Cost-effectiveness analysis of dyevert™ Power XT in patients with chronic kidney disease undergoing percutaneous coronary intervention procedures in Spain.

OBJECTIVE: To assess the efficiency of Dyevert™ Power XT compared to the standard clinical practice when used for percutaneous coronary interventions (PCI). METHODS: A Markov model was developed to estimate, over 3-month cycles and a lifetime time horizon, the cumulative costs and health outcomes (life years gained [LYG] and quality-adjusted life years [QALY]) in a hypothetical cohort of 1,000 patients with chronic kidney disease (CKD) 3b-4 and an average age of 72 years. The incidence of contrast-induced acute kidney injury for these patients is 18.89% in routine practice and 7.78% with Dyevert. QALYs were estimated by applying utilities by health state. Transitions between states and utilities were obtained from the literature. Overall all-cause and state-specific mortality were considered. The total cost (€2,022) estimated with the National Health System perspective included cost of the procedure and of CKD management. The parameters were validated by a panel of experts. A discount rate (3% per year) was applied to costs and outcomes. RESULTS: The use of Dyevert yielded more health benefits (34.60 LYG and 5.69 QALYs) compared to the current standard practice (33.11 LYG and 5.38 QALYs). Lifetime cost accumulated at the end of the simulation resulted €30,211/patient with Dyevert and €33,895/patient with current standard clinical practice. CONCLUSIONS: The use of Dyevert™ Power XT resulted dominant option, due to its higher effectiveness and lower cost as compared to standard clinical practice and, therefore, a preferred option in patients with CKD stages 3b-4 undergoing PCI in Spain.

Prophylaxis against postcontrast acute kidney injury (PC-AKI): updates in the ESUR guidelines 10.0 and critical review. / Profilaxis de la lesión renal aguda poscontraste (LRA-PC). Actualización según la guía clínica ESUR 10.0 y revisión crítica.

The European Society of Urogenital Radiology (ESUR) updated its guidelines for prophylaxis against postcontrast acute kidney injury (PC-AKI) in 2018 (ESUR 10.0). These guidelines drastically reduce the indications for prophylaxis against PC-AKI after iodine-based contrast administration, lowering the cutoff for administering prophylaxis to glomerular filtration rates <30ml/min/1.73m2 and eliminating most of the prior risk factors. Moreover, in cases where prophylaxis is considered necessary, the periods of hydration are shorter than in the previous version. These guidelines have been approved by most radiological societies, although they have also been criticized for excessive relaxation regarding risk factors, especially by the nephrological community. In this article, we critically review the changes to the guidelines.

New oral anticoagulants in patients with chronic kidney disease. / Nuevos anticoagulantes orales en pacientes con enfermedad renal crónica.

Patients with chronic kidney disease (CKD) develop bleeding and thrombotic tendencies, so the indication of anticoagulation at the onset of atrial fibrillation (AF) is complex. AF is the most common chronic cardiac arrhythmia, and thromboembolism and ischemic stroke in particular are major complications. In recent years, new oral anticoagulant drugs have been developed, and they have shown superiority over the classical AVK in preventing stroke, systemic embolism and bleeding risk, constituting an effective alternative to those resources.

Satisfaction and perceived effectiveness in patients on subcutaneous immunotherapy with a high-dose hypoallergenic pollen extract.

This study was designed to determine the level of satisfaction, tolerance and perceived effectiveness by patients in the first pollen season after starting treatment with Alergovit(®). For this purpose, a nationwide, retrospective, multicentre and cross-sectional observational study was carried on 256 patients. Perceived effectiveness by the patients was measured using a visual analogue scale and was clinically significant in 92.4% of the patients. The satisfaction level was evaluated with a specific questionnaire. 32.5% of the patients were totally satisfied with Allergovit(®) and 48.8% reported a high degree of satisfaction. The treatment was well tolerated by 99.2% of the patients. Our results demonstrate that subcutaneous immunotherapy with Allergovit(®) is effective and well-tolerated in routine clinical practice.

Compliance with mineral metabolism targets in haemodialysis patients: moving backwards?

BACKGROUND: To standardize therapy and improve the clinical outcome for chronic haemodialysis (HD) patients, guidelines have been developed for mineral metabolism management. We evaluated compliance with different mineral metabolism guidelines. METHODS: 2,951 chronic HD patients from 61 dialysis centres in Spain were studied. Mineral metabolism management data from a 1-year period were analysed according to KDOQI, KDIGO, and Spanish guidelines. RESULTS: Only 1% (KDOQI), 6% (KDIGO) and 11% (Spanish guidelines) of patients continuously achieved total calcium (Ca), phosphate (P) and parathyroid hormone (PTH) target-range values during the year with higher percentages if we considered the 1-year average. The yearly Ca, P and iPTH average accomplished Spanish guidelines with different percentage among centres: CA 62-100%, P 59-91%, PTH 61-89%, and 28-77% considering all three targets together. The KDIGO guidelines recommend similar percentages except for P (33-77%). No differences were found related to eKt/V, online haemodiafiltration/HD, weight, body mass index, or dialysis vintage. They were only related to age, blood flow, effective treatment time, and dialysate calcium but without relevant clinical differences. Patients outside the target ranges generated significantly higher treatment costs. CONCLUSIONS: Compliance with mineral metabolism targets in HD patients was poor and showed a wide variation between treatment centres.

Food preferences of middle aged and elderly subjects in a Brazilian city.

OBJECTIVES: The objectives of this study were to assess data on the consumption frequency of some food items and the places they are purchased, especially by adults and elderly subjects, and finally to determine their food preference using cluster and correspondence analyses as a diagnosis and prevention factor. DESIGN: Cross-sectional study. SETTING: Town of Serranópolis do Iguaçú, State of Paraná, Brazil, city with 4,854 inhabitants of which 22% are over 50 years old. PARTICIPANTS: Two hundred and ninety five randomly selected subjects (96 men and 199 women), between 51 and 91 years old. MEASUREMENTS: A socio-demographic and food frequency questionnaire was applied via home visits including questions on socioeconomic, anthopometric and health characteristics concerning the consumption frequency of 45 food items and the places they were purchased, using a five point category scale to obtain consumption data as well. The body mass index (BMI) was calculated using the Quetelet Index and compared with the World Health Organization Report Consultation on obesity. The cluster and correspondence statistical analysis were used to determine their food preference. RESULTS: From the correspondence mapping (which explained 89.1 % of the variance), it was possible to determine aspects regarding the non-consumption of instant soups, frozen vegetables, cookies, crystallized fruits, canned fruit, distilled drinks and beer. CONCLUSIONS: The dimensional representation structure demonstrated that the population of Serranópolis, who were 62 % overweight, preferred high fat content products, suggesting a reevaluation of their eating habits in the expectation of preventing non transmissible chronic diseases. The value given to farm production in Serranópolis do Iguaçú was also observed.

New-onset diabetes after transplantation: drug-related risk factors.

INTRODUCTION: New-onset diabetes after transplantation (NODAT), an important complication of renal transplantation leads to reduced graft function and increased patient morbidity and mortality. Because of its high incidence and immense impact on clinical outcomes, prevention of NODAT is highly desirable. Several modifiable and nonmodifiable risk factors for NODAT have been described. The aim of this study was to analyze the influence of various drugs on the development of NODAT during the first year. METHODS: A retrospective analysis was performed on 303 adult kidney transplant recipients free of previously known diabetes. NODAT was defined as a fasting plasma glucose level ≥ 126 mg/dL confirmed by repeat testing on a different day. We excluded patients with transiently elevated fasting plasma glucose during the first 3 months. RESULTS: NODAT was diagnosed in 37 recipients (12.2%). Univariate analysis identified several variables related to NODAT: recipient age (P < .001), body mass index (P < .001), donor age (P = .005), family history of diabetes (P < .001), statin use (P = .005), diuretic use (P = .040) and tacrolimus therapy (P = .029). After multivariate analysis, recipient age (relative risk [RR] = 1.060, 95% confidence interval [CI] 1.019- 1.102, P = .004), family history of diabetes (RR = 3.562, 95% CI 1.574-8.058, P = .002), smoking habit (RR 2.514, 95% CI 1.118-5.655, P = .026) and diuretic use (RR = 2.496, 95% CI 1.087-5.733, P = .031) were independently associated with NODAT development. CONCLUSIONS: In our population of kidney transplant recipients, the main nonmodifiable risk factors for NODAT were recipient age and a family history of diabetes. Diuretic use was a modifiable risk factor associated with the development of NODAT. To reduce NODAT incidence, it is necessary to consider not only immunosuppressive therapy, but also concomitant drugs such as diuretics.

Transferability of microsatellite primers developed for stingless bees to four other species of the genus Melipona.

Microsatellite markers are a useful tool for ecological monitoring of natural and managed populations. A technical limitation is the necessity for investment in the development of primers. Heterologous primers can provide an alternative to searching for new loci. In bees, these markers have been used in populational and intracolonial genetic analyses. The genus Melipona has the largest number of species among bee genera, about 70, occurring throughout the Neotropical region. However, only five species of the genus Melipona have specific microsatellite markers. Given the great diversity of this genus, this number is not representative. We analyzed the transferability of 49 microsatellite loci to four other species of the genus Melipona (M. scutellaris, M. mondury, M. mandacaia, and M. quadrifasciata). Four individuals of each species, from different localities, were used in amplification tests. Primer pairs described for five Melipona species and for Trigona carbonaria were tested. Among the 49 loci, 22 gave amplification products for all four species, while three gave nonspecific bands and five showed no amplification products. The remaining loci varied in the pattern of amplification, according to the species examined. The number of alleles ranged from 1 to 6. The results demonstrate the possibility of using these heterologous markers in other Melipona species, increasing the number of loci that can be analyzed and contributing to further genetic analyses of intra- and intercolonial structure, which is required for conservation measure planning, genetic improvement and resolution of taxonomic problems.

Economic impact of vitamin D treatment on chronic kidney disease patients.

During recent years, increasing recognition has been given to the endocrine action that vitamin D has on the extraskeletal system, and its deep involvement in CKD. This has meant that many vitamin D compounds (both nutritional and active) have been made available, with an important cost reduction. This review looks at the evidence available regarding the usefulness of different types of vitamin D (nutritional and active) for patients with stage 3-5 CKD and those undergoing dialysis. Emphasis is given to its usefulness to control hyperparathyroidism and its impact on morbidity and mortality. We also analysed pharmacoeconomic studies that have been published which compare active vitamin D metabolites. From this review, we are able to conclude that there is still not enough scientific evidence to be able to prefer one active vitamin D over another. In the meantime, doctors should follow the recommendations given in clinical practice guidelines, always taking into account their personal experience with patients. Furthermore, they must consider the economic impact that their treatment decisions may have.

Fewer dose changes with once-monthly C.E.R.A. in patients with chronic kidney disease.

BACKGROUND: Frequent dosing and requirements for dose adjustments of erythropoiesis-stimulating agents (ESAs) create significant burdens for healthcare providers and have been associated with hemoglobin (Hb) cycling, hampering maintenance of target Hb levels. We compared the frequency of dose changes in dialysis patients who received methoxy polyethylene glycolepoetin beta; (a continuous erythropoietin receptor activator (C.E.R.A.)) or a shorter-acting ESA. METHODS: Data were analyzed from three Phase III maintenance trials, using almost identical protocols, in dialysis patients treated with C.E.R.A. every 2 weeks (q2w) or every 4 weeks (q4w) or a comparator ESA (epoetin or darbepoetin alpha; at their previous dose/administration interval). Dosage was adjusted to maintain Hb ± 1 g/dl of baseline and 10 - 13.5 g/dl during titration (28 weeks) and evaluation (8 weeks), and 11 - 13 g/dl during follow-up (16 weeks). RESULTS: Data were analyzed from 564 patients treated with C.E.R.A. q2w, 410 with C.E.R.A. q4w and 572 with comparator ESA at their usual dosing interval. Significantly fewer dose changes were needed in patients receiving C.E.R.A. q2w (p < 0.05) or C.E.R.A. q4w (p < 0.001) than in patients treated with comparator ESAs. CONCLUSION: This retrospective analysis suggests that C.E.R.A. q4w maintains Hb levels in dialysis patients and requires fewer dose changes compared with other ESAs.

Under-recognized renal insufficiency in hospitalized patients: implications for care.

BACKGROUND: The consequences of undetected low glomerular filtration rate (GFR) are important in hospitalized patients who receive potentially nephrotoxic drugs or undergo major surgery. This study estimated the prevalence of estimated GFR (eGFR) <60mL/min/1.73m(2) in hospitalized patients. METHODS: This cross-sectional descriptive study included 14,658 adults hospitalized at 10 centers in Spain. Serum samples were analyzed for hemoglobin, creatinine, albumin and urea nitrogen. eGFR was estimated using Modification of Diet in Renal Disease (MDRD) 4 or MDRD IDMS, and MDRD 6 when serum albumin and BUN were included (n=8611). Individuals were classified as having GFR>or=60mL/min/1.73m(2), stages 3, 4 and 5 (GFR 30-59, 15-29 and <15mL/min/1.73m(2), respectively). Additionally, stages 3a and 3b (GFR 45-59 and 30-44mL/min/1.73m(2), respectively) were assessed. RESULTS: MDRD 4 eGFR showed that 28.3% of patients had renal insufficiency stages 3-5 and 14.2% had stages 3b, 4 or 5, which represents important-severe renal deterioration. Forty-three percent of patients with stages 3-5 had hemoglobin or=60mL/min/1.73m(2). A good correlation was observed between eGFR MDRD 4 and MDRD 6. CONCLUSIONS: A high percentage of hospitalized patients in Spain have deteriorated renal function stages 3-5. Using eGFR equations to assess eGFR could identify more hospitalized patients with renal insufficiency, potentially leading to improved care.

[The Bahía 2008 Study: hydration barometer in the Spanish population]. / Estudio Bahía 2008: barómetro de la hidratación de la población española.

BACKGROUND: Vital functions require a balance between the loss and ingestion of liquids. There are no studies about hydration on Spanish population. MATERIAL AND METHODS: 6,508 questionnaires were applied to a randomly selected Spanish population, together with a 24-hour recall in order to measure liquid consumption and variables related to it. RESULTS: The average consumption of liquids was 2,089.5 +/- 771.4 and 6.05 drinking times/day. 3,423 persons (52.6% of the studied people, CI 95% 51.3%-53.8%) were well-hydrated when considering their individual intake. The frequency and volume of drinking decreased with age. 61% (CI 95% 58.64%-64.01%) of the population older than 65 years were badly hydrated. The greatest bottled water consumption corresponded to the youngest population (18-29 years). The greater the physical activity, the greater the beverages consumption (1,987.6 +/- 705.5 ml vs 2,345.8 +/- 928.1 ml, low vs. intense physical activity, respectively). With regard to the intake frequency and volume, mineral and tap water were the most consumed. Those who drank mineral water exceeded the 2 l-recommendation in order to maintain a good hydration status. 59.8% (CI 95% 57.83%-61.76%) of those who preferred mineral water drank more than 2 l/day and drank more times/day and in greater amounts. There was a greater frequency and amount of beverage consumption when people lived in the same house, and particularly more in houses where children were living (2,197.4 +/- 767.8 ml vs 2,055.7 +/- 769.86 ml and 6.4 +/- 2.2 times vs 5.9 +/- 1,9 times, in homes with or without children, respectively). Bottled water was preferred at home (79.07%) and at work (15.61%). CONCLUSIONS: Only half of the Spanish population is well hydrated. Sixty-one percent of people over the age of 65 years were poorly hydrated, consequence it is imperative to promote its consumption.

[Evolution of the darbepoetin alpha resistance index in patients on dialysis who change from weekly to fortnightly treatments in clinical practice]. / Evolución del índice de resistencia a darbepoetina alfa en pacientes dializados que cambian de administración semanal a quincenal en la práctica clínica.

BACKGROUND: Darbepoetin alpha (DA) administered every-other-week (Q2W) is efficacious and safe for the treatment of anaemia in patients undergoing dialysis. There are no data available regarding the evolution of erythropoietic resistance index (ERI) after conversion from weekly (QW) to Q2W administration of DA in clinical practice. MATERIAL AND METHODS: Multicenter, observational, retrospective, 16-weeks study, which included stable patients undergoing dialysis who were converted from DA QW to DA Q2W in clinical practice. Conversion was done according to product specifications (duplicating QW dose). The ERI to DA was calculated by dividing the weekly DA dose per kilogram of weight (microg/wk.kg)*200 by the Hb level (g/dL). ERI evolution with time was evaluated by multivariate repeated measures ANOVA, adjusting for significant covariates. RESULTS: A total of 202 patients were included (137 patients undergoing haemodialysis [HD], intravenous (IV) DA, and 65 patients receiving peritoneal dialysis [PD], subcutaneous DA). Mean (SD) age was 66 (17) years; 61% of patients were men. Large intercentre variability was observed for the ERI at conversion time (coefficient of variation of 88%, p < 0.001 for differences between centres). In the univariate analysis, predictor factors for high baseline ERI were low albumin level (r = -0.29; p =0.001), HD (mean ERI of 9.3 [8.4] vs 6.8 [4.6] for PD; p = 0.005), or previous cardiovascular disease (9.9 [8.7] vs 7.4 [6.3] for patients without history; p =0.025). During the follow up, the ERI was slightly increased in HD patients (9.3 [8.4] at conversion vs 11.1 [7.3] at 16 weeks; p < 0.05), and remained stable in PD patients (6.8 [4.6] vs 6.7 [4.0], respectively; NS). In the multivariate analysis, there were no significant differences in ERI during the 16 weeks post-conversion after adjusting for albumin levels and centre (adjusted baseline mean [95% CI] of 10.0 [8.7-11.4] vs 10.5 [9.3-11.8] at 16 weeks, adjusted change of +0.5 [-0.67; 1.67]; NS). After 16 weeks, only 7 patients (3.5%) had discontinued Q2W administration. CONCLUSIONS: Extension from weekly to once every other-week darbepoetin alpha allows to simplify anaemia treatment without increasing the resistance index, regardless of dialysis type. The multivariate analysis shows that, after adjusting by center and inflammation/nutritional status, there were no changes in the response to darbepoetin alpha during the first 16 weeks after conversion in clinical practice.

The phenomenon of hemoglobin variability with erythropoiesis stimulating agents in renal transplant patients.

Treatment with erythropoiesis-stimulating agents (ESA) is often associated with fluctuation in hemoglobin (Hb) levels that has been considered a factor that influences morbidity/mortality in hemodialysis patients. Our aim was to describe the hemoglobin variability during ESA treatment and to study associated factors in kidney transplants. Hb variability (defined as fluctuations of Hb +/- 1.5 g/dl) was assessed in 85 renal transplant patients treated with ESA for at least 3 months and with a minimum of 6 Hb measurements along 1 year. 58% of patients experienced Hb variability during follow-up. Although 71.3% of patients maintained Hb levels greater than 11 g/dl along the whole follow-up, only 3% of patients maintained stable Hb levels within the target range all the time (11 - 13 g/dl). By multivariate analysis, clinical factors associated with variability were changes in ESA dose (RR 2.92, p = 0.04), infectious events with hospitalization (RR 1.95, p = 0.03) and the use of sirolimus (RR 1.1, p < 0.05). Excluding dose changes and hospitalization in the analysis variability was an independent predictor of graft function deterioration. In conclusion, Hb variability is common in renal transplants treated with ESA. Only few patients maintained Hb levels in the therapeutic range (11 - 13 g/dl). Dose changes, inflammatory status and graft function deterioration are the determining factors.

Mental health research priorities in low- and middle-income countries of Africa, Asia, Latin America and the Caribbean.

BACKGROUND: Studies suggest a paucity of and lack of prioritisation in mental health research from low- and middle-income (LAMI) countries. AIMS: To investigate research priorities in mental health among researchers and other stakeholders in LAMI countries. METHOD: We used a two-stage design that included identification, through literature searches and snowball technique, of researchers and stakeholders in 114 countries of Africa, Asia, Latin America and the Caribbean; and a mail survey on priorities in research. RESULTS: The study identified broad agreement between researchers and stakeholders and across regions regarding research priorities. Epidemiology (burden and risk factors), health systems and social science ranked highest for type of research. Depression/anxiety, substance use disorders and psychoses; and children and adolescents, women, and people exposed to violence/trauma were prioritised among the disorders and population groups respectively. Important criteria for prioritising research were burden of disease, social justice, and availability of funds. Stakeholder groups differed in the importance they gave to the personal interest of researchers as a criterion for prioritising research. Researchers' and stakeholders' priorities were consistent with burden of disease estimates, however suicide was underprioritised compared with its burden. Researchers' and stakeholders' priorities were also largely congruent with the researchers' projects. CONCLUSIONS: The results of this first ever conducted survey of researchers and stakeholders regarding research priorities in mental health suggest that it should be possible to develop consensus at regional and international levels regarding the research agenda that is necessary to support health system objectives in LAMI countries.