Arrhythmias & electrophysiologySecondary analysis
Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus
- Secondary analysis of the DECLARE-TIMI 58 randomised trial
- placebo-controlled
- exploratory analysis
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)
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
Dapagliflozin vs Placebo
HR 0.81 (95% CI 0.68–0.95); P = 0.009
As reported in the abstract
Further findings
events
| Outcome | Dapagliflozin | Placebo | IRR (95% CI) | P value | |
|---|---|---|---|---|---|
| Total (first and recurrent) AF/AFL events | 337 | 432 | 0.77 (0.64–0.92) | P = 0.005 | |
| 0.512Incidence rate ratio (log scale) |
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. Circulation. Published 27 January 2020. doi:10.1161/circulationaha.119.044183
Summarised from the published abstract; every number is checked against it