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非布司他与托匹司他治疗合并心血管疾病的高尿酸血症的转换试验:慢性肾脏病亚组分析(TROFEO CKD试验)

Changeover Trial of Febuxostat and Topiroxostat for Hyperuricemia with Cardiovascular Disease: Sub-Analysis for Chronic Kidney Disease (TROFEO CKD Trial).

作者信息

Sezai Akira, Unosawa Satoshi, Taoka Makoto, Osaka Shunji, Sekino Hisakuni, Tanaka Masashi

机构信息

Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.

Department of Cardiovascular Surgery, Sekino Hospital, Tokyo, Japan.

出版信息

Ann Thorac Cardiovasc Surg. 2020 Aug 20;26(4):202-208. doi: 10.5761/atcs.oa.19-00162. Epub 2019 Nov 21.

DOI:10.5761/atcs.oa.19-00162
PMID:31748427
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7435131/
Abstract

BACKGROUND

The TROFEO trial demonstrated that febuxostat causes greater and more rapid reduction of serum uric acid (s-UA) than topiroxostat. We compared these drugs in patients with chronic kidney disease (CKD) by sub-analysis of the TROFEO trial.

METHODS

This sub-analysis targeted patients with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m. The primary endpoint was the s-UA level. Secondary endpoints included creatinine, eGFR, urinary albumin, cystatin-C, oxidized low-density lipoprotein (Ox-LDL), eicosapentaenoic acid/arachidonic acid ratio, lipid biomarkers, high-sensitivity C-reactive protein, and B-type natriuretic peptide (BNP).

RESULTS

There was no significant difference of s-UA between the two groups either before or after treatment. However, s-UA did not exceed 6.0 mg/dL in febuxostat group during the study period, but it exceeded this level in seven patients from topiroxostat group, with the number being significantly higher in topiroxostat group. Serum creatinine (s-Cr) and eGFR were significantly better after 6 months of febuxostat treatment compared with topiroxostat Cystatin-C was significantly lower after 6 months of febuxostat treatment compared with topiroxostat. The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.

CONCLUSION

Febuxostat had stronger renoprotective and antioxidant effects than topiroxostat in patients with hyperuricemia and CKD.

摘要

背景

TROFEO试验表明,非布司他降低血清尿酸(s-UA)的幅度比托匹司他更大且更迅速。我们通过对TROFEO试验进行亚组分析,比较了这两种药物在慢性肾脏病(CKD)患者中的疗效。

方法

该亚组分析针对估算肾小球滤过率(eGFR)≤60 mL/min/1.73 m²的患者。主要终点为s-UA水平。次要终点包括肌酐、eGFR、尿白蛋白、胱抑素C、氧化型低密度脂蛋白(Ox-LDL)、二十碳五烯酸/花生四烯酸比值、脂质生物标志物、高敏C反应蛋白和B型利钠肽(BNP)。

结果

两组治疗前后的s-UA水平均无显著差异。然而,在研究期间非布司他组的s-UA未超过6.0 mg/dL,但托匹司他组有7例患者超过了该水平,托匹司他组的这一数字显著更高。与托匹司他相比,非布司他治疗6个月后血清肌酐(s-Cr)和eGFR显著更佳。与托匹司他相比,非布司他治疗6个月后胱抑素C显著更低。与托匹司他相比,非布司他治疗3个月和6个月后的Ox-LDL显著更低。

结论

在高尿酸血症合并CKD患者中,非布司他的肾脏保护和抗氧化作用比托匹司他更强。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf5/7435131/2c4c52fcdf86/atcs-26-202-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf5/7435131/cb5e65b9de75/atcs-26-202-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf5/7435131/e2855d14a7a5/atcs-26-202-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf5/7435131/2c4c52fcdf86/atcs-26-202-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf5/7435131/cb5e65b9de75/atcs-26-202-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf5/7435131/e2855d14a7a5/atcs-26-202-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf5/7435131/2c4c52fcdf86/atcs-26-202-g003.jpg

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Impact of Uric Acid Levels on Kidney Disease Progression.
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