Over-active bladder is a problem with bladder-storage function that causes a sudden urge to urinate. The urge may be difficult to stop, and may lead to the involuntary loss of urine (incontinence) and thus, negatively impact the quality of life and social functioning. Management of over-active bladder often begins with behavioural strategies but, if these efforts don't help enough to reduce symptoms, medical treatment may be required. Antimuscarinic agents, used to relax the bladder muscle and increase the bladder capacity, are the cornerstone of medical treatment. Side-effects of these drugs, more pronounced in children and the elderly, include dry mouth, flatulence, taste disturbances, blurred vision, dry eyes, drowsiness, dizziness, and fatigue.
A poor tolerability is the principal reason for patients stopping treatment. Mirabegron is the first of a new class of medications for over-active bladder which, in clinical trials, controlled symptoms with fewer side-effects. This study will assess whether patients with over-active bladder persist with mirabegron treatment for longer than the established antimuscarinic drugs. In addition, the association between the duration of use of these drugs (persistence) and the consistency of refills of these drugs (adherence) with healthcare care resource use and burden of illness will be explored.
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.
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.
Florent Guelfucci - Chief Investigator - Creativ-Ceutical ( do not use )
Florent Guelfucci - Corresponding Applicant - Creativ-Ceutical ( do not use )
Adrian Wagg - Collaborator - University of Alberta
Amine Khemiri - Collaborator - Creativ-Ceutical ( do not use )
Ashley Jaggi - Collaborator - Astellas Pharmaceuticals
Francis Fatoye - Collaborator - Manchester Metropolitan University
Jameel Nazir - Collaborator - Astellas Pharmaceuticals
Zalmai Hakimi - Collaborator - Astellas Pharmaceuticals
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation