Abstract
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.