Multicriteria Decision Analysis Applied to the Clinical Use of Pharmacotherapy for Overactive Bladder Symptom Complex

Chapple, Christopher R.; Mironska, Emma; Wagg, Adrian; Milsom, Ian; Castro-Díaz, David; Koelbl, Heinz; Pushkar, Dmitry; Tubaro, Andrea; Ridder, Dirk De; Chartier‐Kastler, Emmanuel; Phillips, Lawrence D.

doi:10.1016/j.euf.2019.09.020

Cited by 23 publications

(29 citation statements)

References 4 publications

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“…This facilitated‐group process has been applied by several pharmaceutical manufacturers to compare their products with other drugs for the same medical condition. Recent examples include Reckitt Benckiser for over‐the‐counter analgesics, 43 Merck Serono for multiple sclerosis 44 and Pfizer for post‐operative analgesics and overactive bladder 46 . In every case, the company explored the literature to establish three to five favourable effects and up to 11 or 12 unfavourable effects, gathered the associated data, and created a model in a decision conference of company and external experts and clinicians, facilitated by one of the co‐authors.…”

Section: European Experience With Quantitative Benefit–risk Modellingmentioning

confidence: 99%

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Advancing structured decision‐making in drug regulation at the FDA and EMA

Angelis

Phillips

2020

Brit J Clinical Pharma

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The recent benefit–risk framework (BRF) developed by the Food and Drug Administration (FDA) is intended to improve the clarity and consistency in communicating the reasoning behind the FDA's decisions, acting as an important advancement in US drug regulation. In the PDUFA VI implementation plan, the FDA states that it will continue to explore more structured or quantitative decision analysis approaches; however, it restricts their use within the current BRF that is purely qualitative. By contrast, European regulators and researchers have been long exploring the use of quantitative decision analysis approaches for evaluating drug benefit–risk balance. In this paper, we show how quantitative modelling, backed by decision theory, could complement and extend the FDA's BRF to better support the appraisal of evidence and improve decision outcomes. After providing relevant scientific definitions for benefit–risk assessment and describing the FDA and European Medicines Agency (EMA) frameworks, we explain the components of and differences between qualitative and quantitative approaches. We present lessons learned from the EMA experience with the use of quantitative modelling and we provide evidence of its benefits, illustrated by a real case study that helped to resolve differences of judgements among EMA regulators.

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Section: European Experience With Quantitative Benefit–risk Modellingmentioning

confidence: 99%

“…Recent examples include Reckitt Benckiser for over-the-counter analgesics, 43 Merck Serono for multiple sclerosis 44 and Pfizer for post-operative analgesics and overactive bladder. 46 In every case, the company explored the literature to…”

Section: European Experience With Quantitative Benefit-risk Modellimentioning

confidence: 99%

Advancing structured decision‐making in drug regulation at the FDA and EMA

Angelis

Phillips

2020

Brit J Clinical Pharma

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“…A multicriterion decision analysis has been contrasted using the available efficacy and safety data from published randomized and placebo-controlled trials of mirabegron, antimuscarinic agents, and the combination. 57 Sixty references were identified and included, covering 14 common drugs, and an expert panel including urologists, urogynaecologists, and geriatricians constructed and validated the model. The conclusions drawn were that flexible-dose fesoterodine (4mg or 8mg) provided the highest efficacy, and mirabegron 25mg the highest tolerability, with the combination of mirabegron 25mg and solifenacin 5mg being the closest to the ideal treatment option of perfect efficacy with no side effects.…”

Section: Pharmacological Management Of Incontinence In the Frailmentioning

confidence: 99%

<p>Mirabegron in the Treatment of Overactive Bladder: Safety and Efficacy in the Very Elderly Patient</p>

Makhani¹,

Thake²,

Gibson³

2020

CIA

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Lower urinary tract symptoms, including urgency, urgency incontinence, frequency, and nocturia, are highly prevalent in older adults and are associated with significant morbidity and impairment in quality of life. When conservative measures such as bladder training fail to improve symptoms, pharmacological management is recommended by national and international guidelines. Mirabegron, an agonist of the β3 adrenergic receptor, demonstrates similar efficacy to the anticholinergic drugs without the risk of anticholinergic effects, but experience and evidence in the very elderly population are limited. This narrative review examines the current evidence base for mirabegron in very elderly adults.

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“…The MCDA model has been applied to OAB drug treatment, results of which have been recently published. 31 The study assessed the benefit-safety profile of OAB drugs, using published data and clinical judgment to perform a sensitivity analysis of benefit vs safety for individual OAB symptoms. Efficacy and safety data from published RCTs of muscarinic antagonists, the β3 agonist mirabegron, and the combination of an AM and β3 agonist using the EAU Guidelines database as a starting point, coupled with a full literature search of trials, were used for this analysis.…”

Section: What Do We Learn From the Multicriteria Decision Analysis Model?mentioning

confidence: 99%

“…BR, benefit-risk. Reprinted from Chapple et al 31 with permission of Elsevier were urgency, UUI, frequency, and nocturia, as well as seven harmful effects: dry mouth, constipation, headache, dizziness, UTI, retention, and tachycardia (Figure 2).…”

Section: What Do We Learn From the Multicriteria Decision Analysis Model?mentioning

confidence: 99%

Which drugs are best for overactive bladder? From patients’ expectations to physicians’ decisions

et al. 2020

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Aim In order to help physicians determine which drugs are the best for treating overactive bladder (OAB) symptoms, this review considered three questions: what are the patient's expectations? What information is generated by the Multicriteria Decision Analysis (MCDA) model? What can physicians expect from medical treatments? Methods A comprehensive literature search was undertaken on these three topics in order to assist physicians regarding the optimum treatment modality for OAB. Results Patients’ difficulties in reporting symptoms and their expectations of treatment outcomes interfere with the success of treatment. To assist physicians in meeting patients’ expectations and to choose the most appropriate treatment, a new approach, recognised by the European Medicines Agency, the MCDA model was used to compare the benefits and safety of OAB treatments. Conclusion The MCDA model is useful for comparing the benefit‐safety profiles of OAB drugs in order to equip clinicians with information on the drug that might best meet their patient's needs. Flexibly dosed fesoterodine appeared to be most efficacious in resolving urgency and urgency incontinence compared with other drugs, and resolution of urinary urgency appears to be associated with a reduced number of reported adverse events.

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Multicriteria Decision Analysis Applied to the Clinical Use of Pharmacotherapy for Overactive Bladder Symptom Complex

Cited by 23 publications

References 4 publications

Advancing structured decision‐making in drug regulation at the FDA and EMA

Advancing structured decision‐making in drug regulation at the FDA and EMA

<p>Mirabegron in the Treatment of Overactive Bladder: Safety and Efficacy in the Very Elderly Patient</p>

Which drugs are best for overactive bladder? From patients’ expectations to physicians’ decisions

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