Safety and Efficacy of Liraglutide, 3.0 mg, Once Daily vs Placebo in Patients With Poor Weight Loss Following Metabolic Surgery: The BARI-OPTIMISE Randomized Clinical Trial.

Importance: Metabolic surgery leads to weight loss and improved health, but these outcomes are highly variable. Poor weight loss is associated with lower circulating levels of glucagon-like peptide-1 (GLP-1). Objective: To assess the efficacy and safety of the GLP-1 receptor agonist, liraglutide, 3.0 mg, on percentage body weight reduction in patients with poor weight loss and suboptimal GLP-1 response after metabolic surgery. Design, Setting, and Participants: The Evaluation of Liraglutide 3.0 mg in Patients With Poor Weight Loss and a Suboptimal Glucagon-Like Peptide-1 Response (BARI-OPTIMISE) randomized placebo-controlled trial recruited adult patients at least 1 year after metabolic surgery who had experienced 20% or less body weight loss from the day of surgery and a suboptimal nutrient-stimulated GLP-1 response from 2 hospitals in London, United Kingdom, between October 2018 and November 2019. Key exclusion criteria were type 1 diabetes; severe concomitant psychiatric, gastrointestinal, cardiac, kidney or metabolic disease; and use of insulin, GLP-1 receptor analogues, and medication that can affect weight. The study period was 24 weeks followed by a 4-week follow-up period. Last participant follow-up was completed in June 2020. All participants and clinical study personnel were blinded to treatment allocation. Of 154 assessed for eligibility, 70 met trial criteria and were included in the study, and 57 completed follow-up. Interventions: Liraglutide, 3.0 mg, once daily or placebo as an adjunct to lifestyle intervention with a 500-kcal daily energy deficit for 24 weeks, on a 1:1 allocation by computer-generated randomization sequence, stratified by surgery type (Roux-en-Y gastric bypass [RYGB] or sleeve gastrectomy [SG]) and type 2 diabetes status. Main Outcome and Measures: The primary outcome was change in percentage body weight from baseline to the end of the 24-week study period based on an intention-to-treat analysis. Participant safety was assessed through monitoring of biochemical parameters, including kidney and liver function, physical examination, and assessment for adverse events. Results: A total of 70 participants (mean [SD] age, 47.6 [10.7] years; 52 [74%] female) with a poor weight loss response following RYGB or SG were randomized to receive 3.0-mg liraglutide (n = 35) or placebo (n = 35). All participants received at least 1 dose of the trial drug. Eight participants discontinued treatment (4 per group), and 2 in the 3.0-mg liraglutide group and 1 in the placebo group were lost to follow-up. Due to COVID-19 restrictions, 3 participants in the 3.0-mg liraglutide group and 7 in the placebo group were unable to attend their final in-person assessment. Estimated change in mean (SD) percentage body weight from baseline to week 24 was -8.82 (4.94) with liraglutide, 3.0 mg (n = 31), vs -0.54 (3.32) with placebo (n = 26). The mean difference in percentage body weight change for liraglutide, 3.0 mg, vs placebo was -8.03 (95% CI, -10.39 to -5.66; P < .001). Adverse events, predominantly gastrointestinal, were more frequent with liraglutide, 3.0 mg (28 events [80%]), than placebo (20 events [57%]). There were no serious adverse events and no treatment-related deaths. Conclusion and Relevance: These findings support the use of adjuvant liraglutide, 3.0 mg, for weight management in patients with poor weight loss and suboptimal GLP-1 response after metabolic surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT03341429.

Implicaciones clínicas de la enfermedad diverticular del apéndice. Experiencia en los últimos 10 años / Clinical implications of diverticular disease of the appendix. Experience over the past 10 years

INTRODUCCIÓN: La enfermedad diverticular del apéndice es infrecuente, con una incidencia que varía desde 0,004 a 2,1%. Suele presentarse entre la cuarta o quinta década de vida, con ausencia de síntomas gastrointestinales y dolor abdominal insidioso. Los pacientes habitualmente consultan de forma tardía, con el consiguiente aumento de morbimortalidad. El objetivo de este estudio fue determinar las características clínicas de la enfermedad diverticular del apéndice. MÉTODOS: Se realizó un estudio retrospectivo de todos los pacientes operados de apendicectomía en un hospital terciario desde septiembre de 2003 hasta septiembre de 2013. RESULTADOS: Durante este periodo se realizaron 7.044 apendicectomías, encontrándose 42 casos de enfermedad diverticular del apéndice, que representa una incidencia de 0,59%. De ellos, 27 pacientes fueron de sexo masculino. La edad media fue de 46,6 ± 21 años. El promedio de la estancia hospitalaria fue de 4,5 días. El 46% de los casos presentaban perforación del apéndice. En el 80% de los casos se realizó una prueba de imagen complementaria. La incidencia de neoplasia asociada a enfermedad diverticular fue de 7,1%. CONCLUSIONES: La enfermedad diverticular del apéndice es un hallazgo incidental. En la fase aguda presenta síntomas indiferenciables de la apendicitis aguda. El tratamiento de elección es la apendicectomía. Presenta una mayor probabilidad de desarrollar neoplasias del apéndice

BACKGROUND: Diverticular disease of the appendix is an uncommon condition, with an incidence from 0.004 to 2.1%. It usually occurs between the fourth or fifth decades of life, does not present gastrointestinal symptoms but only insidious abdominal pain. Patients usually delay consultation, leading to increased morbidity and mortality. The aim of this study was to determine the clinical features of diverticular disease of the appendix. METHODS: A retrospective study of all patients undergoing appendectomy in a tertiary hospital between September 2003 and September 2013 was performed. RESULTS: During this period, 7,044 appendectomies were performed, and 42 cases of diverticular disease of the appendix were found, which represents an incidence of 0.59%. A total of 27 patients were male. The mean age was 46.6 ± 21 years. The average hospital stay was 4.5 days. A perforated appendix was identified in 46% of patients. In 80% of the cases, a complementary imaging test was performed. The incidence of neoplastic disease with diverticulum of the appendix was 7.1%. CONCLUSIONS: Diverticular disease of the appendix is an incidental finding. In its acute phase, it presents as an acute appendicitis. The treatment of choice is appendectomy. It presents a higher risk of developing neoplastic disease of the appendix

Clinical implications of diverticular disease of the appendix. Experience over the past 10 years.

BACKGROUND: Diverticular disease of the appendix is an uncommon condition, with an incidence from 0.004 to 2.1%. It usually occurs between the fourth or fifth decades of life, does not present gastrointestinal symptoms but only insidious abdominal pain. Patients usually delay consultation, leading to increased morbidity and mortality. The aim of this study was to determine the clinical features of diverticular disease of the appendix. METHODS: A retrospective study of all patients undergoing appendectomy in a tertiary hospital between September 2003 and September 2013 was performed. RESULTS: During this period, 7,044 appendectomies were performed, and 42 cases of diverticular disease of the appendix were found, which represents an incidence of 0.59%. A total of 27 patients were male. The mean age was 46.6±21 years. The average hospital stay was 4.5 days. A perforated appendix was identified in 46% of patients. In 80% of the cases, a complementary imaging test was performed. The incidence of neoplastic disease with diverticulum of the appendix was 7.1%. CONCLUSIONS: Diverticular disease of the appendix is an incidental finding. In its acute phase, it presents as an acute appendicitis. The treatment of choice is appendectomy. It presents a higher risk of developing neoplastic disease of the appendix.