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.

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.

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.

Fesoterodine flexible dosing for OAB has a more favourable benefit-risk profile than tolterodine or fixed-dose fesoterodine.

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.

Moore A, et al. J Pharm Pharmacol. 2017;69(10):1364-1373.
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.