Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 26
Filter
1.
G Ital Nefrol ; 40(2)2023 Apr 27.
Article in Italian | MEDLINE | ID: mdl-37179481

ABSTRACT

Dialysis (hemodialysis and peritoneal dialysis) is one of the main therapeutic alternatives for patients with end-stage renal disease. It can be provided in different settings, including the home setting. Published literature shows that home dialysis improves both survival and quality of life, while producing economic advantages. However, there are also significant barriers. Home dialysis patients often report "abandonment issues" by healthcare personnel. This work aimed at assessing the efficiency of the Doctor Plus® Nephro telemedicine system (adopted in the Nephrology Center of the P.O. G.B. Grassi di Roma-ASL Roma 3) in monitoring patient health status and improving the quality of care. From 2017 to 2022, N=26 patients were included in the analysis (mean duration of observation: 2.3 years). The analysis showed that the program was able to promptly identify possible anomalies of the vital parameters and activate a series of interventions aimed at normalizing the altered profile. During the study period, the system issued N=41,563 alerts (N=1.87 alerts per patient/day), of which N=16,325 (39.3%) were clinical and N=25,238 (60.7%) were missed measurements. These warnings ensured stabilization of the parameters, with clear benefits on patients' quality of life. A trend of improvement was reported by patients, regarding their perception of the health state (EQ-5D questionnaire; +11.1 points on the VAS scale), the number of hospital admissions (-0.43 accesses/patient in 4 months), and of working days lost (-3.6 days lost in 4 months). Therefore, Doctor Plus® Nephro represents a useful and efficient tool for home dialysis patients' management.


Subject(s)
Kidney Failure, Chronic , Peritoneal Dialysis , Humans , Hemodialysis, Home , Quality of Life , Renal Dialysis , Kidney Failure, Chronic/therapy
2.
Int Urol Nephrol ; 55(7): 1865-1873, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36790677

ABSTRACT

BACKGROUND: Patients with end-stage renal failure (ESRD) or dialysis frequently suffer from secondary hyperparathyroidism (sHPTH), a severe complication of mineral metabolism disorders. The calcimimetic etelcalcetide has been approved and shown efficacy in randomized controlled trials, however, data are limited from real-life studies. This study aimed to evaluate the long-term use etelcalcetide for the treatment of sHPTH (PTH > 600 pg/mL) in patients undergoing extracorporeal hemodialysis for ESRD for at least 2 years. METHODS: In 45 patients, we administered etelcalcetide for the treatment of sHPTH (PTH > 600 pg/mL); One group of patients (control group, Group A; N = 26) were previously treated with intravenous vitamin D analogues only (paricalcitol 5 µg/ml, three times/week) and then treated with etelcalcetide and a second group of patients already on cinacalcet therapy for at least six months in combination with iv paricalcitol were switched to etelcalcetide (Group B, N = 19). RESULTS: PTH levels decreased over time in both groups of patients, with higher values for patients previously treated with cinacalcet (Group B) compared to Group A for the entire study duration even if the final value of the two groups was comparable. After 12 months, the percentage of subjects who had PTH concentrations within the targets recommended by KDIGO guidelines was 87% in Group A and 58% in Group B. In seven patients, despite a parathyroid gland volume > 1000 mm3, an adequate response in the reduction of PTH was obtained. CONCLUSION: Findings from this study demonstrate that the efficacy of etelcalcetide is maintained over the long term.


Subject(s)
Hyperparathyroidism, Secondary , Kidney Failure, Chronic , Humans , Cinacalcet/therapeutic use , Calcimimetic Agents/therapeutic use , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/therapy , Hyperparathyroidism, Secondary/drug therapy , Hyperparathyroidism, Secondary/etiology , Renal Dialysis/adverse effects , Parathyroid Hormone , Calcium
3.
BMC Nephrol ; 23(1): 336, 2022 10 20.
Article in English | MEDLINE | ID: mdl-36266621

ABSTRACT

BACKGROUND: Anaemia and iron deficiency (ID) are common in chronic kidney disease (CKD) patients and related to outcomes. There is growing interest about the role of iron supplementation in CKD, particularly ferric carboxymaltose (FCM), also in relation to the use of erythropoiesis stimulating agents (ESAs). Despite a greater knowledge on ID management in patients receiving haemodialysis, a paucity of data exists about peritoneal dialysis (PD). Furthermore, the aim of this paper is to provide the results of a nationwide Italian survey about ID in PD using the Delphi method. METHODS: A list of 16 statements (48 items) was developed about four main topics: (1) approach to iron therapy in PD; (2) management experience about iron therapy in PD; (3) ESA and iron in PD; (4) pharmacoeconomic impact. Using the Delphi methodology, the survey was distributed online to 36 Italian nephrologists with expertise in PD, who rated their level of agreement with each item on a 5-point Likert scale. Consensus was predefined as more than 66% of the panel agreeing/disagreeing with any given statement. RESULTS: Twenty-five experts (70%) answered the survey. 35 items (73%) achieved a consensus (8 negative and 27 positive). In particular, the diagnosis of ID is widely known, but some doubts exist about how frequently test it. The use of I.V. iron seems to be routinary and can save money reducing the administration of ESAs. However, internal protocols are welcome. CONCLUSIONS: Expert PD nephrologists know well the problem of ID and feel the necessity of shared protocols to optimize the iron therapy and consequently the use of ESAs.


Subject(s)
Anemia, Iron-Deficiency , Hematinics , Iron Deficiencies , Peritoneal Dialysis , Renal Insufficiency, Chronic , Humans , Delphi Technique , Consensus , Hemoglobins , Iron/therapeutic use , Ferric Compounds , Renal Insufficiency, Chronic/therapy , Renal Insufficiency, Chronic/chemically induced , Peritoneal Dialysis/adverse effects , Anemia, Iron-Deficiency/diagnosis , Anemia, Iron-Deficiency/drug therapy , Anemia, Iron-Deficiency/epidemiology
5.
J Hypertens ; 38(9): 1849-1856, 2020 09.
Article in English | MEDLINE | ID: mdl-32649620

ABSTRACT

BACKGROUND: Uncontrolled hypertension notwithstanding the use of at least three drugs or hypertension controlled with at least four drugs, the widely accepted definition of treatment-resistant hypertension (TRH), is considered as a common problem in the hemodialysis population. However, to date there is no estimate of the prevalence of this condition in hemodialysis patients. METHOD: We estimated the prevalence of TRH by 44-h ambulatory BP monitoring (ABPM) in 506 hemodialysis patients in 10 renal units in Europe included in the registry of the European Renal and Cardiovascular Medicine (EURECAm,), a working group of the European Association, European Dialysis and Transplantation Association (ERA EDTA). In a sub-group of 114 patients, we tested the relationship between fluid overload (Body Composition monitor) and TRH. RESULTS: The prevalence of hypertension with 44-h ABPM criteria was estimated at 85.6% (434 out of 506 patients). Of these, 296 (58%) patients were classified as uncontrolled hypertensive patients by 44-h ABPM criteria (≥130/80 mmHg). Two hundred and thirteen patients had uncontrolled hypertension while on treatment with less than three drugs and 210 patients were normotensive while on drug therapy (n = 138) or off drug treatment (n = 72). The prevalence of TRH was 24% (93 among 386 treated hypertensive patients). The prevalence of predialysis fluid overload was 33% among TRH patients, 34% in uncontrolled hypertensive patients and 26% in normotensive patients. The vast majority (67%) of hemodialysis patients with TRH had no fluid overload. CONCLUSION: TRH occurs in about one in four treated hypertensive patients on hemodialysis. Fluid overload per se only in part explains TRH and the 67% of these patients show no fluid overload.


Subject(s)
Blood Pressure Monitoring, Ambulatory , Hypertension , Kidney Diseases , Renal Dialysis , Humans , Hypertension/complications , Hypertension/diagnosis , Hypertension/epidemiology , Kidney Diseases/complications , Kidney Diseases/epidemiology , Kidney Diseases/therapy , Prevalence
6.
G Ital Nefrol ; 37(2)2020 Apr 09.
Article in Italian | MEDLINE | ID: mdl-32281764

ABSTRACT

Introduction. Home dialysis (both extracorporeal and peritoneal) can improve the management and the quality of life of patients with chronic disease. In this study we evaluated the possible clinical and social advantages derived from remote patient monitoring using the Doctor Plus® Nephro program, as opposed to the standard of care. Methods. We included in our analysis the patients participating in the remote monitoring program of the Nephrology Center of ASL 3 in Rome from July 2017 to April 2019. Each patient was observed from a minimum of 4 months to a maximum of 22 months. Systolic and diastolic pressure, heart rate, weight and oximetry were monitored. An SF-12 questionnaire was also administered to evaluate the level of satisfaction with the program Doctor Plus® Nephro. Results. 16 patients (56,3% males, mean age 62 years) were observed as part of the analysis. During the program there was a reduction of systolic pressure in 69% of the patients and of diastolic pressure in 62,5%. Mean heart rate decreased from 69,4 bpm to 68,8 bpm (p<0,0046). The answers to the SF-12 questionnaire showed that the perceived health status of all patients had improved. Due to the closer clinical monitoring, the number of patients accessing emergency services also decreased. Conclusion. Doctor Plus® Nephro could improve access to home treatment; the results of this study in fact show it to be a useful tool for Nephrological Centers to monitor patients undergoing home dialysis.


Subject(s)
Hemodialysis, Home , Kidney Failure, Chronic/therapy , Monitoring, Physiologic/methods , Telemedicine , Female , Humans , Male , Middle Aged , Quality of Life , Remote Consultation
7.
G Ital Nefrol ; 37(1)2020 Feb 12.
Article in Italian | MEDLINE | ID: mdl-32068362

ABSTRACT

In 2011, a first peritoneal dialysis audit was held in the Lazio region to analyze the problems hindering the spread of this method and to improve the quality of care through the sharing of best practices across Centers. A scientific board was therefore set up, representing all the Centers offering PD, in order to assess clinical effectiveness using KPIs (Key Performance Indicators) and to quantify the objectives to be achieved. The analysis made it possible to identify the main problems and take action, all the while monitoring progress through KPIs. A second audit was carried out in 2017 and the collected data was analyzed and compared with the findings of the previous study. Overall, data showed an increase in prevalence, although the incidence showed a slight decrease. Indicators on the change of dialysis treatment, the dropout from domiciliary treatment and the incidence of late referral appeared stable over time. A slight improvement was observed in clinical data on peritonitis and on the length of hospitalization. All participants in the audit declared that sharing and discussing clinical practices had been really useful. In addition, through the drafting of practical documents (guides for patients, guidance on informed consent, protocols of clinical follow-up), a number of tools have been provided to ensure a uniformly high level of care across the different regional Centers.


Subject(s)
Advisory Committees/organization & administration , Benchmarking , Medical Audit , Peritoneal Dialysis/statistics & numerical data , Quality Improvement/statistics & numerical data , Hemodialysis, Home/statistics & numerical data , Humans , Italy , Kidney Failure, Chronic/therapy , Length of Stay , Medical Audit/methods , Patient Dropouts/statistics & numerical data , Peritoneal Dialysis/adverse effects , Peritoneal Dialysis/standards , Peritoneal Dialysis, Continuous Ambulatory/statistics & numerical data , Peritonitis/epidemiology , Quality Improvement/standards , Referral and Consultation , Treatment Outcome
8.
Nephrol Dial Transplant ; 34(9): 1542-1548, 2019 09 01.
Article in English | MEDLINE | ID: mdl-30007295

ABSTRACT

BACKGROUND: Population-specific consensus documents recommend that the diagnosis of hypertension in haemodialysis patients be based on 48-h ambulatory blood pressure (ABP) monitoring. However, until now there is just one study in the USA on the prevalence of hypertension in haemodialysis patients by 44-h recordings. Since there is a knowledge gap on the problem in European countries, we reassessed the problem in the European Cardiovascular and Renal Medicine working group Registry of the European Renal Association-European Dialysis and Transplant Association. METHODS: A total of 396 haemodialysis patients underwent 48-h ABP monitoring during a regular haemodialysis session and the subsequent interdialytic interval. Hypertension was defined as (i) pre-haemodialysis blood pressure (BP) ≥140/90 mmHg or use of antihypertensive agents and (ii) ABP ≥130/80 mmHg or use of antihypertensive agents. RESULTS: The prevalence of hypertension by 48-h ABP monitoring was very high (84.3%) and close to that by pre-haemodialysis BP (89.4%) but the agreement of the two techniques was not of the same magnitude (κ statistics = 0.648; P <0.001). In all, 290 participants were receiving antihypertensive treatment. In all, 9.1% of haemodialysis patients were categorized as normotensives, 12.6% had controlled hypertension confirmed by the two BP techniques, while 46.0% had uncontrolled hypertension with both techniques. The prevalence of white coat hypertension was 18.2% and that of masked hypertension 14.1%. Of note, hypertension was confined only to night-time in 22.2% of patients while just 1% of patients had only daytime hypertension. Pre-dialysis BP ≥140/90 mmHg had 76% sensitivity and 54% specificity for the diagnosis of BP ≥130/80 mmHg by 48-h ABP monitoring. CONCLUSIONS: The prevalence of hypertension in haemodialysis patients assessed by 48-h ABP monitoring is very high. Pre-haemodialysis BP poorly reflects the 48 h-ABP burden. About a third of the haemodialysis population has white coat or masked hypertension. These findings add weight to consensus documents supporting the use of ABP monitoring for proper hypertension diagnosis and treatment in this population.


Subject(s)
Hypertension/epidemiology , Hypertension/prevention & control , Renal Dialysis/adverse effects , Antihypertensive Agents/therapeutic use , Blood Pressure Determination , Blood Pressure Monitoring, Ambulatory , Europe/epidemiology , Female , Humans , Hypertension/etiology , Male , Middle Aged , Prevalence
9.
J Nephrol ; 31(5): 767-773, 2018 Oct.
Article in English | MEDLINE | ID: mdl-30155676

ABSTRACT

BACKGROUND: When medical therapy is unable to achieve biochemical control of secondary hyperparathyroidism, parathyroidectomy (PTX) is indicated, fortunately in a minority of patients. Thus, data on PTX prevalence and biochemical control are limited and, in particular in Italy, date back to 1999. METHODS: We designed a prospective, observational and multicenter study to collect data from dialysis units distributed throughout the Italian regions. Clinical data were collected with a dedicated data sheet. RESULTS: From January to December 2010, 149 Centers serving a total of 12,515 patients provided data on 528 living PTX cases (PTX prevalence = 4.2%). Prevalence was higher in hemo- than in peritoneal dialysis (4.5 vs. 1.9%, X2 = 21.52; p < 0.001), with non-significant regional differences (range 0.8-7.4%). PTX patients were younger (57.6 ± 12.5 vs. 67.1 ± 14.5 years; p < 0.001), more frequently female (56 vs. 38%, X2 = 68.05, p < 0.001) and had been on dialysis for a longer time (14.63 ± 8.37 vs. 4.8 ± 6.0 years, p < 0.001) compared to the 11,987 who did not undergo neck surgery. Median time since surgery was 6.0 years (3.0-9.0; 50%, IQR). The most frequent type of surgery was subtotal PTX (sPTX = 55.0%), significantly higher than total PTX (tPTX = 38.7%) or total PTX plus auto-transplantation (aPTX = 6.3%) (X2 = 5.18; Bonferroni post-hoc test, sPTX vs. tPTX + aPTX = p < 0.05). As for parathyroid hormone (PTH), calcium and phosphate control, cases targeting the KDOQI ranges were 18, 50.1 and 54.4%, respectively. The most prevalent biochemical condition was low PTH (62.7%). CONCLUSION: PTX prevalence in Italy is stable compared to previous observations, is higher in hemodialysis than in peritoneal dialysis and results in a suboptimal biochemical control.


Subject(s)
Hyperparathyroidism, Secondary/surgery , Parathyroidectomy/trends , Age Factors , Aged , Aged, 80 and over , Humans , Hyperparathyroidism, Secondary/diagnosis , Hyperparathyroidism, Secondary/epidemiology , Italy/epidemiology , Middle Aged , Parathyroidectomy/adverse effects , Peritoneal Dialysis/adverse effects , Peritoneal Dialysis/trends , Preliminary Data , Prevalence , Prospective Studies , Renal Dialysis/adverse effects , Renal Dialysis/trends , Risk Assessment , Risk Factors , Sex Factors , Time Factors , Treatment Outcome
11.
G Ital Nefrol ; 34(1)2017.
Article in Italian | MEDLINE | ID: mdl-28177100

ABSTRACT

The diffusion of peritoneal methodology can not be something out of the real organizational context and the regional directive can not be the only means to encourage the diffusion. There is the need to provide effective and sustainable levels of assistance through a clinical scientific support and sharing of best-practises. On one side, the aim is to provide an aid by the centers with great expertise in the methodology, recognized as reference points; on the other side, to establish the shared K.P.I.s (Key Performance Index), to asses the clinical effectiveness and measure the objectives to be achieved, through a modality of valuation to establish the real applicability. For this purpose, a scientific board was founded, composed by the heads of UU.OO, that provide the peritoneal dialysis, to determine which aspects to investigate and identify factors of supply improvement. The selected method was the clinical audit. The analysis of the 2011 data has allowed us to capture the situation of the peritoneal dialysis in the Lazio Region. The formative procedure has enabled the centers to share and standardize protocols and therapeutic procedures, identify the strengths of peritoneal dialysis in the Lazio Region and define the KPIs through whose compare and monitor the centers over time. The conclusive analysis of the audit has enabled to identify a series of activities to be undertaken together in order to improve the situation of the peritoneal dialysis in the Lazio Region. In the following years, surveys will be carried out to verify the KPIs trend.


Subject(s)
Kidney Failure, Chronic/therapy , Peritoneal Dialysis/standards , Benchmarking , Humans , Italy , Medical Audit
12.
Nephrology (Carlton) ; 20(9): 654-9, 2015 Sep.
Article in English | MEDLINE | ID: mdl-25943286

ABSTRACT

BACKGROUND: Oxford classification of Immunoglobulin A Nephropathy (IgAN) identifies four pathological features as predictors of renal outcome (MEST-score): mesangial proliferation (M); endocapillary proliferation (E); segmental glomerulosclerosis (S); tubular atrophy/interstitial fibrosis (T). In particular extracapillary proliferation (Ex) was not considered as an independent histological variable predicting renal outcome. Recently the VALIGA study provided a validation of the Oxford classification in a large European cohort of IgAN patients and re-stated that Ex is not associated with a worse renal prognosis. We propose a retrospective study to evaluate the predictive value of the MEST-score in a multi-centre, single region group of patients from central Italy and in addition, to investigate Ex as a marker predicting renal outcome. METHODS: One hundred and seven patients were enrolled in this study. Clinical data of each patient were available at diagnosis and follow-up. The median age at diagnosis was 36.7 years; 72% of the patients were males. Histological parameters were those included in the MEST-score of the Oxford classification; in addition, Ex was also assessed. RESULTS: Multiple linear regression models for survey were used. Statistical analysis showed a correlation between the progression of renal decline, in terms of estimated glomerular filtration rate (slope eGFR), and M, S, T. Differently from Oxford and VALIGA studies, no correlation was found with E, while Ex correlated with a decline of eGFR. CONCLUSIONS: Our results suggest that Ex represents an additional independent variable associated with a faster decline of renal function in IgAN.


Subject(s)
Cell Proliferation , Glomerulonephritis, IGA/pathology , Kidney Glomerulus/pathology , Adolescent , Adult , Aged , Biopsy , Disease Progression , Female , Glomerular Filtration Rate , Glomerulonephritis, IGA/physiopathology , Humans , Italy , Kidney Glomerulus/physiopathology , Linear Models , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies , Young Adult
13.
Article in English | MEDLINE | ID: mdl-23550080

ABSTRACT

BACKGROUND: A lack of awareness of chronic kidney disease (CKD) often results in delayed diagnosis and inadequate treatment. PURPOSE: The objective of this study was to assess the therapeutic management and outcome of nondialysis CKD patients. METHODS: Three hundred ninety-seven patients (54.9% males aged 67.5 ± 14.6 years) were retrospectively screened at the Nephrology Department, GB Grassi Hospital, Rome, Italy. After a baseline visit, patient data were collected every 6 months for a total of 24 months. Clinical characteristics were measured at baseline, then the following outcomes were measured every 6 months: staging of CKD, presence of concomitant diseases, treatment and adherence to Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines for anemia management. RESULTS: Three hundred sixty-eight (92.7%) patients attended at least one visit and 92 (23.2%) patients attended all four visits. Patients were mainly referred to a nephrologist for chronic renal failure (61.7%) or hypertension (42.8%). At baseline, 79.6% of patients had previous hospitalization and 79.1% were receiving antihypertensive medication. Serum creatinine and/or glomerular filtration rate was examined in >90% of patients, whereas parathyroid hormone was rarely examined (5.5%). Vitamin D supplementation was received by 6.5% of patients. The majority of patients were staged at 3 or 4 CKD (32% and 23.9%, respectively) and did not significantly change over time. The use of antithrombotic, antilipidemic and erythropoietin medication increased over the four surveys. The majority of patients (86.8%) achieved hemoglobin K/DOQI target levels. CONCLUSION: These findings demonstrate a current lack of attention of CKD and related disorders (mineral metabolism, electrolyte balance, and anemia) at the level of the general practitioner (GP) and non-nephrology specialist, which can result in both delayed referral and inadequate treatment. By increasing both awareness of CKD and the coordinated relationship between GPs and nephrologists, patient clinical and therapeutic outcome may be improved.

14.
G Ital Nefrol ; 30(2)2013.
Article in Italian | MEDLINE | ID: mdl-25077320

ABSTRACT

The ERA-EDTA codes for primary renal disease (ERA-EDTA PRD code) were implemented many years ago as a tool to use during the annual census of the European Register. They encompassed all those kidney diseases that terminate in uremia, grouped together in various sections, to produce a document that, in a pre-computer age, would guarantee the simplicity of use required at the time, when the census was compiled manually. Over the years, the refinement of diagnostic techniques and the evolution of medical knowledge in general has limited the use of these codes. In addition, the expansion of computer technology has simplified word search in documents thereby permitting the use of far more complex lists containing greater numbers of codes. For this reason, ERA-EDTA has initiated a comprehensive revision of the PRD codes, producing a new list (ERA-EDTA PRD code 2012) which is considerably more detailed and thorough: for example, renal disease not leading to uremia is included, thereby extending the use of codes for scientific applications not restricted to dialysis. In addition, it is amenable to 'recoding' into different encoding systems, including ICD-10, SNOMED-CT data and the Mendelian Inheritance in Man. The new ERA-EDTA codes are accompanied by detailed notes to guide the user. Both codes and notes have been translated accurately into Italian and are now available on the site of the Italian Dialysis Register www.sin-ridt.org together with further information and a search tool for ease of use. This article introduces thenew codesand describesthe Italian language translation process.


Subject(s)
Kidney Diseases/classification , Vocabulary, Controlled , Humans , Italy , Kidney Diseases/diagnosis , Male , Middle Aged , Registries , Translating
15.
G Ital Nefrol ; 30(5)2013.
Article in English | MEDLINE | ID: mdl-24402624

ABSTRACT

The link between serum parathyroid hormone (iPTH) and cardiovascular (CVS) mortality has not been fully elucidated. The EVOLVE Study was designed to test whether a drug such as cinacalcet, aimed at lowering iPTH, could reduce the astonishingly high cardiovascular risk in patients on maintenance dialysis (CKD-5D). Accordingly, the primary outcome of the study was the combined endpoint of time to death or hospitalization due to CVS factors or from any cause. Time to bone fracture and parathyroidectomy were regarded as secondary endpoints. At study completion, the Intention-To-Treat analysis documented a non- significant 7% (Hazard Ratio: 0.93; 95% Confidence interval: 0.85-1.02; P = 0.11) reduction of the primary composite endpoint. However, the intention to treat analysis does not take into account adherence to drug regimens or control for factors that may potentially jeopardize the conduction of the study. In particular, in spite of a careful pre-planned study sample calculation, the final power of the EVOLVE study was 54% instead of the assumed 90%, greatly reducing the reliability of study results. Furthermore, the pre-planned multivariable adjustment of the primary endpoint suggests a nominally significant reduction of the risk of the primary composite endpoint when age is entered into the statistical model. The sensitivity analysis further corroborates this result. The Lag Time Censoring Analysis (LTCA) evidenced a nominally significant 15% risk reduction of the composite endpoint among patients allocated to cinacalcet if the patients follow-up was terminated 6 months after the study drug discontinuation, as pre-planned in the protocol. It is interesting that the LTCA suggests that the effect of cinacalcet weakened over time and became insignificant after about 1 year from drug discontinuation. Although authors could not detect any effect of cinacalcet on bone fracture associated with cinacalcet use, the secondary analyses of the EVOLVE trial suggest a nominally significant 60-70% risk reduction of parathyroidectomy and a reassuring safety profile of prolonged exposure to cinacalcet. In summary, the EVOLVE study adds to the list of inconclusive randomized clinical trials in Nephrology. However, the preplanned exploratory and sensitivity analyses suggest that when imbalances of patients characteristics at study entry (i.e. age) or study drug discontinuation are considered, a 'nominally' significant risk reduction in CVS and parathyroidectomy associated with cinacalcet treatment is noted.


Subject(s)
Early Termination of Clinical Trials , Hyperparathyroidism/drug therapy , Naphthalenes/therapeutic use , Cinacalcet , Humans , Intention to Treat Analysis
16.
J Med Econ ; 15(6): 1110-7, 2012.
Article in English | MEDLINE | ID: mdl-22702445

ABSTRACT

BACKGROUND AND OBJECTIVES: Secondary hyperparathyroidism (SHPT) is a frequent complication of CKD with incidence, prevalence, and costs increasing worldwide. The objective of this analysis was to estimate therapy cost of SHPT in a sub-population of the FARO study. MATERIALS AND METHODS: In the FARO study, an observational survey aimed to evaluate patterns of treatment in patients with SHPT who had undergone hemodialysis, pharmacological treatments and biochemical parameters evolution data were collected in four surveys. Patients maintaining the same treatment in all sessions were grouped by type of treatment and evaluated for costs from the Italian National Health Service perspective. RESULTS: Four cohorts were identified: patients treated with oral (PO) calcitriol (n=182), intravenous (IV) calcitriol (n=34), IV paricalcitol (n=62), and IV paricalcitol+cinacalcet therapy (n=20); the cinacalcet monotherapy group was not analysed due to low number of patients (n=9). Parathyroid hormone (PTH) level at baseline and effectiveness of treatments in suppressing PTH level were assessed to test comparability among cohorts: calcitriol PO patients were significantly less severe than others (PTH level at baseline lower than 300 pg/ml; p<0.0001); calcitriol IV patients did not reach significant reduction in PTH level. Paricalcitol and paricalcitol+cinacalcet treatment groups results were comparable, while only the IV paricalcitol cohort's PTH level, weekly dosage, and cost decreased significantly from the first to the fourth survey (p=0.020, p=0.012, and p=0.0124, respectively). Total costs per week of treatment (including calcium-based phosphate binder and sevelamer) were significantly lower in the paricalcitol vs paricalcitol+cinacalcet cohort (p<0.001). Major limitations of this study are related to the survey design: not controlled and lack of comparability between cohorts; however, reflective of true practice patterns. CONCLUSIONS: The IV Paricalcitol cohort had significantly lower treatment costs compared with patients treated with paricalcitol+calcimemtics (p<0.001), without a significant difference in terms of baseline severity and PTH control.


Subject(s)
Calcitriol/economics , Ergocalciferols/economics , Hyperparathyroidism, Secondary/drug therapy , Naphthalenes/economics , Renal Dialysis , Aged , Aged, 80 and over , Calcitriol/therapeutic use , Cinacalcet , Comorbidity , Cost-Benefit Analysis , Drug Therapy, Combination , Ergocalciferols/therapeutic use , Fees, Pharmaceutical , Female , Humans , Hyperparathyroidism, Secondary/economics , Hyperparathyroidism, Secondary/etiology , Male , Middle Aged , Naphthalenes/therapeutic use , Parathyroid Hormone/blood , Renal Insufficiency, Chronic/complications
17.
J Vasc Surg ; 54(6): 1713-9, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21803519

ABSTRACT

BACKGROUND: Vascular access (VA) complications account for a significant number of hospital admissions in dialysis and have substantial costs. A native arteriovenous fistula (AVF) cannot be successfully obtained in all patients. At our center, we established an autogenous brachial-basilic AVF (BBAVF) in the upper arm in patients with a failed forearm fistula or with superficial vessels that were unsuitable for preparing a good site for VA. In most of these patients, we resort to prosthetic materials for creating a functioning VA as the last strategy. The present study compared the outcomes of BBAVF and AV graft (AVG) in patients undergoing long-term hemodialysis in whom there was no other possibility of creating a VA. METHODS: We analyzed 57 complex patients, 27 randomized to receive AVG and 30 randomized to BBAVF, between 2002 and 2008. The Omniflow II Vascular Prosthesis (Bio Nova International Pty Ltd, North Melbourne, VIC, Australia), the latest-generation collagen-polyester composite, was used to create the prosthetic VA. Primary patency (PP) and secondary patency (SP) rates were calculated using the Kaplan-Meier test. The log-rank test was used to compare PP and SP rates of the single VA. RESULTS: Length of hospital admission time, total intervention time, and mean interval to the first venipuncture for dialysis were longer for BBAVF. In the early postoperative period, patients who received BBAVF had a complication rate similar to those who received AVG; however, patients who received AVG showed a higher rate of long-term adverse events. PP and SP rates were higher for BBAVF than for AVG, although this was not statistically significant for SP. CONCLUSIONS: Our results show that BBAVF should be the first choice in patients with a good life expectancy and who can rely on an available temporary VA. However, given the shorter time to use, AVG could be an alternative in patients with compromised clinical conditions and in whom a temporary VA is not reliable, considering that the long-term outcome may be considered beneficial regardless.


Subject(s)
Arteriovenous Shunt, Surgical , Axillary Vein , Bioprosthesis , Blood Vessel Prosthesis , Brachial Artery , Renal Dialysis , Aged , Aged, 80 and over , Blood Vessel Prosthesis Implantation , Cohort Studies , Female , Humans , Kidney Failure, Chronic/therapy , Male , Middle Aged , Treatment Outcome , Vascular Patency
18.
G Ital Nefrol ; 28(4): 408-15, 2011.
Article in Italian | MEDLINE | ID: mdl-21809310

ABSTRACT

Electrolyte disorders may constitute a life-threatening emergency. Sometimes they can be treated with medical therapy but there are cases where emergency dialysis will be necessary. An important role is played by the dialysate (including different concentrations of electrolytes), which removes uremic toxins and balances the electrolyte disorders in patients with end-stage renal disease. The choice of dialysate is also important for control of the patient's vital functions during the dialysis session and in the period between sessions. Sodium is strongly related to weight gain between dialysis sessions and its concentration causes fluid overload or, on the contrary, hypotension. The choice of the buffer takes into account any possible bicarbonate- or acetate-related systemic effects. Potassium is very important for heart contraction and its fast removal could be associated with cardiac arrhythmias. The role of magnesium is still controversial. Calcium is related to hemodynamic stability, mineral bone disease and also cardiac arrhythmias. A correctly balanced dialysate is important to prevent and reduce intradialytic and interdialytic complications. The dialysate should be tailored to the needs of the individual patient.


Subject(s)
Acid-Base Imbalance/therapy , Arrhythmias, Cardiac/prevention & control , Dialysis Solutions/administration & dosage , Renal Dialysis , Acid-Base Imbalance/blood , Acid-Base Imbalance/etiology , Bicarbonates/administration & dosage , Calcium/administration & dosage , Dialysis Solutions/adverse effects , Dialysis Solutions/chemistry , Humans , Kidney Failure, Chronic/therapy , Magnesium/administration & dosage , Potassium/administration & dosage , Renal Dialysis/methods , Risk Factors , Sodium/administration & dosage , Treatment Outcome
19.
Am J Kidney Dis ; 58(1): 93-100, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21601329

ABSTRACT

BACKGROUND: Hemodialysis is complicated by a high incidence of intradialytic hypotension and disequilibrium symptoms caused by hypovolemia and a decrease in extracellular osmolarity. Automatic adaptive system dialysis (AASD) is a proprietary dialysis system that provides automated elaboration of dialysate and ultrafiltration profiles based on the prescribed decrease in body weight and sodium content. STUDY DESIGN: A noncontrolled (single arm), multicenter, prospective, clinical trial. SETTING & PARTICIPANTS: 55 patients with intradialytic hypotension or disequilibrium syndrome in 15 dialysis units were studied over a 1-month interval using standard treatment (642 sessions) followed by 6 months using AASD (2,376 sessions). INTERVENTION: AASD (bicarbonate dialysis with dialysate sodium concentration and ultrafiltration rate profiles determined by the automated procedure). OUTCOMES: Primary and major secondary outcomes were the frequency of intradialytic hypotension and symptoms (hypotensive events, headache, nausea, vomiting, and cramps), respectively. RESULTS: More stable intradialytic systolic and diastolic blood pressures with lower heart rate were found using AASD compared with standard treatment. Sessions complicated by hypotension decreased from 58.7% ± 7.3% to 0.9% ± 0.6% (P < 0.001). The incidence of other disequilibrium syndrome symptoms was lower in patients receiving AASD. There were no differences in end-session body weight, interdialytic weight gain, or presession natremia between the standard and AASD treatment periods. LIMITATIONS: A noncontrolled (single arm) study, no crossover from AASD to standard treatment. CONCLUSIONS: This study shows the long-term clinical efficacy of AASD for intradialytic hypotension and disequilibrium symptoms in a large number of patients and dialysis sessions.


Subject(s)
Hypotension/etiology , Hypotension/prevention & control , Hypovolemia/complications , Renal Dialysis/adverse effects , Renal Dialysis/methods , Aged , Blood Pressure , Body Weight , Female , Headache/prevention & control , Heart Rate , Humans , Hypotension/epidemiology , Male , Middle Aged , Models, Theoretical , Muscle Cramp/prevention & control , Nausea/prevention & control , Prospective Studies , Sodium/blood , Syndrome , Treatment Outcome , Vomiting/prevention & control
20.
Intervirology ; 53(3): 173-5, 2010.
Article in English | MEDLINE | ID: mdl-20130415

ABSTRACT

Occult hepatitis B virus infection (OBI) is characterized by the presence of ongoing viral replication with very low levels of viremia (<200 IU/ml), and negativity for HBsAg, while the so-called 'false' OBI with higher levels of HBV-DNA that are negative for HBsAg are usually due to the occurrence of mutations of the HBsAg sequence that may alter the recognition by some immunoassays. We describe here a case of occult HBV infection that combines both aspects. A male patient with severe systemic diseases, positive for anti-HBc and anti-HBs and negative for all other HBV markers, including HBsAg, since at least 4 years, showed a positivity for HBeAg at a follow-up control in November 2008; HBV-DNA testing by real-time PCR evidenced very low levels of viremia (<40 IU/ml), direct sequencing of the surface antigen-coding and Pol/RT coding regions allowed the identification of genotype D, serotype adw2, one immune escape mutation (G145R) and no drug resistance mutations. The positivity for HBeAg could be attributed to a superinfection in a naturally immune subject or to reactivation of a latent infection; the mutated virus had a reduced fitness and was therefore able to replicate only at low levels, resulting in a mild form of occult HBV infection.


Subject(s)
Hepatitis B Antibodies/blood , Hepatitis B e Antigens/blood , Hepatitis B virus/genetics , Hepatitis B virus/immunology , Hepatitis B/diagnosis , Aged , DNA, Viral/blood , DNA, Viral/chemistry , DNA, Viral/genetics , Genotype , Hepatitis B/virology , Hepatitis B Surface Antigens/blood , Humans , Male , Mutation, Missense , Sequence Analysis, DNA , Viral Load
SELECTION OF CITATIONS
SEARCH DETAIL
...