OPTIMISE-CKD Drug Utilization

AstraZeneca2,682,052 enrolled

Overview

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).

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: 1. Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and 2. 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.

Study Type

OBSERVATIONAL

Enrollment

2,682,052

Conditions

Chronic Kidney Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * History of type 1 diabetes, gestational diabetes or dialysis * History of dapagliflozin 10mg prescriptions before index date

Locations (5)

Research Site

Minneota, Minnesota, United States

Research Site

Kyoto, Kyoto, Japan

Research Site

Tokyo, Japan

Research Site

Uppsala, Sweden

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

Baseline demographics

Patient demographic characteristics including age, sex, race and insurance type (if data are available)

Time frame: 1 year pre-index

Baseline clinical characteristics

Number and proportion of patients with comorbidities, including heart failure, cardiovascular disease, type 2 diabetes, hypertension, hyperkalemia, myocardial infarction, stroke

Time frame: 1 year pre-index

Baseline comedications

Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia

Time frame: 1 year pre-index

Baseline eGFR in ml/min/1.73m2

Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum

Time frame: 1 year pre-index

Baseline uACR in mg/g

Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum

Time frame: 1 year pre-index

Baseline serum creatinine in mg/dl

Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum

Time frame: 1 year pre-index

Baseline calcium in mg/dl

Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum

Time frame: 1 year pre-index

Baseline sodium in mmol/L

Data from ClinicalTrials.gov

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Secondary Outcomes

Proportion of patients who initiate cardiorenal protective medication

Treatment initiation (RASi and/or SGLT2i/dapagliflozin 10mg) following incident CKD index date

Time frame: 1 year post-index

Proportion of patients who continue cardiorenal protective medication

Treatment persistence (RASi and/or SGLT2i/dapagliflozin 10mg) following initiation after incident CKD index date

Time frame: 1 year post-index

Proportion of patients with hospitalisations following incident CKD index

Hospitalisations (any reason, CKD, heart failure) following incident CKD index

Time frame: 1 year post-index

Average healthcare cost for specific outcomes/reasons

Healthcare costs related to hospitalisation for CKD, heart failure, atherosclerotic CVD following incident CKD index

Time frame: 1 year post-index