1 GlaxoSmithKline, Durham, North Carolina.
2 Analysis Group, Boston, Massachusetts.
J Manag Care Spec Pharm. 2016 Jul;22(7):833-47. doi: 10.18553/jmcp.2016.22.7.833.
Systemic corticosteroids are a leading cause of drug-related complications, yet little has been done to quantify the dose-response relationship between systemic corticosteroid exposure and complications in patients with severe asthma.
To (a) evaluate the risk of developing systemic corticosteroid-related complications by corticosteroid exposure in severe asthma and (b) quantify the associated health care resource utilization and costs.
This is a retrospective study using administrative claims data from a large commercial database between 2003 and 2014. Multivariate generalized estimating equation models were used to compare corticosteroid-related complications in patients continuously exposed to at least 5 mg of prednisone or equivalent for ≥ 6 months with a 1:1 ratio of propensity score-matched patients with asthma who did not use corticosteroids.
A total of 12,697 corticosteroid users and as many matched nonusers were identified. The odds of developing associated complications increased significantly in a dose-dependent manner with systemic corticosteroid exposure: odds ratios were 2.50, 2.95, and 3.32 (P values <0.05) for low (defined as < 5 mg/day), medium (≥ 5-10 mg/day), and high (>10 mg/day) exposure, respectively, relative to no exposure. Health care resource utilization increased significantly with levels of systemic corticosteroid exposure. Hence, incidence rate ratios for inpatient visits with low, medium, and high exposure relative to none were estimated to be 1.86, 2.40, and 3.37, respectively (P < 0.05).
A significant dose-response relationship was found between the long-term use of systemic corticosteroids and the risk of developing systemic corticosteroid-related complications in patients with severe asthma, resulting in increased burden and costs on the health care system that intensified with systemic corticosteroid exposure.
Funding for this study was provided by GlaxoSmithKline, Study number H0-15-15930, to Analysis Group for the conduct of this study. Lefebvre, Duh, and Gozalo are employees of Analysis Group, a contract research organization that has received research grants from GlaxoSmithKline. Robitaille was employed by Analysis Group at the time of this study. Yancey, Forshag, Lin, and Albers are employees of GlaxoSmithKline and own company stock. Dalal and Ortega were employed by GlaxoSmithKline at the time of this study. Lefebvre had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Additionally, all listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. Study concept and design were contributed by Dalal, Duh, Albers, Yancey, Ortega, Forshag, and Lefebvre. Data acquisition was by Dalal, Gozalo, Robitaille, Forshag, and Lefebvre and was analyzed and interpreted by Dalal, Gozalo, Robitaille, Albers, Yancey, Ortega, Forshag, and Lefebvre. The manuscript was drafted and approved by Dalal, Duh, Gozalo, Robitaille, Albers, Yancey, Ortega, Forshag, Lin, and Lefebvre.
全身皮质类固醇是药物相关并发症的主要原因，但在严重哮喘患者中，全身皮质类固醇暴露与并发症之间的剂量反应关系尚未得到充分研究。
（a）评估严重哮喘患者中全身皮质类固醇暴露与并发症发生风险之间的关系，（b）量化相关的医疗资源利用和成本。
这是一项回顾性研究，使用了 2003 年至 2014 年期间来自大型商业数据库的行政索赔数据。使用多变量广义估计方程模型比较至少连续接受 5 毫克泼尼松或等效剂量治疗≥6 个月的患者与未使用皮质类固醇的具有 1：1 比例的哮喘患者在皮质类固醇相关并发症方面的差异。
共确定了 12697 名皮质类固醇使用者和 12697 名匹配的非使用者。随着全身皮质类固醇暴露，发生相关并发症的可能性呈剂量依赖性显著增加：与无暴露相比，低剂量（定义为<5 毫克/天）、中剂量（≥5-10 毫克/天）和高剂量（>10 毫克/天）暴露的比值比分别为 2.50、2.95 和 3.32（P 值均<0.05）。随着全身皮质类固醇暴露水平的增加，医疗资源利用也显著增加。因此，与无暴露相比，低、中、高暴露水平的住院就诊发生率比分别估计为 1.86、2.40 和 3.37（P 值均<0.05）。
在严重哮喘患者中，长期使用全身皮质类固醇与发生全身皮质类固醇相关并发症的风险之间存在显著的剂量反应关系，导致医疗系统负担和成本增加，且随着全身皮质类固醇暴露而加剧。
本研究的资金由葛兰素史克公司提供，研究编号为 H0-15-15930，由分析集团负责进行这项研究。Lefebvre、Duh 和 Gozalo 是分析集团的员工，该合同研究组织已从葛兰素史克公司获得研究经费。Robitaille 在进行本研究时受雇于分析集团。Yancey、Forshag、Lin 和 Albers 是葛兰素史克公司的员工，拥有公司股票。Dalal 和 Ortega 在进行本研究时受雇于葛兰素史克公司。Lefebvre 全面掌握了研究中的所有数据，并对数据的完整性和数据分析的准确性负责。此外，所有列出的作者均符合国际医学期刊编辑委员会规定的作者标准。研究概念和设计由 Dalal、Duh、Albers、Yancey、Ortega、Forshag 和 Lefebvre 提出。数据采集由 Dalal、Gozalo、Robitaille、Forshag 和 Lefebvre 完成，并由 Dalal、Gozalo、Robitaille、Albers、Yancey、Ortega、Forshag 和 Lefebvre 进行分析和解释。手稿由 Dalal、Duh、Gozalo、Robitaille、Albers、Yancey、Ortega、Forshag 和 Lefebvre 起草和批准。
