Effects of dapagliflozin on hospitalisations in people with type 2 diabetes: post-hoc analyses of the DECLARE-TIMI 58 trial

Schechter, M; Wiviott, SD; Raz, I; Goodrich, EL; Rozenberg, A; Yanuv, I; Murphy, SA; Zelniker, TA; Fredriksson, M; Johansson, PA; Leiter, LA; Bhatt, DL; McGuire, DK; Wilding, JPH; Gause-Nilsson, IAM; Cahn, A; Langkilde, AM; Sabatine, MS; Mosenzon, O

doi:10.1016/s2213-8587(23)00009-8

Type 2 & other diabetes

Effects of dapagliflozin on hospitalisations in people with type 2 diabetes: post-hoc analyses of the DECLARE-TIMI 58 trial

Lancet Diabetes EndocrinolPublished 3 Mar 2023Post-hoc analysis of the DECLARE-TIMI 58 randomised controlled trial

Primary result · First non-elective hospitalisation for any causeResultHazard ratio 0.89 95% CI 0.85–0.94

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Authors' conclusion

Dapagliflozin reduced the risk of first and total non-elective hospitalisations for any cause in people with type 2 diabetes, regardless of the presence of atherosclerotic cardiovascular disease, including hospitalisations not directly attributed to cardiac, kidney, or metabolic causes. These findings might have implications on health-related quality of life for people with type 2 diabetes and on health-care costs attributable this condition.

Study context

Population: People with T2D and either risk factors for or established atherosclerotic CVD; mean age 63.9 years, 37.4% womenrandomised 1:1
Participants: 17,160 people

Comparison: Dapagliflozin 10 mg once daily vs placebo
Dapagliflozinn = 8,582
Placebon = 8,578reference
Primary endpoint: First non-elective hospitalisation for any cause
Follow-up: Median 4.2 years (IQR 3.9-4.4)

Methodological detailsdouble-blind, multicentre, placebo-controlled

Double-blind
Multicentre
Placebo-controlled

Primary result

As reported in the abstract

median 4.2 years

Hazard ratio

0.89

95% CI 0.85–0.94

Events by treatment group

Dapagliflozin32.4%2779 of 8582

Placebo35.4%3036 of 8578

Dapagliflozinvs Placebo

HR 0.89 (95% CI 0.85–0.94)

Further findings

Outcome	← Lower risk with dapagliflozin ←→ Higher risk with dapagliflozin →	Estimate	P value
Total (first plus subsequent) non-elective hospitalisations for any cause	0.512	risk ratio 0.92 (95% CI 0.86–0.97)
First non-elective any-cause hospitalisation, subgroup with atherosclerotic CVD	0.512	HR 0.92 (95% CI 0.85–0.99)	P for interaction = 0.31
First non-elective any-cause hospitalisation, subgroup without atherosclerotic CVD	0.512	HR 0.87 (CI 0.81–0.94)	P for interaction = 0.31
First hospitalisation by causeDapagliflozinvs PlaceboCardiac disorders	0.512	HR 0.91 (95% CI 0.84–1.00)
First hospitalisation by causeDapagliflozinvs PlaceboMetabolism and nutrition disorders	0.512	HR 0.73 (95% CI 0.60–0.89)
First hospitalisation by causeDapagliflozinvs PlaceboRenal and urinary disorders	0.512	HR 0.61 (95% CI 0.49–0.77)
First hospitalisation by causeDapagliflozinvs PlaceboAny other cause excluding these three	0.512	HR 0.90 (95% CI 0.85–0.96)
First hospitalisation by causeDapagliflozinvs PlaceboMusculoskeletal and connective tissue disorders	0.512	HR 0.81 (95% CI 0.67–0.99)
First hospitalisation by causeDapagliflozinvs PlaceboInfections and infestations	0.512	HR 0.86 (95% CI 0.78–0.96)
	0.512Ratio (log scale)

Original publication

Effects of dapagliflozin on hospitalisations in people with type 2 diabetes: post-hoc analyses of the DECLARE-TIMI 58 trial. Lancet Diabetes Endocrinol. Published 3 March 2023. doi:10.1016/s2213-8587(23)00009-8

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