Real-world safety and effectiveness of dapagliflozin in people living with type 1 diabetes in Spain: The Dapa-ON multicenter retrospective study
Authors' 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.
Study context
- Population
- People living with T1D receiving dapagliflozin add-on to insulin, Spain207 with 12-month follow-up
- Participants
- 250 people
- Outcome
- Number of DKA events
- Follow-up
- 12-month follow-up
Methodological detailsmulticentre, real-world
- Multicentre
- Real-world
Main finding
As reported in the abstract
Dapagliflozin
2.4 %
5
- Diabetic ketoacidosis (DKA) related to insulin pump malfunction
- 2
- DKA related to concomitant illnesses
- 2
- DKA related to insulin dose omission
- 1
- DKA events within first 6 months after initiation
- 4
- Deaths or persistent sequelae due to DKA
- 0
Observational data: associations, not effects.
Further findings
DKA by insulin delivery: insulin pump users vs MDI · 12-month follow-up
- DKA more frequent with insulin pump than MDI
- 7.7 % versus 1.2 %
Change from baseline in body weight, HbA1c and total daily insulin dose · 12 months
- Mean body weight change
- −3.3 kg
- HbA1c change
- −0.6 %
- Total daily insulin dose change
- −8.6 %
- P value
- P < 0.001
Continuous glucose monitoring (CGM) metrics (subgroup with CGM data) · 12 months
- TIR change
- +9.3 %
- TAR change
- −7.2 %
- TBR change
- −2.5 %
- CV change
- −5.1 %
- P value
- P < 0.001
Urinary albumin-to-creatinine ratio (UACR) in participants with UACR ≥ 30 mg/g at baseline · 12 months
- Median decrease in UACR
- 99 mg/g
- P value
- P = 0.001
Safety
Severe hypoglycaemia · 12-month follow-up
- Severe hypoglycaemia episodes
- 0
Original publication
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