptive intervention.
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Análise Custo-Benefício , Recursos em Saúde/estatística & dados numéricos , Falência Renal Crônica/economia , Transplante de Rim/economia , Qualidade de Vida , Diálise Renal/economia , Adulto , Feminino , Seguimentos , Humanos , Falência Renal Crônica/cirurgia , Transplante de Rim/métodos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos RetrospectivosRESUMO
Cardiovascular disease (CVD) is a highly common complication and the first cause of death in patients with end-stage renal disease (ESRD) on haemodialysis (HD). In this population, mortality due to CVD is 20 times higher than in the general population and the majority of maintenance HD patients have CVD. This is likely due to ventricular hypertrophy as well as non-traditional risk factors, such as chronic volume overload, anaemia, inflammation, oxidative stress, chronic kidney disease-mineral bone disorder and other aspects of the 'uraemic milieu'. Better understanding the impact of these numerous factors on CVD would be an important step for prevention and treatment. In this review we focus non-traditional CVD risk factors in HD patients.
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Doenças Cardiovasculares/etiologia , Falência Renal Crônica/complicações , Diálise Renal/efeitos adversos , Humanos , Falência Renal Crônica/terapia , Fatores de RiscoRESUMO
BACKGROUND/AIMS: This study aimed to evaluate total and sudden death (SD) in a cohort of dialysis patients, comparing hemodialysis (HD) vs. peritoneal dialysis (PD). METHODS: This is a multicenter retrospective cohort study. RESULTS: Deaths were 626 out of 1,823 in HD and 62 of 249 in PD patients. HD patients had a greater number of comorbidities (p < 0.05). PD patients had a lower risk of death than HD patients (p < 0.001); however, the advantage decreased with time (p < 0.001). Mortality predictors were left ventricular ejection fraction (LVEF) ≤35%, older age, ischemic heart disease, diabetes mellitus, previous stroke, and atrial fibrillation (p < 0.03). SDs were 84:71 in HD and 13 in PD population (12.1 and 22.8% of all causes of death, respectively). A non-significant risk of SD among PD compared to HD patients was detected. SD predictors were older age, ischemic heart disease, and LVEF ≤35% (p < 0.05). CONCLUSIONS: HD patients showed a greater presence of comorbidities and reduced survival compared to PD patients; however, the incidence of SD does not differ in the 2 populations. Video Journal Club "Cappuccino with Claudio Ronco" at http://www.karger.com/?doi=464347.
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BACKGROUND: Oral anticoagulation therapy (OAT) is the choice treatment for thromboembolism prevention in atrial fibrillation (AF), although data about OAT use in haemodialysis (HD) patients with AF are contradictory. METHODS: The effect of OAT on the risk of mortality, stroke and bleeding was prospectively evaluated in a population of HD patients with AF. All the patients of 10 HD Italian centres alive on 31 October 2010 with documented AF episode(s) were recruited and followed-up for 2 years. OAT and antiplatelet intake, age, dialytic age, comorbidities and percentage time in the target international normalized ratio (INR) range (target therapeutic range; TTR) were considered as predictors of hazard of death, thromboembolic and bleeding events. RESULTS: At recruitment, 134 patients out of 290 were taking OAT. During the follow-up, 115 patients died (4 strokes, 3 haemorrhagic and 1 thromboembolic). Antiplatelet therapy, but not OAT, was associated with increased mortality (HR 1.71, CI 1.10-2.64, P = 0.02). The estimated survival of patients always taking OAT tended to be higher than that of patients who stopped taking (68.6 versus 49.6%, P = 0.07). OAT was not correlated to a significant decreased risk of thromboembolic events (HR 0.12, CI 0.00-3.59, P = 0.20), while it was associated with an increased risk of bleeding (HR 3.96, CI 1.15-13.68, P = 0.03). Higher TTR was associated with a reduced bleeding risk (HR 0.09, CI 0.01-0.76, P = 0.03), while previous haemorrhagic events were associated with higher haemorrhagic risk (HR 2.17, CI 1.09-4.35, P = 0.03). CONCLUSIONS: In our population of HD patients with AF, the mortality is very high. OAT is not associated with increased mortality, while antiplatelet drugs are. OAT seems, on the contrary, associated with a better survival; however, it does not decrease the incidence of ischaemic stroke, whereas it increases the incidence of bleeding. Bleeding risk is lower in subjects in whom the INR is kept within the therapeutic range.
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Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Hemorragia/etiologia , Diálise Renal , Acidente Vascular Cerebral/etiologia , Varfarina/efeitos adversos , Idoso , Fibrilação Atrial/mortalidade , Feminino , Hemorragia/mortalidade , Humanos , Incidência , Itália/epidemiologia , Masculino , Estudos Prospectivos , Fatores de Risco , Acidente Vascular Cerebral/mortalidade , Taxa de SobrevidaRESUMO
Chronic kidney disease and the need for kidney replacement therapy have increased dramatically in recent decades. Forecasts for the coming years predict an even greater increase, especially in low- and middle-income countries, due to the rise in metabolic and cardiovascular diseases and the aging population. Access to kidney replacement treatments may not be available to all patients, making it especially strategic to set up therapy programs that can ensure the best possible treatment for the greatest number of patients. The choice of the "ideal" kidney replacement therapy often conflicts with medical availability and the patient's tolerance. This paper discusses the pros and cons of various kidney replacement therapy options and their real-world applicability limits.
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Patients with CKD on RRT are at high risk for severe disease and mortality in COVID-19 disease. We decided to conduct an observational prospective study to evaluate antibody response after vaccination for COVID-19 in a cohort of 210 adult patients on RRT (148 on HD; 20 on PD; and 42 kidney transplant recipients). Blood samples were taken before and 4 weeks after vaccination. Antibody levels were evaluated with CLIA immunoassay testing for IgG anti-trimeric spike protein of SARS-CoV-2. A positive antibody titer was present in 89.9% of HD patients, 90% of PD patients, and 52.4% of kidney transplant recipients. Non-responders were more frequent among patients on immunosuppressive therapy. Mycophenolate use in kidney transplant patients was associated with lower antibody response. The median antibody titer was 626 (228-1480) BAU/mL; higher in younger patients and those previously exposed to the virus and lower in HD patients with neoplasms and/or on immunosuppressive therapy. Only two patients developed COVID-19 in the observation period: they both had mild disease and antibody titers lower than 1000 BAU/mL. Our data show a valid response to COVID-19 mRNA vaccination in HD and PD patients and a reduced response in kidney transplant recipients. Mycophenolate was the most relevant factor associated with low response.
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BACKGROUND: Indoxyl sulfate (IS) and p-cresyl sulfate (PCS) are uremic toxins associated with cardiovascular outcome in CKD patients. The present work is an analysis of the association of serum free, total IS and PCS with cardiovascular events and calcium-phosphate metabolism variables in hemodialysis patients. METHODS: Serum levels of total and free IS and PCS were measured in 139 hemodialysis patients. Their relationship with calcium-phosphate metabolism variables were tested in an observational cohort study. In addition, their association with cardiovascular events was investigated during a 4-year follow-up. RESULTS: Patients in the highest tertile (T3) of serum free IS showed lower serum 1,25(OH)2D compared to patients in the middle (T2) and lowest tertile (T1); in addition to this, T3 patients showed lower serum irisin than T1 patients and lower serum PTH than all the other subjects (T1 + T2) combined. Serum PTH was also measured during the two years after the baseline measurement and was higher in patients in the T1 than in those in the T3 of serum free IS. Cox regression analysis showed that cardiovascular risk was lower in T1 patients than in those in the T3 of serum free PCS, both using a univariate (OR 2.55, 95% CI 1.2-5.43; p = 0.015) or multivariate model (OR 2.48, 95% CI 1.12-5.51; p = 0.003). CONCLUSIONS: Serum free IS may be associated with PTH and 1,25(OH)2D secretion, whereas free PCS may predict cardiovascular risk in hemodialysis patients.
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Doenças Cardiovasculares , Ésteres do Ácido Sulfúrico , Biomarcadores , Cálcio , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Cresóis , Fatores de Risco de Doenças Cardíacas , Humanos , Indicã , Indóis , Minerais , Fosfatos , Diálise Renal/efeitos adversos , Fatores de Risco , SulfatosRESUMO
BACKGROUND: Despite significant advances in haemodialysis (HD) in recent decades, current dialysis techniques are limited by inadequate removal of uraemic solutes such as middle molecules and protein-bound uraemic toxins. Novel medium cut-off (MCO) membrane or 'expanded haemodialysis' (HDx) provides diffusive removal of conventional and large middle molecular weight uraemic toxins, with marginal albumin leak. METHODS: This prospective, open-label, controlled, cross-over pilot study compared HDx (novel MCO membrane Theranova® 400) and conventional HD in 20 prevalent HD patients. Biochemical, dialysis adequacy and safety measures (adverse events, infections and hospitalization frequency) were recorded. Ten patients underwent conventional HD high-flux dialyser and 10 patients underwent HDx for 3 months, and the patients then switched and received the other treatment for a further 3 months. RESULTS: Treatment with HDx was associated with a significant reduction in serum albumin concentration [median (interquartile range) reduction -0.45 g/dL (-0.575 to -0.05); P = 0.025]. However, median albumin levels were ≥3.5 g/dL and no patients had clinical symptoms of hypoalbuminaemia or needed intravenous albumin administration. The number of infections was lower in patients treated with HDx (n = 7/19) compared with patients treated with HD (n = 14/20; P = 0.03). Patients treated with HDx had reduced levels of interleukin (IL)-1ß (from 0.06 ± 0.02 pg/mL versus 0.28 ± 0.18 pg/mL with HD) and IL-6 (6.45 ± 1.57 pg/mL versus 9.48 ± 2.15 pg/mL), while tumour necrosis factor-α levels remain unchanged. CONCLUSIONS: This study demonstrates that the chronic use of the novel MCO dialyser Theranova® appears to be safe and well-tolerated, without serious side effects or hypoalbuminaemia, as well as fewer infections. These results need to be confirmed in larger randomized clinical trials.
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The novel coronavirus, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was declared a pandemic in March 2020 by the World Health Organization. Older individuals and patients with comorbid conditions such as hypertension, heart disease, diabetes, lung disease, chronic kidney disease (CKD) and immunologic diseases are at higher risk of contracting this severe infection. In particular, patients with advanced CKD constitute a vulnerable population and a challenge in the prevention and control of the disease. Home-based renal replacement therapies offer an opportunity to manage patients remotely, thus reducing the likelihood of infection due to direct human interaction. Patients are seen less frequently, limiting the close interaction between patients and healthcare workers who may contract and spread the disease. However, while home dialysis is a reasonable choice at this time due to the advantage of isolation of patients, measures must be assured to implement the program. Despite its logistical benefits, outpatient haemodialysis also presents certain challenges during times of crises such as the coronavirus disease 2019 (COVID-19) pandemic and potentially future ones.
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BACKGROUND: Patients on dialysis often have secondary hyperparathyroidism (SHPT), a disorder associated with renal osteodystrophy, progressive vascular calcification, cardiovascular disease, and death. The objective of this retrospective observational study was to evaluate, in dialysis patients with SHPT, the impact of different levels of adherence to cinacalcet therapy on hospitalisations and direct healthcare costs charged to the Lombardy Regional Health Service (Italy). METHODS: Data recorded in the administrative databases on all citizens undergoing dialysis between 1 January 2011 and 31 December 2011 were selected. For the aim of this study, patients with SHPT already on dialysis in the first 6 months of 2009 who had been treated with cinacalcet for at least 365 days were selected and retrospectively analysed through to end of 2012. Healthcare resource utilisation, cinacalcet adherence, and costs for medication, hospitalisations, and diagnostic/therapeutic procedures were estimated. RESULTS: A total of 994 patients were identified (mean age 63.0 years, females 43.5%). The first patient tertile had an adherence to cinacalcet of <64.1%, whereas the third had an adherence of over 91.5%. Patients in the third adherence tertile experienced fewer all-causes hospitalisations than those in the first tertile (-19.2%; p=0.01423), fractures (-37.1%; p=0.59422), cardiovascular disease (-23.8%; p=0.04025), and sepsis (-32.3%; p=0.01386). The increase in costs for cinacalcet-adherent patients is almost completely offset by the reduction in costs for hospitalisations. CONCLUSIONS: The results of the analysis suggest that there may be some correlation between a high level of cinacalcet adherence and a decrease in hospitalisations.
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INTRODUCTION: The most accurate way of assessing kidney function is the measurement of the glomerular filtration rate (GFR). Since, we do not have good formulae to estimate GFR in elderly, in this study we evaluate the accuracy of the most commonly used formulas for the estimation of GFR in comparison with direct measurement in elderly. MATERIALS AND METHODS: 85 patients (51 males and 34 females), with an average age of 76.2 ± 4.4 years, 42% already diagnosed with chronic kidney disease (CKD) were investigated. Two plasma samples were collected between 60-90 and 165-195 minutes after injection of 99mTc-DTPA, and the GFR was calculated applying Charles D. Russell's two-sample method. RESULTS: When comparing the GFR values obtained from the various formulae by creatinine levels with the GFR values obtained by measuring 99mTc-DTPA residue, the following concordance values emerged: (1) MDRD: 57.5 ± 9.59 %; (2) Cockroft-Gault: 48.33 ± 24.93; (3) CKD-EPI: 49.40 ± 26.30; (4) BIS1: 58 ± 6.79. CONCLUSION: Our data shows a greater concordance between the GFR values calculated with the Russell's method and the estimated values of GFR when the latter are calculated using the MDRD or BIS1 formulae.
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Insuficiência Renal Crônica , Idoso , Idoso de 80 Anos ou mais , Biomarcadores , Creatinina , Feminino , Taxa de Filtração Glomerular , Humanos , Masculino , Insuficiência Renal Crônica/diagnósticoRESUMO
BACKGROUND: Chronic kidney disease (CKD) patients under hemodialysis show a higher risk of cardiovascular (CV) mortality and morbidity than the general population. This study aims to identify genetic markers that could explain the increased CV risk in hemodialysis. METHODS: A total of 245 CKD patients under hemodialysis were recruited and followed up for 5 years to record CV events. Genetic analysis was performed using single-nucleotide polymorphisms (SNPs) genotyping by Infinium Expanded Multi-Ethnic Genotyping Array (Illumina, San Diego, CA, USA) comparing patients with and without a history of CV events [161 cardiovascular diseases (CVDs) and 84 no CVDs]. The fixation index (Fst) measure was used to identify the most differentiated SNPs, and gene ontology analysis [Protein Analysis THrough Evolutionary Relationships (PANTHER) and Ingenuity Pathway Analysis (IPA)] was applied to define the biological/pathological roles of the associated SNPs. Partitioning tree analysis interrogated the genotype-phenotype relationship between discovered genetic variants and CV phenotypes. Cox regression analysis measured the effect of these SNPs on new CV events during the follow-up (FU). RESULTS: Fst analysis identified 3218 SNPs that were significantly different between CVD and no CVD. Gene ontology analysis identified two of these SNPs as involved in cardiovascular disease pathways (Ingenuity Pathway) and heart development (Panther) and belonging to 2 different genes: Glucagon-like peptide-1 receptor (GLP1R) and Sarcoglycan delta (SGCD). The phenotype-genotype analysis found a higher percentage of CVD patients carrying the GLP1R rs10305445 allele A (P = 0.03) and lower percentages of CVD patients carrying the SGCD rs145292439 allele A (P = 0.038). Moreover, SGCD rs145292439 was associated with higher levels of high-density lipoprotein (P = 0.015). Cox analysis confirmed the increased frequency of CV events during the 5-year FU in patients carrying GLP1R rs1035445 allele A but it did not show any significant association with SGCD rs145292439. CONCLUSIONS: This study identified GLP1R rs10305445 and SCGD rs145292439 as potential genetic markers that may explain the higher risk of CVD in hemodialysis patients.
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End-stage renal disease (ESRD) is a global health problem. There are differences in mortality among patients with ESRD amid industrialized countries that may be related to their respective systems of delivery of care. A nationwide survey was completed in Italy, a country with low mortality rate for ESRD patients, in order to help understand key aspects of ESRD delivery of care that contribute to mortality. Survey responses were obtained and analyzed from 131 of 575 dialysis centers (23%), covering data from 13,170 dialysis patients in 2006. The mortality rate was 11.2% and the prevalence of diabetes-associated kidney disease was 21%. Of the patients, 88% were on hemodialysis and 12% were on peritoneal dialysis. Most patients were in the age range of 65-75 years (66.7%), were seen by a nephrologist at CKD stage 3, and began dialysis at mean estimated GFR of 9.6 ml/min/1.73 m2. AV fistulae were the prevailing form of vascular access (83%) and were most frequently placed by a nephrologist (61.2%). In 98% of the dialysis centers, a nephrologist was present during dialysis sessions. The following may explain the low mortality for ESRD patients in Italy: low prevalence of diabetes, high use of AV fistulae, delivery of care by nephrologists beginning in pre-ESRD stages, their involvement in placement of dialysis vascular access, and their physical presence requirement during dialysis sessions. These findings portray key aspects of the contemporary delivery of care for Italian dialysis patients and provide a platform for international comparison of healthcare systems for ESRD.
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Falência Renal Crônica/mortalidade , Falência Renal Crônica/terapia , Diálise Renal/estatística & dados numéricos , Idoso , Comorbidade , Atenção à Saúde/métodos , Diabetes Mellitus/epidemiologia , Geografia , Inquéritos Epidemiológicos , Humanos , Hipertensão/epidemiologia , Entrevistas como Assunto , Itália/epidemiologia , Falência Renal Crônica/epidemiologia , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Diálise Peritoneal/instrumentação , Diálise Peritoneal/métodos , Diálise Peritoneal/estatística & dados numéricos , Prevalência , Diálise Renal/instrumentação , Diálise Renal/métodos , Taxa de SobrevidaRESUMO
BACKGROUND: Chronic kidney disease (CKD) progression is associated with significant comorbidities and costs. In Italy, limited evidence of healthcare resource consumption and costs is available. We therefore aimed to investigate the direct healthcare costs in charge to the Lombardy Regional Health Service (RHS) for the treatment of CKD patients in the first year after starting hemodialysis and in the 2 years prior to dialysis. METHODS: Citizens resident in the Lombardy Region (Italy) who initiated dialysis in the year 2011 (Jan 1 to Dec 31) were selected and data were extracted from Lombardy Regional databases on their direct healthcare costs in the first year after starting dialysis and in the 2 years prior to it was analyzed. Drugs, hospitalizations, diagnostic procedures and outpatient costs covered by RHS were estimated. Patients treated for acute kidney injury, or who died or stopped dialysis during the observational period were excluded. RESULTS: From the regional population (>9,700,000 inhabitants), 1067 patients (34.3 % females) initiating dialysis were identified, of whom 82 % underwent only hemodialysis (HD), 13 % only peritoneal dialysis (PD) and the remaining 5 % both treatments. Direct healthcare costs/patient were 5239, 12,303 and 38,821 ( 40,132 for HD vs. 30,444 for PD patients) for the periods 24-12 months pre-dialysis, 12-0 months pre-dialysis, and in the first year of dialysis, respectively. CONCLUSIONS: This study highlights a significant economic burden related to CKD and an increase in direct healthcare costs associated with the start of dialysis, pointing to the importance of prevention programs and early diagnosis.
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Custos de Cuidados de Saúde , Diálise Peritoneal/economia , Avaliação de Processos em Cuidados de Saúde/economia , Diálise Renal/economia , Insuficiência Renal Crônica/economia , Insuficiência Renal Crônica/terapia , Demandas Administrativas em Assistência à Saúde , Idoso , Assistência Ambulatorial/economia , Bases de Dados Factuais , Testes Diagnósticos de Rotina/economia , Progressão da Doença , Custos de Medicamentos , Feminino , Custos Hospitalares , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Insuficiência Renal Crônica/diagnóstico , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Deranged vitamin D metabolism represents an active trigger of secondary hyperparathyroidism (SHPT) in CKD. Correction of 25(OH)D deficiency by nutritional Vitamin D administration is suggested by KDIGO guidelines, to prevent and treat SHPT in CKD stage G3-G5 and G1T-G5T patients, although with a still inconsistent background. Nutritional vitamin D is available as cholecalciferol, ergocalciferol, or calcifediol. Superiority of calcifediol in increasing 25(OH)D levels has been suggested due to its better bioavailability. The safer pharmacokinetic of the recent modified-release (MR) formulation of calcifediol was effective in replenishing 25(OH)D levels with minimal impact on vitamin D catabolism and fibroblast-growth factor-23 (FGF-23) activation. Areas covered: the review discusses utility of calcifediol for treating SHPT in different CKD stages under physiology driven approach, focusing on vitamin D metabolism, guidelines suggestions and comparison between clinical effects on SHPT elicited by calcifediol, cholecalciferol and ergocalciferol. Expert commentary: although optimal targets of 25(OH)D and parathormone remain uncertain, calcifediol, especially in its newer MR formulation, may represent an intriguing option to combine an efficacious correction of 25(OH)D deficit and SHPT, with a limited impact on vitamin D catabolism and FGF-23 activation. Newer data are required to better explore the role of MR calcifediol in treating SHPT.
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Calcifediol/uso terapêutico , Hiperparatireoidismo Secundário/tratamento farmacológico , Insuficiência Renal Crônica/complicações , Animais , Disponibilidade Biológica , Calcifediol/administração & dosagem , Calcifediol/farmacocinética , Colecalciferol/uso terapêutico , Preparações de Ação Retardada , Ergocalciferóis/uso terapêutico , Fator de Crescimento de Fibroblastos 23 , Humanos , Hiperparatireoidismo Secundário/etiologia , Guias de Prática Clínica como Assunto , Vitamina D/análogos & derivados , Vitamina D/sangue , Vitamina D/metabolismo , Vitaminas/administração & dosagem , Vitaminas/farmacocinética , Vitaminas/uso terapêuticoRESUMO
It is well documented that chronic kidney disease patients have an extremely high risk of developing cardiovascular (CV) disease (CVD) compared to the general population. Declining renal function itself represents a continuum of CV risk, and in those individuals who survive to reach end-stage renal disease, the risk of suffering a cardiac event is uncomfortably and unacceptably high. Several pathophysiological pathways have been suggested to account for this, including endothelial dysfunction, dyslipidemia, inflammation, left ventricular hypertrophy, troponins, phosphate, vitamin D, fibroblast growth factor-23, and NT-proBNP. All these conditions and biomarkers may have clear associations with current and subsequent CVD.
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Doenças Cardiovasculares/etiologia , Falência Renal Crônica/complicações , Biomarcadores , Humanos , Fatores de RiscoRESUMO
Secondary hyperparathyroidism (SHPT), a very frequent, severe, and worsening complication of chronic kidney disease, is characterized by high serum parathyroid hormone (PTH), parathyroid gland hyperplasia, and disturbances in mineral metabolism. Clinically, SHPT shows renal osteodystrophy, vascular calcification, cardiovascular damage, and fatal outcome. Calcium-sensing receptor (CaSR) is the main physiological regulator of PTH secretion; its activation by calcium rapidly inhibits PTH. Another important player in regulating mineral metabolism is vitamin D receptor (VDR), which is under the influence of vitamin D and influences the intestinal absorption of calcium and phosphate, PTH gene expression, and bone calcium mobilization. Serum phosphate levels influence fibroblast growth factor 23 (FGF-23) production, a phosphatonin that modulates serum phosphate reabsorption, PTH synthesis, and vitamin D production. Current therapeutic approaches consist of 1) phosphate intake control by diet or phosphate binders, 2) vitamin D by VDR activation, and 3) calcimimetic agents that activate CaSR. Recently, a new long-acting peptide (etelcalcetide) belonging to the calcimimetics class was approved for intravenous use in hemodialysis patients with SHPT. Etelcalcetide binds directly to CaSR, by a sulfide bond, inhibiting the production and secretion of PTH by parathyroid glands. After intravenous administration in rats, etelcalcetide is quickly distributed to the tissues and eliminated by kidneys, while in uremic animals the nonrenal excretion is only 1.2%. In hemodialysis patients, the treatment itself is the main route of elimination. Etelcalcetide in hemodialysis patients with SHPT was more effective than placebo and cinacalcet, with a PTH reduction of >30% in 76% of patients with etelcalcetide versus 10% with placebo. Particular attention was paid to the safety of the drug; the most common adverse event was asymptomatic blood calcium reduction, similar to cinacalcet, while gastrointestinal symptoms were less frequent. This promising new drug available for better control of SHPT will, together with drugs already in use, optimize the treatment to normalize the biochemical parameters.
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BACKGROUND: The aim of this study was to evaluate, in a cohort of haemodialysis patients with atrial fibrillation (AF), the relationship between oral anticoagulant therapy (OAT) and mortality, thromboembolic events and haemorrhage. METHODS: Two hundred and ninety patients with AF were prospectively followed for 4 years. Warfarin and antiplatelet intake, age, dialytic age, comorbidities, CHA2DS2-VASc and HAS-BLED scores were considered as predictors of risk of death, thromboembolism and bleeding events. In patients taking OAT, the international normalized ratio (INR) was assessed and the percentage time in the target therapeutic range (TTR) was calculated. RESULTS: At recruitment, 134/290 patients were taking warfarin. During follow-up there were 170 deaths, 28 thromboembolic events and 95 bleedings. After balancing for treatment propensity, intention-to-treat analysis on OAT intake at recruitment did not show differences in total mortality, thromboembolic events and bleedings, while the as-treated analysis, accounting for treatment switch, showed that patients taking OAT at recruitment had a significantly lower mortality than those not taking it [hazard ratio, HR 0.53 (95% confidence interval 0.28-0.90), p = 0.04], with a decrease of thromboembolic events [HR 0.36 (0.13-1.05), p = 0.06], and an increase of bleedings [HR 1.79 (0.72-4.39), p = 0.20], both non-significant. Among patients taking OAT at recruitment, those continuing to take warfarin had a significant reduction in the risk of total [HR 0.28 (0.14-0.53), p < 0.001] and cardiovascular [HR 0.21 (0.11-0.40), p < 0.001] mortality compared to patients stopping OAT. CONCLUSIONS: In haemodialysis patients with AF, continuously taking warfarin is associated with a reduction of the risk of total and cardiovascular mortality.
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Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/mortalidade , Falência Renal Crônica/mortalidade , Falência Renal Crônica/terapia , Diálise Renal/mortalidade , Tromboembolia/mortalidade , Tromboembolia/prevenção & controle , Varfarina/administração & dosagem , Administração Oral , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/diagnóstico , Comorbidade , Feminino , Hemorragia/induzido quimicamente , Hemorragia/mortalidade , Humanos , Análise de Intenção de Tratamento , Itália , Estimativa de Kaplan-Meier , Falência Renal Crônica/diagnóstico , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/administração & dosagem , Modelos de Riscos Proporcionais , Estudos Prospectivos , Fatores de Proteção , Diálise Renal/efeitos adversos , Fatores de Risco , Tromboembolia/diagnóstico , Fatores de Tempo , Resultado do Tratamento , Varfarina/efeitos adversosRESUMO
UNLABELLED: The Italian Registry of Dialysis and Transplantation (RIDT) has recently resumed the collection of data of patients on RRT in Italy. Data were requested to Regional Registries for the years 2011-2013 and they contributed according to their possibilities. Eighteen Regions or autonomous Provinces provided data with various degrees of completeness and this made possible to bridge the gap between the current and the previous census (referring to 2010). RESULTS: Incidencedata were associated to a sample with a coverage of 77% of the national population (46/60 million inhabitants). Patients who started dialysis in these three years were, respectively, 168, 166 and 160 patients pmp. If we project this data to the national population is reasonable to think that 9500-10000 patients per year start the dialytic treatment. PREVALENCE: The prevalence of patients on dialysis in Italy range, in the 10 years of RIDT, between 750 and 825 patients pmp. Based on this we can reasonably estimate that in Italy there are 45-49000 dialysis patients. Incidence and prevalence vary widely in different regions. Mortalityon dialysis in Italy during the period 2011-2013 was on average 16.2 per 100 patient-years (95% CI: 16.1-16.7) with regional variation smaller than that observed in incidence and prevalence. CONCLUSIONS: In this paper, data analysis are presented in a direct and non comparative manner. However, it provides information on the status of the RRT in Italy and the temporal consistency of the data is a proof of their validity. Registry data were published in the official site of Italian Registry that can be reached through the website of SIN (www.sin-italy.org).
Assuntos
Transplante de Rim/estatística & dados numéricos , Sistema de Registros , Diálise Renal/estatística & dados numéricos , Humanos , ItáliaRESUMO
INTRODUCTION: Catheter-related infections are an important clinical problem in maintenance hemodialysis patients. Catheter-related bloodstream infections have a negative effect on survival, hospitalization and cost of care. Tegaderm™ chlorhexidine gluconate (CHG) dressing may be useful to reduce catheter-related infection rates. METHODS: We performed a study to assess the efficacy of Tegaderm™ CHG dressing for reducing catheter-related infections. We designed a prospective randomized cross-over study with a scheme of two treatments, Tegaderm™ CHG dressing versus standard dressing, and two periods of six months. Catheter-related infection rate was the primary outcome. We enrolled 59 prevalent hemodialysis patients. RESULTS: Catheter-related infection rate per 1000 catheter days was reduced from 1.21 in patients using standard dressing to 0.28 in patients with Tegaderm™ CHG dressing (p = 0.02). Catheter-related bloodstream infection rate per 1000 catheter days was equal to 0.09 in patients with Tegaderm™ CHG dressing versus 0.65 in patients with standard dressing (p = 0.05). Annual total healthcare costs for catheter-related bloodstream infections were estimated equal to EUR62,459 versus EUR300,399, respectively, for patients with Tegaderm™ CHG versus standard dressing. CONCLUSIONS: This is the first prospective study to show that Tegaderm™ CHG dressing significantly reduces catheter-related infection rates in hemodialysis patients.