The University of Toledo Translation Journal of Medical Sciences 
Internal Medicine Abstract, Department of Medicine Research Symposium UTJMS 2023 May 5; 11(1):e1-e1 

The Rate of Adverse Events of Sodium-
Glucose Cotransporter 2 Inhibitors: A 
Meta-Analysis of Randomized Clinical 
Trials 
Omar Sajdeya, MD1*, Ziad Abuhelwa, MD1, Wasef Sayeh, MD1, Said Malhas, MD1, 
Clarissa Pena, MD1, Ehab Eltahawy, MD2

1Division of Internal Medicine, Department of Medicine, The University of Toledo, 
Toledo, OH 43614 
2Division of Cardiovascular Medicine, Department of Medicine, The University of 
Toledo, Toledo, OH 43614 

*Corresponding author: Omar.Sajdeya@utoledo.edu

Published: 05 May 2023 

Introduction: Sodium-glucose cotransporter 2 (SGLT2) inhibitors have proven cardiovascular benefits 
in diabetics and in patients with heart failure in the presence or absence of diabetes. We sought to assess 
the rate of adverse events with the use of SGLT2 inhibitors compared to placebo. 

Methods: We included all randomized, double-blinded, placebo-controlled trials of SGLT2 inhibitors 
regardless of the indication. Data were pooled using the Mantel-Haenszel random-effects model to 
calculate the relative risk (RR) and 95% confidence interval (CI). 

Results: We included a total of 62 trial comprising 95,594 patients (55,739 patients in the SGLT2 arm 
and 39,855 patients in the placebo arm). Compared to placebo, use of SGLT2 inhibitors was associated 
with a statistically significant increased rate of overall infections (9.6% vs. 5.7%, RR: 1.28, 95% CI: 
1.18 - 1.40), and diabetic ketoacidosis (0.2% vs. 0.08%, RR: 2.7, 95% CI: 1.62 - 4.50). The increased 
rate of overall infections was primarily driven by higher rates of genital infections (3.6% vs. 0.7%, RR: 
3.23, 95% CI: 2.73 - 3.82). The rates of hypoglycemia, bone fracture and amputation were not 
significantly different between both treatment arms (10.0% vs. 7.3%, RR: 1.06, 95% CI: 0.98 - 1.14), 
(3.6% vs. 3.6%, RR: 1.02, 95% CI: 0.94 - 1.10), and (1.5% vs. 1.3%, RR: 1.09, 95% CI: 0.94 - 1.27), 
respectively. 

Conclusion: SGLT2 inhibitors increase the risk of diabetic ketoacidosis and genital infections. The 
overall rate of diabetic ketoacidosis was, however, low. 

https://dx.doi.org/10.46570/utjms.vol11-2023-720 

https://dx.doi.org/10.46570/utjms.vol11-2023-720
mailto:Omar.Sajdeya@utoledo.edu