Momentum toward patient outcome trials in chronic kidney disease-mineral bone disorder.

IF 2.2 3区 医学 Q3 PERIPHERAL VASCULAR DISEASE
Varsha Pothula Venkata, Julia J Scialla
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引用次数: 0

Abstract

Purpose of review: The purpose of this review is to: evaluate the clinical trial evidence base for the treatment of chronic kidney disease mineral and bone disorder (CKD-MBD) in patients with kidney failure as it relates to highly prioritized clinical outcomes; and discuss approaches and principles to develop needed trials in CKD-MBD.

Recent finding: Most clinical trials in CKD-MBD focus on biochemical outcomes, with few trials of surrogate outcomes (e.g., vascular calcification, left ventricular hypertrophy, bone mineral density), and even fewer of highly prioritized clinically important outcomes, such as mortality, cardiovascular disease events, or hospitalization. Within phosphate management, the recent LANDMARK trial did not detect a difference in a cardiovascular composite outcome between patients randomized to lanthanum carbonate vs. a calcium-based phosphate binder strategy over 3 years. The ongoing PHOSPHATE trial will provide needed evidence on phosphate treatment targets. There are no comparable, large trials of parathyroid hormone (PTH) targets. Observational approaches using clinical trial emulation suggest the potential for reduced cardiovascular disease and mortality with an 'emulated' low PTH target, but trials must be designed to confirm this. To ensure success, these trials must focus on practical treatment approaches, leveraging areas of practice variation and recognizing the dynamic nature of longitudinal CKD-MBD care.

Summary: More intensive treatment of CKD-MBD remains a promising approach to improve clinical outcomes in patients with kidney failure and should prompt ongoing efforts to obtain needed trials.

慢性肾脏疾病-矿物质骨紊乱患者结局试验的势头。
综述的目的:本综述的目的是:评价治疗肾衰竭患者慢性肾脏疾病矿物质和骨骼疾病(CKD-MBD)的临床试验证据基础,因为它与高度优先的临床结果相关;并讨论在CKD-MBD中开展所需试验的方法和原则。最近发现:大多数CKD-MBD的临床试验关注的是生化结果,很少有替代结果的试验(如血管钙化、左心室肥厚、骨矿物质密度),更少有高度优先的临床重要结果,如死亡率、心血管疾病事件或住院治疗。在磷酸盐治疗中,最近的LANDMARK试验没有发现随机分配到碳酸镧和钙基磷酸盐结合剂策略的患者在3年内心血管复合结局的差异。正在进行的磷酸盐试验将为磷酸盐治疗靶点提供所需的证据。目前还没有类似的针对甲状旁腺激素(PTH)靶点的大型试验。采用临床试验模拟的观察方法表明,“模拟”的低甲状旁腺激素目标有可能降低心血管疾病和死亡率,但必须设计试验来证实这一点。为了确保成功,这些试验必须关注实际的治疗方法,利用实践变化的领域,并认识到纵向CKD-MBD护理的动态性质。总结:加强CKD-MBD的治疗仍然是改善肾衰竭患者临床结果的一种有希望的方法,并应促使持续努力获得所需的试验。
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来源期刊
Current Opinion in Nephrology and Hypertension
Current Opinion in Nephrology and Hypertension 医学-泌尿学与肾脏学
CiteScore
5.70
自引率
6.20%
发文量
132
审稿时长
6-12 weeks
期刊介绍: A reader-friendly resource, Current Opinion in Nephrology and Hypertension provides an up-to-date account of the most important advances in the field of nephrology and hypertension. Each issue contains either two or three sections delivering a diverse and comprehensive coverage of all the key issues, including pathophysiology of hypertension, circulation and hemodynamics, and clinical nephrology. Current Opinion in Nephrology and Hypertension is an indispensable journal for the busy clinician, researcher or student.
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