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Tirzepatide in Hispanic/Latino Patients With Type 2 Diabetes: A Subgroup Analysis of the SURPASS Program.
Frías, Juan Pablo; Galindo, Rodolfo J; Wang, Hui; Malik, Raleigh E; Chivukula, K Karthik; Maldonado, Juan M.
Afiliación
  • Frías JP; Velocity Clinical Research, Los Angeles, CA 90057, USA.
  • Galindo RJ; Division of Endocrinology, University of Miami Miller School of Medicine, Miami, FL 33136, USA.
  • Wang H; TechData Service, King of Prussia, PA 19406, USA.
  • Malik RE; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
  • Chivukula KK; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
  • Maldonado JM; Lilly Research Laboratories, Eli Lilly and Company, San Juan 00918, Puerto Rico.
J Clin Endocrinol Metab ; 109(2): 557-568, 2024 Jan 18.
Article en En | MEDLINE | ID: mdl-37602701
CONTEXT: Efficacy and safety of tirzepatide, a once-weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, have been studied in patients with type 2 diabetes in the global phase 3 SURPASS program. OBJECTIVE: This work aimed to assess the efficacy and safety of tirzepatide in Hispanic/Latino and non-Hispanic/Latino patients in SURPASS-1 to -4 clinical trials. METHODS: A total of 5679 patients were included, 2895 of self-reported Hispanic/Latino ethnicity, in this exploratory analysis of SURPASS-1 to -4 trial data. Interventions included tirzepatide 5, 10, or 15 mg, placebo, or active comparator (semaglutide 1 mg, insulin degludec, and insulin glargine). Change in glycated hemoglobin A1c (HbA1c) and body weight from baseline to week 40 (SURPASS-1 and -2) and to week 52 (SURPASS-3 and -4), and other efficacy and safety outcomes were evaluated within Hispanic/Latino and non-Hispanic/Latino subgroups. RESULTS: Among Hispanic/Latino and non-Hispanic/Latino patients treated with tirzepatide, respectively, HbA1c decreased significantly from baseline, ranging from 1.9% to 2.7% and 1.7% to 2.5%, and body weight decreased significantly from baseline, ranging from 5.3 kg to 12.4 and 6.5 kg to 17.1 kg (both P < .05) vs comparators across all trials. Subgroup trends were consistent with the overall trial populations. Treatment-emergent adverse events were reported in similar proportions across the subgroups and were primarily gastrointestinal disorders. The incidence of hypoglycemia was low. CONCLUSION: Tirzepatide significatively reduced HbA1c and body weight in Hispanic/Latino and non-Hispanic/Latino patients. Tirzepatide was generally well tolerated in both subgroups. Efficacy and safety trends were comparable between subgroups and within the overall trial populations.
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 / Incretinas / Receptor del Péptido 1 Similar al Glucagón / Hipoglucemiantes Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: J Clin Endocrinol Metab Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 / Incretinas / Receptor del Péptido 1 Similar al Glucagón / Hipoglucemiantes Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: J Clin Endocrinol Metab Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos