Mirabegron has longer treatment persistence than antimuscarinics: Real‐world data from a Korean national cohort database

Lee, Kyu‐Sung; Park, Hye Jeong; Kang, Danbee; Byun, Hye Jin; Foo, Chee Yoong; Hadi, Farid A; Kim, Soyoung; Cho, Juhee

doi:10.1002/nau.24776

Cited by 5 publications

(4 citation statements)

References 27 publications

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“…In previous 15 clinical studies, Mirabegron, Solifenacin, and Fesoterodine were associated with the highest persistence rates. However, a real‐world data set from South Korea 21 demonstrated the persistence rate at 1 year to be 13.5% for Mirabegron and 4.9% for all antimuscarinics. Multicriteria Decision Analysis 22 Applied to the Clinical Use of Pharmacotherapy found Solifenacin 5 mg in combination with Mirabegron 50 mg is the best compromise between the higher benefits but lower safety of Fesoterodine 4 or 8 mg, or the safer but lesser benefits of Mirabegron 25 mg. We found high claims of Fesoterodine indeed but also high claims of Trospium.…”

Section: Discussionmentioning

confidence: 99%

Persistence of overactive bladder pharmacological treatment in women as reflected from large‐scale real‐world data of prescription claims: A retrospective cohort study

Karin,

Igor,

Chen

et al. 2023

Neurourology and Urodynamics

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Introduction and ObjectivesMedical treatments for overactive bladder (OAB) have proven efficacy in controlled trials. However, 1‐year treatment persistence is reported to be as low as 25% for anticholinergics and 40% for β3 agonists. Real‐world data on treatment continuation and treatment sequence is limited. Therefore, we aimed to study treatment persistence trends in women initiated on OAB medications.Materials and MethodsWe used advanced data‐mining techniques to query the largest regional provider's medication purchase database, dispensing for patients, for all women initiating OAB pharmacotherapy between 2010 and 2020. Treatment persistence was measured as days in which the patient was in possession of medication and nonpersistence was defined as prescription nonrefilling for 90 days. We employed a Sankey diagram to explore trends in OAB medication acquisition and treatment sequence. We compared treatment persistence using Kaplan–Meier survival curves and pairwise log‐rank analysis.ResultsHere, 46 079 women made 791 681 unique claims of OAB medications. Only 39% of the patients tried more than one OAB formulation, including dose change. The overall persistence rate for all drugs was 55% in 30 days, 46% in 90 days, and 37% per year. The persistence rate for Mirabegron at 30 days was 54%, 42% at 90 days, and 17% at 1 year. Overall, persistence rates were unchanged when stratifying by the time Mirabegron insurance acceptance into coverage (p > 0.05).ConclusionsReal‐world OAB pharmacotherapy persistence rates are lower than previously reported. The introduction of Mirabegron did not seem to improve these rates or affect the treatment sequence.

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Section: Discussionmentioning

confidence: 99%

Persistence of overactive bladder pharmacological treatment in women as reflected from large‐scale real‐world data of prescription claims: A retrospective cohort study

Karin,

Igor,

Chen

et al. 2023

Neurourology and Urodynamics

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“…These findings are in line with other previous persistence investigations, which have typically found that older and treatment-experienced patients persist with OAB medication for a longer period of time than younger and treatment-naïve patients [ 8 , 10 , 21 – 23 ]. Furthermore, some studies that have also been conducted in East Asia have found that male patients persist with treatment longer than female patients [ 10 , 22 ]. Older and treatment-experienced patients may be willing to persist with treatment as they may have experienced the condition for a longer duration and might be more familiar with the benefit–risk profile of OAB therapies.…”

Section: Discussionmentioning

confidence: 99%

Treatment Patterns with Mirabegron and Antimuscarinics for Overactive Bladder: A Prospective, Registry Study in Taiwan and South Korea (FAITH)

Oh,

Cho,

Kuo

et al. 2024

Adv Ther

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Introduction This study aimed to assess overactive bladder (OAB) treatment patterns and factors associated with effectiveness and persistence. Methods A prospective, longitudinal, observational registry study of adults starting OAB therapy with mirabegron or antimuscarinics was undertaken. Primary endpoints were time from treatment initiation to discontinuation/switching; proportion who discontinued/switched; and reasons for discontinuation/switching. Secondary endpoints included OAB Symptom Score (OABSS), OAB Questionnaire: Short Form, and OAB Bladder Assessment Tool scores; factors associated with effectiveness and persistence; and safety. Results In total, 556 patients initiating mirabegron and 250 initiating antimuscarinics were enrolled. There was no treatment switch, change, or discontinuation in 68.5% of the mirabegron initiator group and median time to treatment change was not reached. Mean initial treatment duration was 130.8 days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, and patients with mild and moderate OAB had significantly better persistence with mirabegron than those with severe OAB. Urinary tract infection was the most common adverse event with mirabegron. There was no treatment switch, change, or discontinuation in 60.4% of the antimuscarinics initiator group and median time to treatment change was not reached. Solifenacin was the most frequent initial treatment (66.0%). Mean treatment duration was 122.2 days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, while patients with OAB medication in the 12 months before enrollment had significantly better persistence with antimuscarinics than those with no previous OAB medication. Dry mouth was the most common adverse event with antimuscarinics. Conclusions Mirabegron and solifenacin were commonly prescribed as first-line OAB medications. There was no treatment switch, change, or discontinuation in more than 60% of the mirabegron initiator and antimuscarinics initiator groups. Mean initial treatment duration was 130.8 days and 122.2 days for mirabegron and antimuscarinics, respectively. Graphical Abstract available for this article. Trial Registration ClinicalTrials.gov NCT03572231. Graphical Abstract Supplementary Information The online version contains supplementary material available at 10.1007/s12325-024-02784-2.

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“…Int Neurourol J June 30, 2023 isfaction with the treatment was assessed with the Patient Global Impression (PGI) scale at week 12. The level of satisfaction was based on a 7-point scale; very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7). A PGI ≤3 was defined as 'effective improvement' and a PGI ≤2 was defined as 'significant improvement. '…”

Section: Injmentioning

confidence: 99%

“…Mirabegron, the first U.S. Food and Drug Administration (FDA)-approved β3 agonist for treating OAB, has been the only available drug for patient's intolerant to anticholinergics. Compliance to mirabegron is reported to be higher than that of anticholinergics due to different in possible side effects and their intensity [6,7]. In addition, combination therapy with various anticholinergics has expanded possible treatment options.…”

Section: Introductionmentioning

confidence: 99%

A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladder

et al. 2023

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Purpose: Vibegron, a novel, potent β3 agonist, has been approved for clinical use in overactive bladder (OAB) treatment in Japan and the Unites States. We performed a bridging study to investigate the efficacy and safety of a daily 50-mg vibegron (code name JLP-2002) dose in Korean patients with OAB.Methods: A multicenter, randomized, double-blind, placebo-controlled study was conducted from September 2020 to August 2021. Adult patients with OAB with a symptom duration of more than 6 months entered a 2-week placebo run-in phase. Eligibility was assessed at the end of this phase and selected patients entered a double-blind treatment phase after 1:1 randomization to either the placebo or vibegron (50 mg) group. The study drug was administered once daily for 12 weeks and follow-up visits were scheduled at weeks 4, 8, and 12. The primary endpoint was the change in mean daily micturition at the end of treatment. The secondary endpoints included changes in OAB symptoms (daily micturition, nocturia, urgency, urgency incontinence, and incontinence episodes, and mean voided volume per micturition) and safety. A constrained longitudinal data model was used for statistical analysis.Results: Patients who took daily vibegron had significant improvements over the placebo group in both primary and secondary endpoints, except for daily nocturia episodes. The proportions of patients with normalized micturition and resolution of urgency incontinence and incontinence episodes were significantly higher in vibegron group than in the placebo. Vibegron also improved the patients’ quality of life with higher satisfaction rates. The incidence of adverse events in the vibegron and placebo groups was similar with no serious, unexpected adverse drug reactions. No abnormality in electrocardiographs was observed as well as no significant increase in postvoid residual volume.Conclusions: Once daily vibegron (50 mg) for 12 weeks was effective, safe, and well-tolerated in Korean patients with OAB.

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Mirabegron has longer treatment persistence than antimuscarinics: Real‐world data from a Korean national cohort database

Cited by 5 publications

References 27 publications

Persistence of overactive bladder pharmacological treatment in women as reflected from large‐scale real‐world data of prescription claims: A retrospective cohort study

Persistence of overactive bladder pharmacological treatment in women as reflected from large‐scale real‐world data of prescription claims: A retrospective cohort study

Treatment Patterns with Mirabegron and Antimuscarinics for Overactive Bladder: A Prospective, Registry Study in Taiwan and South Korea (FAITH)

A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladder

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