Randomized Double-blind, Active-controlled Phase 3 Study to Assess 12-Month Safety and Efficacy of Mirabegron, a β3-Adrenoceptor Agonist, in Overactive Bladder

Chapple, Christopher R.; Kaplan, Steven A.; Mitcheson, David; Klečka, Jiří; Cummings, Jana; Drogendijk, T.; Dorrepaal, Caroline; Martin, Nancy

doi:10.1016/j.eururo.2012.10.048

Cited by 320 publications

(322 citation statements)

References 10 publications

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“…18 In a 1-year study, mirabegron and tolterodine extended release (ER) 4 mg were similarly effective, but mirabegron 50 mg had a lower incidence of dry mouth (2.8% vs. 8.6%). 19 In a sub-analysis of patients aged ≥65 years, the incidence of dry mouth after 1 year was 6-fold lower with mirabegron than with tolterodine ER. 20 We report our early experience with mirabegron in Canada, using retrospective prescription claims data to compare persistence and adherence versus antimuscarinic drugs over 12 months.…”

Section: Introductionmentioning

confidence: 99%

Persistence and adherence with the new beta-3 receptor agonist, mirabegron, versus antimuscarinics in overactive bladder: Early experience in Canada

Wagg¹,

Franks²,

Ramos³

et al. 2015

CUAJ

104

132

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Introduction: Antimuscarinics are the principal pharmacological treatment for overactive bladder (OAB), but frequently give rise to anticholinergic side effects, such as dry mouth, a factor leading to poor persistence. The ß 3 -adrenoceptor agonist mirabegron is devoid of significant anticholinergic activity, while being effective in OAB. We evaluated persistence and adherence with mirabegron versus antimuscarinics over 12 months. Methods: We obtained retrospective claims from a Canadian Private Drug Plan database for patients 18 years old and over, with a first claim for mirabegron or antimuscarinics during a 6-month index period (April-September 2013). A 6-month look-back identified those with no prior claims for OAB medication (treatmentnaïve) or ≥1 prior OAB drug (treatment-experienced). Time to end of persistence (≥30 day therapy gap or switch of therapy) was evaluated over 12 months; adherence with medication (medication possession ratio) was also measured. Results: Persistence data from 19 485 patients (74% female, 92% naïve, 19.9% aged ≥65 years) showed that for experienced patients the median number of days on mirabegron was 299 days, compared with a range of 96 to 242 days for the different antimuscarinics; for naïve patients, it was 196 versus 70 to 100 days, respectively. Persistence at 12 months was for mirabegron 39% versus 14% to 35% for antimuscarinics, (experienced) and 30% mirabegron versus 14% to 21% antimuscarinics, (naïve). Patients taking mirabegron demonstrated statistically significantly greater adherence than those taking antimuscarinics. Conclusion: Patients who received mirabegron remained longer on treatment than those treated with antimuscarinics, and had higher 12-month persistence and adherence rates.

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Section: Introductionmentioning

confidence: 99%

Persistence and adherence with the new beta-3 receptor agonist, mirabegron, versus antimuscarinics in overactive bladder: Early experience in Canada

Wagg¹,

Franks²,

Ramos³

et al. 2015

CUAJ

104

132

View full text Add to dashboard Cite

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“…From months 0 to 3, monthly transition probabilities between symptom levels for solifenacin 5 mg/day were estimated by applying a multinomial regression model to the 905-CL-015 data (Table S3). Transition probabilities after Month 3 were assumed to be the same as between Months 2 and 3, based on evidence from two long-term studies which suggested that the treatment effect of antimuscarinic agents at 3 or 4 months is sustained up to 24 months [19,20]. For other antimuscarinics, transition probabilities were derived from the NMA results using a calibration approach [21], which aimed to minimize the difference between changes in symptom severity predicted from the model and changes estimated from the NMA.…”

Section: Methodsmentioning

confidence: 99%

Cost-effectiveness of solifenacin compared with oral antimuscarinic agents for the treatment of patients with overactive bladder in the UK

Hakimi

Kelleher

Aballéa

et al. 2018

Journal of Market Access & Health Policy

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Objective: To evaluate the cost-effectiveness of solifenacin 5 mg/day versus other oral antimuscarinic agents used for overactive bladder (OAB) from a UK National Health Service (NHS) perspective. Study design: In a Markov model, hypothetical patients received solifenacin 5 mg/day or a comparator antimuscarinic, after which they could switch to an alternative antimuscarinic. The model estimated incremental cost-effectiveness ratios (ICER), expressed as cost per quality-adjusted life year (QALY) over a 5-year period. Results: Solifenacin 5 mg/day was the dominant treatment strategy (i.e., less costly and more effective) versus tolterodine extended-release (ER) 4 mg/day, fesoterodine 4 and 8 mg/day, oxybutynin ER 10 mg/day and solifenacin 10 mg/day, and was cost-effective (i.e., ICERs below the £30,000 per QALY threshold generally applied in the NHS) versus oxybutynin immediate release (IR) 10 mg/day, tolterodine IR 4 mg/day and trospium chloride 60 mg/day. The probability of solifenacin 5 mg/day being dominant/cost-effective at a willingness-to-pay threshold of £30,000 per QALY was 57–98%. Conclusions: Solifenacin 5 mg/day appears to be a cost-effective strategy for the treatment of OAB over a 5-year timeframe compared with other oral antimuscarinic agents in the UK. These findings are important for decision-makers considering the economic implications of selecting treatments for OAB.

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“…A 12-month study comparing mirabegron and tolterodine ER 4 mg in OAB reported that dry mouth, which contributed to the improved cost-effectiveness of mirabegron in the current analysis, was more frequently observed with tolterodine ER 4 mg. 54,55 Anticholinergic side effects are also likely to affect medication persistence and adherence, which are reported to decrease one month after treatment initiation with antimuscarinics. 24,56 Medication persistence and adherence are also reported to be important drivers of cost-effectiveness 57 and early real-world evidence in Canada suggests that median treatment persistence is greater with mirabegron (299 days or 196 days) compared to different antimuscarinics (96-242 days or 70-100 days) in previously treated and treatment-naïve patients, respectively.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness of mirabegron compared to tolterodine ER 4 mg for overactive bladder in Canada

Herschorn¹,

Nazir²,

Ramos³

et al. 2017

CUAJ

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Introduction: This analysis compared the cost-effectiveness of once-daily regimens of mirabegron 50 mg and generic tolterodine ER 4 mg in a hypothetical cohort of previously treated patients with overactive bladder (OAB) in Canada. Methods: A Markov model was developed to represent different health states according to OAB symptoms (frequency, incontinence), presence/absence of adverse events (AEs; dry mouth, constipation, blurred vision), and treatment status (on-treatment, discontinue treatment, restart previous treatment). The time horizon used was one year, with monthly transitions between health states. The model was populated using data from a phase 3, placebo-controlled trial of mirabegron that included tolterodine as an active comparator (SCORPIO), as well as other published literature and expert opinion. Cost-effectiveness was calculated from Canadian public payer (based on Quebec list prices) and societal perspectives. Results: The incremental one-year cost per patient for mirabegron over tolterodine was $182 CAD and $157 CAD from the payer and societal perspectives, respectively. The incremental quality-adjusted life year (QALY) gain for mirabegron was 0.0066 when using EQ-5D health-state utilities. Mirabegron was cost-effective compared with tolterodine, from both payer and societal perspectives, and remained cost-effective vs. tolterodine across the majority of sensitivity analyses. The model was based on limited clinical trial evidence supplemented with expert opinion and assumptions; a select number of OAB symptoms, AEs, and direct and indirect medical costs associated with OAB; and a timeframe of only one year. Conclusions: From the payer and societal perspectives, the health economic model indicates that in Canada, mirabegron is a cost-effective treatment strategy compared with tolterodine, leading to improved health outcomes (QALYs) at an acceptable incremental cost. IntroductionOveractive bladder (OAB) is a bothersome condition with a relatively high prevalence in the general population. In a survey of over 16 500 subjects aged ≥40 years in six European countries, the prevalence of OAB was 16.6%.1 In a subsequent survey of over 19 000 subjects aged ≥18 years in Canada and Europe, the prevalence of OAB was 11.8%. OAB has a substantial negative impact on patients' health-related quality of life (HRQoL) and mental health. 5The cardinal symptoms -urgency with or without incontinence, usually associated with frequency, and nocturia 6 -interfere with basic activities of daily living, such as work, travel, sleep, interpersonal activities, sexual function, and physical activities. 7,8 Studies have often focused specifically on the impact of incontinence, but it has been shown that frequency and urgency, which are more prevalent, are as bothersome as urgency incontinence.1 In terms of mental health, it is estimated that approximately one-third of men and women with lower urinary tract symptoms may have comorbid clinical anxiety and/or depression. 9 In addition, it has been shown that the prevale...

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Randomized Double-blind, Active-controlled Phase 3 Study to Assess 12-Month Safety and Efficacy of Mirabegron, a β3-Adrenoceptor Agonist, in Overactive Bladder

Cited by 320 publications

References 10 publications

Persistence and adherence with the new beta-3 receptor agonist, mirabegron, versus antimuscarinics in overactive bladder: Early experience in Canada

Persistence and adherence with the new beta-3 receptor agonist, mirabegron, versus antimuscarinics in overactive bladder: Early experience in Canada

Cost-effectiveness of solifenacin compared with oral antimuscarinic agents for the treatment of patients with overactive bladder in the UK

Cost-effectiveness of mirabegron compared to tolterodine ER 4 mg for overactive bladder in Canada

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