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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 - 06/12/23

Doi : 10.1016/j.diabet.2023.101501 
María Durán-Martínez 1, 2, Sharona Azriel-Mira 2, 3, Viyey Kishore Doulatram-Gamgaram 4, Óscar Moreno-Pérez 5, Pedro J. Pinés- Corrales 6, Cristina Tejera-Pérez 7, Juan Francisco Merino 8, 9, 10, Miguel Brito-Sanfiel 11, Ana Chico 12, 13, Amparo Marco 2, 14, Elena García-Fernández 15, José Ignacio Martínez-Montoro 16, 17, 18, 19, #,
on behalf of the

Diabetes Area of the Spanish Society of Endocrinology and Nutrition (SEEN)

1 Department of Endocrinology and Nutrition, Getafe University Hospital, Madrid, Spain 
2 Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Spain 
3 Department of Endocrinology and Nutrition, Infanta Sofia University Hospital, Madrid, Spain 
4 Department of Endocrinology and Nutrition, Regional University Hospital of Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA)-Plataforma Bionand, Málaga, Spain 
5 Endocrinology and Nutrition Department, Dr. Balmis General University Hospital - Alicante Institute of Sanitary and Biomedical Research (ISABIAL), Alicante, Spain; Clinical Medicine Department, Miguel Hernández University of Elche, Spain 
6 Department of Endocrinology and Nutrition, Albacete University Hospital, Albacete, Spain 
7 Department of Endocrinology and Nutrition, Complejo Hospitalario Universitario de Ferrol (CHUF/SERGAS), A Coruña, Spain; Epigenomics in Endocrinology and Nutrition Group, Epigenomics Unit, Instituto de Investigacion Sanitaria de Santiago de Compostela (IDIS), Complejo Hospitalario Universitario de Santiago de Compostela (CHUS/SERGAS), Santiago de Compostela, Spain 
8 Department of Endocrinology and Nutrition, University and Polytechnic Hospital La Fe, Valencia, Spain 
9 Joint Research Unit On Endocrinology, Nutrition and Clinical Dietetics, University of Valencia-Health Research Institute La Fe, Valencia, Spain 
10 Medicine Department, Universitat de València,Valencia, Spain 
11 Department of Endocrinology and Nutrition, Puerta de Hierro University Hospital, Madrid, Spain 
12 Department of Endocrinology and Nutrition, Hospital Santa Creu i Sant Pau, Barcelona, Spain 
13 CIBER-BBN, Instituto de Salud Carlos III, Madrid, Spain. Universitat Autònoma de Barcelona, Barcelona, Spain 
14 Department of Endocrinology and Nutrition, Toledo University Hospital, Toledo, Spain 
15 Department of Endocrinology and Nutrition, 12 de Octubre University Hospital, Madrid, Spain 
16 Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, Málaga, Spain 
17 Instituto de Investigación Biomédica de Málaga (IBIMA)-Plataforma Bionand, Málaga, Spain 
18 Faculty of Medicine, University of Málaga, Málaga, Spain 
19 Centro de Investigación Biomédica en Red de la Fisiopatología de la Obesidad y la Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain 

Correspondence to: José Ignacio Martínez-Montoro, Department of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, Instituto de Investigación Biomédica de Málaga (IBIMA), Faculty of Medicine, University of Málaga, 29010 Málaga, SpainDepartment of Endocrinology and Nutrition, Virgen de la Victoria University Hospital, Instituto de Investigación Biomédica de Málaga (IBIMA), Faculty of Medicine, University of MálagaMálaga29010Spain
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ABSTRACT

Objective

To assess real-world safety and effectiveness of dapagliflozin in people living with type 1 diabetes mellitus (T1DM).

Methods

We conducted a multicenter retrospective study in Spain including data from 250 people living with T1DM receiving dapagliflozin as add-on therapy to insulin (80.8% on-label use). The number of diabetic ketoacidosis (DKA) events was calculated over a 12-month follow-up (primary outcome). Changes in body weight, HbA1c, total daily insulin dose, and continuous glucose monitoring (CGM) metrics from baseline (at dapagliflozin prescription) to 12 months were also evaluated.

Results

A total of five DKA events (2.4% [95% CI 0.3;4.5] were reported in patients with a 12-month follow-up, n= 207): two events related to insulin pump malfunction, two events related to concomitant illnesses, and one event related to insulin dose omission. DKA events were more frequent among insulin pump users (7.7% versus 1.2%). Four of the reported DKA events occurred within the first six months after initiation of dapagliflozin. No deaths or persistent sequelae due to DKA were reported. No severe hypoglycemia episodes were reported. Significant reductions in mean body weight (-3.3 kg), HbA1c (-0.6%), and total daily insulin dose (- 8.6%), P < 0.001, were observed 12 months after dapagliflozin prescription. Significant improvements in TIR (+ 9.3%), TAR (-7.2%), TBR (-2.5%), and coefficient of variation (- 5.1%), P < 0.001, were also observed in the subgroup of patients with available CGM data. Finally, an improvement in urinary albumin-to-creatinine ratio (UACR) was found among participants with UACR ≥ 30 mg/g at baseline (median decrease of 99 mg/g in UACR, P = 0.001).

Conclusion

The use of dapagliflozin in people living with T1DM has an appropriate safety profile after careful selection of participants and implementation of strategies to reduce the risk of DKA (i.e., prescribed according to the recommendations of the European Medicines Agency), and also leads to clinical improvements in this population.

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Keywords : Dapagliflozin, Diabetic ketoacidosis, Glycemic control Safety, Type 1 diabetes, Weight


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