SGLT2i are associated with lower SAEs and higher incidence of genital infections, UTIs, and hypotension.

Sodium-glucose co-transporter inhibitors (SGLT2i) are emerging as a new treatment for heart failure (HF) after demonstrating favorable clinical outcomes in several randomized controlled trials (RCTs). In this meta-analysis, we assessed the safety of SGLT2i in the trials that prespecified heart failure in their inclusion criteria.

We searched the databases for RCTs comparing SGLT2i to placebo in heart failure patients. The primary outcome was the incidence of serious adverse events (SAEs). A sensitivity analysis according to the class of HF was also performed.

The incidence of SAEs was significantly lower in the SGLT2i group (OR, 0.85; 95% CI, 0.77–0.92; P, 0.0002) and SAEs remained significantly lower after performing the sensitivity analysis (OR, 0.82; 95% CI, 0.75–0.89; P, <0.00001). Genital infections, urinary tract infections (UTIs), and hypotension were significantly higher in the SGLT2i group.

SGLT2i remain a safe option for patients with HF with a lower incidence of SAEs. However, since they increase the risk of genital infection, UTIs and hypotension, the risks vs benefits in each patient should be weighed when making a prescribing decision.

Sodium-glucose co-transporter inhibitors(SGLT2i)

Heart failure (HF)

Heart failure with reduced ejection fraction (HfrEF)

Heart failure with preserved ejection fraction (HfpEF)

Safety outcomes

Empagliflozin

Dapagliflozin

Sotagliflozin

Sodium-glucose co-transporter inhibitors

Randomized controlled trials

serious adverse events

Urinary tract infections

type 2 diabetes mellitus

The American College of Cardiology

New York Heart Association

Heart failure with reduced ejection fraction

heart failure with preserved ejection fraction

Left ventricular ejection fraction

Venous thromboembolism

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