Complications of UTI in Patients on Dapagliflozin
Study Details
Study Description
Brief Summary
The objective of this study is to compare, by insulin use at the index date, the sex-specific incidence of hospitalization or emergency department (ED) visit for severe complications of urinary tract infections (UTI), defined as pyelonephritis and urosepsis, among patients with type 2 diabetes mellitus (T2DM) who are new users of dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
The overall goal of this research study is to estimate the sex-specific incidence of hospitalization or emergency department visit for severe complications of urinary tract infections, defined as pyelonephritis and urosepsis, in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs. Dapagliflozin and other antidiabetic drugs are used to treat type 2 diabetes mellitus. Because of the mechanism of action for dapagliflozin and results from small safety monitoring studies, there is interest in further evaluating the safety of dapagliflozin in large populations.
The study will be implemented in three administrative health care data sources in two countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD); and in the United States, the Centers for Medicare and Medicaid Services (CMS) Medicare databases and the HealthCore Integrated Research Database (HIRDSM). Individuals in the databases will be included in the study if they meet the following age criteria; 18 years and older (CPRD and HIRD), or 65 years or older (Medicare); and if they did not have type 1 diabetes, are new users of one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug. The study period starts July 1, 2013 in CPRD, January 1, 2014 in PHARMO and January 9, 2014 in the United States data sources, and will end at the latest available data at each database at the time of analysis
Study Design
Outcome Measures
Primary Outcome Measures
- Incidence of urinary tract infections (UTI) complications [Day after index date up to six years]
Patients will be followed from their index date (date of first study drug prescription or dispensing) until they experience one of the following: an event under study, end of time at risk for index medication, death, addition of a non-dapagliflozin SGLT2 inhibitor, termination of health plan or transfer out of the GP practice, or end of the study period (up to six years)
Secondary Outcome Measures
- Incidence of pyelonephritis [Day after index date up to six years]
Patients will be followed from their index date (date of first study drug prescription or dispensing) until they experience one of the following: an event under study, end of time at risk for index medication, death, addition of a non-dapagliflozin SGLT2 inhibitor, termination of health plan or transfer out of the GP practice, or end of the study period (up to six years)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years and older (CPRD and HIRD), or 65 years or older (Medicare);
-
no diagnosisi of type 1 diabetes,
-
are new users of one of the study drugs and
-
have at least 180 days of electronic data before their first prescription of the study drug
Exclusion Criteria:
-
The patient experienced chronic pyelonephritis at any time before the index date (i.e., during the available lookback time).
-
The patient was prescribed an SGLT2 inhibitor other than dapagliflozin on or before the index date.
-
The patient initiated metformin or sulfonylurea as AD monotherapy at the index date.
-
The patient initiated insulin therapy at the index date.
-
The patient had evidence of type 1 diabetes before cohort entry or first recorded AD is insulin monotherapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Wilmington | Delaware | United States | |
| 2 | Research Site | Washington | District of Columbia | United States | |
| 3 | Research Site | London | United Kingdom |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: Catherine Johannes, Dr, RTI Health Solutions
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- D1690R00008
- EUPAS12113