Benefit-Risk Evaluation of Tolterodine (4 mg) and Fesoterodine (Fixed and Flexible Dosing): Using Multi-criteria Decision Analysis Modelling to Help Physicians Optimise Treatment in Patients Diagnosed With Overactive Bladder

Chapple C R1, Phillips L2, Pawinski R3, Mauer J3, Lizarraga I3, Chaudhuri S3

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 147
Open Discussion ePosters
Scientific Open Discussion Session 7
Wednesday 29th August 2018
12:55 - 13:00 (ePoster Station 8)
Exhibition Hall
Overactive Bladder Mathematical or statistical modelling Retrospective Study
1. University of Sheffield, 2. London School of Economics, 3. Pfizer Inc
Presenter
C

Christopher R Chapple

Links

Poster

Abstract

Hypothesis / aims of study
Clinicians use the most recent available clinical data to select and optimise treatment options for overactive bladder (OAB). These data are often driven by safety or efficacy, with limited published benefit-risk data available. However, clinical decision making can be challenging when data are fragmented. Herein, an adapted multi-criteria decision analysis (MCDA) model incorporating published data and clinical judgement was used to assess the benefit-risk profile of drug-treatment options in OAB.
Study design, materials and methods
Efficacy and safety data from published, randomised, placebo-controlled trials of the antimuscarinic antagonists tolterodine and fesoterodine indicated for OAB were used to populate an MCDA model adapted from Moore and colleagues [1]. Using European Medicines Agency–accepted methodology [2], data were evaluated against the 4 favourable and 7 unfavourable effects judged most likely to affect patient outcomes (Figure 1). An analysis of tolterodine 4 mg and fesoterodine was performed, which included fesoterodine 4- and 8-mg fixed doses and a fesoterodine flexible-dosing regimen.
Results
The MCDA model showed a favourable benefit-risk profile for flexible dosing of fesoterodine compared to single-dose interventions of tolterodine and fesoterodine (Figure 2). The model was robust over a range of sensitivity analyses, confirming that results remained relatively unchanged even with significant changes in weighting or changes to the published evidence.
Interpretation of results
Fesoterodine flexible dosing for OAB has a more favourable benefit-risk profile than tolterodine or fixed-dose fesoterodine.
Concluding message
The MCDA model is a useful output that can compare multiple treatment options, providing clinicians with an easy-to-interpret benefit-risk analysis to help inform clinical decision making.
Figure 1
Figure 2
References
  1. Moore A, et al. J Pharm Pharmacol. 2017;69(10):1364-1373.
  2. European Medicines Agency. Benefit-risk methodology work packages. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000314.jsp. Accessed March 3, 2018.
Disclosures
Funding This work was supported by Pfizer Inc. Clinical Trial No Subjects Human Ethics not Req'd Data were obtained from published sources Helsinki not Req'd Data were obtained from published sources; the individual published studies followed the Declaration of Helsinki Informed Consent No
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