Chronic hyperkalemia has negative consequences in the medium and long term, and determines the suspension of nephro and cardioprotective drugs, such as renin–angiotensin–aldosterone system inhibitors ...(RAASi). There is an alternative to the suspension or dose reduction of these treatments: the administration of potassium chelators. The aim of this study is to estimate the economic impact of the use of patiromer in patients with chronic kidney disease (CKD) or heart failure (HF) and hyperkalemia in Spain.
The annual economic impact of the use of patiromer has been estimated from the perspective of the Spanish society. Two scenarios were compared: patients with CKD or HF and hyperkalemia treated with and without patiromer. The costs have been updated to 2020 euros, using the Health Consumer Price Index. Direct healthcare costs related to the use of resources (treatment with RAASi, CKD progression, cardiovascular events and hospitalization due to hyperkalemia), direct non-healthcare costs (informal care: costs derived from time dedicated by patient’s relatives), the indirect costs (productivity loss), as well as an intangible cost (due to premature mortality) were considered. A deterministic sensitivity analysis was performed to validate the robustness of the study results.
The mean annual cost per patient in the scenario without patiromer is €9,834.09 and €10,739.37 in CKD and HF, respectively. The use of patiromer would lead to cost savings of over 30% in both diseases. The greatest savings in CKD come from the delay in the progression of CKD. While in the case of HF, 80.1% of these savings come from premature mortality reduction. The sensitivity analyses carried out show the robustness of the results, obtaining savings in all cases.
The incorporation of patiromer allows better control of hyperkalemia and, as a consequence, maintain treatment with RAASi in patients with CKD or HF. This would generate a 32% of annual savings in Spain (€3,127 in CKD; €3,466 in HF). The results support the positive contribution of patiromer to health cost in patients with only CKD or in patients with only HF.
La hiperpotasemia crónica tiene consecuencias negativas a medio y largo plazo, condicionando generalmente la suspensión de fármacos nefro y cardioprotectores, en pacientes con enfermedad renal crónica (ERC) e insuficiencia cardíaca (IC), como son los inhibidores del sistema renina-angiotensina-aldosterona. Existe una alternativa a la suspensión o reducción de dosis de estos tratamientos y es la administración de quelantes del potasio. El objetivo de este estudio es estimar el impacto económico que supondría el uso de patiromer en pacientes con ERC o IC e hiperpotasemia en España.
Se ha estimado el impacto económico anual del uso de patiromer desde la perspectiva de la sociedad española, comparando 2 escenarios: pacientes con ERC o IC e hiperpotasemia tratada con patiromer y sin patiromer. Los costes se han actualizado a euros de 2020, utilizando el índice de precios de consumo de Sanidad. Se han considerado los costes directos sanitarios relacionados con el uso de recursos (el tratamiento con inhibidores del sistema renina-angiotensina-aldosterona, la progresión de la ERC, los eventos cardiovasculares y la hospitalización por hiperpotasemia), los costes directos no sanitarios (cuidados informales: costes derivados del tiempo de dedicación por parte de los familiares del paciente), los costes indirectos (pérdidas de productividad laboral), así como un coste intangible (por mortalidad prematura). Se realizó un análisis de sensibilidad determinístico para validar la consistencia de los resultados del estudio.
El coste medio anual por paciente en el escenario sin patiromer es de 9.834,09 y 10.739,37 € en ERC e IC, respectivamente. El uso de patiromer supondría un ahorro de costes superior al 30% en ambas enfermedades. En el caso de la ERC, el mayor ahorro procede del retraso de la progresión de la ERC. Mientras que en IC el 80,1% de estos ahorros provienen de la reducción de la mortalidad prematura. Los análisis de sensibilidad realizados muestran la consistencia de los resultados, obteniendo ahorros en todos los casos.
La incorporación de patiromer permite controlar la hiperpotasemia y, como consecuencia, mantener el tratamiento con inhibidores del sistema renina-angiotensina-aldosterona en los pacientes con ERC o IC, generando unos ahorros anuales en España del 32% (3.127 € en ERC; 3.466 € en IC). Estos resultados apoyan la contribución positiva que patiromer puede tener tanto en los pacientes con ERC como en aquellos que solo tienen IC.
Resumen: Introducción: La hiperpotasemia crónica tiene consecuencias negativas a medio y largo plazo, condicionando generalmente la suspensión de fármacos nefro y cardioprotectores, en pacientes con ...enfermedad renal crónica (ERC) e insuficiencia cardíaca (IC), como son los inhibidores del sistema renina-angiotensina-aldosterona. Existe una alternativa a la suspensión o reducción de dosis de estos tratamientos y es la administración de quelantes del potasio. El objetivo de este estudio es estimar el impacto económico que supondría el uso de patiromer en pacientes con ERC o IC e hiperpotasemia en España. Material y métodos: Se ha estimado el impacto económico anual del uso de patiromer desde la perspectiva de la sociedad española, comparando 2 escenarios: pacientes con ERC o IC e hiperpotasemia tratada con patiromer y sin patiromer. Los costes se han actualizado a euros de 2020, utilizando el índice de precios de consumo de Sanidad. Se han considerado los costes directos sanitarios relacionados con el uso de recursos (el tratamiento con inhibidores del sistema renina-angiotensina-aldosterona, la progresión de la ERC, los eventos cardiovasculares y la hospitalización por hiperpotasemia), los costes directos no sanitarios (cuidados informales: costes derivados del tiempo de dedicación por parte de los familiares del paciente), los costes indirectos (pérdidas de productividad laboral), así como un coste intangible (por mortalidad prematura). Se realizó un análisis de sensibilidad determinístico para validar la consistencia de los resultados del estudio. Resultados: El coste medio anual por paciente en el escenario sin patiromer es de 9.834,09 € y 10.739,37 € en ERC e IC, respectivamente. El uso de patiromer supondría un ahorro de costes superior al 30% en ambas enfermedades. En el caso de la ERC, el mayor ahorro procede del retraso de la progresión de la ERC. Mientras que en IC el 80,1% de estos ahorros provienen de la reducción de la mortalidad prematura. Los análisis de sensibilidad realizados muestran la consistencia de los resultados, obteniendo ahorros en todos los casos. Conclusiones: La incorporación de patiromer permite controlar la hiperpotasemia y, como consecuencia, mantener el tratamiento con inhibidores del sistema renina-angiotensina-aldosterona en los pacientes con ERC o IC, generando unos ahorros anuales en España del 32% (3.127 € en ERC; 3.466 € en IC). Estos resultados apoyan la contribución positiva que patiromer puede tener tanto en los pacientes con ERC como en aquellos que solo tienen IC. Abstract: Introduction: Chronic hyperkalemia has negative consequences in the medium and long term, and determines the suspension of nephro and cardioprotective drugs, such as renin–angiotensin–aldosterone system inhibitors (RAASi). There is an alternative to the suspension or dose reduction of these treatments: the administration of potassium chelators. The aim of this study is to estimate the economic impact of the use of patiromer in patients with chronic kidney disease (CKD) or heart failure (HF) and hyperkalemia in Spain. Materials and method: The annual economic impact of the use of patiromer has been estimated from the perspective of the Spanish society. Two scenarios were compared: patients with CKD or HF and hyperkalemia treated with and without patiromer. The costs have been updated to 2020 euros, using the Health Consumer Price Index. Direct healthcare costs related to the use of resources (treatment with RAASi, CKD progression, cardiovascular events and hospitalization due to hyperkalemia), direct non-healthcare costs (informal care: costs derived from time dedicated by patient's relatives), the indirect costs (productivity loss), as well as an intangible cost (due to premature mortality) were considered. A deterministic sensitivity analysis was performed to validate the robustness of the study results. Results: The mean annual cost per patient in the scenario without patiromer is €9834.09 and €10,739.37 in CKD and HF, respectively. The use of patiromer would lead to cost savings of over 30% in both diseases. The greatest savings in CKD come from the delay in the progression of CKD. While in the case of HF, 80.1% of these savings come from premature mortality reduction. The sensitivity analyses carried out show the robustness of the results, obtaining savings in all cases. Conclusions: The incorporation of patiromer allows better control of hyperkalemia and, as a consequence, maintain treatment with RAASi in patients with CKD or HF. This would generate a 32% of annual savings in Spain (€3127 in CKD; €3466 in HF). The results support the positive contribution of patiromer to health cost in patients with only CKD or in patients with only HF.
The mouth can be affected by important inflammatory processes resulting from localized or systemic diseases such as diabetes, AIDS and leukemia, among others, and are manifested in various types of ...buccal sores typically presenting pain. This work focuses on the design, formulation, and characterization of four semisolid formulations for oral mucosa in order to symptomatically treat these painful processes. The formulations have two active pharmaceutical ingredients, triamcinolone acetonide (TA) and lidocaine hydrochloride (LIDO). The formula also contains, as an excipient, Orabase®, which is a protective, hydrophobic, and anhydrous adhesive vehicle, used to retain or facilitate the application of active pharmaceutical ingredients to the oral mucosa. After designing the formulations, an analytical method for TA was validated using HPLC so as to achieve reliable analytical results. Franz-type diffusion cells were used to perform drug release studies using synthetic membrane, and permeation studies using buccal mucosa, estimating the amount and rate of TA permeated across the tissue. Additionally, sublingual permeation studies were carried out to evaluate a scenario of a continuous contact of the tongue with the applied formulation. Permeation fluxes and the amount of TA retained within sublingual mucosa were similar to those in buccal mucosa, also implying anti-inflammatory activity in the part of the tongue that is in direct contact with the formulation. In addition, the dynamic conditions of the mouth were recreated in terms of the presence of phosphate buffered saline, constant movement of the tongue, pH, and temperature, using dissolution equipment. The amount of TA released into the phosphate buffered saline in dynamic conditions (subject to being ingested) is well below the normal oral doses of TA, for which the formulation can be considered safe. The formulations applied to buccal or sublingual mucosas under dynamic conditions permit the successful retention of TA within either tissue, where it exerts anti-inflammatory activity. The four formulations studied show a pseudoplastic and thixotropic behavior, ideal for topical application. These results evidence the potential of these topical formulations in the treatment of inflammatory processes in the buccal mucosa.
Background and objectives: Diffuse idiopathic skeletal hyperostosis (DISH) is a bone formation disease in which only skeletal signs are considered in classification criteria. The aim of the study was ...to describe different phenotypes in DISH patients based on clinicoradiological features. Materials and Methods: We evaluated 97 patients who met the Resnick or modified Utsinger classification criteria for DISH and were diagnosed at our hospital from 2004 to 2015. Patients were stratified into: (a) peripheral pattern (PP)—Resnick criteria not met but presenting ≥3 peripheral enthesopathies; (b) axial pattern (AP)—Resnick criteria met but <3 enthesopathies; and (c) mixed pattern (MP)—Resnick criteria met with ≥3 enthesopathies. Statistical analysis was carried out to identify variables that might predict classification in a given group. Results: Fifty-six of the 97 patients included (57.7%) were male and 72.2% fulfilled the Resnick criteria. Applying our classification, 39.7% were stratified as MP, 30.9% as AP and 29.4% as PP. Clinical enthesopathy was reported in 40.2% of patients during the course of the disease. Sixty-eight patients were included in a comparative analysis of variables between DISH patterns. The results showed a predominance of women (p < 0.004), early onset (p < 0.03), hip involvement (p < 0.003) and enthesitis (p < 0.001) as hallmarks of PP. Asymptomatic patients were most frequently observed in AP (28.6%, MP 3.8%, PP 5.0%) while MP was characterized by a more extensive disease. Conclusions: We believe DISH has distinct phenotypes and describe a PP phenotype that is not usually considered. Extravertebral manifestations should be included in the new classification criteria in order to cover the entire spectrum of the disease.
•Analytics demonstrate a dynamic and diverse scenario concerning the production and Distribution of ceramics from the County of Empúries between the 10th-11th centuries.•Most of the analysed ceramics ...are related to a local or regional origin and suggest a dispersed production.•There is evidence of the circulation of ceramics over the Albera range, at least from the North to the South.•Most low-fired ceramics exhibit the presence of talc, which might be evidence of regional provenance.•Some ceramics exhibit extremely high sodium concentrations that could be explained by the presence of the high sodium plagioclase albite identified in pegmatite rocks belonging to the area of Cap de Creus.
The sixty ceramic individuals studied in this project were recovered in Empúries county, including a few ceramics from Besalú and Rosselló counties (Catalonia) for comparison. These ceramics, dated to the 10th—11th centuries AD, belong to a historical period related to the creation and consolidation of the Catalan Counties. This period is poorly studied from an archaeological point of view, so there is little information about ceramic production and distribution, which this research aims to change by identifying the provenance and some elements of the manufacturing techniques. For this purpose, the ceramic sherds have been chemically and mineralogically characterised by X-ray fluorescence (XRF) and X-ray diffraction (XRD), respectively. Their microstructure and sintering state have been determined by scanning electron microscopy coupled to energy-dispersive X-ray spectroscopy (SEM), and petrographic analyses have been performed, too. Results confirm distribution patterns and the evidence of similar technical traditions in different Counties. Finally, the contrast with the database enables us to relate some of the individuals analysed in this study to some others from the area of the County of Empúries dating from the Visigoth period (7th—8th centuries) in line with their exceptionally high concentrations of Na2O.
Aims
To analyze whether episiotomy affects the urogenital hiatal area and the difference in the hiatus at rest and during contraction, as an indirect measurement of the contractile capacity of the ...levator ani muscle.
Methods
We performed an observational, comparative, retrospective study of primiparous women who had normal vaginal deliveries. The urogenital hiatal area was compared in women with and without episiotomy. All women underwent transperineal ultrasound scanning after delivery, and all the images were analyzed offline by the principal investigator who was blinded to all clinical data. The urogenital hiatal area was measured at rest and during both Valsalva and contraction manoeuvres. The difference in the hiatus at rest and during contraction was also calculated. These scanning variables were compared between the study groups.
Results
In total, 194 women were analysed (101 with, and 93 without, episiotomy). There were no statistically significant differences between the groups regarding the area of the hiatus at rest (P = 0.583), on Valsalva (P = 0.158), and on contraction (P = 0.468), or in the difference in the hiatus at rest and during contraction (P = 0.095).
Conclusions
In normal vaginal delivery, neither the area of the urogenital hiatus nor its difference at rest and during contraction, as measured by ultrasound, were modified by performing an episiotomy.
MASEI is the main validated ultrasound score for the evaluation of enthesis. The lack of studies facing the agreement to achieve for the interpretation of the MAdrid Sonographic Enthesis Index ...(MASEI) among researchers from different centers in multicenter studies is of concern. The aim of this multicenter was to evaluate the interobserver reliability of MASEI. An experienced ultrasonographer-rheumatologist performed ultrasound scans of the areas included in MASEI index in three patients with Ankylosing Spondylitis and Psoriatic Arthritis. Videos were captured. The videos were then evaluated by 24 rheumatologists of the ultrasound working group of the Catalan Society of Rheumatology (EcoCAT). A face-to-face training meeting was held. Ten days after the workshop, the study participants evaluated the videos. A reliability assessment was performed. The ICC for the MASEI scores after the workshop was of 0.97 (95% CI 89–99). Reliability did not vary statistically with examiner experience. Globally, no problems of reliability by structures were seen, and all the ICCs were above 0.90 and improved slightly after the educational program. However, the correlation observed between examiners at plantar aponeursis and triceps tendon was weak. The small variability observed in the results of the index validation in our study, suggests that the MASEI index is reproducible by different observers when those are well trained and show awesome results of the enthesis when examined by ultrasound.
Renin-angiotensin-aldosterone system inhibitors (RAASi) therapy is commonly used to reduce the risk of death and to slow down disease progression in patients with chronic kidney disease (CKD), heart ...failure (HF) and hypertension. However, the cardio-renal benefits of RAASi therapy are also associated with an increased risk of hyperkalemia (HK), which may lead to dose reduction or discontinuation of therapy. Patiromer has demonstrated to reduce the risk of HK, which enables to maintain optimal doses of RAASi therapy. This study aimed to assess the cost-effectiveness of patiromer for the management of HK in CKD patients with and without HF in Spain.
A Markov model was developed to evaluate the costs and benefits of patiromer for the management of HK in patients with CKD stages 3-4 with and without HF treated with RAASi over a lifetime horizon. The main outcomes included total direct costs (€2021), quality-adjusted life-years (QALYs), life-years gained (LYG) and incremental cost-effectiveness ratio (ICER). Deterministic one-way and probabilistic sensitivity analyses were performed to assess the robustness of the results.
Patiromer was more effective compared to no patiromer (5.76 vs 5.57 QALYs; 7.73 vs 7.50 LYG), and resulted in an incremental cost of €3,574, yielding an ICER of €19,092/QALY gained and of €15,236/LYG. Sensitivity analyses suggested that the results were robust to changes in most input parameters.
Patiromer is a cost-effective intervention in maintaining normokalemia and enabling optimal RAASi therapy in patients with CKD stages 3-4 with and without HF in Spain.
Objective
To analyze the economic burden of secondary hyperparathyroidism (sHPT) in Spain by quantifying differences in costs of pharmacological treatments and associated cardiovascular events (CVE) ...between renal patients with and without sHPT.
Methods
We used data collected in the NEFRONA cohort study and obtained treatment and CVE costs from the BOT PLUS database and Hospital Discharge Records in the Spanish Health System (CMBD-H), respectively. We examined data from 2445 renal patients followed during 2 years for chronic kidney disease (CKD) progression and 4 years for CVE, stratifying by presence of sHPT. Patient characteristics, administered treatments and CVE were directly extracted from NEFRONA registries. Dosage for each treatment regimen was assumed based on guidelines and multiplied by official unit costs to obtain treatment costs. Costs of CVE were based on ICD-9-CM.
Results
Prevalence of sHPT in the cohort was 65.6% (63.6; 67.6). Average yearly pharmacological costs for patients without sHPT were 610.33€, while costs were 1483.17€ for sHPT patients (average increase of 143.0%). Two hundred three patients registered CVE, resulting in 4-year average costs of 582.57€ for non-sHPT patients compared to 941.87€ for sHPT patients (61.7% average increase). Bivariate analyses considering presence of dialysis, hypercalcemia or hyperphosphatemia and stratified by sHPT showed higher costs for sHPT patients.
Conclusions
These results show that sHPT is associated with substantially higher costs of both, pharmacological treatments and associated CVEs. Preventing the development of sHPT with early management in the course of CKD could possibly lead to better health outcomes and cost balance for health care systems.
Aquest text mostra l’estat actual dels coneixements en relació a la fortalesa de Miravet (Cabanes, Castelló) i el seu territori amb la voluntat de proposar un seguit de línies de treball en relació ...al jaciment. Es compilen, doncs, els estudis de territori amb l’anàlisi de les fonts documentals relacionades i l’estudi arqueològic del propi jaciment, tant pel que fa a les estructures com als artefactes. Tot això amb la finalitat de posar en relació les diferents investigacions dutes a terme les darreres dècades i, sobretot, d’establir una base sobre la qual projectar noves actuacions i línies de recerca en via a una desitjable futura excavació arqueològica que permeti un estudi complet i sistemàtic de la fortalesa.
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