Measuring the Impact of tolvaptan-induced polyuria on quality of life in patients with autosomal dominant polycystic kidney disease

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ID: 313814
2026
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Abstract
INTRODUCTION: Tolvaptan, a vasopressin V2 receptor antagonist (V2RA), is the only proven renoprotective therapy for patients with autosomal dominant polycystic kidney disease (ADPKD), but aquaretic side-effects limit its tolerability. Currently, no patient-reported outcome measures (PROMs) specifically assess the impact of tolvaptan on health-related quality of life (HRQoL) in ADPKD. METHODS: We developed the Tolvaptan Impact of Polyuria Scale (TIPS) questionnaire to evaluate tolvaptan-related treatment burden, with higher scores indicating greater burden. The TIPS, alongside the ADPKD-Urinary Impact Scale (ADPKD-UIS) and Short-Form 12 (SF-12) questionnaires, was administered to 152 participants: 47 healthy controls and repeatedly in 105 patients with ADPKD, including those that were untreated (n = 48), on a stable tolvaptan dose (n = 33), or undergoing tolvaptan dose titration (n = 24). All participants also completed standardized 24-hour urine collections. RESULTS: Untreated patients with ADPKD reported a lower HRQoL than healthy controls. Tolvaptan-treated patients had significantly higher 24-hour urine volumes (5139 ± 193 versus 2474±180 ml, p < 0.001), with elevated TIPS total (48.0 ± 3.8 versus 37.3 ± 3.4, p = 0.04) and ADPKD-UIS total scores (19.2 ± 1.0 versus 15.6 ± 0.9, p = 0.01) compared to untreated patients, reflecting treatment burden. Twenty-four hour urine volume correlated with TIPS total (r = 0.56 [95% CI: 0.38, 0.78, p < 0.001]) and ADPKD-UIS total scores (r = 0.71 [95% CI: 0.58, 0.83, p < 0.001]), but not with SF-12 scores. TIPS scores were stable over time in treated- and untreated ADPKD patients. During tolvaptan titration, the greatest changes in 24-hour urine volume and HRQoL occurred at the initial dose (45/15 mg), with significant treatment burden across HRQoL domains. Among patients who discontinued tolvaptan during titration due to aquaretic side effects, unlike the ADPKD-UIS, TIPS scores were higher compared to those who continued treatment, suggesting better differentiation by the TIPS. CONCLUSION: Tolvaptan treatment significantly impacts HRQoL in ADPKD. The TIPS questionnaire effectively captures the physical, mental, and social burden of tolvaptan-induced polyuria, and provides a reliable PROM for clinical care and research.
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Authors Thomas Bais, P Geertsema, Christine Hanke, Anna M Posthumus, Stephan J L Bakker, Esther Meijer, Ron T Gansevoort
Journal nephrology dialysis transplantation
Year 2026
DOI
10.1093/ndt/gfag102
URL
https://doi.org/10.1093/ndt/gfag102
Keywords Keywords not found

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