A recent study reported in eClinicalMedicine explored dapagliflozin’s impact on the urinary albumin-to-creatinine ratio (UACR) among patients dealing with heart failure (HF) and type 2 diabetes mellitus (T2D). Sodium-glucose cotransporter 2 (SGLT2) inhibitors, primarily developed for T2D treatment, have shown promise in reducing adverse outcomes in HF patients, indicating their potential beyond T2D management. Trials like CREDENCE and DAPA-CKD demonstrated SGLT2 inhibitors’ effectiveness in reducing UACR, a vital marker in chronic kidney disease (CKD) and HF.
However, their precise impact on patients with both HF and T2D remained relatively unexplored, leading to the initiation of the DAPPER study to bridge this evidential gap.
The multicentre randomized trial took place across 18 medical facilities in Japan from May 2017 to March 2022. Supported by AstraZeneca and Ono Pharmaceutical Companies initially, the study underwent oversight by various committees ensuring ethical conduct and rigorous analysis. Participants, aged 20 to 85, dealing with HF and T2D with an estimated GFR of at least ≥45 mL/min/1.73 m2, were eligible. Notably, the study did not impose specific UACR-based entry or exclusion criteria.
While the primary outcome of UACR change did not significantly differ between the dapagliflozin and control groups, the study noted several secondary cardiovascular benefits associated with dapagliflozin. The drug showcased reduced rates of hospitalization due to cardiovascular events and heart failure, along with a decreased need for additional heart failure prescriptions compared to the control group.
Adverse events were reported in both groups, with a slightly lower occurrence of serious adverse events in the dapagliflozin group. Notably, drug-related serious adverse events were marginally higher in the dapagliflozin group, although occurrences of fractures and amputations were similarly rare in both groups. Although dapagliflozin did not show a significant change in the primary UACR outcome, its positive impact on secondary cardiovascular outcomes suggests potential benefits in reducing cardiovascular risks among HF and T2D patients.