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A Multicenter Randomized Clinical Trial of Dapagliflozin in Patients Receiving Chronic Dialysis (The DARE-ESKD-2
Joaquim Barreto1, Marilia Paiva Martins1, Cleide Aparecida Moreira Silva2
1Laboratory of Atherosclerosis and Vascular Biology, School of Medical Sciences, Unicamp, Campinas, Brazil.
Insights
Dapagliflozin is safe for patients on maintenance dialysis but did not show significant cardiovascular benefits in a 24-week trial. Further research is needed to explore its long-term effects and potential benefits in this population.
Area of Science:
- Nephrology
- Cardiology
- Clinical Trials
Background:
- Dapagliflozin has shown benefits in reducing heart failure (HF) and hospitalizations in chronic kidney disease (CKD) patients.
- Its efficacy and safety in patients undergoing maintenance dialysis remain unclear.
Purpose of the Study:
- To evaluate the efficacy and safety of dapagliflozin in patients on maintenance dialysis.
- To assess the impact of dapagliflozin on N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, and 6-minute walk test distance (6MWTD).
Main Methods:
- A prospective, randomized, open-label, blinded end point trial involving 80 adult patients on chronic dialysis.
- Patients were randomized to receive either dapagliflozin 10 mg once daily or standard care for 24 weeks.
- Primary endpoint was the change in NT-proBNP levels; secondary endpoints included KCCQ scores and 6MWTD.
Main Results:
- No statistically significant difference in NT-proBNP levels between the dapagliflozin and standard care groups (P=0.065).
- No significant differences observed in KCCQ scores (P=0.073 for clinical summary, P=0.094 for total summary) or 6MWTD (P=0.956).
- Dapagliflozin did not increase the proportion of patients with improvements in 6MWTD or KCCQ scores, and no differences were found in echocardiographic measurements or safety endpoints.
Conclusions:
- Dapagliflozin was found to be safe in patients receiving maintenance dialysis.
- The study did not demonstrate a significant effect of dapagliflozin on surrogate markers of heart failure compared to standard care over 24 weeks.
- These findings suggest no demonstrable cardiovascular benefit of dapagliflozin in this population within the study period.
Introduction:
Dapagliflozin reduces heart failure (HF) incidence and hospitalizations in chronic kidney disease (CKD), but its efficacy and safety in patients on maintenance dialysis remain uncertain.
Methods:
In this prospective, randomized, open-label, blinded end point trial performed at 3 dialysis clinics between January 2023 and September 2024, adults on chronic dialysis were randomized to once daily dapagliflozin 10 mg or standard care for 24 weeks. The primary end point was change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. Secondary end points included changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores and 6-minute walk test distance (6MWTD). Exploratory analysis examined intergroup differences in echocardiographic measurements and laboratory tests. Safety analysis comprised adverse event rates.
Results:
Of 110 screened individuals, 80 were consecutively assigned (mean age: 56 years; 54% male). The median (95% confidence interval [CI]) adjusted change in NT-proBNP was 13 (-64 to 281) pg/ml in the control group and -109 (-356 to 55) pg/ml in the dapagliflozin group. The intergroup difference in NT-proBNP change was not statistically significant after adjustment by baseline values (median [95% CI] difference: -155 [-327 to -33] pg/ml; P = 0.065). No difference was found between study arms regarding the least mean (95% CI) square difference (LSD) in KCCQ clinical summary score (7 points; P = 0.073), total summary score (7 points; P = 0.094), or 6MWTD (-0.9 m; P = 0.956). Dapagliflozin did not increase the proportion of patients with improvement in 6MWTD (34.5% vs. 40.0%; odds ratio [OR]: 1.27 [95% CI: 0.44-3.74]; P = 0.657) or KCCQ clinical summary score (18.8% vs. 22.9%; OR: 1.63 [95% CI: 0.33-9.12]; P = 0.548). No difference was found between study arms regarding echocardiographic measurements or safety end points.
Conclusion:
Dapagliflozin was safe but did not affect surrogate markers of HF compared with standard care in patients receiving maintenance dialysis, suggesting no demonstrable cardiovascular benefit over 24 weeks in this population.
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