J Diabetes Res. 2026;2026(1):e6584068. doi: 10.1155/jdr/6584068.
ABSTRACT
BACKGROUND: Sodium-glucose co-transporter-2 (SGLT2) inhibitors have demonstrated significant benefits in heart failure (HF) patients in randomised controlled trials (RCTs). However, real-world evidence (RWE) is crucial to confirm their efficacy in broader, unselected patient populations. This meta-analysis is aimed at synthesising real-world data on SGLT2 inhibitors in HF across various ejection fraction phenotypes.
METHODS: We conducted a systematic review and meta-analysis of real-world observational studies on SGLT2 inhibitor use in HF patients. Comprehensive searches were performed across PubMed/MEDLINE, Embase, Web of Science, and Scopus. Data were pooled using random-effects models, assessing heterogeneity and bias and performing subgroup analyses. The review followed PRISMA guidelines and was PROSPERO-registered (CRD420261356715).
RESULTS: Our search yielded over 4000 unique articles, with 21 observational studies (encompassing nearly 4.8 million HF patients from 17 countries) included in the quantitative meta-analysis. SGLT2 inhibitors consistently reduced HF hospitalisation rates in real-world use (pooled HR 0.65, 95% CI 0.59-0.72). This included a significant reduction in those with cardiovascular disease (HR 0.78, 95% CI 0.68-0.89) and without cardiovascular disease (HR 0.53, 95% CI 0.39-0.71). The absolute risk reduction for hospitalisation for HF in people with a history of CVD (ARR 1.17, 95% CI 0.78-1.55) was significantly greater than for those without CVD (ARR 0.39, 95% CI 0.32-0.47). The number-needed-to-treat to prevent one hospitalisation for HF was 86 (95% CI 65-128) over 1 year of treatment for the CVD group and 256 (95% CI 215-316) over 1 year of treatment for those without CVD. SGLT2 inhibitors also significantly reduced all-cause mortality (pooled OR 0.60, 95% CI 0.50-0.70) and cardiovascular mortality (OR 0.65, 95% CI 0.55-0.75). No new safety signals emerged, with SGLT2 inhibitors generally well tolerated.
CONCLUSION: Real-world SGLT2 inhibitor use significantly reduces hospitalisations and mortality across diverse HF phenotypes, mirroring trial results. Broad implementation could substantially improve population-level outcomes.
PMID:42126925 | DOI:10.1155/jdr/6584068