Evaluate Side Effects of Sglt-2 Inhibitors in Extreme Elderly Outpatients: Real-world Evidence From a Low- and Middle-income Country

Background: Very elderly patients are increasingly represented in clinical practice but remain underrepresented in randomized trials evaluating sodium–glucose cotransporter-2 inhibitors (SGLT2i). Although these agents have demonstrated substantial cardiovascular and renal benefits in heart failure (HF) and type 2 diabetes mellitus (T2DM), concerns regarding safety and tolerability. Evidence is particularly limited in low- and middle-income countries (LMICs), where socioeconomic and healthcare factors may influence treatment persistence. This study aimed to evaluate the safety profile, adverse events, and treatment discontinuation of SGLT2 inhibitors in very elderly outpatients. Methods: We conducted a retrospective observational study at the outpatient clinics of Hanoi Heart Hospital, Vietnam, between May 2023 and July 2024. Patients aged ≥ 85 years with HF or T2DM receiving SGLT2 inhibitors were included. Baseline demographic, clinical, laboratory, and medication data were collected. The primary outcome was severe adverse events leading to permanent discontinuation of SGLT2 inhibitor therapy. Secondary outcomes included non-severe adverse events, hospital readmission within one year, and mortality. Clinical outcomes were analyzed descriptively and stratified by age group (< 90 vs ≥ 90 years). Results A total of 316 patients were included (mean age 87.98 ± 3.09 years; 57.6% female). Heart failure was present in 94.0% of the cohort, with a median left ventricular ejection fraction of 50% (IQR 40–62). Major comorbidities included ischemic heart disease (70.9%), hypertension (62.3%), diabetes mellitus (43.4%), and chronic kidney disease (34.8%). Over one year of follow-up, SGLT2 inhibitor therapy was discontinued in 34.2% of patients. The most common causes of discontinuation were economic constraints (21.9%), acute kidney injury (11.4%), and death (12.4%). Notably, patients aged ≥ 90 years experienced substantially higher discontinuation due to acute kidney injury (25.0%) and death (33.3%) compared with those aged < 90 years. The one-year readmission rate was 11.7%, and overall mortality was 4.1%. Conclusions In this real-world cohort of very elderly outpatients, SGLT2 inhibitors demonstrated an acceptable safety profile but were associated with a relatively high treatment discontinuation rate. Clinical adverse events, particularly acute kidney injury, were more frequent among patients aged ≥ 90 years, while economic factors substantially influenced treatment persistence. These findings highlight the importance of individualized risk assessment, close monitoring, and consideration of socioeconomic barriers when prescribing SGLT2 inhibitors in very elderly populations in LMIC settings. Clinical trial registration Not applicable.