Long-Term Treatment and Effect of Discontinuation of Calcifediol in Postmenopausal Women with Vitamin D Deficiency: A Randomized Trial.

Vitamin D plays a major role in bone health and probably also in multiple extraskeletal acute and chronic diseases. Although supplementation with calcifediol, a vitamin D metabolite, has demonstrated efficacy and safety in short-term clinical trials, its effects after long-term monthly administration have been studied less extensively. This report describes the results of a 1-year, phase III-IV, double-blind, randomized, controlled, parallel, multicenter superiority clinical trial to assess the efficacy and safety of monthly calcifediol 0.266 mg versus cholecalciferol 25,000 IU (0.625 mg) in postmenopausal women with vitamin D deficiency (25(OH)D < 20 ng/mL). A total of 303 women were randomized and 298 evaluated. Patients were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months (Group A1), calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months (Group A2), and cholecalciferol 25,000 IU/month (0.625 mg/month) for 12 months (Group B). By month 4, stable 25(OH)D levels were documented with both calcifediol and cholecalciferol (intention-to-treat population): 26.8 ± 8.5 ng/mL (Group A1) and 23.1 ± 5.4 ng/mL (Group B). By month 12, 25(OH)D levels were 23.9 ± 8.0 ng/mL (Group A1) and 22.4 ± 5.5 ng/mL (Group B). When calcifediol treatment was withdrawn in Group A2, 25(OH)D levels decreased to baseline levels (28.5 ± 8.7 ng/mL at month 4 versus 14.4 ± 6.0 ng/mL at month 12). No relevant treatment-related safety issues were reported in any of the groups. The results confirm that long-term treatment with monthly calcifediol in vitamin D-deficient patients is effective and safe. The withdrawal of treatment leads to a pronounced decrease of 25(OH)D levels. Calcifediol presented a faster onset of action compared to monthly cholecalciferol. Long-term treatment produces stable and sustained 25(OH)D concentrations with no associated safety concerns. © 2023 Faes Farma SA. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Guide of management of alterations in mineral and bone metabolism during gestation and lactation.

OBJECTIVE: To provide practical recommendations for the management of mineral and bone metabolism alterations in pregnancy and lactation. PARTICIPANTS: Members of the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition. METHODS: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. A systematic search was carried out in Medline of the available evidence for each pathology. Papers in English with publication date until 29 February 2020 were included. A methodologist resolved the differences that arose during the process of reviewing the literature and formulating recommendations. The recommendations were discussed and approved by all members of the Working Group. CONCLUSIONS: The document establishes practical recommendations based on evidence about the management of mineral and bone metabolism disorders in pregnancy and lactation.

Guide of management of alterations in mineral and bone metabolism during gestation and lactation / Guía de manejo de las alteraciones del metabolismo mineral y óseo en la gestación y la lactancia

Objective: To provide practical recommendations for the management of mineral and bone metabolism alterations in pregnancy and lactation. Participants: Members of the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition. Methods: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. A systematic search was carried out in Medline of the available evidence for each pathology. Papers in English with publication date until 29 February 2020 were included. A methodology resolved the differences that arose during the process of reviewing the literature and formulating recommendations. The recommendations were discussed and approved by all members of the Working Group. Conclusions: The document establishes practical recommendations based on evidence about the management of mineral and bone metabolism disorders in pregnancy and lactation.

Objetivo: Proporcionar unas recomendaciones prácticas para el manejo de las alteraciones del metabolismo mineral y óseo en la gestación y la lactancia. Participantes: Miembros del Grupo de Metabolismo Mineral de la Sociedad Española de Endocrinología y Nutrición. Métodos:Las recomendaciones se formularon de acuerdo con el sistema Grading of Recommendations Assessment, Development, and Evaluation (GRADE) para establecer tanto la fuerza de las recomendaciones como el grado de evidencia. Se realizó una búsqueda sistemática en Medline de la evidencia disponible para cada patología. Se revisaron artículos escritos en inglés con fecha de inclusión hasta 29 de febrero del 2020. Un metodólogo resolvió las diferencias que surgieron durante el proceso de revisión de bibliografía y formulación de recomendaciones. Tras la formulación de las recomendaciones éstas se discutieron en una reunión conjunta del Grupo de Trabajo. Conclusiones: El documento establece unas recomendaciones prácticas basadas en la evidencia acerca del manejo de las alteraciones del metabolismo mineral y óseo en la gestación y la lactancia.

Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial.

Vitamin D has shown to play a role in multiple diseases due to its skeletal and extraskeletal actions. Furthermore, vitamin D deficiency has become a worldwide health issue. Few supplementation guidelines mention calcifediol treatment, despite being the direct precursor of calcitriol and the biomarker of vitamin D status. This 1-year, phase III-IV, double-blind, randomized, controlled, multicenter clinical trial assessed the efficacy and safety of calcifediol 0.266 mg soft capsules in vitamin D-deficient postmenopausal women, compared to cholecalciferol. Results reported here are from a prespecified interim analysis, for the evaluation of the study's primary endpoint: the percentage of patients with serum 25-hydroxyvitamin D (25(OH)D) levels above 30 ng/ml after 4 months. A total of 303 patients were enrolled, of whom 298 were included in the intention-to-treat (ITT) population. Patients with baseline levels of serum 25(OH)D <20 ng/ml were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months, calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months, and cholecalciferol 25,000 IU/month for 12 months. At month 4, 35.0% of postmenopausal women treated with calcifediol and 8.2% of those treated with cholecalciferol reached serum 25(OH)D levels above 30 ng/ml (p < 0.0001). The most remarkable difference between both drugs in terms of mean change in serum 25(OH)D levels was observed after the first month of treatment (mean ± standard deviation change = 9.7 ± 6.7 and 5.1 ± 3.5 ng/ml in patients treated with calcifediol and cholecalciferol, respectively). No relevant treatment-related safety issues were reported in any of the groups studied. These results thus confirm that calcifediol is effective, faster, and more potent than cholecalciferol in raising serum 25(OH)D levels and is a valuable option for the treatment of vitamin D deficiency. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Trastornos del fosfato y actitud clínica ante situaciones de hipofosfatemia e hiperfosfatemia / Phosphate disorders and clinical management of hypophosphatemia and hyperphosphatemia

La concentración sérica de fósforo oscila entre 2,5 y 4,5 mg/dl (0,81-1,45 mmol/l) en adultos, con niveles más altos en la infancia, la adolescencia y durante la gestación. El fosfato intracelular está implicado en el metabolismo intermediario y otras funciones celulares esenciales, mientras que el extracelular es fundamental para la mineralización de la matriz ósea. La fosforemia se mantiene en un estrecho rango mediante la regulación de la absorción intestinal, la redistribución y la reabsorción tubular renal de fósforo. La hipofosfatemia y la hiperfosfatemia son situaciones clínicas frecuentes, aunque, en la mayoría de las ocasiones, se trata de alteraciones leves y poco sintomáticas. Sin embargo, pueden presentarse cuadros agudos y severos que requieren tratamiento específico. En este documento elaborado por miembros del Grupo de Trabajo de Metabolismo Mineral y Óseo de la Sociedad Española de Endocrinología y Nutrición se revisan los trastornos del fosfato y se proporcionan algoritmos de manejo clínico de la hipofosfatemia y la hiperfosfatemia

Serum phosphorus levels range from 2.5 and 4.5 mg/dL (0.81-1.45 mmol/L) in adults, with higher levels in childhood, adolescence, and pregnancy. Intracellular phosphate is involved in intermediary metabolism and other essential cell functions, while extracellular phosphate is essential for bone matrix mineralization. Plasma phosphorus levels are maintained within a narrow range by regulation of intestinal absorption, redistribution, and renal tubular absorption of the mineral. Hypophosphatemia and hyperphosphatemia are common clinical situations, although changes are most often mild and oligosymptomatic. However, acute and severe conditions that require specific treatment may occur. In this document, members of the Mineral and Bone Metabolism Working Group of the Spanish Society of Endocrinology and Nutrition review phosphate disorders and provide algorithms for adequate clinical management of hypophosphatemia and hyperphosphatemia

Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA1c in Andalusia (Spain): PLATEDIAN Study.

OBJECTIVE: To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients' health-related quality of life (HRQoL), and physicians' satisfaction in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbA1c <8% [<64 mmol/mol]), treated with multiple daily injections. A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three face-to-face visits (control cohort [CC]) (n = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC]) (n = 163). The primary efficacy end point was the mean change of HbA1c levels from baseline to month 6. Other efficacy and safety end points were mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction. RESULTS: At month 6, the mean change in HbA1c levels was -0.04 ± 0.5% (-0.5 ± 5.8 mmol/mol) in the CC and 0.01 ± 0.6% (0.1 ± 6.0 mmol/mol) in the IC (P = 0.4941). The number of patients who achieved HbA1c <7% (<53 mmol/mol) was 73 and 78 in the CC and IC, respectively. Significant differences were not found regarding safety end points at 6 months. Changes in HRQoL between the first visit and final visit did not differ between cohorts, and, regarding fear of hypoglycemia (FH-15 score ≥28), statistically significant differences observed at baseline remained unchanged at 6 months (P < 0.05). CONCLUSIONS: The use of telemedicine in patients with type 1 diabetes with HbA1c <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits.

Phosphate disorders and clinical management of hypophosphatemia and hyperphosphatemia. / Trastornos del fosfato y actitud clínica ante situaciones de hipofosfatemia e hiperfosfatemia.

Serum phosphorus levels range from 2.5 and 4.5mg/dL (0.81-1.45 mmol/L) in adults, with higher levels in childhood, adolescence, and pregnancy. Intracellular phosphate is involved in intermediary metabolism and other essential cell functions, while extracellular phosphate is essential for bone matrix mineralization. Plasma phosphorus levels are maintained within a narrow range by regulation of intestinal absorption, redistribution, and renal tubular absorption of the mineral. Hypophosphatemia and hyperphosphatemia are common clinical situations, although changes are most often mild and oligosymptomatic. However, acute and severe conditions that require specific treatment may occur. In this document, members of the Mineral and Bone Metabolism Working Group of the Spanish Society of Endocrinology and Nutrition review phosphate disorders and provide algorithms for adequate clinical management of hypophosphatemia and hyperphosphatemia.

[Recommendations of the GARIN group for dietary managing of patient with chronic kidney disease]. / Recomendaciones del grupo GARIN para el tratamiento dietético de los pacientes con enfermedad renal crónica.

INTRODUCTION: Background and objectives: by means of this update, the GARIN working group aims to define its position regarding the dietary treatment of patients with chronic kidney disease (CKD). In this area there are many aspects of uncertainty. Material and methods: bibliographical review and specific questions in advance were discussed and answered at a meeting in the form of conclusions. Results: the therapeutic action must be individualized and taking into account the degree of renal failure that the patient presents and their comorbidities. Regarding nutritional medical therapy, our group proposes three different levels of action, in which the recommendations of protein intake, fiber, fatty acids or potassium are different. In addition, we suggest using the phosphorus/protein ratio concept in adjusting the diet of the patient with CKD. We give recommendations regarding treatment in diabetes and artificial supplementation. Conclusions: these recommendations about dietary issues in patients with CKD can add value to clinical work.

INTRODUCCIÓN: Introducción y objetivos: en el tratamiento dietético de los pacientes con enfermedad renal crónica (ERC) existen muchas áreas de incertidumbre. El grupo de trabajo GARIN tiene como objetivo definir su posición en este campo. Material y métodos: revisión bibliográfica previa y reunión presencial en la que se discutieron y contestaron preguntas específicas sobre el tema. Resultados: la actuación terapéutica debe ser individualizada y atendiendo al grado de enfermedad renal que presente el paciente y a sus comorbilidades. En cuanto a la terapia médica nutricional, nuestro grupo propone tres niveles diferentes de actuación, en los que las recomendaciones de ingesta proteica, fibra, ácidos grasos o potasio son distintas. Además, sugerimos utilizar el concepto ratio fósforo/proteína en el ajuste de la dieta del paciente con ERC. Damos recomendaciones en cuanto al tratamiento en diabetes y en suplementación artificial. Conclusiones: estas recomendaciones aportan respuestas concretas sobre cuestiones comunes en la asistencia a pacientes con ERC.

Recomendaciones del grupo GARIN para el tratamiento dietético de los pacientes con enfermedad renal crónica / Recommendations of the GARIN group for dietary managing of patient with chronic kidney disease

Introducción y objetivos: en el tratamiento dietético de los pacientes con enfermedad renal crónica (ERC) existen muchas áreas de incertidumbre. El grupo de trabajo GARIN tiene como objetivo definir su posición en este campo. Material y métodos: revisión bibliográfica previa y reunión presencial en la que se discutieron y contestaron preguntas específicas sobre el tema. Resultados: la actuación terapéutica debe ser individualizada y atendiendo al grado de enfermedad renal que presente el paciente y a sus comorbilidades. En cuanto a la terapia médica nutricional, nuestro grupo propone tres niveles diferentes de actuación, en los que las recomendaciones de ingesta proteica, fibra, ácidos grasos o potasio son distintas. Además, sugerimos utilizar el concepto ratio fósforo/proteína en el ajuste de la dieta del paciente con ERC. Damos recomendaciones en cuanto al tratamiento en diabetes y en suplementación artificial. Conclusiones: estas recomendaciones aportan respuestas concretas sobre cuestiones comunes en la asistencia a pacientes con ERC

Background and objectives: by means of this update, the GARIN working group aims to define its position regarding the dietary treatment of patients with chronic kidney disease (CKD). In this area there are many aspects of uncertainty. Material and methods: bibliographical review and specific questions in advance were discussed and answered at a meeting in the form of conclusions. Results: the therapeutic action must be individualized and taking into account the degree of renal failure that the patient presents and their comorbidities. Regarding nutritional medical therapy, our group proposes three different levels of action, in which the recommendations of protein intake, fiber, fatty acids or potassium are different. In addition, we suggest using the phosphorus/protein ratio concept in adjusting the diet of the patient with CKD. We give recommendations regarding treatment in diabetes and artificial supplementation. Conclusions: these recommendations about dietary issues in patients with CKD can add value to clinical work

Early nutrition support therapy in patients with head-neck cancer.

BACKGROUND: weight loss is commonly observed in head-neck cancer patients, affecting 75-80% of them during their treatment period; weight loss is severe in 30-50% of cases. According to ESPEN publications, nutritional assessment in cancer patients should be frequently performed and nutrition support therapy must be started when any deficiency is observed. OBJECTIVE: to evaluate the effect of early nutrition support (ENS) in nutritional markers and treatment response in patients with head-neck cancer receiving radiotherapy (RT). PATIENTS AND METHODS: one hundred and two patients with head-neck cancer and more than two points in the malnutrition screening tool (MUST) before receiving RT were included. ENS was provided to all patients consisting in nutrition counselling, oral supplements and/or enteral nutrition. RESULTS: one hundred and two patients were included; 76% had a stage IV of disease. At the end of RT, after ENS, a slightly decreased body mass index (BMI) with an increased fat-free body mass was observed (p < 0.001); biochemical nutrition parameters remained stable despite decreased oral intake. Less than 40% of patients had severe epithelitis or mucositis; 92% of patients received the total amount and doses of originally planned RT sessions, while 22.8% required RT-sessions interruption. Patients with caloric malnutrition had a lower fulfillment of RT than those without caloric malnutrition (p < 0.001). Mortality was related to lower Karnosfsky, higher weight loss before RT and higher grade of mucositis/epitelitis (p < 0.05). CONCLUSIONS: patients who receive ENS keep their nutritional condition instead of associated effects due to RT. ENS represents an efficient treatment and could prevent malnutrition associated comorbidities in oncologic patients.

Early nutrition support therapy in patients with head-neck cancer / Soporte nutricional precoz en pacientes con cáncer de cabeza y cuello

Background: weight loss is commonly observed in head-neck cancer patients, affecting 75-80% of them during their treatment period; weight loss is severe in 30-50% of cases. According to ESPEN publications, nutritional assessment in cancer patients should be frequently performed and nutrition support therapy must be started when any deficiency is observed. Objective: to evaluate the effect of early nutrition support (ENS) in nutritional markers and treatment response in patients with head-neck cancer receiving radiotherapy (RT).Patients and methods: one hundred and two patients with head-neck cancer and more than two points in the malnutrition screening tool (MUST) before receiving RT were included. ENS was provided to all patients consisting in nutrition counselling, oral supplements and/or enteral nutrition. Results: one hundred and two patients were included; 76% had a stage IV of disease. At the end of RT, after ENS, a slightly decreased body mass index (BMI) with an increased fat-free body mass was observed (p < 0.001); biochemical nutrition parameters remained stable despite decreased oral intake. Less than 40% of patients had severe epithelitis or mucositis; 92% of patients received the total amount and doses of originally planned RT sessions, while 22.8% required RT-sessions interruption. Patients with caloric malnutrition had a lower fulfillment of RT than those without caloric malnutrition (p < 0.001). Mortality was related to lower Karnosfsky, higher weight loss before RT and higher grade of mucositis/epitelitis (p < 0.05).Conclusions: patients who receive ENS keep their nutritional condition instead of associated effects due to RT. ENS represents an efficient treatment and could prevent malnutrition associated comorbidities in oncologic patients

Antecedentes: la pérdida de peso es un síntoma frecuente en el cáncer de cabeza y cuello (CCC), afecta a un 75-80% de los pacientes y es severa en un 30-50% de los casos. Según las publicaciones de la ESPEN, la valoración nutricional puede realizarse periódicamente y se debe comenzar el soporte nutricional cuando se observe algún déficit nutricional. Objetivo: evaluar el efecto del soporte nutricional precoz (SNP) en marcadores nutricionales y la respuesta terapéutica en pacientes con CCC que reciben radioterapia (RT). Pacientes y métodos: se incluyeron 102 pacientes con CCC que tuviesen al menos dos puntos en la escala de screening nutricional (MUST) antes de recibir RT. Todos los pacientes recibieron SNP, que consistió en asesoramiento nutricional y suplementos orales o nutrición enteral. Resultados: se incluyeron 102 pacientes, el 76% de ellos en estadio IV de la enfermedad. Al final de la RT, después de recibir SNP, se observó una disminución discreta en el índice de masa corporal (IMC) acompañada de aumento de la masa libre de grasa (p < 0,001); los parámetros bioquímicos nutricionales permanecieron estables a pesar de la disminución en la ingesta. La incidencia de mucositis o epitelitis severa fue menor al 40%; el 92% de los pacientes recibieron la totalidad de las sesiones de RT planeadas, mientras que solo el 22,8% interrumpió parcial o totalmente la RT. Aquellos pacientes con desnutrición calórica previa tuvieron un menor cumplimiento terapéutico (p < 0,001). La mortalidad se relacionó con el índice de Karnosfsky, con una mayor pérdida de peso previa a la RT y mayor grado de mucositis o epitelitis (p < 0,05). Conclusiones: aquellos pacientes que reciben SNP mantienen su estado nutricional a pesar de los efectos asociados con RT. El SNP representa una estrategia terapéutica eficiente para prevenir complicaciones relacionadas con la nutrición en pacientes oncológicos

Arterial Calcium Stimulation with Hepatic Venous Sampling in the Localization Diagnosis of Endogenous Hyperinsulinism.

Objective. The aim of this study was to assess the utility of arterial calcium stimulation with hepatic venous sampling (ASVS) in the localization diagnosis of endogenous hyperinsulinism. Patients and Methods. A retrospective descriptive study was performed including patients with endogenous hyperinsulinism who underwent ASVS. The histopathological diagnosis in patients who underwent a surgical procedure was used as the reference for the statistical study of the accuracy of this technique. Results. 30 patients were included with endogenous hyperinsulinism and nonconclusive imaging diagnosis was included. ASVS was performed in all cases. Surgery was performed in 20 cases. Insulinoma was removed in 19 patients; the location of all cases was detected in the ASVS. All cases of endogenous hyperinsulinism had a positive result for the ASVS, with this association being statistically significant (χ2 = 15.771; p < 0.001). A good and statistically significant agreement was obtained between histopathologic diagnosis and ASVS results (K = 0.518, p < 0.001). Conclusions. ASVS is a useful procedure in the localization diagnosis of endogenous hyperinsulinism undetected by other imaging tests. This technique allows the localization of intrapancreatic insulinomas and represents useful tool for the diagnosis and surgical management of these tumors.

Vitamin D3 and calcidiol are not equipotent.

Despite the discussion on the optimal threshold of 25-hydroxyvitamin D serum level continues, there is now consensus on the fact that post-menopausal and elderly populations have inadequate Vitamin D serum levels worldwide. The adjustment of these levels is necessary to improve both bone and general health, as it is to optimize bone response to antiresortive treatments. It is recommended, as endorsed by international clinical guides, to use Vitamin D3, the physiological form of Vitamin D, in a dose range between 600-2000IU. It should be administered on a daily basis or on its weekly or monthly equivalents. In Spain, the use of calcidiol (25(OH)D3) at the same dose than Vitamin D3 is the most extended prescription, notwithstanding the available evidence stating that they are not equipotent. This may lead to over-dosage. In order to provide evidence on this circumstance, a convenience study was performed. Four groups of ten post-menopausal osteoporotic women each (average age 67), deficient in Vitamin D ((25(OH)D 37.5±10 nmol/L)) were enrolled. Each group followed a different treatment regimen: (G1) vitamin D3 20µg/day [800IU/day]; (G2) 25 (OH)D3 20µg/day; (G3) 25(OH)D3 266µg/week and (G4) 25(OH)D3 0.266mg every two weeks. 25(OH)D levels were measured for each group at 0, 6 and 12 months, with the following results: G1 (40.5±4.7;80.0±2; 86.2±23.7), G2 (37,2±4.2; 161±21.7;188.0±24.0), G3 (38±3.7;213.5±80.0; 233.0±81.2), G4 (39.5±4;164.5±41,7;210.5±22.2). These data reveal that both metabolites are not equipotent. Calcidiol is faster and 3-6 times more potent to obtain serum levels of 25(OH)D in the medium to long term. This circumstance must be assessed and included in the therapeutic prescription guides for Osteoporosis, since it should be of concern when planning and prescribing treatments to normalize serum levels of 25(OH)D3 and avoid potential adverse impacts.

[Screening for Cushing's syndrome in obese patients; is it really necessary?]. / Despistaje rutinario de síndrome de Cushing en pacientes con obesidad mórbida: ¿es realmente necesario?

to be more frequent among patients with metabolic syndrome. Previous studies have suggested to perform a routine screening for CS in obese patients; however, more recent reports only recommend a case-finding approach in patients with uncontrolled diabetes and hypertension, despite appropriate treatment. Objective: The aim of this study was to evaluate the prevalence of unsuspected CS in morbidly obese patients in an outpatient's clinic. Patients and methods: Retrospective case-note study. We reviewed the medical records of morbidly obese patients referred to our clinic prior to bariatric surgery between january 2001 and december 2011. All patients had a complete medical history including physical examination, and 399 underwent screening for CS as part of our pre-surgical protocol. As screening for autonomous cortisol secretion, we performed an overnight 1 mg Dexamethasone Suppression Test (DST). Serum cortisol < 1.8 µg/dl was the cut-off point for normal suppression. Results: 399 patients (308 female; mean age 41.9 ± 10.5 years; mean BMI 51.5 ± 8.4 kg/m2). In the retrospective analysis, prediabetes and diabetes mellitus were observed in 10.3% and 27.8% respectively. In 21 of 399 patients, screening was considered to be abnormal. Eight of these 21 patients had subsequent normal 24h Urinary Free Cortisol (UFC) levels (150 µg/24h). In 13 of 20 patients, we repeated an overnight 1mg DST, on suspicion of failing to take the dexamethasone correctly. Three patients failed to suppress their cortisol levels, two of them were on carbamazepine, which was considered to be a false positive result. The other patient with abnormal UFC levels was diagnosed with CS (0.26%), whose cause was a pituitary microadenoma. Conclusion: A low proportion of patients with morbid obesity were found to have CS. Our findings suggest that morbidly obese patients should not be routinely screened for CS.

Introducción: El síndrome de Cushing (SC) es más frecuente en pacientes con síndrome metabólico. Estudios previos han sugerido que es necesario realizar un despistaje de SC en pacientes obesos; sin embargo, estudios más recientes sólo recomiendan el despistaje en pacientes con hipertensión o diabetes mal controlados, a pesar de tratamiento. Objetivo: Evaluar la prevalencia de SC oculto en pacientes con obesidad mórbida. Pacientes y métodos: Estudio observacional retrospectivo en el que se incluyeron 399 pacientes que iban a someterse a cirugía bariátrica. A todos los pacientes se les realizó una historia clínica completa, incluyendo exploración física y test de Nugent, como parte del protocolo precirugía. Resultados: 399 pacientes (308 mujeres, edad media 41,9 ± 10,5 años; IMC medio 51,5 ± 8,4 kg/m2). El 10,3% de los pacientes presentaban prediabetes y el 27,8% diabetes. En 21 de los 399 pacientes, el despistaje fue anormal. En 8 pacientes, medimos cortisol libre en orina de 24 horas (CLU), siendo en todos normal al menos en dos ocasiones (CLU < 150 mcg/24 h), lo que descartaba SC. En 13 pacientes, repetimos el test de Nugent; sólo en 3, el test resultó patológico. Dos de los pacientes estaban en tratamiento con carbamacepina, lo que se consideró un falso positivo. El otro paciente se diagnosticó de Enfermedad de Cushing. Conclusión: La prevalencia de SC fue muy baja en pacientes con obesidad mórbida. Nuestros datos sugieren que no se debería realizarse un despistaje de SC de forma rutinaria.

Despistaje rutinario de Síndrome de Cushing en pacientes con obesidad mórbida; ¿es realmente necesario? / Screeening for cushing’s syndrome in obese patients: is it really necessary?

Introducción: El síndrome de Cushing (SC) es más frecuente en pacientes con síndrome metabólico. Estudios previos han sugerido que es necesario realizar un despistaje de SC en pacientes obesos; sin embargo, estudios más recientes sólo recomiendan el despistaje en pacientes con hipertensión o diabetes mal controlados, a pesar de tratamiento. Objetivo: Evaluar la prevalencia de SC oculto en pacientes con obesidad mórbida. Pacientes y métodos: Estudio observacional retrospectivo en el que se incluyeron 399 pacientes que iban a someterse a cirugía bariátrica. A todos los pacientes se les realizó una historia clínica completa, incluyendo exploración física y test de Nugent, como parte del protocolo precirugía. Resultados: 399 pacientes (308 mujeres, edad media 41,9 ± 10,5 años; IMC medio 51,5 ± 8,4 kg/m2 ). El 10,3% de los pacientes presentaban prediabetes y el 27,8% diabetes. En 21 de los 399 pacientes, el despistaje fue anormal. En 8 pacientes, medimos cortisol libre en orina de 24 horas (CLU), siendo en todos normal al menos en dos ocasiones (CLU < 150 mcg/24 h), lo que descartaba SC. En 13 pacientes, repetimos el test de Nugent; sólo en 3, el test resultó patológico. Dos de los pacientes estaban en tratamiento con carbamacepina, lo que se consideró un falso positivo. El otro paciente se diagnosticó de Enfermedad de Cushing. Conclusión: La prevalencia de SC fue muy baja en pacientes con obesidad mórbida. Nuestros datos sugieren que no se debería realizarse un despistaje de SC de forma rutinaria (AU)

Background: Cushing’s syndrome (CS) is considered to be more frequent among patients with metabolic syndrome. Previous studies have suggested to perform a routine screening for CS in obese patients; however, more recent reports only recommend a case-finding approach in patients with uncontrolled diabetes and hypertension, despite appropriate treatment. Objective: The aim of this study was to evaluate the prevalence of unsuspected CS in morbidly obese patients in an outpatient’s clinic. Patients and methods: Retrospective case-note study. We reviewed the medical records of morbidly obese patients referred to our clinic prior to bariatric surgery between january 2001 and december 2011. All patients had a complete medical history including physical examination, and 399 underwent screening for CS as part of our pre-surgical protocol. As screening for autonomous cortisol secretion, we performed an overnight 1 mg Dexamethasone Suppression Test (DST). Serum cortisol < 1.8 µg/dl was the cut-off point for normal suppression. Results: 399 patients (308 female; mean age 41.9 ± 10.5 years; mean BMI 51.5 ± 8.4 kg/m2). In the retrospective analysis, prediabetes and diabetes mellitus were observed in 10.3% and 27.8% respectively. In 21 of 399 patients, screening was considered to be abnormal. Eight of these 21 patients had subsequent normal 24h Urinary Free Cortisol (UFC) levels (150 µg/24h). In 13 of 20 patients, we repeated an overnight 1mg DST, on suspicion of failing to take the dexamethasone correctly. Three patients failed to suppress their cortisol levels, two of them were on carbamazepine, which was considered to be a false positive result. The other patient with abnormal UFC levels was diagnosed with CS (0.26%), whose cause was a pituitary microadenoma. Conclusion: A low proportion of patients with morbid obesity were found to have CS. Our findings suggest that morbidly obese patients should not be routinely screened for CS (AU)

Evaluación de la efectividad del tratamiento con glucocorticoides intravenosos en la oftalmopatía de Graves / Obesity: etiologic and pathophysiological analysis

Objetivo: Evaluar la efectividad del protocolo de tratamiento intermitente con glucocorticoides a altas dosis por vía intravenosa (i.v.) en la oftalmopatía de Graves (OG) moderada-grave del Hospital Reina Sofía. Material y métodos Se incluyeron los pacientes con OG tratados con glucocorticoides i.v. en nuestro servicio desde agosto de 2007 a agosto de 2011. Se administró prednisolona i.v. en dosis de 7,5mg/kg/d 2d alternos durante 6 semanas alternas y mitad de la dosis durante 6 semanas más. Resultados Analizamos 18 pacientes (83,3% mujeres) con una edad media de 43±11 años. Cuatro eran fumadores, 5 habían dejado el hábito y el resto nunca habían fumado. El 66,7% presentaban hipertiroidismo por enfermedad de Graves, de los cuales el 41,6% habían recibido radioyodo. La respuesta al tratamiento fue buena en el 72,2%, parcial en 11,1% y mala en 16,7%. En 5 aparecieron efectos secundarios leves. Antes del tratamiento el 83,3% presentaron diplopía, el 33,3% retracción palpebral, el 72,2% dolor ocular y el 44,4% exoftalmos. Después del tratamiento solo el 33,3% continuaron con diplopía (p=0,004), el 5,6% con retracción palpebral (p=0,063), el 16,7% con dolor ocular (p=0,002) y el 11,1% con exoftalmos (p=0,031). El 22,2% precisaron radioterapia. La respuesta al tratamiento no se asoció a la enfermedad de base (p=0,866) al haber recibido radioyodo previo como tratamiento del hipertiroidismo (p=0,447) o al ser fumador (p=0,368).Conclusiones El tratamiento con glucocorticoides i.v. en la oftalmopatía tiroidea reduce significativamente la diplopía, el dolor ocular y el exoftalmos. Los efectos secundarios son leves y poco frecuentes. La respuesta al tratamiento es independiente de la enfermedad de base, de haber recibido radioyodo y de ser fumador (AU)

Objective: To assess the efficacy of intermittent, high-dose treatment with intravenous glucocorticoids (IV GCs) in moderate to severe Graves’ ophthalmopathy (GO).Materials and methods: Patients with GO treated with IV GCs from August 2007 to August 2011at the Endocrinology Department of Reina Sofía Hospital were enrolled into the study. IV pulseprednisol one (7.5 mg/kg/day) was administered twice weekly every two weeks for 6 weeks, and at half the dose for 6 additional weeks. Results: Eighteen patients (mean age, 43+/-11 years) with moderate to severe GO were analyzed (83.3% females). Four were active smokers, five former smokers, and the rest had never smoked. Hyperthyroidism due to Graves’ disease was found in 66.7% of patients, 41.6% of whom had received radioiodine therapy. Response to treatment was satisfactory in 72.2%, partial in11.1%, and poor in 16.7%. Mild side effects were reported by 5 patients. Before treatment,83.3% had diplopia, 33.3% eyelid retraction, 72.2% eye pain, and 44.4% exophthalmos. After treatment, only 33.3% had diplopia (P = .004), 5.6% eyelid retraction (P = .063), 16.7% eye pain(P = .002), and 11.1% exophthalmos (P = .031). Response to treatment was not related to the underlying disease (P = .866), prior radioiodine treatment (P = .447), or smoking status (P = .368).Conclusions: Intravenous glucocorticoid therapy decreased activity in patients with moderate to severe active GO, with major improvement occurring in diplopia, eye pain, and exophthalmos. Side effects were mild and uncommon. Treatment response was independent from the underlying disease, prior radioiodine treatment, or smoking status (AU)

Clinical efficacy of intravenous glucocorticoid treatment in Graves' ophtalmopathy.

OBJECTIVE: To assess the efficacy of intermittent, high-dose treatment with intravenous glucocorticoids (IV GCs) in moderate to severe Graves' ophthalmopathy (GO). MATERIALS AND METHODS: Patients with GO treated with IV GCs from August 2007 to August 2011 at the Endocrinology Department of Reina Sofía Hospital were enrolled into the study. IV pulse prednisolone (7.5 mg/kg/day) was administered twice weekly every two weeks for 6 weeks, and at half the dose for 6 additional weeks. RESULTS: Eighteen patients (mean age, 43 ± 11 years) with moderate to severe GO were analyzed (83.3% females). Four were active smokers, five former smokers, and the rest had never smoked. Hyperthyroidism due to Graves' disease was found in 66.7% of patients, 41.6% of whom had received radioiodine therapy. Response to treatment was satisfactory in 72.2%, partial in 11.1%, and poor in 16.7%. Mild side effects were reported by 5 patients. Before treatment, 83.3% had diplopia, 33.3% eyelid retraction, 72.2% eye pain, and 44.4% exophthalmos. After treatment, only 33.3% had diplopia (P=.004), 5.6% eyelid retraction (P=.063), 16.7% eye pain (P=.002), and 11.1% exophthalmos (P=.031). Response to treatment was not related to the underlying disease (P=.866), prior radioiodine treatment (P=.447), or smoking status (P=.368). CONCLUSIONS: Intravenous glucocorticoid therapy decreased activity in patients with moderate to severe active GO, with major improvement occurring in diplopia, eye pain, and exophthalmos. Side effects were mild and uncommon. Treatment response was independent from the underlying disease, prior radioiodine treatment, or smoking status.