Use of Tirzepatide in Adults with Type 2 Diabetes Mellitus: Scientific Evidence and Practical Aspects.

Tirzepatide is a novel antidiabetic medication a single-molecule, agonist to the glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptors. It is approved in the USA and EU for the treatment of type 2 diabetes mellitus (T2DM) and obesity. Due to the potential novelty represented by incorporating tirzepatide to clinical practice, we aim to review practical aspects of tirzepatide use in T2DM and the supporting scientific evidence. A group of ten endocrinologists involved as investigators in the phase 3 SURPASS clinical trial program followed a nominal group technique, a qualitative research methodology designed as a semi-structured group discussion to reach a consensus on the selection of a set of practical aspects. The scientific evidence for tirzepatide has been reviewed with respect to a number of patients' clinical profiles and care goals. Information of interest related to adverse events, special warnings and precautions, and other considerations for tirzepatide use has been included. Finally, information provided to the patients has been summarized. The practical aspects reported herein may be helpful in guiding physicians in the use of tirzepatide and contribute to optimizing the management of T2DM.

Real-World Evaluation of Once-Weekly Subcutaneous Semaglutide in Patients with Type 2 Diabetes Mellitus in Spain (SEMA-RW Study).

Although, in randomized clinical trials, once-weekly subcutaneous semaglutide (OW s.c.) has demonstrated superior efficacy in comparison with placebo and active controls in terms of glycemic control and body weight reduction in patients with type 2 diabetes mellitus (T2DM), these results need to be confirmed in a real-world (RW) setting. An RW ambispective study (6 months retrospective and 6 months prospective) was conducted in 10 tertiary hospitals in Spain. We evaluated changes in HbA1c and body weight in patients with T2DM treated with semaglutide OW s.c. Additionally, we analyzed different subgroups of patients treated with semaglutide OW s.c. as an add-on to glucose-lowering therapy. A total of 752 patients with a mean age of 60.2 years, a mean HbA1c level of 8.5%, a mean body weight of 101.6 kg, and a mean T2DM duration of 10 years were included. At 12 months, compared with baseline, there was a mean difference of -2.1% in HbA1c levels (p < 0.001) and a mean difference of 9.2 kg in body weight (p < 0.001). Moreover, there were statistically significant differences (p < 0.001) between baseline and month 12 in both HbA1c and body weight in the four subgroups receiving semaglutide OW s.c. as an add-on to glucose-lowering therapy. Semaglutide OW s.c. was well tolerated, with gastrointestinal disorders being the most commonly reported side effects. In this RW study, 12 months of treatment with semaglutide OW s.c. in patients with T2DM was associated with significant and clinically relevant improvements in glycemic control and weight loss, regardless of the glucose-lowering therapy received, and the overall safety profile was positive.

ZODIAC: Consenso para la prevención del herpes zóster en personas con diabetes mellitus / ZODIAC: Consensus on herpes zoster prevention in persons with diabetes mellitus

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Relación entre el control metabólico y la automonitorización de la glucemia capilar en pacientes con diabetes mellitus tratados con insulina / Relationship between metabolic control and self-monitoring of blood glucose in insulin-treated patients with diabetes mellitus

OBJETIVO: Evaluar la relación entre el grado de control metabólico (CM) y la frecuencia de la automonitorización de la glucemia capilar (AGC) en pacientes con diabetes mellitus (DM) tipo 1 (DM1) y 2 (DM2) tratados con insulina, y analizar factores asociados al CM. MATERIAL Y MÉTODOS: Estudio observacional multicéntrico transversal en el que endocrinólogos incluyeron a pacientes con DM tratados con insulina que utilizaban un glucómetro. El punto de corte para definir un CM fue una HbA1c ≤ 7% y no control > 7%. Se valoró en una escala analógica visual (EAV) el grado de aceptación del glucómetro. RESULTADOS: Fueron evaluables 341 pacientes (53,5% varones), con una edad media ± DE de 52,8 ± 16,3 años, HbA1c media de 7,69 ± 1,25%, 128 (37,5%) con DM1 y 211 (61,9%) con DM2. El 86,1% de los pacientes utilizaron el glucómetro al menos una vez en la semana. No se observó ninguna relación entre el CM y la AGC ni en la muestra total (p = 0,678), ni en DM1 (p = 0,940) ni DM2 (p = 0,343). En el modelo de regresión logística, se asociaron a un mal CM en la muestra total y en DM2 los episodios de hiperglucemias (Exp-b [riesgo] 1,794, p = 0,022, y Exp-b 2,538, p = 0,004, respectivamente), las concentraciones de HbA1c falsamente elevadas (Exp-b 3,182 p = 0,005, y Exp-b 3,125, p = 0,012), y la EAV (Exp-b 1,269, p = 0,008, y Exp-b 1,316, p = 0,026), y en la DM1 el índice de masa corporal (Exp-b 1,143, p = 0,046). CONCLUSIONES: En este estudio observacional no controlado en pacientes con DM tratados con insulina que utilizan un glucómetro no se observa ninguna relación entre el grado de CM y la frecuencia de su uso en el último mes

OBJECTIVE: To assess the relationship between metabolic control (MC) and frequency of self-monitoring of blood glucose (SMBG) in insulin-treated patients with type 1 (T1DM) and type 2 (T2DM) diabetes mellitus, and to analyze the factors associated to MC. MATERIAL AND METHODS: A multicenter, cross-sectional, observational study was conducted in which endocrinologists enrolled diabetic patients treated with insulin who used a glucometer. The cut-off value for MC was HbA1c ≤ 7%. Grade of acceptance of the glucometer was assessed using a visual analogue scale (VAS). RESULTS: A total of 341 patients (53.5% males) with a mean age (SD) 52.8 (16.3) years, mean HbA1c of 7.69% (1.25) and 128 (37.5%) with T1DM and 211 (61.9%) with T2DM were evaluable. SMBG was done by 86.1% at least once weekly. No relationship was seen between MC and SMBG (P=.678) in the overall sample or in the T1DM (P=.940) or T2DM (P=.343) subgroups. In the logistic regression model, hyperglycemic episodes (Exp-b [risk] 1.794, P=0.022), falsely elevated HbA1c values (Exp-b 3.182,P=.005), and VAS (Exp-b 1.269, P=.008) were associated to poor MC in the total sample. Hyperglycemic episodes (Exp-b 2.538, P=.004), falsely elevated HbA1c values (Exp-b 3.125, P=.012), and VAS (Exp-b 1.316, P=.026) were associated to poor MC in the T2DM subgroup, while body mass index (Exp-b 1.143, P=.046) was associated to poor MC in the T1DM subgroup. CONCLUSIONS: In this retrospective, non-controlled study on patients with DM treated with insulin who used a glucometer, no relationship was seen between the degree of metabolic control and frequency of use of the glucometer

Documento de posicionamiento: evaluación y manejo de la hipoglucemia en el paciente concon diabetes mellitus. Grupo de Trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición / Position statement: Hypoglycemia management in patients with diabetes mellitus. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition

Objetivo Proporcionar unas recomendaciones prácticas para la evaluación y el manejo de la hipoglucemia en pacientes con diabetes mellitus. Participantes Miembros del Grupo de Trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición (SEEN).Métodos Las recomendaciones se formularon de acuerdo al sistema Grading of Recommendations, Assessment, Development, and Evaluation para establecer tanto la fuerza de las recomendaciones como el grado de evidencia. Se realizó una búsqueda sistemática en MEDLINE (PubMed) de la evidencia disponible para cada tema, y se revisaron artículos escritos en inglés y castellano con fecha de inclusión hasta el 15 de febrero de 2013. Para las recomendaciones acerca del uso de fármacos, se consideraron tratamientos aprobados por la Agencia Europea de Medicamentos con esa misma fecha. Tras la formulación de las recomendaciones estas se discutieron conjuntamente por el Grupo de trabajo. Conclusiones El documento establece unas recomendaciones prácticas basadas en la evidencia acerca de la evaluación y manejo de la hipoglucemia en pacientes con diabetes mellitus (AU)

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 (AU)

Distribución de la circunferencia de la cintura y de la relación circunferencia de la cintura con respecto a la talla según la categoría del índice de masa corporal en los pacientes atendidos en consultas de endocrinología y nutrición / Distribution of waist circumference and waist-to-height ratio by categories of body mass index in patients attended in endocrinology and nutrition units

Introducción La circunferencia de cintura (CC) y la relación circunferencia de cintura/talla (CT) son medidas antropométricas muy utilizadas en la práctica clínica para valorar la grasa visceral y por tanto el riesgo cardiovascular. Sin embargo, los umbrales de riesgo para diferentes rangos de índice de masa corporal (IMC) no han sido suficientemente validados.ObjetivoDeterminar la distribución de CC y CT en función de los puntos de corte de IMC actualmente vigentes para definir el sobrepeso y la obesidad.Material y métodosSe determinó la CC, la CT y el IMC en 3521 pacientes adultos (mayores de 18 años) atendidos en las consultas de endocrinología y nutrición.ResultadosEl 20,8% (734) de los pacientes eran diabéticos. El 82,1% de los pacientes diabéticos eran obesos, así como el 75% de los no diabéticos. Los umbrales de riesgo (..) (AU)

Introduction Waist circumference (WC) and the waist-to-height ratio (WHtR) are anthropometric measures widely used in clinical practice to evaluate visceral fat and the consequent cardiovascular risk. However, risk thresholds should be standardized according to body mass index (BMI).ObjectiveTo determine the distribution of WC and WHtR according to the BMI cut-points currently used to describe overweight and obesity.Materials and methodsWC, WHtR and BMI were measured in 3521 adult patients (>18 years) attended in Endocrinology and Nutrition units.ResultsA total of 20.8% (734 patients) were diabetic. Obesity was found in 82.1% of diabetic patients and in 75% of non-diabetic patients. The WC thresholds proposed by the National Institute of Health (..) (AU)

Síndrome metabólico e inflamación / Metabolic syndrome and inflammation

Introducción. Los pacientes con síndrome metabólico (SM) presentan un incremento del riesgo de presentar ateroesclerosis y enfermedad cardiovascular. La inflamación desempeña un papel crucial en el proceso de la ateroesclerosis. Varios estudios, aunque son escasos, han demostrado la relación entre la elevación de los valores de ferritina, con cada uno de los componentes del SM. Material y métodos. Se realizó un estudio de cohorte, transversal con 598 individuos con sobrepeso u obesidad. Se estudió la composición corporal y los parámetros analíticos: glucosa, insulina, colesterol total, triglicéridos, colesterol unido a lipoproteínas de alta densidad (cHDL) y ferritina. La resistencia a la insulina (RI) se valoró por el método HOMA. Para definir el SM se emplearon los criterios del ATP III. Resultados. Se observaron valores de ferritina significativamente más altos en los pacientes con valores mayores de triglicéridos (124,6 ng/ml frente a 65,0 ng/ml; p = 0,001) o glucosa (105,9 ng/ml frente a 78,6 ng/ml; p = 0,023). El número de criterios del SM se incrementa al aumentar los valores de ferritina. Los pacientes con RI presentan valores superiores de ferritina (119,27 ng/ml frente a 79,05 ng/ml; p = 0,001), con un área bajo la curva ROC (receiver operating characteristic) de 0,678. Conclusiones. El hecho de utilizar parámetros inflamatorios como la ferritina podría resultar útil como marcador temprano del proceso inflamatorio subclínico crónico, en la práctica clínica diaria (AU)

Introduction. Patients with metabolic syndrome (MS) have an increased risk to have atherosclerosis and cardiovascular disease. Inflammation plays a crucial role in the atherosclerosis process. Some studies, even few, have shown the relationship between high levels of ferritin, with each component of the MS. Material and methods. We studied 598 patients with overweight or obesity. We evaluated: the body composition and analytical parameters: glucose, cholesterol, triglycerides, high-density cholesterol and ferritin. Insulin resistance (IR) was defined by HOMA method. ATP III criteria were used to define MS. Results. Higher levels of triglycerides have significant more elevated levels of ferritin (124.6 ng/ml versus 65.0 ng/ml; p = .001) or glucose (105.9 ng/ml versus 78.6 ng/ml; p = .023). The number of components of the MS increases with the values of ferritin. Patients with IR have higher values of ferritin (119.27 ng/ml versus 79.05 ng/ml; p = .001), with an area under the ROC curve of 0.678. Conclusions. An Inflammatory parameter as ferritin could be useful and a precocious marker to evaluate chronic subclinic inflammatory process in daily medical practice (AU)