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
Drug utilisation
Other

If ‘other’, further details on the scope of the study

Validation of the database Danish National Health Registries for the study of CV and neoplasm events in users of treatments for overactive bladder

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Database validation study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(G04BD04) oxybutynin
(G04BD07) tolterodine
(G04BD08) solifenacin
(G04BD09) trospium
(G04BD10) darifenacin
(G04BD11) fesoterodine

Medical condition to be studied

Urinary incontinence
Population studied

Short description of the study population

New users of individual overactive bladder (OAB) medications: oxybutynin, tolterodine, darifenacin, solifenacin, trospium, and fesoterodine.

Subjects in the program were required to meet all of the following inclusion criteria:
 Have at least 12 months of continuous residence in Denmark (thereby providing medical and prescription history data) before the first prescription or dispensing
of an overactive bladder (OAB) drug of interest.
 Have a first recorded prescription or dispensing for oxybutynin, tolterodine, darifenacin, solifenacin, trospium, or fesoterodine.
 Be aged 18 years or older at the time of first prescription of a drug of interest

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

Overactive Bladder patients

Estimated number of subjects

90000
Study design details

Main study objective

Characterize users of OAB drugs.Describe patterns of usage of OAB drugs.Describe the availability of potential confounders in the database, to help in the design of the PASS studies of mirabegron.Estimate IRs of study endpoints in new users of OAB drugs.Estimate the IRRs of CV outcomes in users of OAB drugs compared with tolterodine.

Outcomes

CV endpoints: AMI, stroke, CV mortality, all-cause mortality, major adverse cardiac events (MACE).Composite cancer endpoints: lung & bronchus, colon & rectum, melanoma of skin, urinary bladder, non-Hodgkin lymphoma, kidney & renal pelvis, pancreas, prostate (males), breast (females), corpus uteri (females).

Data analysis plan

Summary statistics of the covariates will be generated. Characteristics of the users at cohort entry and the patterns of use of the study medications will be described.Users of OAB medications will be characterized with respect to selected covariates.Patterns of use of OAB drugs including dose, duration of treatment, drug switching, and use of drugs as add-on therapy will be described.The frequency of the different characteristics of the covariates and the degree of missing information will be described.3 types of incidence endpoints will be estimated:-IRs of 4 different CV events+all-cause mortality in new users of antimuscarinic drugs for the treatment of OAB.-IRR of 4 different CV outcomes+all-cause mortality in new users of each of the OAB drugs compared with tolterodine. -IRs of 2 sex-specific, multiple-cancer composite endpoints (1 for men/1 for women) during the first year after start of treatment and during subsequent years, among new users of antimuscarinic drugs
Documents
Study results

178-cl-119-clrr-03-disc01-en-final-02_redacted

English (3.32 MB - PDF)View document
Study publications
Margulis AV, Hallas J, Pottegard A, Kristiansen NS, Atsma WJ, Franks B, D'Silva…
Hallas J, Margulis AV, Pottegard A, Kristiansen NS, Atsma WJ, Appenteng K, de V…
Margulis AV, Linder M, Arana A, Pottegard A, Anveden-Berglind I, Bui CB, Kristi…