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간행물 검색
Phase II Dose-Selection, Randomised, Controlled Trial of ASi BI 690517 With and Without EMPA in CKD: Subgroup Analysis by T2D Status
David Cherney
2024 ; 2024(1):
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춘계학술대회 초록집
Objectives: We investigated efficacy and safety of BI 690517, a novel aldosterone synthase inhibitor (ASI), in people with CKD with or without type 2 diabetes (T2D), and present an analysis by T2D status, pooled for background randomisation to empagliflozin (EMPA) or placebo (PBOEMPA). Methods: Trial design is shown in Figure 1. Results: 586 people were randomised at R2; 414 (70.6%) with T2D, and 172 (29.4%) without T2D. Baseline demographics and clinical characteristics were mostly similar between these groups. However, those with T2D had higher mean BMI (30.6 vs 28.3 kg/m2), systolic BP (135.3 vs 130.2 mmHg), eGFR (53.0 vs 49.4 mL/min/1.73m2), and median UACR (444.7 vs 409.2 mg/g) than those without T2D. BI 690517 consistently reduced UACR versus PBOASI in people with and without T2D (p = 0.38, indicating no between-group difference in treatment effect), with the largest reductions observed in the 10 and 20 mg dose-groups; however, for the 3 mg dose-group, UACR reduction was only observed in people with T2D (Figure 2). UACR response (≥30% reduction in UACR at week 14) was achieved in more than half of people with and without T2D in the BI 690517 10 and 20 mg dose-groups, with the highest response rates in those also receiving EMPA (10 mg dose-group: with T2D, 74.3%; without T2D, 64.0%). Adverse events leading to discontinuation of BI 690517 10 and 20 mg were more common among people with T2D than among those without T2D. Conclusions: In people who had CKD, with or without T2D, BI 690517 dose-dependently reduced UACR, with high rates of UACR response suggestive of additive beneficial effects when given with EMPA.
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