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Treatment with the sodium–glucose cotransporter 2 (SGLT-2) inhibitor, dapagliflozin, attenuates progression of kidney disease and reduces the risks of heart failure and death in patients with chronic kidney disease (CKD). Data on the effects of dapagliflozin on health-related quality of life (HRQoL) are limited in patients with CKD.
In DAPA-CKD, adults with CKD, with and without type 2 diabetes, with estimated glomerular filtration rate (eGFR) 25–75 mL/min/1.73m2 and urinary albumin-to-creatinine ratio 200–5000 mg/g were randomized to dapagliflozin (10 mg/day) or placebo. We assessed HRQoL using the Kidney Disease Quality of Life (KDQOL-36) questionnaire at baseline and at 12, 24, and 36 months. We determined the overall effects of dapagliflozin versus placebo, as well as the effects of non-fatal clinical events on HRQoL
A total of 3760/4304 (87.4%) randomized patients (mean age 62 years, 32% female) had information on KDQOL-36 at baseline and at least once during follow-up. Baseline mean scores on the physical health composite (PHC); mental health composite (MHC); and kidney disease symptoms, effects, and burden were similar between randomized groups. During follow-up, mean scores were significantly higher in patients randomized to dapagliflozin for PHC (0.33 [95% CI 0.02, 0.64]), kidney disease symptoms (0.49 [0.02, 0.95]), and kidney disease effects (0.60 [0.06, 1.13]). Scores did not differ significantly between treatment groups for MHC (0.34 [0.00, 0.68]) and kidney disease burden (0.57 [−0.28, 1.42]; Figure). Patients randomized to dapagliflozin were significantly less likely to experience a clinically meaningful (≥5 units) decline in PHC, compared with placebo (hazard ratio [HR] 0.90; 95% CI 0.81, 0.99). Corresponding relative hazard ratios for ≥5-unit decline in MHC, and kidney disease symptoms, effects, and burden were 0.97 (95% CI 0.88, 1.07), 0.89 (95% CI 0.80, 0.98), and 0.89 (95% CI 0.81, 0.98) and 0.97 (95% CI 0.88, 1.05), respectively (Table). Overall, 285 (7.6%) patients experienced a ≥50% eGFR decline, 236 (6.3%) experienced end-stage kidney disease (ESKD), and 85 (2.3%) were hospitalized for heart failure during study follow-up. A ≥50% eGFR decline was associated with a lower PHC score at subsequent visits compared to prior visits with a difference in PHC score of −1.71 (95% CI −2.78, −0.65). The difference in PHC score after occurrence of ESKD and hospitalization for heart failure was −3.20 (95% CI −4.41, −1.99) and −2.33 (95% CI −5.28, 0.62), respectively. Results were similar for MHC, and kidney disease symptoms, effects, and burden.
Treatment with dapagliflozin attenuates the average decline and the risk of sizeable declines in physical health composite and kidney disease symptoms and effects in patients with CKD.