Complications of UTI in Patients on Dapagliflozin

AstraZeneca

Status: Completed

Conditions: Severe Complications of Urinary Tract Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT02695173

D1690R00008

EUPAS12113 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 683,380 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years and older (CPRD and HIRD), or 65 years or older (Medicare);
2. no diagnosisi of type 1 diabetes,
3. are new users of one of the study drugs and
4. have at least 180 days of electronic data before their first prescription of the study drug

Exclusion criteria

1. The patient experienced chronic pyelonephritis at any time before the index date (i.e., during the available lookback time).
2. The patient was prescribed an SGLT2 inhibitor other than dapagliflozin on or before the index date.
3. The patient initiated metformin or sulfonylurea as AD monotherapy at the index date.
4. The patient initiated insulin therapy at the index date.
5. The patient had evidence of type 1 diabetes before cohort entry or first recorded AD is insulin monotherapy