Patorno Elisabetta, Gopalakrishnan Chandrasekar, Bartels Dorothee B, Brodovicz Kimberly G, Liu Jun, Schneeweiss Sebastian
Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston MA USA.
Corporate Department Global Epidemiology Boehringer Ingelheim GmbH Ingelheim Germany.
Endocrinol Diabetes Metab. 2017 Nov 27;1(1):e00005. doi: 10.1002/edm2.5. eCollection 2018 Jan.
Although many newer diabetes medications have become available in the last decade, most have not been widely studied in populations with chronic kidney disease under routine care. Linagliptin, a recently marketed dipeptidyl peptidase 4 (DPP-4) inhibitor, is the only agent in the U.S. that does not require dose adjustment in patients with diabetes mellitus type 2 (T2DM) and renal impairment. We sought to describe baseline kidney function and other key characteristics among patients with diabetes mellitus type 2 (T2DM) initiating linagliptin and other diabetes medications, and to explore prescribing patterns among T2DM patients with moderate to severe renal impairment before and after the launch of linagliptin.
Using a population-based cohort study design nested in a large U.S. commercial healthcare dataset linked to laboratory values, we described characteristics of T2DM patients initiating linagliptin and other diabetes medications between May 2011 (launch of linagliptin) and September 2015. We also explored prescribing trends among T2DM patients with moderate to severe renal impairment (ICD-9 diagnosis code 585.3x-6x) who initiated linagliptin and other diabetes medications between January 2006 to September 2015 (before and after the launch of linagliptin).
We identified 1,174,476 T2DM patients initiating a diabetes medication (28,900 linagliptin initiators) between 05/2011-09/2015. We also identified 100,847 T2DM patients with moderate to severe renal impairment initiating a diabetes agent between 01/2006-09/2015.
Among patients initiating newer diabetes medications between 05/2011-09/2015, those initiating linagliptin had the highest prevalence of moderate to severe renal impairment, suggesting preferential prescribing in routine care. DPP-4 inhibitors overall were among the most frequently chosen agents among T2DM patients with moderate to severe renal impairment between 01/2006-09/2015. Further investigation of the safety and effectiveness of DPP-4 inhibitors in routine care of T2DM patients with renal impairment is needed to either corroborate or discourage current prescribing patterns.
尽管在过去十年间有许多新型糖尿病药物可供使用,但大多数药物在常规护理的慢性肾脏病患者群体中尚未得到广泛研究。利那格列汀是一种最近上市的二肽基肽酶4(DPP-4)抑制剂,是美国唯一一种在2型糖尿病(T2DM)合并肾功能损害患者中无需调整剂量的药物。我们试图描述开始使用利那格列汀和其他糖尿病药物的2型糖尿病(T2DM)患者的基线肾功能及其他关键特征,并探讨在利那格列汀上市前后中重度肾功能损害的T2DM患者的处方模式。
采用基于人群的队列研究设计,该研究嵌套于一个与实验室检查值相关联的大型美国商业医疗保健数据集,我们描述了在2011年5月(利那格列汀上市)至2015年9月期间开始使用利那格列汀和其他糖尿病药物的T2DM患者的特征。我们还探讨了在2006年1月至2015年9月期间(利那格列汀上市前后)开始使用利那格列汀和其他糖尿病药物的中重度肾功能损害(国际疾病分类第九版诊断代码585.3x - 6x)的T2DM患者的处方趋势。
我们确定了在2011年5月 - 2015年9月期间开始使用糖尿病药物的1,174,476例T2DM患者(28,900例开始使用利那格列汀的患者)。我们还确定了在2006年1月 - 2015年9月期间开始使用糖尿病药物的100,847例中重度肾功能损害的T2DM患者。
在2011年5月 - 2015年9月期间开始使用新型糖尿病药物的患者中,开始使用利那格列汀的患者中重度肾功能损害的患病率最高,这表明在常规护理中存在优先处方情况。在2006年1月 - 2015年9月期间,DPP - 4抑制剂总体上是中重度肾功能损害的T2DM患者中最常选用的药物之一。需要进一步研究DPP - 4抑制剂在肾功能损害的T2DM患者常规护理中的安全性和有效性,以证实或改变当前的处方模式。