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.

Osteotomía de descarga ambulatoria mínimamente invasiva en el tratamiento de la úlcera de pie diabético: análisis de 25 pacientes / Minimally invasive offloading osteotomy in the treatment of diabetic foot ulcer: Analysis of 25 patients

Introducción: La diabetes mellitus y sus complicaciones suponen uno de los mayores problemas sanitarios en la actualidad. La úlcera del pie diabético es una de las complicaciones más características. Material, métodos y objetivo: El objetivo es describir los resultados y complicaciones obtenidos en una serie de 25 casos de úlcera neuropática tratada mediante osteotomías de descarga mínimamente invasivas y ambulatorias. Resultados: Del total de intervenciones, 18 fueron sobre úlceras refractarias a un tratamiento conservador previo de una duración media±desviación estándar de 29,28±18,42 meses. El período de seguimiento fue 26,46±4,89 meses. Las tasas agrupadas de respuesta al tratamiento fueron: 100% cicatrización de la úlcera (tiempo medio de cicatrización 22,41±7,01 días), 5,56% recurrencia de la úlcera, 16,67% translocación de la úlcera. En 7 casos se realizó una intervención preventiva sobre áreas con lesiones preulcerosas. Del total, únicamente 3 presentaron infección leve en la zona de la intervención. Conclusiones: La osteotomía de descarga mínimamente invasiva ambulatoria es un procedimiento técnicamente sencillo, que presenta una alta tasa de éxito con mínimas complicaciones en nuestra serie. (AU)

Introduction: Diabetes mellitus and its complications are one of the main burdensome health problems at the present time. The diabetic foot is one of the most characteristic complications. Material, methods and objective: The objective of this work is to describe the results and complications obtained in a series of 25 cases of diabetic foot treated by minimally invasive offloading osteotomies. Results: Of the total number of interventions, 18 were performed on refractory ulcers with prior conservative treatment, for a mean (±SD) duration of 29.28±18.42 months. The mean follow-up period was 26.46±4.89 months. Weighted pooled rates of response to treatment were as follows: 100% for ulcer healing (with a mean healing time of 22.41±7.01 days), 5.56% for ulcer recurrence, and 16.67% for ulcer transfer. In 7cases, a preventive intervention was performed on areas with pre-ulcerative lesions. Of the total number of cases, only 3presented mild infection in the intervention area. Conclusions: Minimally invasive offloading osteotomy is a technically simple intervention, which presents a high success rate with minimal complications in our series. (AU)

[Minimally invasive offloading osteotomy in the treatment of diabetic foot ulcer: Analysis of 25 patients]. / Osteotomía de descarga ambulatoria mínimamente invasiva en el tratamiento de la úlcera de pie diabético: análisis de 25 pacientes.

INTRODUCTION: Diabetes mellitus and its complications are one of the main burdensome health problems at the present time. The diabetic foot is one of the most characteristic complications. MATERIAL, METHODS AND OBJECTIVE: The objective of this work is to describe the results and complications obtained in a series of 25 cases of diabetic foot treated by minimally invasive offloading osteotomies. RESULTS: Of the total number of interventions, 18 were performed on refractory ulcers with prior conservative treatment, for a mean (±SD) duration of 29.28±18.42 months. The mean follow-up period was 26.46±4.89 months. Weighted pooled rates of response to treatment were as follows: 100% for ulcer healing (with a mean healing time of 22.41±7.01 days), 5.56% for ulcer recurrence, and 16.67% for ulcer transfer. In 7cases, a preventive intervention was performed on areas with pre-ulcerative lesions. Of the total number of cases, only 3presented mild infection in the intervention area. CONCLUSIONS: Minimally invasive offloading osteotomy is a technically simple intervention, which presents a high success rate with minimal complications in our series.

Glucagon-Like Peptide 1 Receptor Agonists in Type 2 Diabetes Mellitus: Data from a Real-World Study in Spain.

INTRODUCTION: This study aimed to describe utilization patterns, persistence, resource utilization and costs in patients with type 2 diabetes mellitus initiating treatment with glucagon-like peptide 1 receptor agonists in routine clinical practice in Spain. METHODS: This retrospective study of medical records in the Big-Pac database identified adults starting treatment with once-weekly (QW) dulaglutide, exenatide-QW or once-daily liraglutide between 1 November 2015 and 30 June 2017. Patients were followed for up to 18 months from treatment initiation. Data on clinical characteristics of patients, treatment patterns, average daily dose and costs were obtained for the three cohorts. Persistence over the 18-month period was evaluated using Kaplan-Meier curves. All analyses were descriptive. RESULTS: A total of 1402 patients were included in this study (dulaglutide [n = 492], exenatide-QW [n = 438] or liraglutide [n = 472]); 52.8% were men, and the mean (SD) age was 62 (11) years, glycated haemoglobin (HbA1c) was 8.1% (1.2) and body mass index was 35.5 (3.2) kg/m2 at treatment initiation. Persistence at 18 months was 59.1% (95% confidence interval [CI] 54.8-63.4) for dulaglutide, 45.7% (95% CI 41.0-50.4) for exenatide-QW and 46.6% (95% CI 42.1-51.1) for liraglutide. The average (SD) dose was 1.2 (0.4) mg/week for dulaglutide, 1.9 (0.3) mg/week for exenatide-QW and 1.1 (0.3) mg/day for liraglutide. The average reduction in HbA1c levels at 1 year was - 0.68% for patients who initiated dulaglutide, - 0.54% for patients who initiated exenatide-QW and - 0.50% for patients who initiated liraglutide. The mean (SD) total annual health care costs were €4072 (1946) for dulaglutide, €4418 (2382) for exenatide-QW and €4382 (2389) for liraglutide. CONCLUSION: Results suggest that patients who started treatment with dulaglutide had higher persistence over 18 months, presented lower HbA1c levels at 12 months and incurred lower annual total healthcare costs than patients who initiated exenatide-QW or liraglutide.

Type 2 diabetes has a major impact on patients psychologically and socially, as well as on healthcare costs. The glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are drugs that help maintain blood sugar at healthy levels. They are often used as the first injectable drugs if oral treatments are no longer effective. This study aimed to analyse the use of GLP-1 RAs, and the costs involved, among patients with type 2 diabetes who started treatment with once-weekly dulaglutide, once-weekly exenatide or liraglutide in routine clinical practice in Spain. An electronic database of medical records was used to obtain data from 1402 patients who started treatment with these drugs and were followed for a 1.5-year period. Results of this study suggest that patients who were prescribed dulaglutide stayed on their treatment longer and could reduce their blood sugar levels more efficiently, and at a lower cost, than those who received once-weekly exenatide or liraglutide. These findings could be helpful to physicians prescribing these drugs when considering how to improve the management of type 2 diabetes.

Estructura diagnóstica y funcional de una consulta de alta resolución de nódulo tiroideo / Diagnostic and functional structure of a high-resolution thyroid nodule clinic

La aparición de un nódulo tiroideo se ha convertido en un hecho cotidiano en la práctica clínica diaria. Habitualmente, la adecuada evaluación del nódulo tiroideo requiere la realización de diversas pruebas diagnósticas y múltiples citas médicas, con la consiguiente demora diagnóstica. La instauración de una consulta de alta resolución de nódulo tiroideo evita en gran medida estos inconvenientes, condensando en una única cita todas las pruebas necesarias para la correcta evaluación del nódulo tiroideo. En este trabajo revisamos cuál debe ser la estructura diagnóstica y funcional de una consulta de alta resolución de nódulo tiroideo

Appearance of a thyroid nodule has become a daily occurrence in clinical practice. Adequate thyroid nodule assessment requires several diagnostic tests and multiple medical appointments, which results in a substantial delay in diagnosis. Implementation of a high-resolution thyroid nodule clinic largely avoids these drawbacks by condensing in a single appointment all tests required for adequate evaluation of thyroid nodule. This paper reviews the diagnostic and functional structure of a high-resolution thyroid nodule clinic

Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).

OBJECTIVE: Compare the efficacy and safety of monotherapy with dulaglutide, a once-weekly GLP-1 receptor agonist, to metformin-treated patients with type 2 diabetes. The primary objective compared dulaglutide 1.5 mg and metformin on change from baseline glycosylated hemoglobin A1c (HbA1c) at 26 weeks. RESEARCH DESIGN AND METHODS: This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin. Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period. RESULTS: At 26 weeks, changes from baseline HbA1c (least squares [LS] mean ± SE) were: dulaglutide 1.5 mg, -0.78 ± 0.06% (-8.5 ± 0.70 mmol/mol); dulaglutide 0.75 mg, -0.71 ± 0.06% (-7.8 ± 0.70 mmol/mol); and metformin, -0.56 ± 0.06% (-6.1 ± 0.70 mmol/mol). Dulaglutide 1.5 and 0.75 mg were superior to metformin (LS mean difference): -0.22% (-2.4 mmol/mol) and -0.15% (-1.6 mmol/mol) (one-sided P < 0.025, both comparisons), respectively. Greater percentages reached HbA1c targets <7.0% (<53 mmol/mol) and ≤6.5% (≤48 mmol/mol) with dulaglutide 1.5 and 0.75 mg compared with metformin (P < 0.05, all comparisons). No severe hypoglycemia was reported. Compared with metformin, decrease in weight was similar with dulaglutide 1.5 mg and smaller with dulaglutide 0.75 mg. Over 52 weeks, nausea, diarrhea, and vomiting were the most common adverse events; incidences were similar between dulaglutide and metformin. CONCLUSIONS: Dulaglutide improves glycemic control and is well tolerated as monotherapy in patients with early stage type 2 diabetes.

Diagnostic and functional structure of a high-resolution thyroid nodule clinic.

Appearance of a thyroid nodule has become a daily occurrence in clinical practice. Adequate thyroid nodule assessment requires several diagnostic tests and multiple medical appointments, which results in a substantial delay in diagnosis. Implementation of a high-resolution thyroid nodule clinic largely avoids these drawbacks by condensing in a single appointment all tests required for adequate evaluation of thyroid nodule. This paper reviews the diagnostic and functional structure of a high-resolution thyroid nodule clinic.

[Routine performance of thyroid ultrasound and fine-needle aspiration biopsy in the setting of a high-resolution endocrinology practice]. / Incorporación de la ecografía y la punción de tiroides a la actividad de endocrinología en una consulta de alta resolución.

INTRODUCTION: Fine-needle aspiration biopsy (FNAB) is considered the reference diagnostic procedure for thyroid nodules. MATERIALS AND METHODS: Routine performance of thyroid ultrasound and ultrasound-guided FNAB by endocrinologists allows a more efficient approach in the setting of a high-resolution practice, thus reducing costs and the time elapsed until diagnosis. RESULTS: We present our initial results of this procedure 2 years after its introduction, with a total of 286 biopsies performed. After a progressive learning curve over time and according to the endocrinologists' previous experience, 72.72% samples were considered satisfactory for diagnosis. Greater difficulty was observed in obtaining optimal cytological specimens in smaller nodules. In conclusion, we have successfully incorporated thyroid ultrasound and ultrasound-guided FNAB into routine endocrine practice. CONCLUSION: Routine performance of thyroid ultrasound in endocrine practice will considerably aid the management of nodular thyroid disease.

Incorporación de la ecografía y la punción de tiroides a la actividad de endocrinología en una consulta de alta resolución / Routine performance of thyroid ultrasound and fine-needle aspiration biopsy in the setting of a high-resolution endocrinology practice

Introducción La PAAF es el procedimiento de referencia para el diagnóstico del nódulo tiroideo. Material y métodos La incorporación de la ecografía cervical y la PAAF guiada por ecografía a la actividad del médico endocrinólogo permite abordar esta patología en el ámbito de una consulta de alta resolución, con la consiguiente reducción en el coste del proceso y en la demora del diagnóstico. Resultados Presentamos los resultados iniciales de esta consulta; tras los dos primeros años y con un total de 286 punciones, nos situamos en un 72,72% de citologías aptas para diagnóstico, siguiendo una curva de aprendizaje acorde con el tiempo transcurrido y con la experiencia previa. Observamos una mayor dificultad en la obtención de citologías óptimas para diagnóstico en los nódulos de menor tamaño. En resumen, hemos incorporado la ecografía y la PAAF guiada por ecografía de manera satisfactoria a la consulta endocrinológica. Conclusión El uso de manera rutinaria de la ecografía en la consulta de endocrinología permite agilizar el manejo de la patología nodular tiroidea (AU)

Introduction Fine-needle aspiration biopsy (FNAB) is considered the reference diagnostic procedure for thyroid nodules. Materials and methods Routine performance of thyroid ultrasound and ultrasound-guided FNAB by endocrinologists allows a more efficient approach in the setting of a high-resolution practice, thus reducing costs and the time elapsed until diagnosis. Results We present our initial results of this procedure 2 years after its introduction, with a total of 286 biopsies performed. After a progressive learning curve over time and according to the endocrinologists’ previous experience, 72.72% samples were considered satisfactory for diagnosis. Greater difficulty was observed in obtaining optimal cytological specimens in smaller nodules. In conclusion, we have successfully incorporated thyroid ultrasound and ultrasound-guided FNAB into routine endocrine practice. Conclusion Routine performance of thyroid ultrasound in endocrine practice will considerably aid the management of nodular thyroid disease (AU)

24-hour and nighttime blood pressures in type 2 diabetic hypertensive patients following morning or evening administration of olmesartan.

Ambulatory blood pressure monitoring (ABPM) allows determining of the nocturnal blood pressure fall (NBPF). An NBPF below 10% (nondipper pattern) has been related to increased cardiovascular risk, and it is a common finding in type 2 diabetic hypertensive patients. The authors evaluated the impact on 24-hour blood pressure, NBPF, and albuminuria of olmesartan 40 mg, administered in a morning- vs a nocturnal-based dosing scheme, in type 2 diabetic patients with newly diagnosed hypertension. Using a crossover design, 40 patients (42.1% men) received olmesartan 40 mg once daily at wake up or bedtime for 8 weeks. Patients underwent 24-hour ABPM at baseline and at weeks 8 and 16, and albumin to creatinine ratio was measured at baseline and 8 weeks. Night systolic blood pressure (BP) (P=.007) and mean BP (P=.012) were significantly reduced following the bedtime dose, compared with morning dosing. Night BP fall (%) was significantly reduced by bedtime dosing, compared with morning dosing (P=.0001). No differences were seen for urinary albumin excretion between both arms at week 8. Without affecting 24-hour BP control, night dosing of olmesartan increases nocturnal BP fall significantly more than conventional morning dosing, increasing the number of dipper diabetic hypertensive patients.