Real-world safety and effectiveness of dapagliflozin in people living with type 1 diabetes in Spain: The Dapa-ON multicenter retrospective study

Durán-Martínez, María; Azriel, Sharona; Doulatram-Gamgaram, Viyey Kishore; Moreno-Pérez, Óscar; Pinés-Corrales, Pedro J.; Tejera-Pérez, Cristina; Merino-Torres, Juan Francisco; Brito-Sanfiel, Miguel; Chico, Ana; Marco, Amparo; García-Fernández, Elena; Martínez-Montoro, José Ignacio

doi:10.1016/j.diabet.2023.101501

Cited by 7 publications

(2 citation statements)

References 41 publications

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“…Although older patients treated with dapagliflozin, experienced more renal adverse events than placebo-treated patients, the majority of these events were non-serious small transient changes in serum creatinine. Durán-Martínez et al ( 45 ) reported that dapagliflozin had an appropriate safety profile in patients with T1DM following the careful selection of participants and implementation of strategies to reduce the risk of diabetic ketoacidosis, and the treatment also led to clinical improvements in this population.…”

Section: Discussionmentioning

confidence: 99%

Effects of dapagliflozin on body weight in patients with type 2 diabetes mellitus: Evidence‑based practice

Han,

Li,

et al. 2024

Exp Ther Med

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The dose-dependent pharmacological response to dapagliflozin in patients with type 2 diabetes mellitus (T2DM) with regard to weight loss remain unknown. The aim of the present study was to investigate the effects of dapagliflozin on weight loss in patients with T2DM. A total of 8,545 patients with T2DM from 24 randomized controlled trials reported in the literature were selected for inclusion in the study. Data from these trials were analyzed using maximal effect (E max ) models with nonlinear mixed effects modeling; the evaluation index was the body weight change rate from baseline values. Patients treated with 2.5 mg/day dapagliflozin exhibited an E max of -3.04%, and the time taken for therapy to reach half of the E max (ET 50 ) was estimated to be 30.8 weeks for patients treated with this dose. Patients treated with 5, 10 and 20 mg/day dapagliflozin exhibited E max values of -6.57, -4.12 and -3.23%, respectively, and their ET 50 values were estimated to be 27.3, 20.4 and 4.23 weeks, respectively. The data indicated ideal linear relationships between individual predictions and observations, suggesting the optimal fitting of the final models. The present study is the first systematic analysis of the effect of dapagliflozin on weight loss in patients with T2DM. The application of dapagliflozin at 5 mg/day exhibited a greater weight loss effect compared with the other doses used, and the weight loss onset time shortened as the dose of dapagliflozin increased.

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Section: Discussionmentioning

confidence: 99%

Effects of dapagliflozin on body weight in patients with type 2 diabetes mellitus: Evidence‑based practice

Han,

Li,

et al. 2024

Exp Ther Med

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“…A recently published study [187] included data from 250 people living with T1DM receiving Dapagliflozin as an add-on therapy to insulin. The authors reported five DKA events in patients with a 12-month follow-up: two events related to insulin pump malfunction, two events related to concomitant illnesses, and one event connected to insulin dose omission.…”

Section: Discussionmentioning

confidence: 99%

Risks and Benefits of SGLT-2 Inhibitors for Type 1 Diabetes Patients Using Automated Insulin Delivery Systems—A Literature Review

Elian,

Popovici,

Karampelas

et al. 2024

IJMS

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The primary treatment for autoimmune Diabetes Mellitus (Type 1 Diabetes Mellitus-T1DM) is insulin therapy. Unfortunately, a multitude of clinical cases has demonstrated that the use of insulin as a sole therapeutic intervention fails to address all issues comprehensively. Therefore, non-insulin adjunct treatment has been investigated and shown successful results in clinical trials. Various hypoglycemia-inducing drugs such as Metformin, glucagon-like peptide 1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, amylin analogs, and Sodium-Glucose Cotransporters 2 (SGLT-2) inhibitors, developed good outcomes in patients with T1DM. Currently, SGLT-2 inhibitors have remarkably improved the treatment of patients with diabetes by preventing cardiovascular events, heart failure hospitalization, and progression of renal disease. However, their pharmacological potential has not been explored enough. Thus, the substantial interest in SGLT-2 inhibitors (SGLT-2is) underlines the present review. It begins with an overview of carrier-mediated cellular glucose uptake, evidencing the insulin-independent transport system contribution to glucose homeostasis and the essential roles of Sodium-Glucose Cotransporters 1 and 2. Then, the pharmacological properties of SGLT-2is are detailed, leading to potential applications in treating T1DM patients with automated insulin delivery (AID) systems. Results from several studies demonstrated improvements in glycemic control, an increase in Time in Range (TIR), a decrease in glycemic variability, reduced daily insulin requirements without increasing hyperglycemic events, and benefits in weight management. However, these advantages are counterbalanced by increased risks, particularly concerning Diabetic Ketoacidosis (DKA). Several clinical trials reported a higher incidence of DKA when patients with T1DM received SGLT-2 inhibitors such as Sotagliflozin and Empagliflozin. On the other hand, patients with T1DM and a body mass index (BMI) of ≥27 kg/m2 treated with Dapagliflozin showed similar reduction in hyperglycemia and body weight and insignificantly increased DKA incidence compared to the overall trial population. Additional multicenter and randomized studies are required to establish safer and more effective long-term strategies based on patient selection, education, and continuous ketone body monitoring for optimal integration of SGLT-2 inhibitors into T1DM therapeutic protocol.

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Chronic treatment with SGLT-2 inhibitors is associated with ICU admission and disease severity in patients with diabetic ketoacidosis: a propensity score–matched cohort study

Sebastian-Valles,

Tapia-Sanchiz,

Navas-Moreno

et al. 2024

Intern Emerg Med

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Real-world safety and effectiveness of dapagliflozin in people living with type 1 diabetes in Spain: The Dapa-ON multicenter retrospective study

Cited by 7 publications

References 41 publications

Effects of dapagliflozin on body weight in patients with type 2 diabetes mellitus: Evidence‑based practice

Effects of dapagliflozin on body weight in patients with type 2 diabetes mellitus: Evidence‑based practice

Risks and Benefits of SGLT-2 Inhibitors for Type 1 Diabetes Patients Using Automated Insulin Delivery Systems—A Literature Review

Chronic treatment with SGLT-2 inhibitors is associated with ICU admission and disease severity in patients with diabetic ketoacidosis: a propensity score–matched cohort study

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