Impacto económico del uso de patiromer en enfermedad renal crónica o insuficiencia cardíaca para el tratamiento de la hiperpotasemia crónica en España / Economic impact of the use of patiromer in chronic kidney disease or heart failure for the treatment of chronic hyperkalemia in Spain

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 (AU)

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 (AU)

Economic impact of the use of patiromer in chronic kidney disease or heart failure for the treatment of chronic hyperkalemia in Spain.

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 €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. 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 (€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.

A cost-effectiveness analysis of patiromer for the treatment of hyperkalemia in chronic kidney disease patients with and without heart failure in Spain.

AIMS: 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. METHODS: 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. 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. CONCLUSIONS: 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.

Identifying Clinicoradiological Phenotypes in Diffuse Idiopathic Skeletal Hyperostosis: A Cross-Sectional Study.

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.

Health Care Costs in Patients with and without Secondary Hyperparathyroidism 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.

Biopharmaceutical Study of Triamcinolone Acetonide Semisolid Formulations for Sublingual and Buccal Administration.

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.

An unusual circulating steroid profile in a virilized postmenopausal woman.

BACKGROUND: Virilism is a female disorder in which secondary male sexual characteristics develop, caused by an excessive adrenal or ovarian androgen secretion. CASE PRESENTATION: Here, we report an unusual case of an ovarian steroid cell tumor, not otherwise specified (NOS), in a 68-year-old female who presented with androgenic alopecia, clitoromegaly and an increased muscle mass. Laboratory investigations revealed both ovarian and adrenal hyperandrogenism with an elevation of androgen precursors mimicking congenital adrenal hyperplasia. A left adnexal mass was confirmed by imaging techniques. A laparoscopic bilateral salpingo-oophorectomy was performed and histopathology confirmed the diagnosis of an ovarian steroid cell tumor NOS. After surgical intervention, circulating androgen levels and their precursors returned to normal values in the postmenopausal woman. CONCLUSIONS: A detailed anamnesis and physical examination are key to the correct diagnosis in a woman with hyperandrogenism independent of her circulating androgen profile.

Introital ultrasonography: a comparison of women with stress incontinence due to urethral hypermobility and continent women.

OBJECTIVE: To determine if there is a variable on introital ultrasonography (IUS) that can be used to distinguish between women with stress urinary incontinence (SUI) due to urethral hypermobility (UH) and continent women. PATIENTS AND METHODS: This single-centre, prospective, blind, cohort, observational study comprised 383 women (245 continent and 138 incontinent) who were all appropriately informed volunteers selected according to the inclusion criteria. IUS with a convex probe was performed on all women; the measurement plane was standardized and coordinates were obtained at rest and on straining. Several distances were measured to determine if any provided an objective distinction between continent and incontinent women. RESULTS: Among all the IUS variables assessed, sliding (calculated as the difference between the distance urethra-bladder neck, U-BN, at rest and under stress) was the best for distinguishing continent and incontinent women. The receiver operating characteristic curves showed that with a threshold of 8 mm, sliding had a sensitivity of 92% and a specificity of 79.6% for detecting SUI due to UH. The distances symphysis-urethra (S-U) and U-BN at rest could also discriminate, but with lower significance. CONCLUSIONS: IUS is an important tool for diagnosing SUI; there are three independent variables, one dynamic (sliding) and two static (distances S-U and U-BN), that can be used to distinguish between continent women and those with SUI due to UH. Sliding is the most reliable, as it has the highest sensitivity and specificity. We think that the simplicity, low financial cost and reliability of IUS could allow it to be a routine procedure for physicians working in incontinence units.

Enfermedad de Still del adulto / Still disease in the adult

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