Effectiveness and Safety of Insulin Glargine 300 U/ml in Comparison with Insulin Degludec 100 U/ml Evaluated with Continuous Glucose Monitoring in Adults with Type 1 Diabetes and Suboptimal Glycemic Control in Routine Clinical Practice: The OneCARE Study.

INTRODUCTION: Data regarding efficacy of second-generation basal insulins (BI) using continuous glucose monitoring (CGM) come from clinical trials. We evaluated the effectiveness of insulin glargine 300 U/ml (Gla-300) compared to insulin degludec 100 U/ml (IDeg-100) in terms of percentage of time in range (TIR); 70-180 mg/dl was obtained from CGM in sub-optimally controlled patients with type 1 diabetes (T1D) in routine clinical practice. METHODS: This observational, multicenter, cross-sectional study included patients with T1D (> 3 years diabetes duration, HbA1c ≥ 7.5%) who had switched from first-generation BI to Gla-300/IDeg-100 within the past 24 months according to physician discretion. Clinical and laboratory data were obtained from clinical records and during study visit, and CGM data were collected prior to the visit. RESULTS: One hundred ninety-nine people with T1D were included [42.6 ± 13.4 (mean ± SD) years, 18.4 ± 10.4 years diabetes duration]; 104 received Gla-300, 95 IDeg-100. TIR 70-180 throughout whole day was similar in both groups, 52.4 ± 14.0 vs. 49.3 ± 13.9% Gla-300/IDeg-100, respectively. At night, TIR 70-180 and TIR 70-140 were significantly higher in the Gla-300 group compared to the IDeg-100 (52.4 vs. 46.2 and 31.8 vs. 26.9%, respectively, p = 0.0209 and p = 0.0182), and time above range (180) was significantly lower in the Gla-300 group (40.1% vs. 47.2%, p = 0.0199). Additional CGM glucometric data were comparable in both groups. Patient treatment satisfaction score assessed through the Diabetes Treatment Satisfaction Questionnaire (DTSQ) was high and similar for both insulins. CONCLUSION: This real-world study shows the effectiveness and safety of Gla-300 are more similar to than different from IDeg-100, with a slightly better nocturnal glucose profile, in sub-optimally controlled T1D patients switching from a first-generation BI.

DAPA-RWE: a retrospective multicenter study comparing dapagliflozin and sitagliptin in patients with Type 2 diabetes treated under routine clinical practice in Spain.

Background: Weight reduction and glycemic control are key goals during Type 2 diabetes management. However, there are few country-specific, real-world data on cotransporter 2 inhibitors. Materials & methods: DAPA-RWE was a retrospective, multicenter study comparing the efficacy of dapagliflozin versus sitagliptin in Type 2 diabetes patients in Spain. Results: The study population comprised 1046 patients (594 with dapagliflozin, 452 with sitagliptin). Age was 61.8 ± 10.0 and 66.2 ± 11.4 years and glycosylated hemoglobin (HbA1c) 8.9 and 8.8%, respectively. The main end point (reduction in weight and HbA1c) was reached by 24.4 and 56.1% of patients, respectively; p < 0.05. This was confirmed with a propensity score matching analysis balanced for obesity-related variables at baseline. Conclusion: DAPA-RWE confirmed dapagliflozin to be more effective than sitagliptin in reducing HbA1c and weight.

Gender differences in quality of life in adults with long-standing type 1 diabetes mellitus.

BACKGROUND: To assess gender differences in Quality of life (QoL) and in sociodemographic, clinical and psychological factors associated with impaired QoL in adults with long-standing type 1 diabetes mellitus (DM1). METHODS: Cross-sectional evaluation in a random cohort of DM1 adult patients from a tertiary care hospital. QoL was evaluated using translated and validated self-administered Diabetes QoL questionnaire (Es-DQoL), and results transformed into a 0-100 scale. Psychological assessment included a planned psychological interview and self-reported questionnaires (Beck Depression Inventory II, State-Trait Anxiety Inventory Form Y, Fear of hypoglycaemia Scale, Medical Outcomes Study Social Support Survey). RESULTS: A total of 312 patients (51.6% male; 38.2 ± 12.7 years; HbA1c 7.5 ± 1.1% (58.5 ± 14.2 mmol/mol); 20.4 ± 12.0 years of DM1) were included in the analysis. Male and female subgroups showed similar sociodemographic and diabetes-related features and comparable social support. Among female patients, higher frequency of depression [31.7% (IC95% 26.2-40.8) vs. 14.9% (IC95% 10.1-20.8), p < 0.05] and anxiety [23.2% (IC95% 19.3-33.14) vs. 13.0% (IC95% 8.1-18.4), p < 0.05] and severity of depressive and anxious symptoms were also found. Compared to male patients, female patients showed lower QoL [75 (IC95% 73.6-77.5) vs. 80 (IC95% 75.7-83.1), p < 0.05] and scored significantly worse in subscale Diabetes-related worries [69 (IC95% 50.0-81.0) vs. 75 (IC95% 72.9-79.0), p < 0.05]. Fear of hypoglycemia and severity of depressive and anxious symptoms were factors independently associated to lower QoL in men and women while high frequency of glycemic excursions was a female-specific predictive one. CONCLUSIONS: Adult women with long-standing DM1 showed lower QoL probably related to higher frequency and severity of psychopathological syndromes. Depressive and anxious symptoms and, among women, exposure to glycemic excursions were identified as modifiable, QoL-related variables. Educational, technological and psychological interventions are needed in order to improve QoL in DM1 patients.

Budget impact of using midnight salivary cortisol in the diagnosis of hypercortisolism.

BACKGROUND: A single midnight serum cortisol (MSC) test has been reported to possess the best sensitivity and specificity for diagnosing Cushing's syndrome (CS). However, this test requires patient hospitalization, making it costly. This paper aims to compare the hospital budget impact and accuracy of using midnight salivary cortisol (MSVC), as opposed to MSC, in the diagnosis of hypercortisolism. METHODS: 77 patients with at least two high urinary free cortisol (UFC) values (>360 nmol/24 h) were selected from 611 patients with clinical symptoms of CS. The costs of the method to confirm the diagnosis of hypercortisolism was calculated comparing Option A using MSC (UFCx2, low-dose dexamethasone suppression test [LDDST]) that requires patient hospitalization versus Option B using MSVC (UFCx2, LDDST) in which the evaluation is done outside the Hospital. A budget impact analysis for one year was developed, and a sensitivity analysis in different scenarios was performed. Reproducibility and diagnostic performance of MSVC and MSC were also measured. RESULTS: Salivary cortisol is a sound analytical method for evaluating free serum cortisol due to its classification accuracy, good imprecision, linearity, and stability. AUC(ROC) comparison between MSVC and MSC shows no significant differences. The substitution of the MSC for MSVC in our hospital could save between €16,762 and €132,804 in one year. CONCLUSIONS: The use of MSVC in the diagnosis of hypercortisolism can result in a substantial decrease in the budget impact, without losing diagnosis accuracy and reliability, a significant advantage considering the current emphasis on reducing the financial burden of health care.

[The medical management of Cushing's syndrome]. / Tratamiento farmacológico y seguimiento del síndrome de Cushing.

Cushing's syndrome results from prolonged exposure to excessive circulating glucocorticosteroids and is associated with significant morbidity and mortality. While the treatment of choice in most patients is surgical, the metabolic consequences of this syndrome, including hypertension and diabetes mellitus, increase the risks of such surgery. Hypercortisolemia and its sequelae can be efficiently reversed or controlled using medical therapy, either as a temporary measure prior to definitive treatment or as a longer-term treatment in some particularly difficult cases. Drug treatment has been targeted at the hypothalamic/pituitary level, the adrenal glands and at glucocorticoid receptors. The present review discusses the pharmacotherapeutic agents that have been used in Cushing's syndrome and the criteria for their use, as well as recent drugs that may improve the medical treatment of this complex endocrinological disorder in the future. Finally, the short-and long-term follow-up of patients with Cushing's syndrome after surgery is also discussed.

Tratamiento farmacológico y seguimiento del síndrome de Cushing / The medical management of Cushing's syndrome

El síndrome de Cushing es el resultado de la exposición excesiva, prolongada o inadecuada de glucocorticoides y conlleva un aumento significativo de la morbilidad y la mortalidad de estos pacientes. El tratamiento de elección, en la mayoría de los casos, es la cirugía. Sin embargo, sus consecuencias metabólicas, como hipertensión arterial, diabetes mellitus, etc., pueden aumentar los riesgos en el entorno de la cirugía y cuando no es posible resolver la enfermedad tras la cirugía. El hipercortisolismo y sus secuelas pueden controlarse adecuadamente con tratamiento médico, bien temporalmente antes de la intervención o bien durante un intervalo de tiempo prolongado en casos particulares. El tratamiento farmacológico tiene por objetivo controlar la secreción de cortisol; actúa por mecanismos que regulan la secreción de CRH/ACTH en el hipotálamo o la hipófisis, el cortisol suprarrenal o incluso en los receptores de glucocorticoides. En esta revisión se discute la eficacia de los distintos fármacos utilizados en el tratamiento del síndrome de Cushing, los criterios de su utilización, así como la de fármacos recientes que pueden mejorar las expectativas del tratamiento médico en el futuro. Finalmente, se discute también la monitorización del seguimiento a corto y largo plazo de los pacientes con síndrome de Cushing después de la cirugía (AU)

Cushing's syndrome results from prolonged exposure to excessive circulating glucocorticosteroids and is associated with significant morbidity and mortality. While the treatment of choice in most patients is surgical, the metabolic consequences of this syndrome, including hypertension and diabetes mellitus, increase the risks of such surgery. Hypercortisolemia and its sequelae can be efficiently reversed or controlled using medical therapy, either as a temporary measure prior to definitive treatment or as a longer-term treatment in some particularly difficult cases. Drug treatment has been targeted at the hypothalamic/ pituitary level, the adrenal glands and at glucocorticoid receptors. The present review discusses the pharmacotherapeutic agents that have been used in Cushing¿s syndrome and the criteria for their use, as well as recent drugs that may improve the medical treatment of this complex endocrinological disorder in the future. Finally, the shortand long-term follow-up of patients with Cushing¿s syndrome after surgery is also discussed (AU)

A clinical profile of memory impairment in humans due to endogenous glucocorticoid excess.

OBJECTIVE: Glucocorticoid excess is commonly related to neuropsychiatric and neurological disorders, with memory impairment typically found among these disorders. The objective of this study is to offer a clinical profile of memory deficits resulting from exposure to chronic stress-level elevations of endogenous glucocorticoids in patients with Cushing's Syndrome (CS). STUDY SUBJECTS: Thirty female participants of matching age and education level were studied: 15 had untreated CS (mean age 38 +/- 14) and 15 were healthy. In all patients, CS was confirmed by histology of the lesion after surgery. DESIGN: Different learning and memory processes were assessed using an adapted version of Luria's Memory Words-Revised task (LMW-R). Participants' performances were measured in an immediate condition and, 30 min later, in a delayed condition. Attentional and executive functions were also evaluated. RESULTS: Our data show that chronic exposure to elevated levels of cortisol is clinically associated with significant working memory deficits, which included less shot-term memory volume, slow learning rate, memory contamination and no accurate perception of own performance. Patients also show impairment in the delayed recall task. No relation was detected between learning and delayed conditions. CS group did not differ significantly from control group in basic attentional and executive functioning. CONCLUSIONS: Our clinical profile of memory deficits related to CS relates chronic exposure to hypercortisolemia to impaired attentional-dependent working memory and delayed recall process, suggesting that cortisol levels play a critical role in the modulation of learning and memory. Possible damage to hippocampus and extrahippocampal areas is discussed.

Recomendaciones para el uso adecuado de la densitometría ósea en el diagnóstico y tratamiento de la osteoporosis / Guidelines for the appropriate use of dual energy X-ray absorptiometry in the diagnosis and treatment of osteoporosis

La densitometría dual de doble energía de rayos x (DEXA) permite una medida directa y no invasiva de la densidad mineral ósea (BMD). El objetivo del estudio fue proporcionar recomendaciones para el uso apropiado de la densitometría en nuestro hospital para conseguir un diagnóstico certero y un tratamiento adecuado. Una comisión interdisciplinaria realizó una revisión sistemática de la bibliografía. Beneficios, daños y costes: El diagnóstico temprano de la osteoporosis a través de la densitometría ósea minimiza lesiones, mejora la calidad de vida y reduce el coste personal y social asociado a esta patología. Como inconvenientes tiene la exposición a radiaciones ionizantes y el coste. Los inconvenientes y el coste del uso apropiado de la DEXA son mínimos comparados con el coste de la osteoporosis. Recomendaciones: La densidad mineral ósea debe evaluarse sólo cuando sea necesario para el manejo clínico del paciente. DEXA es el mejor método para medir la densidad mineral ósea. Salvo que se sospeche una pérdida de masa ósea acelerada la DEXA no debe repetirse antes de los 2 años para monitorizar tratamientos. Las medidas y los informes de resultados deben estandarizarse (AU)