Dataset Information

Effectiveness of an intervention to optimise the use of mirabegron for overactive bladder: a quasi-experimental study in primary care.

ABSTRACT: BACKGROUND:Overactive bladder is a composite of lower urinary tract storage symptoms. Pharmacological treatment is widely employed despite markedly modest efficacy data, adverse effects, and costs for the health system. AIM:To determine the 12-month efficacy of an intervention delivered by GPs on mirabegron revision and, if appropriate, discontinuation of treatment. DESIGN AND SETTING:Multicentre, quasi-experimental study in Barcelona (Catalonia), Spain. METHOD:Two groups composed of 17 intervention and 34 control practices were formed. The follow-up period was 12 months, from 1 January to 31 December 2017. A structured intervention was designed consisting of initiatives with GPs and urology/gynaecology specialists. The primary outcome was mirabegron use at 12 months. RESULTS:Of the 1932 patients, a significant discontinuation in treatment was observed at 12 months' follow-up in the intervention group (IG) (n = 433 out of 762, 56.8%), in contrast with the control one (CG) (n = 484 out of 1170, 41.4%) (P<0.001). There was also a reduced incorporation of new treatments in the IG (n = 214 out of 762, 28.1%) compared with the CG (n = 595 out of 1170, 50.9%) (P<0.001). In relation to patients with treatment at the beginning and end of the period, there was a decrease of 219 (28.7%) patients in the IG and an increase of 111 (9.5%) in the CG (P<0.001). CONCLUSION:The structured intervention showed optimisation in the use of mirabegron. When considering discontinuation it is necessary to provide clear data on the benefits and/or risks for patients and their caregivers, as such information is a precondition for shared decision making.

SUBMITTER: Fernandez-Liz E

PROVIDER: S-EPMC6255216 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of an intervention to optimise the use of mirabegron for overactive bladder: a quasi-experimental study in primary care.

Fernández-Liz Eladio E Tristante Pere Vivó PV Martínez Antonio Aranzana AA Colomer Maria Estrella Barceló MEB Rebull Josep Ossó JO Dolcet Maria Josep López MJL

The British journal of general practice : the journal of the Royal College of General Practitioners 20181119 677

<h4>Background</h4>Overactive bladder is a composite of lower urinary tract storage symptoms. Pharmacological treatment is widely employed despite markedly modest efficacy data, adverse effects, and costs for the health system.<h4>Aim</h4>To determine the 12-month efficacy of an intervention delivered by GPs on mirabegron revision and, if appropriate, discontinuation of treatment.<h4>Design and setting</h4>Multicentre, quasi-experimental study in Barcelona (Catalonia), Spain.<h4>Method</h4>Two g ...[more]

PMID: 30455222

Similar Datasets

Project description:ObjectivesThe aim of this study was to evaluate the cost effectiveness of mirabegron relative to two antimuscarinics, oxybutynin extended release (ER) and tolterodine ER, in patients with overactive bladder (OAB) from the perspective of a third-party payer in Colombia.MethodsA Markov model simulated the therapeutic management, disease course, and complications in hypothetical cohorts of OAB patients over a 5-year period. The model predicted costs and three outcomes: quality-adjusted life-years (QALYs), micturition state improvement (MSI), and incontinence state improvement (ISI). In each 1-month cycle, patients could transition between different health states reflecting symptom severity. Transition probabilities were estimated from a published mirabegron trial and mixed treatment comparison. Other inputs such as treatment discontinuation based on treatment-specific rates of persistence, resource use and costs, anticholinergic burden, comorbidity treatment, and drug acquisition were obtained from Società Italiana Scienze Mediche, Instituto de Seguros Sociales Tariff Manual, published literature, and expert opinion. Deterministic and probabilistic sensitivity analyses were conducted. Costs are presented in 2017 Colombia Pesos (COP).ResultsMirabegron was cost effective for all outcome measures at a willingness-to-pay threshold of 124,919,725 COP, which is three times the per capita gross domestic product (GDP). Using QALYs as the measure of effect, mirabegron had an incremental cost-effectiveness ratio (ICER) of 85,802,036 COP/QALY (26,365 USD/QALY) and 66,360,134 COP/QALY (20,384 USD/QALY) versus oxybutynin and tolterodine, respectively. Probabilistic sensitivity analyses showed that mirabegron was cost effective in 99.5% and 100% of simulations compared with oxybutynin and tolterodine, respectively. Using MSI and ISI as the measure of effects yielded ICERs below one GDP.ConclusionsMirabegron is a cost effective alternative to oxybutynin and tolterodine from the perspective of a third-party payer in Colombia.

Project description:OnabotulinumtoxinA and mirabegron have recently gained marketing authorisation to treat symptoms of overactive bladder (OAB).To evaluate the relative efficacy of mirabegron and onabotulinumtoxinA in patients with idiopathic OAB.Network meta-analysis.A search of 9 electronic databases, review documents, guidelines and websites.Randomised trials comparing any licensed dose of onabotulinumtoxinA or mirabegron with each other, anticholinergic drugs or placebo were eligible (19 randomised trials were identified). 1 reviewer extracted data from the studies and a second reviewer checked the data. Candidate trials were assessed for similarity and networks were developed for each outcome. Bayesian network meta-analysis was conducted using both fixed-effects and random-effects models. When there were differences in mean baseline values between mirabegron and onabotulinumtoxinA trials they were adjusted for using network meta-regression (NMR).No studies directly comparing onabotulinumtoxinA to mirabegron were identified. A network was created for each of the 7 outcomes, with 3-9 studies included in each individual network. The trials included in the networks were broadly similar. Patients in the onabotulinumtoxinA trials had more urinary incontinence and urgency episodes at baseline than patients in the mirabegron trials and these differences were adjusted for using NMR. Both onabotulinumtoxinA and mirabegron were more efficacious than placebo at reducing the frequency of urinary incontinence, urgency, urination and nocturia. OnabotulinumtoxinA was more efficacious than mirabegron (50 and 25 mg) in completely resolving daily episodes of urinary incontinence and urgency and in reducing the frequency of urinary incontinence, urgency and urination. NMR supported the results of the network meta-analysis.In the absence of head-to-head trials comparing onabotulinumtoxinA to mirabegron, this indirect comparison indicates that onabotulinumtoxinA may be superior to mirabegron in improving symptoms of urinary incontinence, urgency and urinary frequency in patients with idiopathic OAB.

Project description:BackgroundIn the absence of head-to-head trials, we performed an indirect treatment comparison of the β3-adrenergic agonists vibegron and mirabegron in the treatment of overactive bladder (OAB).MethodsPubMed, Embase, and Cochrane Library were searched for articles related to phase 3, double-blind, controlled trials of vibegron 75 mg and mirabegron 25/50 mg in patients with OAB. Efficacy outcomes included change from baseline at weeks 4, 12, and 52 in mean daily number of total urinary incontinence episodes and micturitions and mean volume voided/micturition. Effect size was computed as placebo-subtracted change from baseline (weeks 4, 12) or active control (tolterodine)-subtracted change from baseline (week 52) for each treatment group. Adverse events (AEs) are presented descriptively.ResultsAfter removal of duplicates, 49 records were identified, and after screening 9 met inclusion criteria for analysis. Vibegron showed significantly greater reduction in mean daily number of total incontinence episodes than mirabegron 25 mg at week 4, mirabegron 50 mg (weeks 4, 52), and tolterodine (weeks 4, 12) (P < 0.05, each) and significantly greater improvement in volume voided versus mirabegron 25 mg (week 12), mirabegron 50 mg (weeks 12, 52), and tolterodine (week 4) (P < 0.05, each). Confidence intervals of point estimates overlapped zero for all other comparisons of vibegron and mirabegron (25 or 50 mg) or tolterodine, indicating no significant differences between treatments for these time/endpoints. Urinary tract infection, hypertension, and dry mouth were the most commonly occurring AEs for vibegron, mirabegron, and tolterodine, respectively, in the short-term trials; hypertension was the most commonly occurring AE with all three treatments in the long-term trials.ConclusionsVibegron was associated with significant improvement in total incontinence episodes versus mirabegron at 4 and 52 weeks and volume voided at 12 and 52 weeks. Improvement in micturitions was similar between vibegron and mirabegron or tolterodine. Incidence of AEs was generally comparable between vibegron and mirabegron.

Dataset Information

Effectiveness of an intervention to optimise the use of mirabegron for overactive bladder: a quasi-experimental study in primary care.

Publications

Effectiveness of an intervention to optimise the use of mirabegron for overactive bladder: a quasi-experimental study in primary care.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets