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.
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.