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在评价 HIV 患者中匹伐他汀的 REPRIEVE 试验中基线肾功能。

An Evaluation of Baseline Kidney Function in the REPRIEVE Trial of Pitavastatin in Human Immunodeficiency Virus.

机构信息

Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.

Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.

出版信息

J Infect Dis. 2020 Jul 9;222(Suppl 1):S41-S51. doi: 10.1093/infdis/jiaa222.

DOI:10.1093/infdis/jiaa222
PMID:32645164
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7347080/
Abstract

BACKGROUND

Chronic kidney disease is a common comorbid condition among persons living with human immunodeficiency virus (PWH). We characterized baseline kidney function in the REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) trial cohort.

METHODS

REPRIEVE enrolled PWH with low to moderate cardiovascular risk based on traditional risk factors to evaluate the effect of statin therapy on cardiovascular events. We determined baseline estimated glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations, and we evaluated baseline factors associated with eGFR <90 mL/min/1.73 m2 by logistic regression. We performed Bland-Altman plots and scatterplots to assess agreement between equations.

RESULTS

Among 7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the median body mass index (calculated as calculated as weight in kilograms divided by height in meters squared) was 25.8, and the median CD4 cell count 620/µL. The median CKD-EPI eGFR was 97 mL/min/1.73 m2, and 38% had an eGFR <90 mL/min/1.73 m2. In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate. The CKD-EPI and Modification of Diet in Renal Disease equations demonstrated strong agreement, particularly at lower eGFR values. Overall, there was 56% concordance between the 3 equations (categories <60, 60 to <90, ≥90 mL/min), improving to 73% after accounting for individual body surface area.

CONCLUSIONS

REPRIEVE enrolled a diverse cohort including a substantial number of PWH with reduced kidney function. Factors associated with reduced eGFR included traditional risk factors and tenofovir disoproxil fumarate exposure. Three commonly used equations have only fair agreement, with potential implications for both clinical care and epidemiologic studies.

CLINICAL TRIALS REGISTRATION

NCT02344290.

摘要

背景

慢性肾脏病是艾滋病毒感染者(PLWH)常见的合并症。我们在 REPRIEVE(预防 HIV 血管事件的随机试验)试验队列中描述了基线肾功能。

方法

REPRIEVE 根据传统危险因素招募了心血管风险低至中度的 PLWH,以评估他汀类药物治疗对心血管事件的影响。我们使用慢性肾脏病流行病学合作(CKD-EPI)、饮食改良肾脏病方程和 Cockcroft-Gault 方程确定基线估计肾小球滤过率(eGFR),并通过逻辑回归评估与 eGFR <90 mL/min/1.73 m2 相关的基线因素。我们进行 Bland-Altman 图和散点图评估方程之间的一致性。

结果

在纳入的 7770 名参与者中,中位年龄为 50 岁,31%为女性(出生性别),43%为黑种人或非裔美国人,15%为亚裔,中位体质指数(计算为体重千克数除以身高米数的平方)为 25.8,中位 CD4 细胞计数为 620/µL。CKD-EPI eGFR 的中位数为 97 mL/min/1.73 m2,38%的人 eGFR <90 mL/min/1.73 m2。在调整后的模型中,与 eGFR <90 mL/min/1.73 m2 相关的因素包括白种人、年龄较大、较高的体质指数、较高的收入地区、高血压和替诺福韦二吡呋酯。CKD-EPI 和饮食改良肾脏病方程显示出较强的一致性,尤其是在较低的 eGFR 值时。总体而言,三种方程(<60、60-<90、≥90 mL/min)之间有 56%的一致性,在考虑到个体体表面积后提高到 73%。

结论

REPRIEVE 招募了一个多样化的队列,包括相当数量的肾功能降低的 PLWH。与 eGFR 降低相关的因素包括传统危险因素和替诺福韦二吡呋酯暴露。三种常用的方程仅有适度的一致性,这可能对临床护理和流行病学研究都有影响。

临床试验注册

NCT02344290。

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