Effectiveness and safety of ferric carboxymaltose therapy in peritoneal dialysis patients: an observational study.

BACKGROUND: The efficacy of intravenous (IV) ferric carboxymaltose (FCM) has been demonstrated in haemodialysis and non-dialysis studies, but evidence is lacking in patients undergoing peritoneal dialysis (PD). METHODS: This multicentre, retrospective study evaluated the effectiveness and safety of FCM in patients on PD over 12 months. We retrospectively reviewed the electronic medical records of PD patients who initiated FCM treatment between 2014 and 2017 across seven Spanish centres. RESULTS: Ninety-one patients were included in the safety population (mean ± SD age 57.7 ± 15.0 years) and 70 in the efficacy population (mean age 50.9 ± 14.5 years). No hypersensitivity reaction, FCM discontinuation or dose adjustment due to a serious adverse event (SAE) was registered in the safety population. The most common non-SAEs reported were headache (four events), mild hypotension (three events) and hypertension (two events), among others. In the efficacy population (n = 70), 68.6% of patients achieved ferritin levels of 200-800 ng/mL, 78.4% achieved transferrin saturation (TSAT) >20%, and 62.8% achieved TSAT >20% and ferritin >200 ng/mL after 12 months of FCM initiation (P < 0.01). Haemoglobin (Hb) levels were maintained at >11 g/dL with a lower dose of darbepoetin throughout the follow-up. The sub-analysis of patients naïve to IV iron and with absolute or relative iron deficiency (n = 51) showed that 76.5% reached ferritin >200 ng/mL, 80.4% TSAT >20% and Hb increased (1.2 g/dL) after 4 months of FCM treatment (P < 0.01). CONCLUSION: In this multicentre, retrospective, real-world study conducted in the PD population, FCM was effective, safe and easy to administer during routine clinical visits.

Risk Factors for Clostridioides Difficile Diarrhea In Solid Organ Transplantation Recipients.

BACKGROUND: There is limited knowledge about risk factors for Clostridioides difficile infection (CDI) and recurrent CDI in solid organ transplant (SOT) recipients. METHODS: A case-control study of CDI in SOT recipients compared with controls (SOT recipients who did not present CDI). RESULTS: Sixty-seven patients from 1089 SOT recipients (6.2%) suffered at least one episode of CDI. The mean age was 55 ± 12 years and 20 cases (69%) were men. The accumulated incidence was 8% in liver transplantation, 6.2% in lung transplantation, 5.4% in heart transplantation, and 4.7% in kidney transplantation. Twenty-nine cases (43.3%) were diagnosed during the first 3 months after SOT. Forty-one cases (61.2%) were hospital acquired. Thirty-one patients with CDI presented with mild-moderate infection (46.3%), 30 patients with severe infection (44.8%), and 6 patients with severe-complicated disease (9%). Independent variables found to be related with CDI were hospitalization in the previous 3 months (odds ratio: 2.99; [95% confidence interval 1.21-7.37]) and the use of quinolones in the previous month (odds ratio: 3.71 [95% confidence interval 1.16-11.8]). Eleven patients (16.4%) had at least one recurrence of CDI. Previous treatment with amoxicillin-clavulanate, severe-complicated index episode, and high serum creatinine were associated with recurrent CDI in the univariant analysis CONCLUSIONS: Liver transplant recipients presented the highest incidence of CDI among SOT recipients. Risk factors for CDI were hospitalization in the previous 3 months and the use of quinolones in the previous month.

Statins and antiplatelet agents are associated with changes in the circulatory markers of endothelial dysfunction in chronic kidney disease. / El uso de estatinas y antiagregantes se asocia con cambios en los marcadores de disfunción endotelial en la enfermedad renal crónica.

BACKGROUNDS AND PURPOSES: Patients with chronic kidney disease (CKD) have higher risk of developing cardiovascular disease. In CKD patients the mechanisms involved in, endothelial damage and the role of different drugs used on these patients are not completely understood. The aim of this work is to analyze the effect of statins and platelet antiaggregant (PA) on endothelial microvesicles (EMVs) and other markers of endothelial dysfunction. EXPERIMENTAL APPROACH: Cross-sectional study of 41 patients with CKD 3b-4 and 8 healthy volunteers. Circulating levels of EMVs, vascular endothelial growth factor (VEGF), and advance oxidized protein products (AOPPS) were quantified and the correlation with different comorbidity variables and therapeutic strategies were evaluated. RESULTS: EMVs are increased in CKD patients as compared with controls (171.1 vs. 68.3/µl, P<.001). It was observed a negative correlation between age and EMVs. Statins and PA were associated with a reduction in EMVs and VEGF levels, independently of the serum total cholesterol levels (TC). The levels of AOPPS and VEGF were not different in CKD vs. controls. CONCLUSION: CKD is associated with a change in EMVs, VEGF and AOPP levels. The treatment with statins and PA normalizes these values to almost the observed in controls and this effect is independently of the prevailing TC level. These findings explain the existence of the pleiotropic effects of statins and PA which deserve further studies.

Heart failure in patients with kidney disease and iron deficiency; the role of iron therapy. / Insuficiencia cardíaca en la enfermedad renal y déficit de hierro: importancia de la ferroterapia.

Chronic kidney disease and anaemia are common in heart failure (HF) and are associated with a worse prognosis in these patients. Iron deficiency is also common in patients with HF and increases the risk of morbidity and mortality, regardless of the presence or absence of anaemia. While the treatment of anaemia with erythropoiesis-stimulating agents in patients with HF have failed to show a benefit in terms of morbidity and mortality, treatment with IV iron in patients with HF and reduced ejection fraction and iron deficiency is associated with clinical improvement. In a posthoc analysis of a clinical trial, iron therapy improved kidney function in patients with HF and iron deficiency. In fact, the European Society of Cardiology's recent clinical guidelines on HF suggest that in symptomatic patients with reduced ejection fraction and iron deficiency, treatment with IV ferric carboxymaltose should be considered to improve symptoms, the ability to exercise and quality of life. Iron plays a key role in oxygen storage (myoglobin) and in energy metabolism, and there are pathophysiological bases that explain the beneficial effect of IV iron therapy in patients with HF. All these aspects are reviewed in this article.

Clinical evolution of chronic renal patients with HIV infection in replacement therapy.

Patients on renal replacement therapy (RRT) infected with the human immunodeficiency virus (HIV) are a special group with growing interest. In order to study the epidemiological data of HIV+ patients on RRT in Spain, we collected individual information from 2004-2011 (period of use of highly active antiretroviral therapy [HAART] in the Autonomous Communities of Andalusia, Aragon, Asturias, Catalonia, Valencia, Castilla la Mancha, Castilla León, Galicia, Madrid, La Rioja and the Basque Country, comprising 85% of the Spanish population. A total of 271 incident and 209 prevalent patients were analysed. They were compared with the remaining patients on RRT during the same period. The annual incidence was 0.8 patients per one million inhabitants, with a significant increase during the follow-up period. The proportion of prevalent HIV+ patients was 5.1 per 1,000 patients on RRT (95% confidence interval [CI] 4.4-5.8. Although glomerular diseases constituted the majority of cases (42%), diabetic nephropathy was the cause in 14% of patients. The nation-wide totals for these percentages were 13 and 25%, respectively. Compared to the total of patients in treatment, the risk of death was significantly higher in the HIV+ group: hazard ratio (HR) adjusted for age, sex and diabetes was 2.26 (95% CI 1.74 - 2.91). Hepatitis C coinfection increased the risk of death in the HIV+ group (HR 1.77; 95% CI 1.10 - 2.85). The probability of kidney transplantation in HIV+ was only 17% after 7 years, comparing with total RTT patients (HR 0.15; 95% CI: 0.10-0.24). Despite the use of HAART, the incidence of HIV+ patients on dialysis has increased; their mortality still exceeds non-HIV patients, and they have a very low rate of transplantation. It is necessary to further our knowledge of this disease in order to improve results.

[Results of the cooperative study of Spanish peritoneal dialysis registries: analysis of 12 years of follow-up]. / Resultados del trabajo cooperativo de los registros españoles de diálisis peritoneal: análisis de 12 años de seguimiento.

INTRODUCTION AND OBJECTIVES: There is currently no registry that gives a complete and overall view of the peritoneal dialysis (PD) situation in Spain. However, a report on PD in Spain was developed for various conferences and meetings over several years from data provided by each registry in the autonomous communities and regions. The main objective of this study is to analyse this data in aggregate and comparatively to obtain a representative sample of the Spanish population on PD in recent years, in order that analysis and results in terms of demographic data, penetration of the technique, geographical differences, incidence and prevalence, technical aspects, intermediate indicators, comorbidity, and outcomes such as patient and technique survival may be extrapolated to the whole country. DESIGN, MATERIAL AND METHOD: Observational cohort study of autonomous PD registries, covering the largest possible percentage of the adult Spanish population (over 14 years of age) on PD, at least in the last decade (1999-2010), and in the largest possible geographical area in which we were able to recruit. A precise data collection strategy was followed for each regional registry. Once the information was received and clarified, they were added as aggregate data for statistical study. RESULTS: The regional registries that participated represent a total geographical area that encompasses 32,853,251 inhabitants over 14 years of age, 84% of the total Spanish population older than that age. The mean annual rate of incidents per million inhabitants (ppm) was variable (between 17.81 ppm in Andalusia and 29.90 ppm in the Basque Country), with a discrete and permanent increase in the overall PD incidence in Spain being observed in recent years. The mean annual prevalence per million population (ppm) was very heterogeneous (from 42 to 99 ppm). A mean progressive increase in the use of automated peritoneal dialysis (APD) was observed. The peritonitis rate was approximately one episode every 25-30 months/patient, with a slight decrease being observed in recent years. The causes of discontinuing PD were distributed fairly evenly between communities; almost a third was due to patient death (mean 28%), a third was due to renal transplantation (mean 39%) and a third was due to transfer to haemodialysis (technique failure: mean 32%). The main comorbidities were cardiovascular disease (30.2%) and diabetes mellitus (24.2%). The overall accumulated mean survival was 92.2%, 82.8%, 74.2%, 64.8% and 57% after one, two, three, four and five years respectively. There was significantly and independently worse survival for older patients and those with cardiovascular disease, patients with diabetes mellitus, those on continuous ambulatory peritoneal dialysis (vs. APD), those who started PD before 2004 (analysed in Andalusia and Catalonia), and patients with lower residual renal function at the start of PD (analysed in the Levante registry). Similarly, the technique survival has improved, showing a mean figure above 50% after 5 years. CONCLUSIONS: The incidence and prevalence of PD in Spain are growing moderately and in a generalised manner and continue to maintain an irregular distribution by autonomous community. Both patient and technique survival were greater than 50% after 5 years, with an improvement being observed in recent years, and are comparable to countries with better results in this treatment.

Recommendations for vaccination against pneumococcus in kidney patients in Spain.

UNLABELLED: Invasive pneumococcal disease (IPD) is a serious problem in some risk groups: patients with stage 4 and 5 chronic kidney disease, stage 3 CKD undergoing immunosuppressive treatment, nephrotic syndrome or diabetes. These individuals are more susceptible to infections and more prone to suffering more severe and worsening symptoms. Vaccination is one of the strategies for preventing IPD, although vaccination coverage in this group at present is lower than desired. Currently, there are two vaccinations for adults. The polysaccharide vaccine (PPSV23), used for decades in patients over the age of 2, includes most serotypes (23), but it does not generate immune memory, causing the immune tolerance phenomenon and it does not act on nasopharyngeal colonisation. The conjugate vaccine (VNC13) can be used from infancy until adulthood (advice in patients over 18 years old received approval from the European Medicines Agency in July 2013) and generates a more powerful immune response than PPSV23 against the majority of the 13 serotypes that it includes. The 16 scientific societies most directly associated with the groups at risk of IPD have discussed and drafted a series of vaccination recommendations based on scientific evidence related to pneumococcal vaccination in adults with underlying conditions and pathologies, which are the subject of the document “ CONSENSUS: Pneumococcal vaccination in adults with underlying pathology”. This text sets out the vaccination recommendations for the chronic kidney disease population.

Development of a program for kidney transplants using organs donated from donors awaiting cardiac arrest (type III Maastricht).

INTRODUCTION: The availability of organ donors is a limiting factor for kidney transplants. Donations from non-heart-beating donors (NHBD) can provide as many as one-third of all organs. Controlled patients awaiting cardiac arrest following limitation of life support techniques, or type III Maastricht donors, constitute an alternative that still has yet to be systematically developed. STUDY TYPE: Descriptive series of 10 cases occurring between January and April 2012. METHOD: Over a period of 6 months, we designed a protocol for extracting and managing kidney transplants and providing immunosuppression therapy. Patients are evaluated in accordance with the criteria agreed by a different team responsible for transplant coordination. We established a maximum duration of time between limitation of life-sustaining therapy and death of 120 minutes and 60 minutes warm ischaemia. Two types of graft perfusion were used, one in situ through direct application to the surgical area, and another using ante mortem vascular canalisation. Immunosuppression therapy included induction with thymoglobulin, steroids, and mycophenolate, with introduction of tacrolimus on the seventh day. Data are expressed as median and (range). RESULTS: We included the first 10 cases of kidney transplants with organs from 5 NHBD (type III Maastricht): 4 males, mean age of 57 years (45-66 years), with limitation of life-sustaining therapy due to anoxic encephalopathy (2), intoxication (1), acute stroke (2) and terminal respiratory failure (1). The following mean time intervals were recorded: effective warm ischaemia: 20 minutes (8-23 minutes) and cold ischaemia: 7.5 hours (4-14.1 hours). Recipients had a mean age of 58 years (32-71 years), with various aetiologies (2 cases of glomerulonephritis, 1 polycystic kidney disease, 2 tubulo-interstitial nephropathy, 4 vascular, and 1 unknown), with a mean 31.7 months on haemodialysis (11-84 months); the kidney was a second transplant in two cases. No patients were hyper-immunised. Six patients required a dialysis session at some point, and four had prolonged acute tubular necrosis, over a mean hospitalisation period of 24.5 days (8-44 days). Mean creatinine (Cr) one month after transplantation was 2.1mg/dl (0.7-3.2mg/dl), and mean nadir creatinine was 1.2mg/dl (0.7-3.2mg/dl). One patient did not improve upon Cr values <3.2mg/dl, despite the absence of evidence of toxicity or rejection in a renal biopsy, and the transplant pair reached a Cr of 1.4mg/dl. Throughout the series, similar surgical complications were recorded to those observed in conventional donor situations. CONCLUSIONS: Despite the limitations of this preliminary study, the use of this type of transplant produces favourable short-term evolution. Expanded use of this type of donor could reduce the waiting-list time for a kidney transplant.