Hydroxychloroquine in Stage 1 Type 1 Diabetes.

IF 14.8 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Diabetes Care Pub Date : 2023-11-01 DOI:10.2337/dc23-1096
Ingrid Libman, Polly J Bingley, Dorothy Becker, Jane H Buckner, Linda A DiMeglio, Stephen E Gitelman, Carla Greenbaum, Michael J Haller, Heba M Ismail, Jeffrey Krischer, Wayne V Moore, Antoinette Moran, Andrew B Muir, Vana Raman, Andrea K Steck, Frederico G S Toledo, John Wentworth, Diane Wherrett, Perrin White, Lu You, Kevan C Herold
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引用次数: 0

Abstract

Objective: Innate immune responses may be involved in the earliest phases of type 1 diabetes (T1D).

Research design and methods: To test whether blocking innate immaune cells modulated progression of the disease, we randomly assigned 273 individuals with stage 1 T1D to treatment with hydroxychloroquine (n = 183; 5 mg/kg per day to a maximum of 400 mg) or placebo (n = 90) and assessed whether hydroxychloroquine treatment delayed or prevented progression to stage 2 T1D (i.e., two or more islet autoantibodies with abnormal glucose tolerance).

Results: After a median follow-up of 23.3 months, the trial was stopped prematurely by the data safety monitoring board because of futility. There were no safety concerns in the hydroxychloroquine arm, including in annual ophthalmologic examinations. Preplanned secondary analyses showed a transient decrease in the glucose average area under the curve to oral glucose in the hydroxychloroquine-treated arm at month 6 and reduced titers of anti-GAD and anti-insulin autoantibodies and acquisition of positive autoantibodies in the hydroxychloroquine arm (P = 0.032).

Conclusions: We conclude that hydroxychloroquine does not delay progression to stage 2 T1D in individuals with stage 1 disease. Drug treatment reduces the acquisition of additional autoantibodies and the titers of autoantibodies to GAD and insulin.

羟氯喹治疗1期1型糖尿病。
目的:先天免疫反应可能参与1型糖尿病(T1D)的早期阶段。研究设计和方法:为了测试阻断先天性未成熟细胞是否调节疾病的进展,我们将273名1期T1D患者随机分配给羟氯喹(n=183;每天5 mg/kg,最多400 mg)或安慰剂(n=90)治疗,并评估羟氯喹治疗是否延迟或阻止了进展到2期T1D(即两种或两种以上具有异常糖耐量的胰岛自身抗体)。结果:在中位随访23.3个月后,由于无效,数据安全监测委员会提前停止了试验。羟氯喹组没有安全问题,包括每年的眼科检查。预先计划的二次分析显示,在第6个月时,羟氯喹治疗组的口服葡萄糖曲线下的葡萄糖平均面积暂时下降,羟氯奎因治疗组的抗GAD和抗胰岛素自身抗体滴度和阳性自身抗体的获得降低(P=0.032)2 T1D。药物治疗减少了额外自身抗体的获得以及GAD和胰岛素自身抗体的滴度。
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
Diabetes Care
Diabetes Care 医学-内分泌学与代谢
CiteScore
27.80
自引率
4.90%
发文量
449
审稿时长
1 months
期刊介绍: The journal's overarching mission can be captured by the simple word "Care," reflecting its commitment to enhancing patient well-being. Diabetes Care aims to support better patient care by addressing the comprehensive needs of healthcare professionals dedicated to managing diabetes. Diabetes Care serves as a valuable resource for healthcare practitioners, aiming to advance knowledge, foster research, and improve diabetes management. The journal publishes original research across various categories, including Clinical Care, Education, Nutrition, Psychosocial Research, Epidemiology, Health Services Research, Emerging Treatments and Technologies, Pathophysiology, Complications, and Cardiovascular and Metabolic Risk. Additionally, Diabetes Care features ADA statements, consensus reports, review articles, letters to the editor, and health/medical news, appealing to a diverse audience of physicians, researchers, psychologists, educators, and other healthcare professionals.
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