The objectives of the study are: 1. To evaluate the association between Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitor use and the occurrence of anemia in patients with chronic kidney disease (CKD) using a nested case-control design with incidence density sampling. 2. To evaluate anemia-related outcomes using a nested case-control-based analytical framework, including assessment of within-subject changes in anemia-related treatments and healthcare costs by comparing the period after study entry with the period after the index date (for cases) or matched reference date (for controls), and comparison according to SGLT2 inhibitor use: A) Prescription patterns and treatment regimens for anemia, including analysis of medication types, dosing strategies, and duration of treatments B) Anemia-related healthcare costs C) Change in laboratory values
Study Type
OBSERVATIONAL
Enrollment
15,000
SGLT2 inhibitor
Nippon Boehringer Ingelheim Co ., Ltd.
Tokyo, Japan
First occurrence of anemia (composite anemia outcomes)
The composite of anemia outcomes is defined as any of the following: * Hb \< 13.0 g/dL for men or \< 12.0 g/dL for women * Clinical diagnosis of anemia using ICD-10 diagnosis codes * Initiation of anemia treatment (Erythropoiesis-Stimulating Agents (ESAs), Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH) inhibitors, iron preparations, or red blood cell (RBC) transfusion
Time frame: From the study cohort entry date to first event occurrence (for cases) or matched reference date (for controls), up to 13 years
Number of administered doses of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions
Erythropoiesis-Stimulating Agents (ESAs) Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH) Red blood cell (RBC) transfusions -outcome evaluated as within-subject changes between pre- and post-index/reference periods
Time frame: 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)
Anemia-related healthcare costs
Anemia-related medical costs are defined as the sum of direct medical costs associated with the treatment of anemia. These costs will include medication costs and costs related to RBC transfusion. -outcome evaluated as within-subject changes between pre- and post-index/reference periods
Time frame: 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)
Frequency of administration of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions
-outcome evaluated as within-subject changes between pre- and post-index/reference periods
Time frame: 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls)
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