A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden

Astellas Pharma Singapore Pte. Ltd.6,295,279 enrolled

Overview

Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.

Study Type

OBSERVATIONAL

Enrollment

6,295,279

Conditions

Overactive Bladder (OAB)

Interventions

Non-InterventionalOTHER

Overview of anticholinergic burden, rather than to evaluate specific drugs

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have at least one dispensing of any medication between January 22, 2016 and December 31, 2016. Inclusion Criteria for Korea: * Have at least one dispensing of any medication between January 1st, 2016 and December 31, 2016. * Participant was diagnosed with OAB (ICD-10 N32.8, N31.0, N31.1, N31.2, N31.8, N31.9, N32.9, N39.8 and N39.40) at index date. * Participant did not have dispensing record of an OAB medication during the washout period (6 months prior to the index date). Exclusion Criteria: * Participants who do not have a complete year of data availability in the database prior to index date. * Have record of hospitalization on the index date. Exclusion Criteria for Korea: * Participant was hospitalized on the index date. * Participant did not have an active insurance status during the washout period or on the index date. * Participant received onabotulinumtoxin A and/or surgical intervention as part of the OAB treatment during the washout period. * Participant was diagnosed with stress incontinence (ICD-10 N39.3 or equivalent) or had dispensing record of medication for stress incontinence (duloxetine) during the washout period. * Participant was diagnosed with urinary tract infection (ICD-10 N30.0 and N39.0 or equivalent) during the washout period or on the index date.

Locations (2)

Site AU61001

Melbourne, Australia

Site KR82001

Seoul, South Korea

Outcomes

Primary Outcomes

Anticholinergic Cognitive Burden (ACB) score

ACB will be calculated based on methodology from Campbell et al (2016). Sum (Drug A #days prescribed X ACB scale score) + (Drug B #days prescribed X ACB scale score) + (Drug X…)/Number of days with any medication prescribed. The cumulative score has a range from 0 to infinity, with higher values indicating a higher cumulative anticholinergic burden of the patient.

Time frame: 100 days

Korea Specific: Percentage of Participants With any Listed Anticholinergic Use

This will be calculated as number of participants with any listed anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.

Time frame: 100 days

Korea Specific: Percentage of Participants With Strong Anticholinergic Use

This will be calculated as number of participants with strong anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.

Time frame: 100 days

Korea Specific: Number of Anticholinergics Dispensed per Participants

This will be calculated as total number of anticholinergics dispensed divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.

Time frame: 100 days

Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort

Attribution proportion of OAB medication to total ACB will be calculated as the ratio between the sum over all OAB patients of the ACB scores of each OAB medication multiplied by the number of days supply in the numerator and the sum over all OAB patients of the ACB scores of each antimuscarinic medication multiplied by the number of days supply in the denominator.

Time frame: 100 days

Data from ClinicalTrials.gov

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A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes