Arrhythmias & electrophysiology

Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus: Insights From the DECLARE-TIMI 58 Trial

CirculationPublished Secondary analysis of the DECLARE-TIMI 58 randomised trial

Primary result · AF/AFL eventsResult — go to the resultHazard ratio 0.81 95% CI 0.68–0.95

Authors' conclusion

Dapagliflozin decreased the incidence of reported episodes of AF/AFL adverse events in high-risk patients with type 2 diabetes mellitus.

Study context

Population
Patients with T2DM and either multiple risk factors for atherosclerotic CVD or known atherosclerotic CVD1,116 with prevalent atrial fibrillation (AF)/atrial flutter (AFL)
Participants
17,160 patients
Comparison
Dapagliflozin vs placebo
Primary endpoint
First AF/atrial flutter event (identified from the safety database by MedDRA preferred terms)
Methodological detailsplacebo-controlled, exploratory analysis
  • Placebo-controlled
  • Exploratory analysis

Primary result

AF/AFL events

Hazard ratio

0.81

95% CI 0.68–0.95

P = 0.009

Events by treatment group

Dapagliflozin

7.8 events per 1000 patient-years

264 events

Placebo

9.6 events per 1000 patient-years

325 events

Dapagliflozinvs Placebo
HR 0.81 (95% CI 0.68–0.95); P = 0.009

As reported in the abstract

Further findings

Events

OutcomeDapagliflozinPlaceboIRR (95% CI)P value
Total (first and recurrent) AF/AFL events3374320.77 (0.64–0.92)P = 0.005

AF/AFL, by history of AF/AFL at baseline (subgroup)

Previous AF/AFL: HR 0.79, 95% CI 0.58-1.09
No AF/AFL: HR 0.81, 95% CI 0.67-0.98
  • P for interaction 0.89

AF/AFL, by ASCVD vs multiple risk factors (subgroup)

Atherosclerotic CVD: HR 0.83, 95% CI 0.66-1.04
Multiple risk factors: HR 0.78, 95% CI 0.62-0.99
  • P for interaction 0.72

AF/AFL, by history of heart failure (HF) (subgroup)

HF: HR 0.78, 95% CI 0.55-1.11
No HF: HR 0.81, 95% CI 0.68-0.97
  • P for interaction 0.88

AF/AFL, other subgroups (sex, ischemic stroke, HbA1c, BMI, BP, eGFR)

No effect modification
all P for interaction >0.20

Original publication

Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus: Insights From the DECLARE-TIMI 58 Trial. Circulation. Published 27 January 2020. doi:10.1161/circulationaha.119.044183

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