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February 11, 2021Cardiovascular DiabetologyOpen Access

SGLT-2 inhibitors and atrial fibrillation in the Food and Drug Administration adverse event reporting system

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Key result

SGLT-2 inhibitors were associated with a significantly lower reporting rate of atrial fibrillation compared to other glucose-lowering medications (4.8 vs 8.7 per 1000 reports; PRR 0.55).

Why the study?

SGLT2i reduce heart failure risk and new data indicate they can prevent AF, prompting evaluation of the association between SGLT2i and AF in real-world adverse event reports.

Population

62,098 adverse event reports for SGLT2i and 642,031 reports for other ATC10 drugs in FAERS

Comparison

SGLT-2 i vs other glucose lowering medications (ATC10 class)

Design

Pharmacovigilance database study of FAERS

Authors

BBBenedetta Maria BonoraEREmanuel RaschiAAAngelo Avogaro

Discussion

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Overview

Supports lower AF reporting with SGLT2 inhibitors in pharmacovigilance data; leaves open confirmation in prospective trials.

Study Design

Type

Observational (n=704,129)

PICO

P
Population
704,129 adverse event reports from the FDA adverse event reporting system (FAERS) between 2014 and 2019 for patients taking SGLT2 inhibitors or other glucose-lowering medications.
E
Exposure / Comparator
SGLT-2 inhibitors vs Other glucose-lowering medications (ATC A10 class)
O
Primary Outcome
Reporting of atrial fibrillation (AF) — PRR 0.55 (0.49-0.62), p=<0.001

Main Result

Effect estimate: PRR 0.55 (95% CI 0.49-0.62)

Absolute Event Rate: 4.8% vs 8.7%

p-value: p=<0.001

Limitations

  • Pharmacovigilance data cannot be used to derive absolute incidence of an event.
  • Clinical-level data such as HbA1c, BMI, and kidney function are not available.
  • Duration of treatment is described in a minority of reports.
  • No means of assessing how atrial fibrillation was diagnosed.

Cite This Study

Bonora et al. (2021) conducted an observational in Adverse events in patients taking glucose-lowering medications (n=704,129). SGLT-2 inhibitors vs. Other glucose-lowering medications (ATC A10 class) was evaluated on Reporting of atrial fibrillation (AF) (PRR 0.55, 95% CI 0.49-0.62, p=<0.001). SGLT-2 inhibitors were associated with a significantly lower reporting rate of atrial fibrillation compared to other glucose-lowering medications (4.8 vs 8.7 per 1000 reports; PRR 0.55).

synapsesocial.com/papers/6a2bd852f816d8ce9df4ec3chttps://doi.org/10.1186/s12933-021-01243-4
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Effect of SGLT2 inhibitors on cardiovascular events in patients with atrial fibrillation: A systematic review and meta‐analysis of randomized controlled trials2023 · 12 citations
  2. 2Sodium-glucose cotransporter-2 inhibitors and the risk of atrial fibrillation in patients with type 2 diabetes: a population-based cohort study2024 · 4 citations
  3. 3Sodium–glucose co-transporter-2 inhibitors for the prevention of atrial fibrillation: a systemic review and meta-analysis2023 · 53 citations
  4. 4Association of SGLT2 Inhibitors With Risk of Atrial Fibrillation and Stroke in Patients With and Without Type 2 Diabetes: A Systemic Review and Meta-Analysis of Randomized Controlled Trials.2022 · 39 citations
  5. 5Sodium-glucose cotransporter-2 inhibitors and incidence of atrial fibrillation in older adults with type 2 diabetes: a retrospective cohort analysis2024 · 8 citations