Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes: pooled 52‐week outcomes from the DEPICT ‐1 and ‐2 studies
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| المؤلفون: | Paresh Dandona, Depict Investigators, Depict, Niki Arya, Simon Heller, Paolo Di Bartolo, Lars Hansen, Richard M. Bergenstal, Eiichi Araki, Moshe Phillip, John Xu, Markus F. Scheerer, Nayyar Iqbal, Chantal Mathieu, Marcus Lind, Fredrik Thoren |
| المصدر: | Diabetes, Obesity & Metabolism |
| بيانات النشر: | Wiley, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, medicine.medical_specialty, Diabetic ketoacidosis, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Body weight, Placebo, 03 medical and health sciences, chemistry.chemical_compound, dapagliflozin, DEPICT, DKA, insulin adjunct, long‐term data, severe hypoglycaemia, SGLT‐2 inhibitor, T1D, 0302 clinical medicine, Endocrinology, Double-Blind Method, Glucosides, Internal medicine, Internal Medicine, medicine, Humans, Hypoglycemic Agents, In patient, Benzhydryl Compounds, Dapagliflozin, Glycated Hemoglobin, Type 1 diabetes, business.industry, Original Articles, medicine.disease, Diabetes Mellitus, Type 1, Treatment Outcome, Pooled analysis, chemistry, Baseline characteristics, Drug Therapy, Combination, Original Article, business |
| الوصف: | Aims This pooled analysis of the DEPICT-1 and -2 trials aimed to evaluate the efficacy and safety of adjunct dapagliflozin therapy in patients with type 1 diabetes (T1D). Materials and methods DEPICT-1 and -2 were randomized, double-blind, parallel-group, 24-week studies, with 28-week extension periods. Adults with T1D and HbA1c 7.5-10.5% were randomized (1:1:1) to receive dapagliflozin 5, 10 mg or placebo. The short- and long-term efficacy and safety of dapagliflozin were examined in an exploratory pooled analysis of both studies. Results Efficacy analyses included 530, 529 and 532 and safety analysis included 548, 566 and 532 patients in the dapagliflozin 5 mg, 10 mg and placebo groups, respectively. Baseline characteristics were similar between treatment groups. At Week 24, reductions were seen with dapagliflozin 5 and 10 mg compared with placebo in HbA1c (-0.40%, -0.43% vs 0.00%) and body weight (-2.45, -2.91 vs 0.11 kg). HbA1c and body weight reductions versus placebo were also seen after 52 weeks of treatment. There was no imbalance in occurrence of severe hypoglycaemic events between groups. The proportion of patients experiencing definite diabetic ketoacidosis (DKA) was higher with dapagliflozin 5 mg (4.0%) and 10 mg (3.5%) compared with placebo (1.1%) over 52 weeks; most events were of mild or moderate severity, and all resolved with treatment. Conclusions Over 52 weeks, dapagliflozin provided glycaemic and weight benefits, with no increased frequency of severe hypoglycaemia compared with placebo. More DKA events were reported with dapagliflozin than placebo, highlighting the importance of appropriate patient selection, education and risk mitigation strategies. This article is protected by copyright. All rights reserved. |
| تدمد: | 1463-1326 1462-8902 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7eeabb346397e1e4e7778837ac220da0Test https://doi.org/10.1111/dom.14248Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....7eeabb346397e1e4e7778837ac220da0 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14631326 14628902 |
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