Dataset Information

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

ABSTRACT:

Background

Sodium glucose cotransporter-2 inhibitors (SGLT2i) reduce the risk of heart failure and new data show they can prevent atrial fibrillation (AF). We examined the association between SGLT2i and AF in the Food and Drug Administration adverse event reporting system (FAERS).

Methods

We mined the FAERS from 2014q1 to 2019q4 to compare AF reporting for SGLT-2 i versus reports for other glucose lowering medications (ATC10 class). Several exclusions were sequentially applied for: concomitant medications; diabetes, cardiovascular or renal disease indication; reports for competing adverse events (genitourinary tract infections, ketoacidosis, Fournier's gangrene, amputation). We provide descriptive statistics and calculated proportional reporting ratios (PRR).

Results

There were 62,098 adverse event reports for SGLT2i and 642,031 reports for other ATC10 drugs. The reporting of AF was significantly lower with SGLT2i than with other ATC10 drugs (4.8 versus 8.7/1000; p?ConclusionsIn a large pharmacovigilance database, AF was robustly and consistently reported more frequently for diabetes medications other than SGLT2i. This finding complements available evidence from trials supporting a protective role of SGLT2i against the occurrence of AF.

SUBMITTER: Bonora BM

PROVIDER: S-EPMC7879696 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

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

Bonora Benedetta Maria BM Raschi Emanuel E Avogaro Angelo A Fadini Gian Paolo GP

Cardiovascular diabetology 20210211 1

<h4>Background</h4>Sodium glucose cotransporter-2 inhibitors (SGLT2i) reduce the risk of heart failure and new data show they can prevent atrial fibrillation (AF). We examined the association between SGLT2i and AF in the Food and Drug Administration adverse event reporting system (FAERS).<h4>Methods</h4>We mined the FAERS from 2014q1 to 2019q4 to compare AF reporting for SGLT-2 i versus reports for other glucose lowering medications (ATC10 class). Several exclusions were sequentially applied for ...[more]

PMID: 33573667

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Dataset Information

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

Background

Methods

Results

Publications

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

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