Blankenburg Michael, Kovesdy Csaba P, Fett Anne-Kathrin, Griner Raymond G, Gay Alain
Market Access, Public Affairs & Sustainability, Pharmaceuticals, Bayer AG, Berlin, Germany.
Division of Nephrology, University of Tennessee Health Science Center, Memphis, TN, USA.
BMC Nephrol. 2020 Feb 26;21(1):61. doi: 10.1186/s12882-020-01719-7.
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.
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).
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.
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.
有限的证据表明，在糖尿病肾病（DKD）患者的标准治疗方案中添加甾体类盐皮质激素受体拮抗剂（MRA）可降低蛋白尿；然而，关于这些患者在现实世界中使用MRA的数据有限。本研究旨在描述使用和未使用螺内酯的DKD患者的特征，并探讨他们的临床结局。
这是一项非干预性回顾性队列研究，使用了2006年至2015年期间来自美国索赔数据库（PharMetrics Plus）和益百利消费者数据资产的人口统计学和临床数据。在匹配的使用和未使用螺内酯的队列（每组n = 5465）中描述了基线特征（如合并症）和纳入后的临床结局。
尽管匹配使队列的关键人口统计学和临床特征一致，但与未使用者相比，使用螺内酯的患者在基线时出现水肿、蛋白尿和心血管疾病的比例显著更高（P < 0.0001）。在纳入后的时期内，与未使用者相比，使用螺内酯的患者更常观察到疾病进展和急性肾损伤等感兴趣的临床事件。使用者的医疗资源利用率和成本也高于未使用者；然而，这些差异在疾病后期有所减少。
在本研究中，使用螺内酯的患者在基线时的合并症负担比匹配的未使用者更大，这表明某些合并症的存在可能是决定开具螺内酯处方的因素。无论是否使用螺内酯，疾病后期患者的高医疗资源利用率和成本凸显了对DKD新疗法的需求。
