Delphi-based recommendations for the management of cardiovascular comorbidities in patients with psoriatic arthritis and moderate-to-severe psoriasis.

The aim of this study was to generate practical recommendations to assist rheumatologists and dermatologists in the management of cardiovascular (CV) comorbidities in patients with moderate-to-severe psoriasis (MS-PSO) and psoriatic arthritis (PsA). A two-round Delphi study was conducted. A panel of experts rated their agreement with a set of statements (n = 52) on a nine-point Likert scale (1 = totally disagree; 9 = totally agree). Statements were classified as inappropriate (median 1-3), irrelevant (median 4-6) or appropriate (median 7-9). Consensus was established when at least two-thirds of the panel responded with a score within any one range. A total of 25 experts, 60% rheumatologists and 40% dermatologists, participated in two consultation rounds. There was overall unanimity on the appropriateness of an initial assessment for CV risk factors in all patients with MS-PSO and PsA. Most panelists (88.0%) also supported the evaluation of patients' psychological and physical status. Additionally, most panelists (72.2%) agreed on a novel sequential approach for the management of CV comorbidities. This sequence starts with the assessment of hypertension, diabetes and dyslipidemia along with the identification of depression and anxiety disorders. Once these factors are under control, smoking cessation programs might be initiated. Finally, if patients have not met weight loss goals with lifestyle modifications, they should receive specialized treatment for obesity. This study has drawn up a set of practical recommendations that will facilitate the management of CV comorbidities in patients with MS-PSO and PsA.

GLP-1 Receptor Agonists and Diabetic Kidney Disease: A Call of Attention to Nephrologists.

Type 2 diabetes mellitus (T2DM) represents the main cause of chronic kidney disease (CKD) and end-stage renal disease (ESKD), and diabetic kidney disease (DKD) is a major cause of morbidity and mortality in diabetes. Despite advances in the nephroprotective treatment of T2DM, DKD remains the most common complication, driving the need for renal replacement therapies (RRT) worldwide, and its incidence is increasing. Until recently, prevention of DKD progression was based around strict blood pressure (BP) control, using renin-angiotensin system blockers that simultaneously reduce BP and proteinuria, adequate glycemic control and control of cardiovascular risk factors. Glucagon-like peptide-1 receptor agonists (GLP-1RA) are a new class of anti-hyperglycemic drugs shown to improve cardiovascular and renal events in DKD. In this regard, GLP-1RA offer the potential for adequate glycemic control in multiple stages of DKD without an increased risk of hypoglycemia, preventing the onset of macroalbuminuria and slowing the decline of glomerular filtration rate (GFR) in diabetic patients, also bringing additional benefit in weight reduction, cardiovascular and other kidney outcomes. Results from ongoing trials are pending to assess the impact of GLP-1RA treatments on primary kidney endpoints in DKD.

Assessing the cost-effectiveness of a once-weekly GLP-1 analogue versus an SGLT-2 inhibitor in the Spanish setting: Once-weekly semaglutide versus empagliflozin.

Aims: Controlling costs while maximizing healthcare gains is the predominant challenge for healthcare providers, and therefore cost-effectiveness analysis is playing an ever-increasing role in healthcare decision making. The aim of the present analysis was to assess the long-term cost-effectiveness of subcutaneous once-weekly semaglutide (0.5 mg and 1 mg) versus empagliflozin (10 mg and 25 mg) in the Spanish setting for the treatment of patients with type 2 diabetes (T2D) with inadequate glycemic control on oral anti-hyperglycemic medications.Material and methods: The IQVIA CORE Diabetes Model was used to project outcomes over patient lifetimes with once-weekly semaglutide versus empagliflozin, with treatment effects based on a network meta-analysis. The analysis captured treatment costs, costs of diabetes-related complications, and the impact of complications on quality of life, based on published sources. Outcomes were discounted at 3.0% per annum.Results: Once-weekly semaglutide 0.5 mg and 1 mg were associated with improvements in discounted quality-adjusted life expectancy of 0.12 and 0.15 quality-adjusted life years (QALYs), respectively, versus empagliflozin 10 mg and improvements of 0.11 and 0.14 QALYs, respectively, versus empagliflozin 25 mg. Treatment costs were higher with once-weekly semaglutide compared with empagliflozin, but this was partially offset by cost savings due to avoidance of diabetes-related complications. Once-weekly semaglutide 0.5 mg and 1 mg were associated with incremental cost-effectiveness ratios of EUR 2,285 and EUR 161 per QALY gained, respectively, versus empagliflozin 10 mg, and EUR 3,090 and EUR 625 per QALY gained, respectively, versus empagliflozin 25 mg.Conclusions: Based on a willingness-to-pay threshold of EUR 30,000 per QALY gained, once-weekly semaglutide 0.5 mg and 1 mg were projected to be cost-effective versus empagliflozin 10 mg and 25 mg for the treatment of patients with T2D with inadequate glycemic control on oral anti-hyperglycemic medications in the Spanish setting, irrespective of patients' BMI at baseline.

Real-world clinical outcomes and predictors of glycaemic and weight response to exenatide once weekly in patients with type 2 diabetes: The CIBELES project.

AIMS: To evaluate in a real-world setting the effectiveness of exenatide once-weekly (ExQW) in patients with T2D and to determine predictors of glycaemic and weight response to this drug at 6 months. METHODS: Observational, retrospective, multicenter study in adult patients with T2D and BMI ≥30 kg/m2 from 4 tertiary Spanish hospitals who started ExQW therapy at least 6 months before the inclusion and had not achieved adequate glycaemic control on oral therapies or other GLP-1 receptor agonists. Glycaemic response was defined as an A1C reduction ≥1.0% and weight response as a weight loss ≥3% 6 months after ExQW. The best predictive models of glycaemic and weight response were estimated by binary logistic regression. RESULTS: One hundred and forty eight patients were included, mean age 58.0 years, A1C 7.7%, weight 105.9 kg and BMI 38.4 kg/m2 . A1C (-1.1%), weight (-3.9 kg), systolic blood pressure (-4.0 mm Hg), diastolic blood pressure (-2.9 mm Hg), LDL-cholesterol (-14.2 mg/dL) and triglycerides (-31.0 mg/dL) significantly decreased 6 months after ExQW. 41.5% of patients had an A1C reduction ≥1.0% and 53.1% lost ≥3% of baseline weight. Glycaemic and weight reductions were sustained in patients completing 1 and 2 years of follow-up. The best predictive model of glycaemic response only included higher A1C levels (OR 3.9), whereas higher BMI (OR 1.1) and prior DPP-4i therapy (OR 3.1) were associated to weight response in the multivariate analysis. CONCLUSIONS: In a real-world setting, ExQW significantly decreased A1C, weight, blood pressure and lipids at 6 months. Our study identified higher baseline A1C as the sole independent predictor of glycaemic response to ExQW and higher BMI and previous DDP4i treatment as predictive factors of meaningful weight response.

Relevance of weight in the management of patients with type 2 diabetes mellitus: towards an adipocentric approach to diabetes. / Importancia del peso en el control del paciente con diabetes mellitus tipo 2: hacia una visión adipocéntrica del abordaje de la diabetes.

In recent decades, there has been a worldwide parallel increase in the prevalence of obesity and type 2 diabetes mellitus (T2DM), which is not surprising, given that increased visceral fat is the main risk factor for the development of T2DM in genetically predisposed individuals. An intervention focused on intensive blood glucose control in T2DM with classic drugs increases the risk of weight gain and the rate of hypoglycaemia. In contrast, weight loss through lifestyle changes, drugs and/or surgery simultaneously improves most cardiovascular (CV) risk factors, including hyperglycemia. Intensive intervention on lifestyle induces an overall benefit in patients with T2DM, but long-term weight loss is modest and has not been shown to reduce CV morbidity and mortality. The emergence of new therapeutic classes for T2DM and obesity, which simultaneously improve HbA1c, weight and other CV risk factors without inducing hypoglycaemia, represents a major change in the management of patients with diabesity. A sodium-glucose cotransporter-2 inhibitor and a GLP-1 receptor agonist have recently been shown to decrease CV and total mortality in type 2 diabetic patients with CV disease. Furthermore, bariatric surgery rapidly induces remission or improvement of T2DM in a large percentage of patients and reduces diabetes-related mortality. The emergence of new therapies raises the possibility of changing the current glucose-centred therapeutic strategy for a weight-centred approach.

Position statement: hypoglycemia management in patients with diabetes mellitus. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition.

OBJECTIVE: To provide practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition. METHODS: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation system to describe both the strength of recommendations and the quality of evidence. A systematic search was made in MEDLINE (PubMed). Papers in English and Spanish with publication date before 15 February 2013 were included. For recommendations about drugs only those approved by the European Medicines Agency were included. After formulation of recommendations, they were discussed by the Working Group. CONCLUSIONS: The document provides evidence-based practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus.

[A retrospective cohort study of patients diagnosed of thyroid cancer in the southwest Madrid area. Predictive factors in differentiated thyroid cancer]. / Estudio de cohorte retrospectivo de pacientes diagnosticados de cáncer de tiroides del área suroeste de Madrid. Factores pronósticos en el cáncer diferenciado de tiroides.

OBJECTIVES: To analyze the clinical and histopathological features of patients with thyroid cancer in the southwest Madrid area and to identify poor prognostic factors in the subgroup with differentiated thyroid carcinoma (DTC) of the follicular epitelium. PATIENTS AND METHODS: A retrospective cohort study of patients diagnosed with thyroid cancer at our hospital from 1998 to 2009. Significant clinical, surgical, and histopathological variables were included in Cox proportional hazard and logistic regression models to identify baseline factors predicting for death, recurrence, and persistent disease in DTC. RESULTS: A total of 150 patients with a median age of 49 years and a median follow-up of 5.4 years were enrolled. Histological subtypes were: papillary carcinoma (86%), follicular carcinoma (6.6%), medullary carcinoma (4%), poorly differentiated carcinoma (2.7%), and anaplastic carcinoma (0.7%). At the end of the study, 68% of patients were cured, 3.3% had died (disease-specific mortality, 1.3%), 1.3% were lost to follow-up, 6.7% had persistent biochemical disease, and 2.7% persistent clinical disease, while 18% of patients were pending assessment. The best prognostic model for DTC recurrence was TNM staging (stage II-IV vs. I: HR 5.9, 95% CI 1.3-26.6), while the best model for persistent disease or death was ETA clinical staging (high risk vs. low or very low risk: OR 9.2, 95% CI 2.6-33.2). CONCLUSIONS: In our study, disease-specific mortality and persistent clinical disease were low. Classification of DTC patients based on ETA staging after initial treatment was a good predictor of persistent disease or death.

[Glucocentricity or adipocentricity: a critical view of consensus and clinical guidelines for the treatment of type 2 diabetes mellitus]. / Glucocentrismo o adipocentrismo: una visión crítica de los consensos y guías clínicas para el tratamiento de la diabetes mellitus tipo 2.

Eighty percent of patients with type 2 diabetes mellitus (T2DM) are overweight or obese, which in turn is associated with other cardiovascular risk factors and an increased risk of cancer. Large intervention studies focused on intensive glycemic control have failed to show a reduction of cardiovascular events in T2DM patients. The two major concerns in these studies were weight gain and severe hypoglycemia in the arms of intensive intervention, which could have mitigated the potential beneficial effect of glycemic control. On the contrary, weight loss in diabetic patients through changes in lifestyle, drugs and/or surgery simultaneously improves all cardiovascular risk factors including hyperglycemia. Bariatric surgery has shown an early resolution of T2DM in a large percentage of patients and a decrease of diabetes-specific mortality. Despite this, all consensus and recommendations for the treatment of T2DM focus their decisions on the glycated hemoglobin value. This article aims to open a debate on the need to replace the glucose-centered therapeutic strategy for a weight-centered strategy.

[Evolution of psychopathological alterations in patients with morbid obesity after bariatric surgery]. / Evolución de alteraciones psicopatológicas en pacientes con obesidad mórbida tras cirugía bariátrica.

BACKGROUND AND OBJECTIVE: The aims of this study were to know the prevalence of the psychopathological alterations among patients with morbid obesity (MO) candidates for bariatric surgery in our centre, to analyze its predictive value on the surgical outcome and to study the evolution after weight stabilization was achieved. PATIENTS AND METHODS: One hundred and forty five patients of the University Hospital Foundation Alcorcón (122 women) candidates for bariatric surgery (108 finally operated) were included in the study. A clinical interview was carried and several scales of psychopathology were applied before and after surgery: Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Maudsley Obsessive-compulsive Interview (MOCI), Barrat Impulsiveness Scale (BIS), Eating Disorder Inventory (EDI), Eating Attitudes Test (EAT), Bulimic Investigation Test Edinburg (BITE), and Body Shape Questionnaire (BSQ). A comparison of means between the initial and final scores of the psychometric tests and a logistic regression analysis to identify the predictive variables of positive evolution after surgery (defined as percentage of lost overweight> 50% and final IMC <35) were performed. RESULTS: An improvement in the scores of BDI, BAI and in the subscales of EDI, Impulse to the thinness (EDI-DT) and corporal Dissatisfaction (EDI-BD) was observed. The differences were not significant for the rest of the psychometric tests. The multivariate analysis identified 3 predictive factors for postsurgical evolution: BDI (OR 0.91, IC95% 0.82-1.02), BIS (OR 1.08, IC 95% 1.0-1.16) y EDI-DT (OR 1.18, IC 95% 1.0-1.39). CONCLUSIONS: In our study, the scales of depression, anxiety, impulse to thinness and corporal dissatisfaction improved in patients with MO after bariatric surgery. Some baseline psychometric variables may predict a favourable postsurgical evolution of these patients.