ABSTRACT
INTRODUCTION: Obesity increases the risk of type 2 diabetes mellitus and cardiovascular disease (CVD). Weight loss (≥5 %) reduces the risk of CVD. Glucagon-like peptide-1 receptor agonists (GLP1 RA) have shown clinically weight loss. OBJECTIVES: 1) To assess differences in the efficacy of weight loss and HbA1c; 2) to evaluate the safety and adherence during the titration phase. METHODS: It is a multicenter, prospective, and observational study on GLP1 RA naïve patients. The primary end point was the weight loss (≥5 %). Changes in weight, BMI and HbA1c were also calculated as co-primary endpoints. Secondary endpoints were safety, adherence, and tolerance. RESULTS: Among 94 subjects, 42.4 % received dulaglutide, 29,3 % subcutaneous semaglutide, 22,8 % oral semaglutide. 45 % female and the mean age was 62. Baseline characteristics were body weight 99.3 kg, BMI 36.7 kg/m2 and Hba1c 8.2 %. Oral semaglutide achieved the highest reduction: 61.1 % of patients achieving ≥ 5 %, subcutaneous semaglutide 45.8 % and dulaglutide 40.6 %. GLP1 RA significantly reduced body weight (-4.95 kg, p < 0.001) and BMI (-1.86 kg/m2, p < 0.001), without significant differences between groups. Gastrointestinal disorders were the most frequently reported events (74.5 %). 62 % of patients on dulaglutide, 25 % on oral semaglutide and 22 % on subcutaneous semaglutide. CONCLUSIONS: Oral semaglutide achieved the highest proportion of patients that lost ≥ 5 %. GLP1 RA significantly reduced BMI and HbA1c. Most of the reported adverse events were gastrointestinal disorders and they were reported in a major frequency in the dulaglutide group. Oral semaglutide would be a reasonable switch in case of future shortages.
Subject(s)
Diabetes Mellitus, Type 2 , Humans , Female , Middle Aged , Male , Diabetes Mellitus, Type 2/diagnosis , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/adverse effects , Glucagon-Like Peptide-1 Receptor/agonists , Glycated Hemoglobin , Prospective Studies , Weight LossABSTRACT
OBJECTIVE: The cardiovascular disease is the first cause of deaths in patients with diabetes mellitus 2. The objective is to evaluate and compare the weight loss in patients with diabetes treated with the different GLP-1 receptor agonists for the first time. Secondary endpoints are glycosylated hemoglobin reduction, changes in quality of life and physical activity and the safety of these drugs. METHOD: It is a postauthorization, multicenter, non-randomized and prospective study. 360 Patients that will start treatment for the first time with GLP-1 receptor agonists will be recruited in 10 centers in the National Health System for a period of 6 months and 44 weeks of follow-up. The primary endpoint will be weight loss achieved with the different GLP-1 receptor agonists and the secondary endpoint will be glycosylated hemoglobin reduction, changes in the quality of life through the EuroQol5D and changes physical activity through the SF-12 questionnaire, and also the safety of these drugs. The estimate recruitment period will be 6 months, from 1 December 2021 to 1 May 2022. The follow up will finish in December 2022. DISCUSSION: The SEVERAL study will try to provide information about weight loss efficacy, changes in quality of life, physical activity and safety of the GLP-1 receptor agonists in patients with diabetes that start treatment with these drugs in the real life. This study try to compare different GLP-1 receptor gonists in terms of effectiveness and safety for a better posterior election when these drugs are used in patients with diabetes mellitus 2 and obesity.
OBJETIVO: La enfermedad cardiovascular es la causa principal de muerte en pacientes con diabetes mellitus 2. El objetivo principal es evaluar y comparar prospectivamente la pérdida de peso en pacientes con diabetes mellitus 2 tratados por primera vez con los diferentes análogos de la GLP-1. Como variables secundarias se estudiará reducción de la hemoglobina glicosilada, cambios en calidad de vida y actividad física y la seguridad de estos fármacos.Método: Se trata de un estudio postautorización, multicéntrico, no leatorizado de seguimiento prospectivo. Se reclutarán 360 pacientes que inicien tratamiento por primera vez con análogos de la GLP1 en 10 centros del sistema público durante un período de 6 meses y un seguimiento de 44 semanas. La variable principal será la pérdida de peso con los diferentes análogos de la GLP1 y como variable secundaria se valorarán: reducción de hemoglobina glicosilada, cambios en la calidad de vida y actividad física a través del EuroQol-5D y SF-12 y seguridad. Se ha estimadoun período de reclutamiento de 6 meses, desde el 1 de Diciembre 2021 al 1 de Mayo 2022. El seguimiento finalizará en Diciembre de 2022.Discusión: El estudio intentará aportar información sobre la efectividad en pérdida de peso, cambios en calidad de vida, actividad física y seguridad de los análogos de la GLP1 en pacientes con diabetes mellitus 2 que inician tratamiento con estos fármacos en la vida real. Este trabajo pretende comparar los diferentes análogos de la GLP1 en términos de eficacia y eguridad para una posterior mejor elección en la prescripción de estos fármacos en pacientes con diabetes mellitus 2 y obesidad.
Subject(s)
Diabetes Mellitus, Type 2 , Glucagon-Like Peptide-1 Receptor , Humans , Glucagon-Like Peptide-1 Receptor/agonists , Glucagon-Like Peptide-1 Receptor/therapeutic use , Hypoglycemic Agents/adverse effects , Glycated Hemoglobin , Quality of Life , Prospective Studies , Diabetes Mellitus, Type 2/drug therapy , Glucagon-Like Peptide 1/therapeutic useABSTRACT
Objetivo: La enfermedad cardiovascular es la causa principal demuerte en pacientes con diabetes mellitus 2. El objetivo principal es evaluar y comparar prospectivamente la pérdida de peso en pacientes condiabetes mellitus 2 tratados por primera vez con los diferentes análogosde la GLP-1. Como variables secundarias se estudiará reducción de lahemoglobina glicosilada, cambios en calidad de vida y actividad física yla seguridad de estos fármacos.Método: Se trata de un estudio postautorización, multicéntrico, no aleatorizado de seguimiento prospectivo. Se reclutarán 360 pacientes queinicien tratamiento por primera vez con análogos de la GLP1 en 10 centros del sistema público durante un período de 6 meses y un seguimientode 44 semanas. La variable principal será la pérdida de peso con los diferentes análogos de la GLP1 y como variable secundaria se valorarán:reducción de hemoglobina glicosilada, cambios en la calidad de vida yactividad física a través del EuroQol-5D y SF-12 y seguridad. Se ha estimado un período de reclutamiento de 6 meses, desde el 1 de Diciembre2021 al 1 de Mayo 2022. El seguimiento finalizará en Diciembre de 2022.Discusión: El estudio intentará aportar información sobre la efectividaden pérdida de peso, cambios en calidad de vida, actividad física y seguridad de los análogos de la GLP1 en pacientes con diabetes mellitus 2que inician tratamiento con estos fármacos en la vida real. Este trabajopretende comparar los diferentes análogos de la GLP1 en términos deeficacia y seguridad para una posterior mejor elección en la prescripciónde estos fármacos en pacientes con diabetes mellitus 2 y obesidad. (AU)
Objective: The cardiovascular disease is the first cause of deaths inpatients with diabetes mellitus 2. The objective is to evaluate and comparethe weight loss in patients with diabetes treated with the different GLP-1receptor agonists for the first time. Secondary endpoints are glycosylatedhemoglobin reduction, changes in quality of life and physical activity andthe safety of these drugs.Method: It is a postauthorization, multicenter, non-randomized and prospective study. 360 Patients that will start treatment for the first time withGLP-1 receptor agonists will be recruited in 10 centers in the NationalHealth System for a period of 6 months and 44 weeks of follow-up. Theprimary endpoint will be weight loss achieved with the different GLP-1receptor agonists and the secondary endpoint will be glycosylated hemoglobin reduction, changes in the quality of life through the EuroQol-5Dand changes physical activity through the SF-12 questionnaire, and alsothe safety of these drugs. The estimate recruitment period will be 6 months,from 1 December 2021 to 1 May 2022. The follow up will finish in December 2022.Discussion: The SEVERAL study will try to provide information aboutweight loss efficacy, changes in quality of life, physical activity and safetyof the GLP-1 receptor agonists in patients with diabetes that start treatmentwith these drugs in the real life. This study try to compare different GLP-1receptor agonists in terms of effectiveness and safety for a better posteriorelection when these drugs are used in patients with diabetes mellitus 2and obesity. (AU)
Subject(s)
Humans , Diabetes Mellitus, Type 2 , Weight Loss , Obesity , Pharmacy , Quality of LifeABSTRACT
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