Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

FORXIGA
XIGDUO

Name of medicine, other

farixga, xigduo xr

Study drug International non-proprietary name (INN) or common name

DAPAGLIFLOZIN

Anatomical Therapeutic Chemical (ATC) code

(A10BD15) metformin and dapagliflozin
metformin and dapagliflozin

Medical condition to be studied

Urosepsis
Pyelonephritis
Population studied

Short description of the study population

The study focused on risk of urinary tract infections (UTI) in patients with type 2 diabetes aged 18 years or more exposed to dapagliflozin and other antidiabetic (ADs) treatments identified from CPRD, HIRD and Medicare database in the US.
Inclusion criteria:
1) receive newly prescribed dapagliflozin (with or without other ADs) or a newly prescribed AD (with or without other ADs) in a class other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy;
(2) do not have evidence of type 1 diabetes;
(3) are aged 18 years or older at the index date for CPRD patients, 18-64 years for HIRDSM patients, or 65 years or older for Medicare patients; and
(4) have been enrolled in the data source for at least 180 days before the first prescription or dispensing dapagliflozin or eligible index comparator AD.

Exclusion criteria:
Patients with a previous diagnosis of chronic pyelonephritis will be excluded.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Patients with type 2 diabetes mellitus

Estimated number of subjects

459636
Study design details

Main study objective

To compare, by insulin use at the index date, the sex-specific incidence of hospitalization or emergency department visit for severe complications of UTIs among patients with type 2 diabetes mellitus who are new users of dapagliflozin with those who are new users of antidiabetic drugs in classes other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy.

Outcomes

urosepsis, pyelonephritis, Hospitalization, ED visit, or outpatient diagnosis of pyelonephritis

Data analysis plan

Descriptive statistics will be calculated to compare baseline characteristics at cohort entry between dapagliflozin users versus comparator antidiabetic users. Propensity scores will be estimated by using logistic regression, with measured potential confounders and predictors of complications of UTI as independent variables in the regression model and actual exposure group (dapagliflozin or comparator) as the outcome. Sex-specific incidence rates of complications of UTI will be estimated during exposure time at risk for dapagliflozin initiators and comparators. Unadjusted sex-specific incidence rate ratios (IRRs) of the outcome of interest with 95% confidence intervals in dapagliflozin users versus other AD users will be calculated, and adjusted using propensity score–stratified analysis. Analyses will be conducted in each data source separately, and a pooled estimate will be calculated if deemed appropriate.
Documents
Study results

0304030_Dapa UTI Final Report_Final_9Nov2020_Abstract_Redacted

English (190.87 KB - PDF)View document
Study publications
Danysh HE, Johannes CB, Beachler DC, Layton JB, Ziemiecki R, Arana A, Dinh J, L…
Johannes C, Layton JB, Beachler DC, Ziemiecki RM, Li L, Danysh HE, Dinh J, Hunt…
Johannes C, Beachler D, Ziemiecki R, Yin R, McGrath L, Jemison J, Lanes S, Gils…
Layton JB, Zhou CK, Danysh HE, Beachler DC, Ziemiecki R, Dinh J, Yin R, Calinga…