Diabetes and Drug-Associated Hyperkalemia: Effect of Laboratory Monitoring

描述（由申请人提供）：在这个项目中，我们建立在HMO治疗学教育和研究研究网络中心（CERTs）和Kaiser Permanente Colorado临床研究单位的研究人员和从业人员不断努力的基础上，以改善门诊护理环境中的药物安全性。该项目是一项基于人群的回顾性队列研究，响应PA-05-094（肥胖、糖尿病、消化和肾脏疾病的二次分析），使用现有的大型自动记录链接系统和四个HMO研究网络CERTs站点的相关医疗记录。本研究将评估大约17000名新开血管紧张素转换酶抑制剂（ACEi）、血管紧张素受体阻滞剂（ARB）和/或醛固酮受体拮抗剂（ARA）的糖尿病患者接受血钾监测与高钾血症相关住院、急诊就诊和死亡之间的关系。ACEi， ARB和/或ARA是重要的治疗方式。不幸的是，它们与潜在的危及生命的高钾血症有关。糖尿病患者占所有处方这些药物患者的一半，并且高钾血症相关不良后果的风险增加，但钾监测是否有助于减少这些不良后果尚不清楚。该项目的结果将提供证据，证明糖尿病患者在新开ACEi、ARB和/或ARA后接受钾监测是否比未监测的患者有更低的高钾相关不良后果发生率。此外，所获得的知识将包括与风险增加相关的患者特征信息。我们的目的是利用这个探索性项目的发现，为未来的工作开发和评估基于证据的血清钾监测建议，建议糖尿病患者使用这些药物。这些发现还将有助于为未来的研究制定框架，以评估对糖尿病患者进行药物实验室监测的效果和成本。

DESCRIPTION (provided by applicant): In this project we build upon ongoing efforts of the researchers and practitioners of the HMO Research Network Center for Education and Research in Therapeutics (CERTs) and of the Kaiser Permanente Colorado Clinical Research Unit to improve medication safety in the ambulatory care environment. This project is a population-based retrospective cohort study in response to PA-05-094 (Secondary Analyses in Obesity, Diabetes, Digestive and Kidney Diseases) that uses the large existing automated record linkage systems and associated medical records of four HMO Research Network CERTs sites. This study will assess the associations between both receipt and timing of serum potassium monitoring and the occurrence of hyperkalemia-associated hospitalizations, emergency department visits, and deaths in approximately 17,000 ambulatory patients with diabetes who are newly-prescribed angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), and/or aldosterone receptor antagonists (ARA). ACEi, ARB and/or ARA are important therapeutic modalities. Unfortunately, they are associated with potentially life-threatening hyperkalemia. Patients with diabetes comprise up to half of all patients prescribed these drugs and are at increased risk of hyperkalemia-associated adverse outcomes, but whether potassium monitoring helps to decrease these adverse outcomes is not clear. Results from this project will supply evidence about whether patients with diabetes who receive potassium monitoring after being newly- prescribed ACEi, ARB, and/or ARA have a lower incidence of hyperkalemia-associated adverse outcomes than patients who are not monitored. Additionally, knowledge gained will include information about patient characteristics associated with increased risks. Our intent is to use the findings from this exploratory project for future work to develop and evaluate evidence-based serum potassium monitoring recommendations for patients with diabetes who are prescribed these drugs. The findings will also assist in developing a framework for future studies to evaluate the effects and costs of medication-laboratory monitoring among patients with diabetes.