OPTIMISE-CKD Drug Utilization
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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:
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Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Dapagliflozin 10mg initiators Adult patients (aged ≥18 years) with chronic kidney disease, who received a dapagliflozin 10mg prescription on or after the country-specific CKD indication approval date, and who did not previously have a prescription for dapagliflozin. |
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| Dapagliflozin 10mg eligible but untreated Adult patients (aged ≥18 years) with chronic kidney disease, who meet the country-specific approved dapagliflozin 10mg treatment criteria for CKD on or after the local CKD indication approval date, but have not received a prescription |
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| Incident CKD Adults patients (aged ≥18 years) who newly meet the CKD definition (diagnosis or laboratory indication) during the study period. |
Outcome Measures
Primary Outcome Measures
- Baseline demographics [1 year pre-index]
Patient demographic characteristics including age, sex, race and insurance type (if data are available)
- Baseline clinical characteristics [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 comedications [1 year pre-index]
Number and proportion of patients with comedications for cardiovascular disease, diabetes, hyperkalemia
- Baseline eGFR in ml/min/1.73m2 [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 [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 [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 [1 year pre-index]
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
- Baseline sodium in mmol/L [1 year pre-index]
Number and proportion of patients with available data mean, standard deviation, median, interquartile range, minimum, maximum
- Baseline hemoglobin A1c in % [1 year pre-index]
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum
- Baseline hematocrit in % [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 [1 year pre-index]
Number and proportion of patients with available data Mean, standard deviation, median, interquartile range, minimum, maximum
Secondary Outcome Measures
- Proportion of patients who initiate cardiorenal protective medication [1 year post-index]
Treatment initiation (RASi and/or SGLT2i/dapagliflozin 10mg) following incident CKD index date
- Proportion of patients who continue cardiorenal protective medication [1 year post-index]
Treatment persistence (RASi and/or SGLT2i/dapagliflozin 10mg) following initiation after incident CKD index date
- Proportion of patients with hospitalisations following incident CKD index [1 year post-index]
Hospitalisations (any reason, CKD, heart failure) following incident CKD index
- Average healthcare cost for specific outcomes/reasons [1 year post-index]
Healthcare costs related to hospitalisation for CKD, heart failure, atherosclerotic CVD following incident CKD index
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients (aged ≥18 years)
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Chronic kidney disease (diagnosis code, uACR >30mg/g or 2 eGFR ≥90 days apart, second value ≥75ml/min/1.73m2)
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≥365 days continuous enrolment in database
Exclusion Criteria:
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History of type 1 diabetes, gestational diabetes or dialysis
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History of dapagliflozin 10mg prescriptions before index date
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OptumInsight Life Sciences Inc. | Minnesota | Minnesota | United States | 13625 |
| 2 | Real Word Data Co. (RWD) | Kyoto City | Kyoto Prefecture | Japan | 604-0086 |
| 3 | Medical Data Vision (MDV) | Tokyo | Japan | 101-0053 |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D169AR00015