Objective: This study aimed to investigate the association between dapagliflozin and the incidence of atrial fibrillation (AF) and atrial flutter (AFL), along with its impact on all-cause mortality in patients with diabetes mellitus (DM).
Material and methods: Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, this meta-analysis conducted a comprehensive search across PubMed, Embase, and ClinicalTrials.gov databases up to June 2021. We focused on randomized controlled trials (RCTs) that compared dapagliflozin with a placebo. Trial sequential analysis (TSA) was utilized to assess the reliability of the findings. All statistical analyses were performed using Review Manager software.
Results: The final analysis included nine studies, encompassing a total of 30,235 patients. The findings indicated a statistically significant reduction in the incidence of AF / AFL in the dapagliflozin group compared to the placebo group (relative risk (RR) = 0.73, 95 % confidence interval (CI) = 0.59 to 0.89, p=0.002), although this result was not corroborated by TSA. The occurrences of AF and all-cause mortality were also lower in the dapagliflozin group than in the placebo group (RR = 0.71, 95 % CI = 0.57 to 0.89, p=0.003 and RR = 0.90, 95 % CI = 0.82 to 0.98, p=0.02, respectively). However, TSA did not confirm these outcomes.
Conclusion: Dapagliflozin appears to offer a significant protective effect against AF / AFL and may reduce the risk of all-cause mortality in patients with DM. However, further research is needed to confirm these findings due to the lack of confirmation by TSA.