OPTIMISE-CKD is a retrospective, observational study, using secondary data. The incidence of renal disease, including CKD, using eGFR or UACR laboratory measurements and diagnostic codes will be assessed in the study population. The study will also assess the incidence of selected cardiovascular and renal events and the current use of kidney-protective treatments
Study Type
OBSERVATIONAL
Enrollment
91,628
Incident renal disease patients in this cohort are defined as those that newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the start date of this cohort study period, the 1st August 2020 and until the 1 st February 2023 (DAPA\_CKD P\&R date in Spain). The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-1 of this study cohort. At the index date-1, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines. Patients will be followed up from the index date-1 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall observation period.
We define the post-P\&R cohort including all incident renal disease patients observed in the dapagliflozin-CKD post-pricing and reimbursement period. Patients in this cohort newly met the renal function measurement definition stated above, with first-ever registered laboratory UACR and/or eGFR measurements or CKD diagnosis on or after the 1 st February 2023 (DAPA\_CKD P\&R date in Spain) and until the end of the study observation period. The first of the dates fulfilling any of the criteria defined above for the renal function measurement or CKD diagnosis, is defined as the patient index date-2 of this study cohort. At the index date-2, the renal disease will be staged based on eGFR (and/or UACR measurements in addition, if available) as specified in the KDIGO guidelines. Patients will be followed up from the index date-2 until the end of continuous enrolment, last date of available data or date of death, until the end of the overall study period
Research Site
Seville, Spain
Baseline demographics and clinical characteristics of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Time frame: from the 1st August 2020 to 30th September 2024
Baseline laboratory measures (number of measures per year and their values) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Time frame: from the 1st August 2020 to 30th September 2024
Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Time frame: Concomitant medications, by drug class and specific drugs of interest (proportion of patients with prescription of selected drugs) of the two cohorts of the study, pre-P&R and post-P&R cohorts, at their respective index dates.
Initiation of kidney-protective treatment (RAASi or SGLT2i or both) among treatment naïve patients in the pre-P&R cohort and post- P&R
Time frame: from the 1st August 2020 to 30th September 2024
Discontinuation of newly initiated RAASi or SGLT-2i treatment in the two cohorts of the study, pre-P&R and post-P&R cohorts
Time frame: from the 1st August 2020 to 30th September 2024
Discontinuation of ongoing RAASi and/or SGLT-2i treatment among treated patients (proportion of patients, time to discontinuation) in the two cohorts of the study, pre-P&R and post-P&R cohorts.
Time frame: from the 1st August 2020 to 30th September 2024
To describe the current clinical landscape among incident renal disease/incident CKD patients and in new initiators of kidney protective treatment- patients during the follow-up period
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Time frame: from the 1st August 2020 to 30th September 2024