A Multinational, Observational, Retrospective, Secondary Data Study Analyzing Dapagliflozin Effectiveness in Routine Clinical Practice Among Patients With Chronic Kidney Disease. Local Adaptation for Spain. Part 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 12,894
- 试验地点
- 1
- 主要终点
- Baseline demographics and clinical characteristics (comorbidities) of the study cohorts
研究概览
简要总结
This is a retrospective, observational study, using secondary data captured in electronic health records (EHRs). The study is a part of the OPTIMISE-CKD program to assess the current CKD treatment landscape, Dapagliflozin utilisation and characterization of incident CKD patient and the burden of disease within an observation period of 39 months (August 2020-November 2024) in two cohorts (preand post-reimbursement of Dapagliflozin for CKD)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets CKD definition criteria: having at least two eGFR measures ≤60 ml/min/1.73m2 measured ≥90 to 730 days apart and/or UACR ≥ 30 mg/g, and/or at least one measurement indicative of proteinuria (or with proteinuria ERA-ICD code) or CKD code.
- •Age ≥18 years.
- •12 months continuous enrolment in the data base prior to index
- •12 months continuous enrolment in the data base after index date.
排除标准
- •T1DM on or before index date.
- •Diagnosis of gestational diabetes mellitus on or before index date
研究组 & 干预措施
Cohort of patients treated with Dapagliflozin 10 mg
Cohort of patients treated with Dapagliflozin 10 mg. Patients who start treatment with Dapagliflozin after meeting the inclusion criteria. The first prescription of Dapagliflozin 10 mg will be considered as the index date.
Comparator cohort without specific treatment for CKD other than RASi
Patients who do not receive Dapagliflozin, but who meet the inclusion criteria and have RASi as CKD treatment or no specific treatment for CKD other than RASi. The index date will be matched with that of your Dapagliflozin-treated counterpart, within a ±10-day window.
结局指标
主要结局
Baseline demographics and clinical characteristics (comorbidities) of the study cohorts
时间窗: From 1-Aug-2021 to 31-Dec-2025
Age (years old) Gender (female, N(%)) Comorbidities (N(%) Cardiovascular comorbidity (ICD code) Type 2 diabetes (ICD code) Hypertension (ICD code)
Baseline laboratory measures (number of measures per year and their values)
时间窗: From 1-Aug-2021 to 31-Dec-2025
Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs and prescriber characteristics for Dapagliflozin if available).
时间窗: From 1-Aug-2021 to 31-Dec-2025
Compare selected outcomes
时间窗: From 1-Aug-2021 to 31-Dec-2025
eGFR decline with time, (difference from baseline value)
Compare selected health-care resource utilization and cost
时间窗: From 1-Aug-2021 to 31-Dec-2025
Compare selected health-care resource utilization and cost (resource consumption refers to that which is directly related to CKD): -initiation of dialysis -all-cause hospitalizations -heart failure hospitalizations (hHF) - CKD hospitalizations -primary care visits -hospital specialty visits -emergency visits
次要结局
未报告次要终点