Can SGLT-2 inhibitors improve cardiovascular outcomes and ensure safety for patients with type 2 diabetes and heart failure in Thailand? A real-world multicentre retrospective cohort study.

OBJECTIVES

To assess the real-world effectiveness and safety of sodium-glucose co-transporter-2 inhibitors (SGLT2i) on cardiovascular outcomes in patients with type 2 diabetes mellitus (T2D) and heart failure (HF) and to evaluate the associated risks of adverse events.

DESIGN

A retrospective cohort study using propensity score analysis to control confounding variables.

SETTING

Data were collected from the electronic health records of two large tertiary care hospitals in Thailand over a 12-year period (2010-2022).

PARTICIPANTS

Adults aged 18 years and older with a diagnosis of T2D and HF were included in the study. Patients who received SGLT2i for a minimum of 3 months were compared with those in a non-SGLT2i group. Participants with a diagnosis of HF that preceded their diagnosis of T2D were excluded from the analysis.

PRIMARY AND SECONDARY OUTCOME MEASURES

The primary outcome was heart failure hospitalisation (HFH). Secondary outcomes included non-fatal stroke, non-fatal myocardial infarction (MI), all-cause mortality and adverse events (urinary tract infections, hypoglycaemia and acute kidney injury).

RESULTS

A total of 11 758 patients were included in the study, with a median follow-up of 2.44 (IQR: 0.72-5.02) years. After applying inverse probability of treatment weighting, covariates were balanced, ensuring the validity of the treatment effect model's assumptions. SGLT2i use was associated with a 59% reduction in HFH (HR 0.41, 95% CI 0.28 to 0.61), a 54% reduction in stroke (HR 0.46, 95% CI 0.33 to 0.63), a 51% reduction in MI (HR 0.49, 95% CI 0.36 to 0.67) and a 76% reduction in in-hospital all-cause mortality (HR 0.24, 95% CI 0.14 to 0.42). Additionally, SGLT2i use was associated with fewer adverse events, including lower rates of urinary tract infections and hypoglycaemia, compared with the non-SGLT2i group.

CONCLUSIONS

SGLT2i significantly improved cardiovascular outcomes in patients with T2D and HF in a real-world clinical setting. These findings support the incorporation of SGLT2i in the management of high-risk patients with T2D and HF. Further research is warranted to explore long-term outcomes and barriers to SGLT2i prescription in routine practice.