Chronic Kidney Disease
Conditions
Brief summary
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
Interventions
DRUGSGLT2 inhibitor
SGLT2 inhibitor
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have two consecutive estimated glomerular filtration rate (eGFR) measurements \< 60 mL/min/1.73 m2 at least 92 days apart between April 17, 2014 and October 31, 2022. 2. Aged 18 years or older at the study cohort entry date. 3. Have at least one haemoglobin (Hb) measurement at the study cohort entry date or within 183 days before the study cohort entry date.
Exclusion criteria
1. Have less than 183 days of record history before the study cohort entry date. 2. Have any prescription record for an SGLT2 inhibitor at the study cohort entry date or within 183 days before the study cohort entry date 3. Have evidence of anemia at the study cohort entry date or within 183 days before the study cohort entry date. * Hemoglobin (Hb) \< 13.0 g/dL for men or \< 12.0 g/dL for women * Hematocrit (Ht) \< 39% for men or \< 36% for women * Have a history of prescribed anemia-related medications and treatments at the study cohort entry date or within 183 days before the study cohort entry date. 4. Have evidence of anemia-causing conditions other than chronic kidney disease (CKD) at the study cohort entry date or within 183 days before the study cohort entry date. 5. Confirm at least one instance of hemodialysis, peritoneal dialysis, or kidney transplantation at the study cohort entry date or within 183 days before the study cohort entry date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First occurrence of anemia (composite anemia outcomes) | From the study cohort entry date to first event occurrence (for cases) or matched reference date (for controls), up to 13 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of administered doses of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions | 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls) | 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 |
| Anemia-related healthcare costs | 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls) | 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 |
| Frequency of administration of ESA, HIF-PH inhibitors, iron preparations, and RBC transfusions | 1, 3, and 6 months after cohort entry and after the index date (cases) or matched reference date (controls) | -outcome evaluated as within-subject changes between pre- and post-index/reference periods |
Countries
Japan
Outcome results
None listed