Empagliflozin in nondiabetic individuals with calcium and uric acid kidney stones: a randomized phase 2 trial

恩帕吉菲 肾结石 医学 安慰剂 泌尿科 尿酸 草酸钙 糖尿病 内科学 置信区间 随机对照试验 胃肠病学 2型糖尿病 外科 内分泌学 病理 替代医学
作者
Manuel Anderegg,Simeon Schietzel,Matteo Bargagli,Lia Bally,Nicolas Faller,Matthias B. Moor,Grazia M. Cereghetti,Marie Roumet,Sven Trelle,Daniel G. Fuster
出处
期刊:Nature Medicine [Nature Portfolio]
标识
DOI:10.1038/s41591-024-03330-x
摘要

Efficacy of sodium-glucose cotransporter 2 inhibitors for kidney stone prevention in nondiabetic patients is unknown. In a double-blind, placebo-controlled, single-center, crossover phase 2 trial, 53 adults (≥18 and <75 years) with calcium (n = 28) or uric acid (UA; n = 25) kidney stones (at least one previous kidney stone event) without diabetes (HbA1c < 6.5%, no diabetes treatment) were randomized to once daily empagliflozin 25 mg followed by placebo or reverse (2 weeks per treatment). Randomization and analysis were performed separately for both stone types. Primary analyses were conducted in the per protocol set. Primary outcomes were urine relative supersaturation ratios (RSRs) for calcium oxalate (CaOx), calcium phosphate (CaP) and UA—validated surrogates for stone recurrence. Prespecified RSR reductions (≥15%) were met in both groups of stone formers. In patients with calcium stones, empagliflozin reduced RSR CaP (relative difference to placebo, −36%; 95% confidence interval, −48% to −21%; P < 0.001), but not RSRs CaOx and UA. In patients with UA stones, empagliflozin reduced RSR UA (−30%; 95% confidence interval, −44% to −12%; P = 0.002) but not RSRs CaOx and CaP. No serious or prespecified adverse events occurred. Thus, empagliflozin substantially reduced RSRs in nondiabetic adults with calcium and UA kidney stones. ClinicalTrials.gov registration: NCT04911660 . As part of the SWEETSTONE trial, the authors report the ability of the sodium-glucose cotransporter 2 inhibitor empagliflozin to reduce the likelihood of kidney stone formation in individuals without diabetes.
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