What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Heart failure (n=16579). Intervention: Sodium-glucose cotransporter 2 inhibitor (SGLT2i) vs. Placebo. Primary outcome: Incidence of atrial fibrillation (AF) events (RR 0.92, 95% CI 0.80-1.06, p=0.23).

May 24, 2023Open Access

Sodium-glucose cotransporter 2 inhibitor may not prevent atrial fibrillation in patients with heart failure: a systematic review

Q: What does this research mean for the field?

Sodium-glucose cotransporter 2 inhibitors do not significantly reduce the risk of atrial fibrillation compared to placebo in patients with heart failure. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

Key Result

Sodium-glucose cotransporter 2 inhibitors did not significantly reduce the risk of atrial fibrillation compared to placebo in patients with heart failure (RR 0.92).

Study Design

Type

Meta-Analysis (n=16,579)

Structured PICO

Does SGLT2i reduce the risk of atrial fibrillation in patients with heart failure?

Population

16,579 patients with a confirmed diagnosis of HFrEF (LVEF ≤40%) or HFpEF (LVEF >40%) pooled from 10 RCTs. Mean age ranged from 61.3 to 73.5 years.

Intervention

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) as a class (specifically dapagliflozin 10 mg or empagliflozin 10 mg)

Comparator

Placebo

Outcome

Incidence of atrial fibrillation (AF) events, collected and defined as AF reported in serious adverse events or other adverse eventssafety

This meta-analysis demonstrates that SGLT2 inhibitors do not significantly prevent the occurrence of atrial fibrillation in patients with heart failure.

Main Result

Effect estimate: RR 0.92 (95% CI 0.80-1.06)

Absolute Event Rate: 4.2% vs 4.57%

p-value: p=0.23

Limitations

None of the trials put AF as the primary endpoint event
Trials could not be grouped according to comorbidities because patient-level data were not available
DELIVER trial was excluded due to unavailable data
Trials could not be grouped by dose because all trials used the same concentration of SGLT2i
The weight ratio of some RCTs was huge, potentially causing bias risk after sensitivity analysis
The AF events recorded did not differentiate between persistent AF and paroxysmal AF
Lack of data regarding the number of events linked to anti-HF drugs used

Abstract

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) frequently coexist because of their similar pathological basis. However, whether sodium-glucose cotransporter 2 inhibitor (SGLT2i), a novel class of anti-HF medication, decreases the risk of AF in HF patients remains unclear. OBJECTIVES: The aim of this study was to assess the relationship between SGLT2i and AF in HF patients. METHODS: A meta-analysis of randomized controlled trails evaluating the effects of SGLT2i on AF in HF patients was performed. PubMed and ClinicalTrails.gov were searched for eligible studies until 27 November 2022. The risk of bias and quality of evidence were assessed through the Cochrane tool. Pooled risk ratio of AF for SGLT2i versus placebo in eligible studies was calculated. RESULTS: A total of 10 eligible RCTs examining 16,579 patients were included in the analysis. AF events occurred in 4.20% (348/8292) patients treated with SGLT2i, and in 4.57% (379/8287) patients treated with placebo. Meta-analysis showed that SGLT2i did not significantly reduce the risk of AF (RR 0.92; 95% CI 0.80-1.06; p = 0.23) in HF patients when compared to placebo. Similar results remained in the subgroup analyses, regardless of the type of SGLT2i, the type of HF, and the duration of follow-up. CONCLUSIONS: Current evidences showed that SGLT2i may have no preventive effects on the risk of AF in patients with HF. TRANSLATIONAL PERSPECTIVE: Despite HF being one of the most common heart diseases and conferring increased risk for AF, affective prevention of AF in HF patients is still unresolved. The present meta-analysis demonstrated that SGLT2i may have no preventive effects on reducing AF in patients with HF. How to effectively prevent and early detect the occurrence of AF is worth discussing.

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