The Empagliflozin vs. DPP-4 Inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German Claims Data Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24,500
- 试验地点
- 1
- 主要终点
- Direct Healthcare Cost
研究概览
简要总结
Empagliflozin vs. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors and Glucagon-like Peptide-1 Receptor Agonists (GLP-1-RA) Cost of Care Study: a German claims data analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuous insurance by the sickness fund for the entire period (01/01/2014 - 31/12/2018; death of a patient is the only accepted exception from this rule)
- •At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11.-) in the period 01/01/2014 to 31/12/2016, but before or on index date (i.e. first Empagliflozin or DPP-4i /Sitagliptin prescription).
- •At least one prescription of Empagliflozin or a DPP-4i /Sitagliptin in the inclusion period (01/01/2015 - 31/12/2016)
排除标准
- •At least one prescription of a sodium glucose transporter 2 inhibitor (SGLT-2i), DPP-4i or GLP-1-RA in the baseline period (01/01/2014 - 31/12/2014)
- •During follow-up, patients will be censored if they switch to any SGLT-2i, DPP-4i or GLP-1-RA or initiate a concomitant use of any SGLT-2i, DPP-4i or GLP-1-RA (free or fixed-dose combinations).
研究组 & 干预措施
All patients who started an Empagliflozin therapy
All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Empagliflozin (EMPA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
干预措施: Empagliflozin (Drug)
All patients who started a DPP-4 inhibitor (specifically Sitagliptin) therapy
All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Dipeptidyl peptidase 4 (DPP-4) inhibitor (DPP-4i) (specifically Sitagliptin) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
干预措施: DPP-4i (Drug)
All patients who started a GLP-1 receptor agonist therapy
All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1-RA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
干预措施: GLP-1-RA (Drug)
结局指标
主要结局
Direct Healthcare Cost
时间窗: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
The direct healthcare cost is reported, including inpatient cost, outpatient cost, medication cost, and total cost. Patients starting Empagliflozin (EMPA) versus either Dipeptidyl peptidase 4 inhibitor (DPP-4i), Sitagliptin (SITA) or Glucagon-like peptide-1 receptor agonist (GLP-1-RA) were matched 1:1 based on a propensity score using a nearest-neighbor matching algorithm without replacement and a maximum caliper of 0.001. The propensity scores were derived by logistic regression models estimating the probability of a patient belonging to the different treatment groups (three estimations: EMPA versus DPP-4i, EMPA versus SITA, and EMPA versus GLP-1-RA). The cost per observed patient year is calculated as the sum of the cost/ sum of the observed time \[year\] over all patients. Final values were rounded to the nearest digit.
Healthcare Resource Utilization
时间窗: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.
次要结局
- Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)(Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.)