Open-Label, Randomized, Controlled, Crossover Trial on the Effect of Dapagliflozin in Patients With ADPKD Receiving Tolvaptan
Abstract
Introduction Although dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, delays the progression of chronic kidney disease (CKD), its effect on patients with autosomal dominant polycystic kidney disease (ADPKD) has not been established. We conducted an open-label, randomized controlled crossover trial to evaluate the additive effects of dapagliflozin in patients with ADPKD receiving tolvaptan. Methods A total of 27 patients were randomly counterbalanced to receive dapagliflozin 10 mg or usual care without dapagliflozin for 6 months. The primary endpoint was the slope of the estimated glomerular filtration rate (eGFR) determined by linear regression from 1 to 6 months, and the secondary endpoints included changes in total kidney volume (TKV). eGFR was calculated based on creatinine levels (eGFRcr), cystatin C levels (eGFRcys), and the mean of eGFRcr and eGFRcys (eGFRcr-cys). Results There were significant attenuations in the eGFRcr-cys and eGFRcys slopes during the dapagliflozin trial compared with the one without dapagliflozin (2.57 ± 7.88 vs. −5.65 ± 9.57 ml/min per 1.73 m2 per year, P = 0.002; 3.91 ± 11.40 vs. −8.43 ± 13.44 ml/min per 1.73 m2 per year, P = 0.003, respectively). Meanwhile, the eGFRcr slope was potentially moderate during the trial with dapagliflozin (1.03 ± 10.78 vs. −3.66 ± 8.88 ml/min per 1.73 m2 per year, P = 0.06). The 6-month change in TKV was significantly attenuated during the trial with dapagliflozin compared with the one without…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 27 participants or records.
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