{"id":"773f9548d9bb","type":"article","url":"https://hartvaat.nl/2026/10/24/empagliflozin-versnelt-niervolume-uitbreiding-bij-adpkd-feasibility-rct/","title":"Empagliflozin versnelt niervolume-uitbreiding bij ADPKD — feasibility RCT","title_en":"Empagliflozin Therapy in Autosomal Dominant Polycystic Kidney Disease: A Feasibility Randomized Controlled Trial.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","internist"],"tags":[],"journal":"Journal of the American Society of Nephrology : JASN","doi":"10.1681/ASN.0000001271","source_url":"https://doi.org/10.1681/ASN.0000001271","authors":["Stephen L Seliger","Berenice Gitomer","Zhiying You","Wei Wang","Anna Ostrow","Emily Andrews","Charalett Diggs","Diana George","Miranda West","Kristen L Nowak","Terry Watnick","Michel Chonchol"],"significance":4,"published":"2026-11-02","source_date":"2026-10-24","image":"https://hartvaat.nl/global/img/6e2cc0469790.webp","kennis":["https://hartvaat.nl/kennis/farmacologie/antiaritmica-farmacologie/"],"congress":"","summary_en":"In a small feasibility RCT of 50 adults with autosomal dominant polycystic kidney disease (ADPKD), empagliflozin 25 mg daily was evaluated for safety and efficacy over 12 months. The drug was well tolerated but significantly accelerated total kidney volume growth compared with placebo (10.5% vs 5.1% per year; p=0.001). While an acute eGFR decline occurred at one month, the chronic eGFR slope over the remaining 11 months did not differ from placebo. These findings suggest empagliflozin should not be used to slow kidney volume progression in ADPKD, highlighting the need for disease-specific trials before considering off-label SGLT2 inhibitor use in this population.","created":"2026-10-26T02:50:51Z","updated":"2026-10-26T02:50:54Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"In een kleine feasibility-RCT onder 50 volwassenen met autosomaal dominante polycystische nierziekte (ADPKD) werd de veiligheid en effectiviteit van empagliflozin 25 mg/dag geëvalueerd. Na 12 maanden was het medicijn goed verdragen, maar het versnelde de groei van het totale niervolume aanzienlijk (10,5% per jaar versus 5,1% bij placebo; p=0,001). Er trad wel een acute daling van het eGFR op na één maand, maar het chronische eGFR-verloop tot 12 maanden verschilde niet van placebo. Voor clinici betekent dit dat empagliflozin momenteel niet ondersteund kan worden voor het remmen van niervolume-uitbreiding bij ADPKD en dat voorzichtigheid geboden is bij off-label gebruik in deze populatie.","abstract_original":"KEY POINTS: Empagliflozin 25 mg once daily for 12 months was safe and well tolerated in adults with autosomal dominant polycystic kidney disease at high risk of rapid progression. Those randomized to empagliflozin had a greater rate of increase in total kidney volume over 12 months compared with placebo. There was no difference between groups in the chronic rate of change in eGFR, nor in change in vascular stiffness, symptoms, and copeptin. BACKGROUND: Sodium-glucose cotransporter 2 inhibitors reduce the risk of diabetic and nondiabetic kidney disease progression; however, their safety and efficacy in patients with autosomal dominant polycystic kidney disease (ADPKD) are undetermined. METHODS: In this pilot and feasibility randomized controlled trial, we assigned 50 participants, 18-55 years of age, with ADPKD, at high risk of progression, not treated with tolvaptan, to receive empagliflozin (25 mg once daily) or placebo in a 1:1 ratio for 12 months. Primary outcomes were medication safety and tolerability. Secondary outcomes were (1) change in height-adjusted total kidney volume; (2) acute and chronic slope of eGFR; and (3) changes in aortic pulse wave velocity, plasma copeptin levels, urine kidney injury molecule-1, and patient-reported outcomes. RESULTS: Mean age was 42±7 years, and eGFR was 70±17 ml/min per 1.73 m2. Frequency of adverse events was similar between the 2 groups. Urinary tract infection occurred in 2 empagliflozin-treated patients versus none in placebo and AKI in 1 placebo-treated patient. In total, 96% of the participants in each group tolerated the full dose of the study drug. Among the secondary outcomes, rate of change in height-adjusted total kidney volume was significantly greater in empagliflozin-treated participants (10.5%/yr; 95% confidence interval, 8.2% to 12.7%) compared with placebo (5.1%/yr; 95% confidence interval, 3.0% to 7.3%; P = 0.001). There was a faster acute decline in eGFR at 1 month among the empagliflozin (-6.2 ml/min per 1.73 m2) versus placebo groups (0.1 ml/min per 1.73 m2; P = 0.01), but no differences in eGFR change from 1 to 12 months (empagliflozin group: -0.77±1.44 ml/min per 1.73 m2 per year versus placebo group: -2.87±1.96 ml/min per 1.73 m2 per year; P = 0.4). No between-group differences were observed in changes in aortic pulse wave velocity, copeptin, urine kidney injury molecule-1, and ADPKD Impact Score. CONCLUSIONS: Empagliflozin at 25 mg once daily was well tolerated by patients with ADPKD. Empagliflozin induced an expected acute decline in eGFR by 1 month, followed by stable eGFR. However, those treated with empagliflozin had a greater increase in kidney volume. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: ClinicalTrials.gov, NCT05510115."}