A Multinational, Observational, Secondary Data Study Describing Management and Treatment With Dapagliflozin in Routine Clinical Practice Among Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,682,052
- 试验地点
- 1
- 主要终点
- Baseline comedications
研究概览
简要总结
This is a multi-national, observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).
详细描述
OPTIMISE-CKD is an observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).
Primary objective: to characterize dapagliflozin 10mg utilisation in clinical practice, by describing treatment naïve patients who (1) are treated with dapagliflozin 10 mg and (2) who are eligible for CKD treatment with dapagliflozin but untreated.
Secondary objectives: to describe the current clinical landscape among incident CKD patients, by:
- Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and
- Describing selected outcomes among overall, treated and untreated incident CKD patients.
Exploratory objectives: to assess the real-world effectiveness of dapagliflozin in CKD patients, pending feasibility.
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
- •Adult patients (aged ≥18 years)
- •Chronic kidney disease (diagnosis code, uACR >30mg/g or 2 eGFR ≥90 days apart, second value ≥75ml/min/1.73m2)
- •≥365 days continuous enrolment in database
排除标准
- •History of type 1 diabetes, gestational diabetes or dialysis
- •History of dapagliflozin 10mg prescriptions before index date
结局指标
主要结局
Baseline comedications
时间窗: 1 year pre-index
Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia
Baseline sodium in mmol/L
时间窗: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline demographics
时间窗: 1 year pre-index
Patient demographic characteristics including age, sex, race and insurance type (if data are available)
Baseline clinical characteristics
时间窗: 1 year pre-index
Number and proportion of patients with comorbidities, including heart failure, cardiovascular disease, type 2 diabetes, hypertension, hyperkalemia, myocardial infarction, stroke
Baseline eGFR in ml/min/1.73m2
时间窗: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline uACR in mg/g
时间窗: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline serum creatinine in mg/dl
时间窗: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline calcium in mg/dl
时间窗: 1 year pre-index
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
Baseline hemoglobin A1c in %
时间窗: 1 year pre-index
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum
Baseline hematocrit in %
时间窗: 1 year pre-index
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum, % patients with value \<40
Baseline systolic blood pressure in mmHg
时间窗: 1 year pre-index
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum
次要结局
- Proportion of patients who initiate cardiorenal protective medication(1 year post-index)
- Proportion of patients with hospitalisations following incident CKD index(1 year post-index)
- Average healthcare cost for specific outcomes/reasons(1 year post-index)
- Proportion of patients who continue cardiorenal protective medication(1 year post-index)