BACKGROUND Limited evidence has indicated that addition of a steroidal mineralocorticoid receptor antagonist (MRA) to the standard of care reduces proteinuria in patients with diabetic kidney disease (DKD); however, there are limited data regarding real-world MRA use in these patients. This study aimed to describe the characteristics of spironolactone users and non-users with DKD, and to explore their clinical outcomes. METHODS This was a non-interventional, retrospective cohort study using demographic and clinical data from a US claims database (PharMetrics Plus) and the Experian consumer data asset during 2006-2015. Baseline characteristics (e.g. comorbidities) and post-inclusion clinical outcomes were described in matched cohorts of spironolactone users and non-users (n = 5465 per group). RESULTS Although matching aligned key demographic and clinical characteristics of the cohorts, a significantly greater proportion of spironolactone users than non-users had oedema, proteinuria, and cardiovascular disease at baseline (P < 0.0001). During the post-inclusion period, disease progression and clinical events of interest such as acute kidney injury were more commonly observed in spironolactone users than non-users. Users also had higher healthcare resource utilization and costs than non-users; however, these differences diminished at later stages of disease. CONCLUSIONS In this study, spironolactone users had a greater comorbidity burden at baseline than matched non-users, suggesting that the presence of certain comorbidities may be contributing factors in the decision to prescribe spironolactone. High healthcare resource utilization and costs for patients at later stages of disease, irrespective of spironolactone use, highlight the need for new therapies for DKD.

中文翻译：

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慢性肾脏疾病和2型糖尿病患者的疾病特征和结局：螺内酯使用者和非使用者的配对队列研究。

背景技术有限的证据表明，在护理标准中添加类固醇盐皮质激素受体拮抗剂（MRA）可以降低糖尿病肾病（DKD）患者的蛋白尿。但是，有关这些患者在现实世界中使用MRA的数据有限。这项研究旨在描述螺内酯使用者和非DKD使用者的特征，并探讨他们的临床结局。方法这是一项非干预性回顾性队列研究，使用了美国索赔数据库（PharMetrics Plus）和Experian消费者数据资产在2006-2015年期间的人口统计学和临床​​数据。螺内酯使用者和非使用者的配对队列（每组n = 5465）中描述了基线特征（例如合并症）和纳入后的临床结果。结果尽管匹配队列的主要人口统计学和临床​​特征，但螺内酯使用者在基线时有水肿，蛋白尿和心血管疾病的比例明显高于非使用者（P <0.0001）。在入组后期间，螺内酯使用者比非使用者更常观察到疾病进展和相关的临床事件，例如急性肾损伤。用户也比非用户拥有更高的医疗资源利用率和成本；但是，这些差异在疾病的后期阶段会减弱。结论在这项研究中，螺内酯使用者在基线时的合并症负担比未使用的螺内酯更大，这表明某些合并症的存在可能是决定开具螺内酯的因素。