Same rhythm, different song-approaches to atrial fibrillation management by cardiologists and nephrologists.

Atrial fibrillation (AF) is common in patients with chronic kidney disease (CKD), affecting 10-25% of patients requiring dialysis. Compared with the general population, patients requiring dialysis are also at increased risk of stroke, the major thromboembolic complication of AF. The evidence base for management strategies of AF specific to patients with advanced CKD is limited and not informed by randomized controlled trials. These gaps in evidence encompass rate and rhythm control strategies as well as a paucity of data informing which patients should receive anticoagulation. The European Renal Association-European Dialysis and Transplant Association and European Heart Rhythm Association undertook a survey of nephrologists and cardiologists exploring management strategies in patients with AF and CKD. We review the results of this survey, highlighting the differences in clinical approaches from cardiologists and nephrologists to these conditions. Closer collaboration between these specialties should lead to improved outcomes for patients with advanced CKD and AF. Specific issues that will need to be addressed may include healthcare burden to patients, location of clinics compared with dialysis sites and awareness of complications of treatments specific to CKD, such as calciphylaxis associated with vitamin K antagonism.

Earliest videofluoromanometric pharyngeal signs of dysphagia in ALS patients.

The aim of this study was to find whether there are manometric pharyngeal changes that may have diagnostic and prognostic relevance in the amyotrophic lateral sclerosis (ALS) patient who does not show changes in contrast-medium oropharyngeal transit in a videofluoroscopic swallowing study. Ten ALS patients, with an ALS Severity Scale Score of at least 7, no need to change dietary habit, no aspiration and/or penetration, and no other changes in contrast-medium oropharyngeal transit, were collected from our institution's database of videofluoromanometric swallowing studies. They were included in the study together with a group of 11 healthy volunteers. For each subject, 12 manometric items-7 for the pharyngeal phase and 5 for UES functionality-were evaluated. Statistically significant differences between the ALS patients and the healthy volunteers were found for pharyngeal contraction time of the upper region (median = 1,120, range = 880-1,420 vs. median = 970, range = 800-1,140), pharyngeal contraction time of the intermediate region (median = 1140, range = 960-1,360 vs. median = 770, range = 280-1,180), pharyngeal contraction time of the lower region (median = 1,320, range = 920-1,760 vs. median = 800, range = 620-1,780), and residual pressure after the relaxation of the UES (median = 2.2, range = -20.2 to 27.8 vs. median = -5.7, range = -2.9 to 8.4). A videofluoromanometric swallowing study may show an increase in the pharyngeal contraction time and in residual pressure after relaxation of the UES in ALS patients without videofluoroscopic changes in contrast-medium oropharyngeal transit.

The regulatory framework of biosimilars in the European Union.

In the European Union (EU), the regulatory policy for biosimilars has enabled different biosimilar products to be marketed through an abridged application, which allows the applicant to submit a reduced dossier. Nevertheless, some manufacturers of biological products that share some characteristics with copies have opted for a full application; therefore, the number and extent of clinical studies required in these cases is increased. Here, we focus on a comparison of recombinant human erythropoietin medicinal products. We analyse and discuss clinical studies submitted to the European Medicines Agency that relate to available biosimilars and biological medicinal products that are authorised with a full dossier. We also discuss the issues of interchangeability and substitution, given that the EU allows each Member State to set their own substitution policies.

International Study of Health Care Organization and Financing for renal replacement therapy in Italy: an evolving reality.

The Italian national health system funds universal health care through general taxation, but health services are provided by local institutions. This study examines the epidemiology, provision, and funding of renal replacement therapy (RRT) in Italy. In 2001, prevalence and incidence of RRT in Italy were 0.083% and 0.014%, respectively. A 1999 donation law markedly increased renal transplantation rates. Italy spends 8.3% of its GDP on health care; 1.8% is for end-stage renal disease (ESRD) patients, who represent 0.083% of the general population. The reorganization of the NHS requires attention from the health community so that economic and geographic health disparities are not exacerbated.

Recombinant human epoetin beta in the treatment of renal anemia.

Cardiovascular disease is the leading cause of the poor long-term survival of patients with chronic kidney disease (CKD). Anemia complicating CKD not only impairs patients' quality of life, but is also an independent risk factor for adverse cardiovascular outcomes. The availability of recombinant human erythropoietin (rHuEPO) has greatly changed the management of anemia in CKD patients. Besides improving hemoglobin levels, rHuEPO therapy has been demonstrated to significantly improve quality of life and decrease morbidity and mortality in patients with CKD. Epoetin beta, together with epoetin alfa and darbepoetin alfa, is one of the erythropoiesis-stimulating agents now available on the market. Different studies have shown that epoetin beta once-weekly administration to hemodialysis patients is as effective as three-times-weekly administration in maintaining hemoglobin levels at equivalent weekly doses. This raises the possibility of reducing the frequency of administration of rHuEPO therapy, thus increasing the alternatives available for tailoring anemia therapy to patients needs, and at the same time reducing nursing times and treatment costs. This is expected to potentially enhance patient compliance, thus helping more patients achieve their target hemoglobin levels.

IgA glomerulonephritis: beyond angiotensin-converting enzyme inhibitors.

IgA glomerulonephritis accounts for 25-50% of renal biopsy diagnoses. About 25-50% of patients progress to end-stage renal disease within 20 years of diagnosis. Angiotensin-converting enzyme inhibitors and angiotensin II type I receptor blockers slow progression of IgA nephropathy (IgAN); however, as drugs of this class are not IgAN specific and are therefore unlikely to alter significantly its natural course, many other therapeutic approaches have been proposed. Most have been tested in a relatively small number of patients and have not yet proven to be effective in the long term. Conflicting and variable data, and a lack of long-term prospective randomized studies, mean that most treatments cannot be recommended as standard therapy for IgAN. Steroids seem to be the best treatment for patients with proteinuria, as drugs in this class ameliorate this symptom and protect against deterioration of renal function. Combined treatment with corticosteroids and cytotoxic drugs has yielded interesting results in several studies, especially in progressive patients with severe IgAN. In this review, we critically analyze the data on these treatments.

The importance of early detection of chronic kidney disease.

Despite the absence of precise epidemiological data, we know there are a great many patients in the conservative phase of chronic kidney disease (CKD). The incidence and prevalence of renal replacement therapy (RRT) is increasing worldwide. As well as being a large and growing clinical problem, CKD is of an economic and organizational concern, since RRT consumes a considerable proportion of health care resources. In this context, any medical intervention that may prevent the progression of CKD towards end-stage renal disease (ESRD) is extremely important. Improving the patients' cardiovascular status is also a major objective in the management of this population, as cardiovascular disease (CVD) is the leading cause of morbidity and mortality for dialysis patients. Several interventions to delay the progressive loss of renal function and/or to prevent the development of CVD are now available. These include low-protein diets; correction of calcium-phosphate disorders and anaemia; blood pressure and proteinuria control; and smoking cessation. Other interventions, such as the administration of lipid-lowering agents, anti-inflammatory drugs, and anti-oxidant agents are emerging as particularly promising therapeutic approaches, although prospective, controlled, randomized clinical trials are needed to demonstrate their clinical usefulness. Intervention in the conservative phase of CKD is likely to be more effective if performed as early as possible in the course of the disease, since it has been widely demonstrated that early and regular nephrology specialist care is associated with decreased morbidity and mortality.

Survival and development of cardiovascular disease by modality of treatment in patients with end-stage renal disease.

Patients undergoing dialysis are at high risk for cardiovascular disease (CVD). The aim of this study was to evaluate the influence of hemodialysis (HD) versus peritoneal dialysis (PD) on survival and the risk of developing de novo CVD. Of the 4191 patients with end-stage renal disease (ESRD) who started renal replacement treatment (RRT) in Lombardy between 1994 and 1997, 4064 (who were on dialysis 30 d after the start of RRT) were considered for survival analysis: 2772 were on HD (mean age 60.9 yr; 21.2% diabetic) and 1292 on PD (mean age 63.6 yr; 16% diabetic). The 3120 patients who were free of CVD at the start of RRT were included in the analysis of the risk of developing de novo CVD. HD and PD were compared by use of a Cox-regression proportional hazard model, stratified by diabetic status; the explanatory covariates were age and gender. The death rate was 13.3 per 100 patient-years (13.0 on HD and 13.9 on PD); 197 (6.3%) of the 3120 patients included in the CVD analysis developed de novo CVD (128 on HD and 69 on PD). After adjustment for age, gender, and established CVD and stratification by diabetic status, there was no significant between-treatment difference in 4-yr survival (relative risk [RR], 0.91; 95% confidence interval [CI], 0.79 to 1.06). The risk of de novo CVD did not differ significantly by treatment modality (RR, 1.06; 95% CI, 0.79 to 1.43). The risk of mortality and de novo CVD for new patients with ESRD assigned to HD or PD was similar in Lombardy in the period 1994 through 1997.