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Introduction: Diabetes stands as one of the leading causes of death worldwide. Glucagon-like peptide-1 receptor agonists rank among the most effective medications for lowering blood glucose and body weight, as well as reducing cardiovascular risk in individuals with diabetes. Observational studies complement experimental evidence in new settings, different populations, and real-world healthcare practices. Methods: A multicentric observational study of adults with type 2 diabetes treated with once-weekly subcutaneous semaglutide in four health centers in Colombia was conducted. The protocol for the present study was not pre-registered. Results: Data from 186 patients were included. Most patients were women (57%) with a mean age of 62.8 ± 12.1 years. One year of once-weekly semaglutide usage was associated with a mean reduction in HbA1C of -1.47% (95% CI -1.76, -1.17), weight loss of -4.23 kg (95% CI -5.34, -3.12), and albumin/creatinine ratio of -18.6 mg/g (95% CI -60.2, -5.9). Approximately half the treated patients achieved a level of HbA1c ≤7% by the end of follow-up. Adverse events were rare and consistent with clinical trial safety profiles. Conclusion: In Colombia, administering semaglutide subcutaneously once a week over a 1-year period led to an average weight loss of 4.2 kg and a decrease of 1.4% in HbA1c.
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Diabetes Mellitus Tipo 2 , Peptídeos Semelhantes ao Glucagon , Hipoglicemiantes , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Peptídeos Semelhantes ao Glucagon/efeitos adversos , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/sangue , Estudos Retrospectivos , Colômbia , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/uso terapêutico , Hipoglicemiantes/efeitos adversos , Idoso , Hemoglobinas Glicadas/análise , Glicemia/efeitos dos fármacos , Glicemia/análise , Resultado do Tratamento , Esquema de MedicaçãoRESUMO
INTRODUCTION: Insulin degludec/liraglutide (IDegLira) is a fixed-ratio combination of insulin degludec (a basal insulin) and liraglutide (a glucagon-like peptide-1 receptor agonist [GLP-1RA]). This study aimed to investigate clinical outcomes in people with type 2 diabetes mellitus (T2DM) after initiating IDegLira treatment in a real-world setting in Colombia. METHODS: SPIRIT is a non-interventional, single-arm, retrospective chart review study to assess clinical outcomes in people with T2DM. Participating patients were switched from a treatment regimen of basal insulin (with or without oral antidiabetics [OADs]) and started on treatment with IDegLira a minimum of 26 ± 6 weeks before the data collection start date. Data were collected from the medical records of 175 patients in ten clinical centers across Colombia. RESULTS: Compared with baseline, there was a significant reduction in glycated hemoglobin (HbA1c) (1.3%; 95% confidence interval [CI] - 1.6 to - 1.0; p < 0.0001) after 26 ± 6 weeks of follow-up. The mean HbA1c at baseline and at the end of the study was 9.1% and 7.8%, respectively. In addition, IDegLira significantly reduced absolute body weight by 1 kg (95% CI - 1.5 to - 0.5; p < 0.0001), from a mean of 76.1 kg at baseline to 75.1 kg after follow-up. The mean IDegLira dose at the end of the study was 21.3 U, and no severe hypoglycemic events were observed during the follow-up period. CONCLUSION: In real-world practice, initiating IDegLira in patients with T2DM previously treated with basal insulin (± OAD) was associated with improved glycemic control, reduced body weight and reduced risk of hypoglycemia. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05324462.
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Purpose: Diabetes is a public health problem that requires strategies to impact glycemic control and reduce the risk of long-term medical complications. Pharmacological management is a necessary treatment for this disease. Therefore, semaglutide is an essential tool to achieve the treatment targets. The present study aimed to evaluate the semaglutide effects on a cohort with type 2 diabetes mellitus (T2DM) in Colombia. Materials and Methods: The cohort included 49 patients with T2DM that have been treated in a specialized care center. Their glycemic outcomes, weight, renal function, and adverse events were evaluated through a 3-, 6- and 12-month follow-up. Results: Significant differences were observed in the outcome evaluation: reduction of glycated hemoglobin levels (MD -2.74 CI -1.95 to -3.52 in 6 months), fasting plasma glucose levels, body weight (MD -7.11 CI -5.97 to -8.24), and the albumin-to-creatinine ratio. The results were maintained throughout the treatment period. The adverse event rate was 16.3%, predominating gastrointestinal events. Conclusion: This real-world evidence shows the efficacy of semaglutide in achieving treatment goals in patients with T2DM.
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Background: Type 2 diabetes mellitus (T2DM) is a chronic, highly prevalent disease with a significant impact on health. Appropriate treatment requires effective and timely escalation to achieve metabolic control. To evaluate the effectiveness and safety of IDegLira on adults with T2DM previously treated with oral antidiabetics and/or insulin in a real-life setting. Methods: An observational study in a real-world setting was conducted. Patients were selected from the outpatient clinic of two centers dedicated to specialized diabetes care. Main outcomes were HbA1c, body weight, insulin dose changes, hypoglycemia, and other adverse events. Results: 67 T2DM patients treated with IDegLira were monitored between 3 and 7 months. At the end of foll ow-up, the median change in HbA1c was -1.05% (CI95% -1.45, -0.65), and a decrease in insulin requirement was also observed (mean difference -10 TDD units (CI95% - 17 to -2.5). No treatment discontinuation was reported, hypoglycemia events were reported in 3 patients at the end of follow-up versus 8 patients at baseline. Conclusions: This real-life study shows the effectiveness in glycemic control of IDegLira use in T2DM patients who do not achieve goals with other therapies, with an adequate safety profile. The findings need to be confirmed with evaluation of therapeutic results in larger cohorts.
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Diabetes Mellitus Tipo 2 , Hipoglicemia , Adulto , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/tratamento farmacológico , Combinação de Medicamentos , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/prevenção & controle , Insulina/uso terapêutico , Insulina de Ação Prolongada , LiraglutidaRESUMO
Resumen Introducción: el abordaje del paciente con diabetes mellitus tipo 2 ha cambiado a lo largo del tiempo. Años anteriores el enfoque terapéutico giraba en torno al nivel de hemoglobina glicada (HbA1c); ahora, con el advenimiento de nuevas moléculas, y luego de entender que la meta terapéutica no es sólo un punto de corte de HbA1c, se ha modificado el objetivo, para estar centrado en el paciente, en sus comorbilidades macro y microvasculares, riesgo cardiovascular y falla cardíaca. En esta revisión de la literatura se exponen las preguntas que se deben resolver al momento de definir una estrategia terapéutica en el paciente con diabetes mellitus tipo 2. Métodos: valoración de guías locales e internacionales de tratamiento de diabetes mellitus tipo 2. Resultados: se valoraron las guías del tratamiento de la diabetes mellitus tipo 2 realizadas por la Asociación Colombiana de Endocrinología, Asociación Colombiana de Medicina Interna, Asociación Colombiana de Nefrología, Sociedad Colombiana de Cardiología y Cirugía Cardiovascular, American Diabetes Association, American Association of Clinical Endocrinology, European Association for the Study of Diabetes y European Society of Cardiology. Además, se revisaron los ensayos clínicos que respaldan el uso de los diferentes grupos farmacológicos disponibles para el tratamiento de los pacientes con diabetes mellitus tipo 2. Conclusión: es menester del clínico realizar el abordaje terapéutico de los pacientes con diabetes mellitus tipo 2 de forma individualizada, centrado en el riesgo cardiovascular, comorbilidades asociadas, riesgo de hipoglucemia y costos de la intervención brindada.
Abstract Introduction: the approach to the patient with diabetes has changed over the past decade. Some years ago, the primary goal of treatment was to achieve a certain level of A1c as a marker of glucose control. Now, with new molecules in the market that can modify the disease and its complications the treatment is focused on the individual patient, his micro and macrovascular complications and the risk of cardiovascular, heart failure and renal complications. In this review of the literature, we expose some questions that need to be solved when approaching the treatment of a patient with type 2 diabetes. Methods: we reviewed local and international guidelines on the treatment of type 2 diabetes. Results: we reviewed guidelines in the treatment of diabetes, local guidelines; Asociación Colombiana de Endocrinología, Asociación Colombiana de Medicina Interna, Asociación Colombiana de Nefrología, Sociedad Colombiana de Cardiología y Cirugía Cardiovascular. International guidelines; American Diabetes Association, American Association of Clinical Endocrinology, European Association for the Study of Diabetes y European Society of Cardiology Additionally, we revised clinical trial that support the use of the different drugs that are recommended by the guidelines as first, second- or third-line treatment. Conclusion: as clinicians we are expected to give the patient an individualized approach, based on their own comorbidities, risk of cardiovascular and renal disease and risk of hypoglycemia guided by national and international guidelines and latest clinical trial that support our approach.
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BACKGROUND AND AIMS: Diabetes mellitus (DM) is one of the most prevalent chronic noncommunicable diseases globally, and the only way to reduce its complications is good glycaemic control. Insulin remains the only approved treatment for type 1 DM (T1DM) and is used by many with type 2 DM (T2DM). Carbohydrate counting is considered the ideal way to calculate meal-related insulin doses as it allows greater flexibility in diet and could, in some people, reduce the burden of the disease. The primary objective of this systematic review was to assess carbohydrate counting efficacy in reducing glycated haemoglobin (HbA1c ) levels and safety by not increasing hypoglycaemia risk, inducing an increase in body weight or blood lipids, or reducing the quality of life of people with T1DM. METHODS: We included randomised controlled clinical trials with a parallel-group design comparing any carbohydrate counting forms with standard care or other forms of dietary advice or insulin dose calculation in people with T1DM with a follow up period of at least 3 months and with no restrictions in language, age or settings. As a primary outcome, we consider the change of HbA1c levels within at least 3 months. Secondary outcomes were hypoglycaemia events, body weight changes, blood lipids levels, and the total daily insulin dose. We also evaluated health-related quality-of-life changes and questionnaires on satisfaction with treatment of diabetes. RESULTS: Data from 11 studies with 899 patients were retrieved with a mean follow-up of 52 ± 35.5 weeks. Carbohydrate counting is not better in reducing HbA1c levels (SMD-0.24%, 95% CI -0.68 to 0.21) than all dietary advice forms. However, this finding was highly heterogeneous. We identified three studies that account for most of the heterogeneity using clustering algorithms. A second analysis excluding these studies shows a meaningful reduction in HbA1c levels (SMD-0.52%, 95% CI -0.82 to -0.23) with low heterogeneity. In the subgroup analysis, carbohydrate counting significantly reduces HbA1c levels compared with usual diabetes education. Carbohydrate counting does not relate to any substantial change in blood lipids, body weight, hypoglycaemia risk or daily insulin dose. Finally, we analysed the effect of trial duration on reduction in HbA1c levels and found no significant change related to time. CONCLUSIONS: Carbohydrate counting is an efficacious technique to safely reduce the levels of HbA1c in adults and children compared with standard diabetes education, and its effect does not appear to change with prolonged time. Standardisation in reporting important outcomes such as hypoglycaemia and quality of life are vital to produce comparable evidence in carbohydrate counting clinical trials. This systematic review was registered in PROSPERO under code: CRD42020218499.
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Diabetes Mellitus Tipo 1 , Hipoglicemia , Adulto , Criança , Humanos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Qualidade de Vida , Hemoglobinas Glicadas/análise , Hipoglicemia/prevenção & controle , Insulina/efeitos adversos , Peso Corporal , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Resumen Introducción: en los últimos 5 años la publicación de conocimiento relacionado con la enfermedad vascular y la diabetes mellitus tipo 2 (DT2) ha ido en aumento. Sin embargo, debido a la ausencia de una revisión que recopilara todos los desenlaces vasculares de la DT2, la presente revisión de literatura tiene como objetivo agrupar todos los desenlaces vasculares relacionados con la DT2 y describir cómo la terapia farmacológica hipoglicemiante puede ser eficaz para lograr el control de estos desenlaces. Los eventos cardiovasculares como desenlace principal demuestran que los medicamentos antidiabéticos innovadores como la empagliflozina y la liraglutida pueden agregar un beneficio significativo para pacientes con DT2. Materiales y métodos: búsqueda sistemática de la literatura, de la cual se obtuvieron 141 referencias, después de eliminar duplicados, para la tamización pareada. Posterior a esto, se identificaron 2l referencias que cumplían con los criterios de inclusión para ser considerados en el análisis. Resultados: el efecto de un buen control glucémico, sobre los resultados clínicos, específicamente en la progresión de la enfermedad renal diabética, ha sido objetivo de múltiples estudios a gran escala, tanto en pacientes diabéticos tipo 1 como en diabéticos tipo 2. Los desenlaces micro y macrovasculares son los principales desenlaces de la DMT2, que incrementan la incidencia de comorbilidades y representan, a su vez, una mayor morbilidad. Conclusiones: dentro de las principales causas de morbilidad y mortalidad de los pacientes con DT2, se encuentran las relacionadas con daño vascular, en especial enfermedad cardiovascular y compromiso renal. En este contexto, el tratamiento farmacológico de la diabetes mellitus se ha enfocado en encontrar medicamentos que reduzcan de manera significativa los eventos cardiovasculares y que al mismo tiempo retrasen la aparición de nefropatía o su progresión. Las tiazolidinedionas, los inhibidores de DPP4 (alogliptina, saxagliptina y sitagliptina), la insulina glargina y degludec han demostrado seguridad cardiovascular, pero no beneficio cardiovascular incremental en pacientes con DT2 que tienen alto riesgo de enfermedad cardiovascular aterosclerótica.
Abstract Introduction: In the last 5 years the publication of knowledge related to vascular disease and diabetes mellitus type 2 (DT2) has been increasing. However, due to the absence of a review that collects all the vascular outcomes of T2D, the current review of the literature aims to group all vascular outcomes related to T2D and describe how hypoglycemic drug therapy can be effective for the control of these outcomes. Cardiovascular events as the main outcome show that innovative antidiabetic drugs such as empagliflozin and liraglutide can add significant benefits for patients with T2D. Materials and methods: Systematic search of the literature, from which 141 references were obtained, after eliminating duplicates, for paired screening. Subsequently, 21 references were identified that met the inclusion criteria to be considered in the analysis. Results: The effect of good glycemic control on clinical outcomes, specifically in the progression of diabetic kidney disease, has been the objective of multiple large-scale studies, both in type 1 diabetic patients and type 2 diabetics and macrovascular outcome of the primary DMT2, increasing the incidence of comorbidities and in turn representing greater morbidity. Conclusions: Among the main causes of morbidity and mortality of patients with T2D, are those with vascular damage, especially cardiovascular disease and renal involvement. In this context, the pharmacological treatment of diabetes mellitus has focused on finding drugs that reduce the importance of cardiovascular events and that at the same time delay the onset of nephropathy or its progression. Thiazolidinediones, DPP4 inhibitors (alogliptin, saxagliptin and sitagliptin), insulin glargine and degludec have demonstrated cardiovascular safety, but not incremental cardiovascular benefits, in patients with T2D who are at high risk of atherosclerotic cardiovascular disease.
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Humanos , Masculino , Feminino , Doenças Cardiovasculares , Tratamento Farmacológico , Pacientes , Glicemia , Colômbia , Diabetes Mellitus Tipo 2 , HipoglicemiantesRESUMO
Resumen En Latinoamérica, Colombia ocupa el segundo lugar en número de pacientes con diabetes mellitus y probablemente en número de pacientes no diagnosticados. En Colombia se calculan más de 2 millones de personas con diabetes mellitus, con prevalencia de 9.6%, es la quinta causa de muerte y está entre las 10 enfermedades que motivan la asistencia clínica. Nuevos tratamientos con agonistas de GLP1 (AGLP1) e inhibidores de SGLT2 (iSGLT2) han demostrado de manera individual y por mecanismos de acción diferentes un efecto significativo en el control metabólico, en otros factores, como presión arterial, perfil lipídico, peso, así como en potencial protección renal y cardiovascular. Las guías actuales de tratamiento de la diabetes mellitus tipo 2 sugieren que en caso de persistencia de concentraciones de hemoglobina glucosilada (HA1c) fuera de metas a pesar de tratamiento dual durante tres meses, tendría lugar progresar a terapia triple. Se hizo una revisión de la bibliografía que incluyó buscadores en Pubmed, Embase y Cochrane; se incluyeron 12 artículos. Con base en esta revisión de la bibliografía, concluimos que deberían hacerse más estudios clínicos con la combinación de AGLP1 más iSGLT2 en el contexto de pacientes con diabetes mellitus tipo 2 con mal control metabólico a pesar de tratamientos duales y triples.
Abstract In South America, Colombia is secondly with number of diagnosed patients with diabetes mellitus (DM) and probably non-diagnostic patients. It has been calculated in Colombia 2 million people with diabetes mellitus, with a prevalence of 9.6% and it is the fifth position of causes of death and within the 10 causes that motivate the search for help. The new therapies with glucagon-like-1 receptors agonists (GLP-1 RAs) and SGLT2 inhibitors (SGLT2i) have been shown individually and through different mechanisms of action impact on the metabolic control and other variables such as blood pressure, lipid profile, weight, renal and cardiovascular protection. Type 2 diabetes mellitus treatment guides recommend for patients with dual therapy who continue HA1c out of goals, consider triple therapy if the patient has not achieved the goals after three months. A systematic search was made that included search engines such as Pubmed, Embase and Cochrane, resulting in 12 articles. More clinical studies should be done with the combination of GLP-1 RAs and SGLT2i in the context of patients with type 2 diabetes mellitus with poor metabolic control despite dual and triple therapies.
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OBJECTIVE: We assessed maternal and perinatal outcomes in pregnant women with type 1 diabetes, treated with continuous subcutaneous insulin infusion and real time continuous glucose monitoring. METHODS: This is a retrospective study, analyzing the basal characteristics, glycemic control, maternal and perinatal outcomes of pregnant women with type 1 diabetes, who were on an insulin pump with continuous glucose monitoring between 2011 and 2015. RESULTS: Fourteen patients were included. The median age was 33 and disease duration 12 years. Indications for therapy were mainly poor glycemic control and severe hypoglycemia. The median A1c decrease was 1.02% between the first and third trimester. Pregnancies were associated with complications: 7.1% of the patients had diabetic ketoacidosis, 7.1% had an abortion, 28.5% gestational hypertension and 12.2% preeclampsia. The median gestational age at birth was 37 weeks and four days; the frequency of preterm birth was 7.1% and macrosomia 21.4%. There were no congenital malformations or perinatal death. CONCLUSIONS: Baseline characteristics and results of patients in this study were similar to those reported in the previous literature. Continuous subcutaneous insulin infusion with continuous glucose monitoring is an alternative treatment option for pregnant women with type 1 diabetes before or during pregnancy.
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Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Adulto , Glicemia/metabolismo , Cesárea , Colômbia , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/complicações , Feminino , Macrossomia Fetal/etiologia , Idade Gestacional , Hemoglobinas Glicadas/análise , Humanos , Hiperglicemia/sangue , Hiperglicemia/etiologia , Bombas de Infusão Implantáveis , Infusões Subcutâneas , Gravidez , Estudos RetrospectivosRESUMO
BACKGROUND: Hyperglycemic crisis are the most serious forms of acute decompensation of diabetes mellitus and require urgent medical attention. The epidemiological data of these conditions in Latin America are scarce and in Colombia unknown, that is why we decided to describe the clinical characteristics and factors associated with the mortality of adults who presented with hyperglycemic crises in a teaching hospital in Colombia. MATERIALS AND METHODS: Retrospective cohort study of all episodes of hyperglycemic crisis treated in Pablo Tobón Uribe Hospital in a three-year period. RESULTS: The records of 2233 hospitalization episodes related to diabetes mellitus were review, the prevalence of hyperglycemic crises was 2%, half of the events were diabetic ketoacidosis and 57% of the events occurred in people with type 2 diabetes mellitus, 32% of the events were precipitated by an infection and 27% by and inadequate therapy. The average hospital length of stay was 14 ± 3 days and the mortality rate 2.27%. CONCLUSIONS: In a teaching hospital in Latin America hyperglycemic crises are common, with diabetic ketoacidosis being the most frequent, and in a significant number of cases may be preventable. The hospital length of stay in our population is longer than reported in the literature.