Investigating Sodium-Glucose Cotransporter 2 Inhibitors Versus Other Glucose-Lowering Drugs on Ventricular
Bo Xu1,2,3,4,5, Tianqiao Zhang1,2,3,4, Bo Kang1,2,3,4
1The First Affiliated Hospital, Hunan Provincial Clinical Medical Research Center for Drug Evaluation of Major Chronic Diseases, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China.
Purpose:
Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been reported to exhibit antiarrhythmic effects. However, there is conflicting evidence regarding the association between SGLT2 inhibitors and ventricular arrhythmias or sudden cardiac death (SCD). We utilized the US FDA Adverse Event Reporting System (FAERS) database to investigate the reporting frequencies of SGLT2 inhibitors with ventricular arrhythmias and SCD compared to other glucose-lowering drugs (ATC-A10B).
Methods:
We used the web data mining tool AERSMine to mine reports of ventricular arrhythmias and SCD from FAERS to compare SGLT2 inhibitors versus other glucose-lowering drugs. The mining range was from 2004q1 to 2023q3. Disproportionality analysis used the proportional reporting ratio (PRR) with 95% confidence interval (CI) and information component (IC) with 95% credible interval.
Results:
From 2004q1 to 2023q3, a total of 121,129 adverse events were reported for SGLT2 inhibitors, with a total of 1,127,485 in the ATC-A10B group. Ventricular arrhythmias reporting frequency in the SGLT2 inhibitors group was similar to that of the control group (1.36/1000 reports vs 1.55/1000 reports; p = 0.10), with a PRR of 0.88 (95%CI 0.75-1.03). However, the reporting frequency of SCD in the SGLT2 inhibitors group was significantly lower than that of the control group (1.43 vs 4.70/1000; p < 0.001), with a PRR of 0.30 (95%CI 0.26-0.35), and this trend was observed within individual molecules of SGLT2 inhibitors. During the sensitivity analysis process, the results obtained when restricting the scope of data mining to between 2013q1 and 2023q3 were similar to those obtained when using data from 2004q1 to 2023q3.
Conclusion:
In this drug pharmacovigilance assessment, the reporting frequency of ventricular arrhythmias associated with SGLT2 inhibitors was similar to that of other antidiabetic medications, while the reporting frequency of SCD related to SGLT2 inhibitors was lower. This real-world study evidence complements existing clinical evidence.
Insights
Sodium-glucose cotransporter 2 (SGLT2) inhibitors showed similar reporting for ventricular arrhythmias compared to other glucose-lowering drugs. However, SGLT2 inhibitors were associated with significantly lower reporting of sudden cardiac death (SCD).
Area of Science:
- Pharmacovigilance
- Cardiology
- Endocrinology
Background:
- Sodium-glucose cotransporter 2 (SGLT2) inhibitors are used for diabetes management.
- Conflicting evidence exists regarding their impact on ventricular arrhythmias and sudden cardiac death (SCD).
Purpose of the Study:
- To investigate the reporting frequencies of SGLT2 inhibitors concerning ventricular arrhythmias and SCD.
- To compare these frequencies with other glucose-lowering drugs using the US FDA Adverse Event Reporting System (FAERS).
Main Methods:
- Data mining of FAERS from 2004q1 to 2023q3 using AERSMine.
- Disproportionality analysis comparing SGLT2 inhibitors with other glucose-lowering drugs (ATC-A10B).
- Utilized proportional reporting ratio (PRR) and information component (IC) for analysis.
Main Results:
- Ventricular arrhythmias reporting frequency was similar between SGLT2 inhibitors and controls (PRR 0.88).
- Sudden cardiac death (SCD) reporting frequency was significantly lower for SGLT2 inhibitors (PRR 0.30).
- These findings were consistent across sensitivity analyses and individual SGLT2 inhibitor molecules.
Conclusions:
- SGLT2 inhibitors demonstrate a similar reporting frequency for ventricular arrhythmias compared to other antidiabetic medications.
- Real-world data suggests a lower reporting frequency of sudden cardiac death (SCD) associated with SGLT2 inhibitors.
- This study complements existing clinical evidence on SGLT2 inhibitors' cardiovascular safety profile.
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