Abstract
OBJECTIVE: To evaluate the effect of lobeglitazone on renal disease progression in patients with type 2 diabetes mellitus using longitudinal real-world data. DESIGN: Retrospective cohort study. SETTING: Hospital-based Common Data Model database. PARTICIPANTS: A total of 14 712 adults with type 2 diabetes mellitus who visited the Diabetes Center of Ewha Womans University Mokdong Hospital between 2013 and 2019 were identified. A 1:2 propensity score matching was performed to compare patients treated with lobeglitazone plus metformin with those receiving metformin monotherapy, sulfonylurea plus metformin, or a dipeptidyl peptidase-4 (DPP4) inhibitor plus metformin. INTERVENTIONS: Treatment with lobeglitazone plus metformin compared with metformin monotherapy, sulfonylurea plus metformin or DPP4 inhibitor plus metformin. PRIMARY OUTCOME MEASURES: Renal progression, defined as initiation of renal replacement therapy, a sustained ≥30% decline in estimated glomerular filtration rate (eGFR) from baseline, or doubling of serum creatinine with a concurrent eGFR ≤45 mL/min/1.73 m². RESULTS: The HR of renal progression was 0.84 (95% CI 0.58 to 1.21) in the lobeglitazone plus metformin compared with metformin monotherapy, 1.00 (95% CI 0.79 to 1.27) compared with sulfonylurea plus metformin group, 1.10 (95% CI 0.84 to 1.44) compared with DPP4 inhibitor plus metformin group after adjusting for multiple variables. Subgroup analyses demonstrated significant interactions by sex in the comparison with metformin monotherapy (P for interaction=0.0179) and by glycaemic control in the comparisons with sulfonylurea plus metformin (P for interaction=0.0161) and DPP4 inhibitor plus metformin (P for interaction=0.0006), suggesting potential heterogeneity in treatment effects. CONCLUSIONS: Lobeglitazone showed renal outcomes comparable to those of other antidiabetic medications, with a possible heterogeneity in treatment effects according to sex and glycaemic control.