Long‐term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study

Maanen, Rob van; Chapple, Christopher R.; Abrams, Paul; Herschorn, Sender; Robinson, Dudley; Stoelzel, Matthias; Yoon, Sang Jin; Al-Shukri, Salman Hasunovich; Rechberger, Tomasz; Gratzke, Christian

doi:10.1002/nau.23919

Cited by 15 publications

(10 citation statements)

References 27 publications

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“…Our study showed that PVR was significantly increased in the solifenacin‐added‐on and mirabegron‐added‐on groups, but no severe adverse events, such as acute urinary retention, was noted. This finding was similar to several solifenacin and mirabegron studies, which showed that a statistically significant increase of PVR was noted in the study group, but an elevated PVR did not increase severe adverse events 2,4 …”

Section: Discussionsupporting

confidence: 90%

“…Patients were randomly assigned to receive treatment with solifenacin 5 mg QD (solifenacin add‐on, 30 patients), mirabegron 50 mg QD (mirabegron add‐on, 31 patients), or no medication (BoNT‐A only, 29 patients). We chose the same dose of solifenacin 5 mg and mirabegron 50 mg as the previous phase III SYNERGY study 4 . The randomization was performed using a computer‐generated randomization scheme (Cenduit GmBH, Allschwil, Switzerland).…”

Section: Methodsmentioning

confidence: 99%

“…Anticholinergics or beta‐3 adrenoceptor agonists are recommended as second‐line treatments, although they have poor persistence and compliance rates 3 . In addition, some evidence has shown that dual therapy with mirabegron or solifenacin lead to greater improvement in OAB symptoms than monotherapy 4 . When OAB is inadequately managed by the first‐ or second‐line treatment, intravesical onabotulinumtoxinA (BoNT‐A) injection is suggested as the third‐line option.…”

Section: Introductionmentioning

confidence: 99%

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Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder

Wang

Lee

Hwang

et al. 2021

LUTS

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Objectives To investigate whether adding an anticholinergic or beta‐3 agonist can improve the therapeutic effect of intravesical onabotuliumtoxinA injection in patients with refractory overactive bladder (OAB). Methods Ninety OAB patients who received an intravesical 100‐U onabotulinumtoxinA injection 1 month previously were consecutively invited into a prospective, randomized, open‐label study. They were randomly adding on solifenacin 5 mg daily (QD) (30 patients), mirabegron 50 mg QD (31 patients), or no medication (29 patients, control). All enrolled patients completed a 3‐day voiding diary, Overactive Bladder Symptom Score (OABSS) and Urgency Severity Scale (USS) questionnaires, Global Response Assessment (GRA) scale, and uroflowmetry at baseline (1 month after intravesical onabotulinumtoxinA injection) and 3‐, 6‐, 9‐, and 12‐month follow‐up. The primary end point was the effective therapeutic outcome defined as no OAB wet during the 12‐month period. The secondary end point included changes of GRA, OABSS, and the parameters of the voiding diary at 3 months. Results The baseline data were comparable among the three groups. The percentage of OAB wet in the mirabegron‐added‐on group was significantly less than that in the solifenacin‐added‐on and onabotulinumtoxinA‐only groups at four different time points (P = .02). At 3 months, the changes of GRA, OABSS, USS, urge urinary incontinence, frequency, nocturia episodes, and functional bladder capacity in the mirabegron‐added‐on group were significantly greater than those in the other groups. No serious adverse events were reported. Conclusions Adding mirabegron could increase the therapeutic effects, mainly on OAB symptoms and GRA scale, after intravesical onabotulinumtoxinA injection in refractory OAB patients.

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Section: Discussionsupporting

confidence: 90%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder

Wang

Lee

Hwang

et al. 2021

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“…24 Over and above, to get higher effectiveness without increasing side effects mirabegron was combined with solifenacin. 25 Improved QoL and prolonged time to micturition were the essential parametres of our study outcomes. Besides, combination was better than other treatment modalities.…”

Section: Discussionmentioning

confidence: 81%

Impact of Reducing Irritative Symptoms in Non-Muscle Invasive Bladder Cancer During BCG Instillation: A Pilot Study

Köse¹,

Akın²,

Gulmez³

et al. 2020

FORBES

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INTRODUCTION: We evaluated use of anticholinergics, mirabegron, and combination of anticholinergics with mirabegron during Bacillus Calmette-Guérin (BCG) instillation for reducing irritative symptoms in patients with non-muscle invasive bladder cancer (NMIBC). METHODS: Prospectively recorded data of NMIBC patients receiving BCG were retrospectively evaluated between August 2015 and April 2019. Patients with low-grade T1 solitary papillary lesions <4 cm were included in the study. Validated questionnaires (OAB-V8) for irritative symptoms adapted to Turkish language, and QoL index forms were filled out by the study participants. OAB-V8 scores of ≥8 were considered as an indication to start medical treatment for irritative symptoms. Groups were formed according to daily used anticholinergic drugs and combinations as follows: Group 1, tolterodine; Group 2, solifenacin 5mg; Group 3, mirabegron, and Group 4, mirabegron with solifenacin 5 mg. RESULTS: Mean follow- up period was 20.4±6.8 months. There were 132 patients [110 men (83%) and 22 (17%) women] with irritative symptoms and NMIBC. Mean age of the study population was 59.7±12.4 years. The OAB-V8 scores and QoL indexes significantly improved with all drugs. However, in subgroup analyses, Group 4 provided the most dramatic improvement in OAB-V8 and QoL index scores (P=0.02 for both). The longest in time to micturition was recorded in Group 4 (P=0.04). Tumour recurrence was similar for groups 12 months after BCG instillation (P=0.9), however the least recurrence was observed in Group 4. DISCUSSION AND CONCLUSION: Combination of solifecacin and mirabegron can reduce irritative symptoms, improve QoL, and prolong time to micturition, during BCG instillation in selected NMIBC patients. This combination may also decrease recurrence rates in this patient population.

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“…Mirabegron, alone or in combination with solifenacin, is also a well tolerated and effective treatment for patients with overactive bladder (OAB) symptoms, irrespective of their age. 15 …”

Section: Introductionmentioning

confidence: 99%

Mirabegron Alleviates the Degree of Burden Experienced by Caregivers of Older Females with Mixed or Urge Incontinence: A Prospective Study

Zachariou¹,

Filiponi

Kaltsas³

et al. 2021

CIA

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Purpose Older people, especially women, have the highest known prevalence of urinary incontinence (UI) of any other age-group. Continual care provision for elderly incontinent females is an incredibly arduous process, yet only very few studies have investigated the issue. Aim of the study was to evaluate the impact of mirabegron’s treatment on the degree of burden experienced by caregivers of elderly female patients with UI. Patients and Methods A hundred and eighty-six caregivers of older females with mixed or urgency UI besides various conditions (strokes, post-operative recovery after major surgery, etc.) were included in the study. Group A comprised 91 patients that did not want to receive any treatment for UI. Group B consisted of 95 elderly females treated for UI with mirabegron 50 mg/daily for three months. All caregivers completed the Zarit Burden Scale (ZBS) questionnaire at the outset and after the three months. All patients completed a bladder diary at the beginning and at the end of the observation/medication period. Results Patients receiving mirabegron presented a statistically significant improvement in UI parameters. Their caregivers showed a statistically significant decrease in the ZBS total score as well as separate domains. Conclusion This pilot study confirms that mirabegron administration can improve the quality of life of older females suffering from UI while substantially relieving caregiver burden. Recognizing the physical and emotional reactions of caregivers may help health providers deliver better support and resources to meet the needs of caregivers and patients alike.

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Long‐term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study

Cited by 15 publications

References 27 publications

Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder

Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder

Impact of Reducing Irritative Symptoms in Non-Muscle Invasive Bladder Cancer During BCG Instillation: A Pilot Study

Mirabegron Alleviates the Degree of Burden Experienced by Caregivers of Older Females with Mixed or Urge Incontinence: A Prospective Study

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