Voclosporin and changes in blood pressure: an analysis of real-world data.

IF 3.3 2区 医学 Q1 RHEUMATOLOGY
Eric T Roberts, Gabriela Schmajuk, Laura Plantinga, Jinoos Yazdany
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引用次数: 0

Abstract

Objective: Hypertension was common in randomized controlled trials (RCTs) of voclosporin, an oral calcineurin inhibitor approved in 2021 to treat lupus nephritis (LN); however, increases in blood pressure (BP) diminished after 4 weeks. Here, we characterize BP changes in real-world data.

Methods: We used electronic health record data from U.S. practices. We calculated time from first voclosporin prescription to a minimal clinically important increase (MCID) in systolic (10-mmHg) or diastolic (5-mmHg) BP, and the mean change in BP between baseline and windows of 0-1, 1-2, 2-3, 3-6, 6-9, and 9-12 months after starting treatment. Analyses were stratified by baseline BP as normal (<130 mmHg systolic and <80 mmHg diastolic), elevated (130-164 mmHg systolic or 80-104 mmHg diastolic and not high), or high (≥165 mmHg systolic or ≥105 mmHg diastolic).

Results: Among 287 patients (mean age, 41.4; 83.6% women; 32.1% Black, 24.0% White, 17.1% Hispanic, and 5.6% Asian), mean baseline BP was 126/79 (SD = 16/11) mmHg. Overall, 60.3% experienced a systolic MCID within a median of 90 (95% CI: 70-102) days; 60.6% a diastolic MCID within a median of 88 days (95%CI: 72-111). Mean BP changes in the first month were 13.7 (±18.6)/6.0 (±13.8), 2.7 (±18.8)/-0.6 (±11.2), and 7.9 (±17.8)/-7.3 (±16.5) mmHg for those with normal, elevated, and high BP at baseline.

Conclusions: Our results may differ because of differences in the intensity of BP management or the higher prevalence of cardiovascular risk factors in U.S.

Patients: More intensive BP management with voclosporin treatment for LN might be warranted.

氯菌素与血压变化:对真实世界数据的分析。
目的:在口服钙调磷酸酶抑制剂voclosporin的随机对照试验(RCTs)中,高血压很常见,voclosporin于2021年被批准用于治疗狼疮性肾炎(LN);然而,血压升高(BP)在4周后下降。在这里,我们描述了真实数据中的BP变化。方法:我们使用来自美国实践的电子健康记录数据。我们计算了从第一次服用氯菌素到收缩压(10毫米汞柱)或舒张压(5毫米汞柱)最小临床重要升高(MCID)的时间,以及开始治疗后0-1、1-2、2-3、3-6、6-9和9-12个月基线和窗口之间的平均血压变化。结果:287例患者(平均年龄41.4岁,83.6%为女性,32.1%为黑人,24.0%为白人,17.1%为西班牙裔,5.6%为亚洲人)平均基线血压为126/79 (SD = 16/11) mmHg。总体而言,60.3%的患者在90天(95% CI: 70-102)内经历了收缩期MCID;60.6%的患者在88天内出现舒张期MCID (95%CI: 72-111)。基线血压正常、升高和高的患者第一个月的平均血压变化分别为13.7(±18.6)/6.0(±13.8)、2.7(±18.8)/-0.6(±11.2)和7.9(±17.8)/-7.3(±16.5)mmHg。结论:我们的结果可能会有所不同,因为美国患者血压管理强度的差异或心血管危险因素的较高患病率:在LN患者中使用氯菌素治疗更强化的血压管理可能是必要的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
9.40
自引率
6.40%
发文量
368
审稿时长
3-6 weeks
期刊介绍: Arthritis Care & Research, an official journal of the American College of Rheumatology and the Association of Rheumatology Health Professionals (a division of the College), is a peer-reviewed publication that publishes original research, review articles, and editorials that promote excellence in the clinical practice of rheumatology. Relevant to the care of individuals with rheumatic diseases, major topics are evidence-based practice studies, clinical problems, practice guidelines, educational, social, and public health issues, health economics, health care policy, and future trends in rheumatology practice.
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