A Multi-Center Randomized Trial on the Effects of Dapagliflozin on Urinary Albumin-to-Creatinine Ratio (UACR) in Patients with Heart Failure (HF) and Type 2 Diabetes Mellitus (T2D)
A recent clinical trial conducted in Japan examined the impact of dapagliflozin on urinary albumin-to-creatinine ratio (UACR) levels in patients with heart failure (HF) and type 2 diabetes mellitus (T2D).
Background
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a class of medications initially developed for the treatment of type 2 diabetes mellitus (T2D). However, recent studies have shown that these medications can also have beneficial effects in patients with heart failure (HF), even in those without T2D. Specifically, SGLT2 inhibitors have been shown to reduce the risk of death and other adverse outcomes in HF patients. Additionally, SGLT2 inhibitors have been shown to improve renal outcomes in patients with chronic kidney disease (CKD), even in those with reduced glomerular filtration rate (GFR).
Study Objectives
The Dapagliflozin for the Attenuation of Albuminuria in Patients with Heart Failure and Type 2 Diabetes (DAPPER) study was a randomized, controlled trial designed to investigate the effects of dapagliflozin on urinary albumin-to-creatinine ratio (UACR) in patients with HF and T2D. UACR is a key marker of kidney function and is an important predictor of cardiovascular risk.
Study Design
The DAPPER study was a multicenter trial conducted at 18 medical facilities in Japan. A total of 285 patients with HF and T2D were enrolled in the study. The patients were randomly assigned to either the dapagliflozin group or the control group. The dapagliflozin group received 10 mg of dapagliflozin daily, while the control group received their usual diabetes medication. The primary outcome of the study was the change in UACR from baseline to 96 weeks. Secondary outcomes included the following:
- Time to hospitalization for cardiovascular events
- Time to hospitalization for heart failure
- Need for additional prescriptions for heart failure
- Change in eGFR
- Occurrence of adverse events
Statistical Analysis
Statistically, changes in UACR and other continuous variables were analyzed using the student t-test and analysis of covariance. Time-to-event data were analyzed using the Kaplan–Meier estimator and Cox proportional hazards model, with R version 4.2.0 used for all statistical analyses.
Study Results
In the present study, 144 patients were assigned to the dapagliflozin group and 141 to the control group. There was, however, no significant difference in demographic and baseline clinical characteristics between the two groups.
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Primary Outcome – The primary outcome, the change in the UACR, did not differ significantly between the dapagliflozin arm and the control group. The difference in median change in UACR between the two groups was -13.0 mg/g Cr, having no statistical significance (3.7 mg/g Cr for dapagliflozin vs 6.9 mg/g Cr control). Both groups also exhibited similar results in log-transformed values of UACR changes.
Secondary Outcomes – In terms of secondary outcomes, no significant shifts were observed in UACR categories or eGFR categories between the two groups. However, there were differences in several cardiovascular outcomes. The dapagliflozin group showed lower rates of hospitalization for cardiovascular events and heart failure, as well as a decreased need for additional prescriptions for heart failure compared to the control group. The hazard ratios for these events were significantly lower in the dapagliflozin group, indicating a reduced risk of these events.
Adverse Events
Adverse events were reported in both groups, with the dapagliflozin group experiencing 158 events and the control group 171. Serious adverse events were lower in the dapagliflozin group (17.8%) compared to the control group (29.0%). There were no cases of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome in either group. Drug-related serious adverse events were slightly more common in the dapagliflozin group, but fractures and amputations were similarly rare in both groups.
Conclusion
The DAPPER study provides evidence that dapagliflozin may have beneficial effects on cardiovascular outcomes in patients with HF and T2D. However, further research is needed to determine the long-term efficacy and safety of dapagliflozin in this patient population.
Study source
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