Towards An Understanding Of Persistence, Switching, And Adherence With Medications For Over-Active Bladder:A Retrospective Observational Study In UK Clinical Practice

Date of Approval
Application Number
16_097
Technical Summary

The overall objectives of this study will be to compare the persistence and adherence (assessed by medication possession ratio [MPR]) of patients with overactive bladder (OAB) receiving mirabegron vs. antimuscarinic (AM) drug therapies; provide a description of these patients; understand whether persistence and adherence as clinical endpoints have health resource implications in standard UK clinical practice.
A retrospective analysis of patients starting a new OAB drug between 01 May 2013 and 30 June 2014 will be conducted using the Clinical Practice Research Datalink GOLD. Patients will be categorised as naive to OAB therapy or having prior therapy, depending on the prescription of other OAB drugs within a 12-month look-back period. The observation period will be 12 months. Adherence will be measured using the medication possession ratio (MPR) and non-adherence will be defined as an MPR≤80%. Persistence will be defined as the duration of uninterrupted OAB therapy.
For each population, we will provide descriptive statistics on patient baseline characteristics, persistence/adherence, resource utilisation and costs. Time to discontinuation and MPR will be compared between index OAB drugs using adjusted regression models. To minimise allocation bias comparative groups will be matched on gender; age; comorbidity and treatment status (naïve/experienced) to prior antimuscarinic treatment.

Health Outcomes to be Measured

The primary endpoint of this study will be the persistence during 12 months of follow-up, defined as the time from initiation of OAB therapy to the discontinuation of OAB therapy.

Collaborators

Florent Guelfucci - Chief Investigator - Creativ-Ceutical
Florent Guelfucci - Corresponding Applicant - Creativ-Ceutical
Adrian Wagg - Collaborator - University of Alberta
Amine Khemiri - Collaborator - Creativ-Ceutical
Ashley Jaggi - Collaborator - Astellas Pharmaceuticals
Francis Fatoye - Collaborator - Manchester Metropolitan University
Jameel Nazir - Collaborator - Astellas Pharmaceuticals
Zalmai Hakimi - Collaborator - Astellas Pharmaceuticals

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation