solifenacin/mirabegron (EB178) / Astellas - LARVOL DELTA

Efficacy and Safety of Mirabegron Add-On Therapy to Solifenacin in Older Patient Populations With Overactive Bladder (AUA 2017) - P3; "Combination therapy with SOLI 5mg+MIRA 50mg provides additional treatment benefit vs SOLI monotherapy in incontinent older OAB patients with an insufficient response to SOLI 5mg."

Clinical • Combination therapy • HEOR • Biosimilar

Solifenacin/Mirabegron Induces an Acute Compliance Increase in the Filling Phase of the Capacity-Reduced Urinary Bladder: A Pressure-Volume Analysis in Rats. (PubMed, Front Pharmacol) - " In addition to their well-known anti-inotropic/relaxative effects, solifenacin, and mirabegron induce an acute increase in bladder compliance to ameliorate OAB-like syndromes. Together with time-domain cystometry, PVA offers a platform for investigating the physiology/pathophysiology/pharmacology of bladder compliance which is crucial for urine storage."

Journal • Preclinical

Mirabegron versus Solifenacin in Children with Overactive Bladder: Prospective Randomized Single-Blind Controlled Trial. (PubMed, Urol Int) - "Both mirabegron and solifenacin have comparable efficacy regarding the control of OAB symptoms in the newly diagnosed children, but mirabegrone seems to have less side effects."

Clinical • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Pediatrics • Xerostomia

Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder. (PubMed, Low Urin Tract Symptoms) - "Adding mirabegron could increase the therapeutic effects, mainly on OAB symptoms and GRA scale, after intravesical onabotulinumtoxinA injection in refractory OAB patients."

Clinical • Journal • Overactive Bladder • Urinary Incontinence • Urology

Vibegron (Gemtesa) for overactive bladder. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Overactive Bladder

A Case of Detrusor Hyperactivity with Impaired Contractility (DHIC) after Transverse Myelitis (PubMed, Hinyokika Kiyo) - "Although storage symptoms did not improve on the mirabegron monotherapy, the symptoms improved by solifenacin added. There is a possibility that combination therapy with mirabegron and solifenacin is effective for DHIC."

Clinical • Journal • CNS Disorders • Urinary Incontinence • MRI

[VIRTUAL] LONG-TERM EFFICACY AND SAFETY OF VIBEGRON VERSUS MIRABEGRON AND ANTICHOLINERGICS FOR OVERACTIVE BLADDER: A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS (AMCP 2021) - "Vibegron was associated with significantly greater improvement in UI episodes than mirabegron and tolterodine and numerically greater improvement in micturitions and volume voided than mirabegron, tolterodine, and solifenacin. Dry mouth and hypertension were the most commonly reported AEs with anticholinergics and β3- adrenergic agonists, respectively."

Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Hypertension • Infectious Disease • Nephrology • Overactive Bladder • Pain • Urinary Incontinence • Urology • Xerostomia

Efficacy and tolerability of mirabegron compared with solifenacin for children with idiopathic overactive bladder: A preliminary study. (PubMed, Investig Clin Urol) - "Mirabegron showed comparable efficacy to solifenacin in pediatric patients with idiopathic OAB. Additionally, only few adverse effects were reported, suggesting that mirabegron can be a safe alternative for the treatment of idiopathic pediatric OAB."

Clinical • Journal • Overactive Bladder • Pediatrics • Urinary Incontinence

Add-on treatment with mirabegron may improve quality of life in patients with benign prostatic hyperplasia complaining of persistent storage symptoms after tamsulosin monotherapy. (PubMed, Ther Adv Urol) - "A combination of tamsulosin and mirabegron might improve the QoL of patients presenting with persistent storage symptoms after tamsulosin monotherapy. Better QoL due to mirabegron compared with solifenacin could be associated with fewer adverse effects, such as dry mouth and constipation."

Clinical • HEOR • Journal • Monotherapy • Benign Prostatic Hyperplasia • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Xerostomia

Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker (clinicaltrials.gov) - P; N=400; Not yet recruiting; Sponsor: Chang Gung Memorial Hospital

Biomarker • Clinical • New trial • Overactive Bladder

Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms (clinicaltrials.gov) - P3; N=240; Recruiting; Sponsor: Mansoura University; Not yet recruiting ➔ Recruiting; Trial completion date: Jul 2020 ➔ Jul 2021; Trial primary completion date: Jun 2020 ➔ Jun 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date

Efficacy and safety of mirabegron versus solifenacin as additional therapy for persistent OAB symptoms after tamsulosin monotherapy in men with probable BPO. (PubMed, World J Urol) - "Our results indicate that the addition of either mirabegron or solifenacin to patients with persistent OAB symptoms after tamsulosin monotherapy has significant efficacy in controlling these symptoms. The adequate balance between efficacy and tolerability reported in this study with mirabegron may result in better QOL and overall patient satisfaction if compared with antimuscarinics."

Clinical • Journal • Monotherapy • Constipation • Gastrointestinal Disorder

Mirabegron versus solifenacin in multiple sclerosis patients with overactive bladder symptoms: a prospective comparative non-randomized study. (PubMed, Urology) - "Among MS patients, we demonstrated similar response rates to mirabegron and solifenacin, with approximately 50-70% achieving each PROM's MCID. Though this small study showed some short-term evidence that improvement in urinary symptom severity was greater with solifenacin, this potential benefit must be weighed against the observed risk of worsening constipation. Further studies are needed to confirm these findings."

Clinical • Journal • CNS Disorders • Constipation • Gastrointestinal Disorder • Multiple Sclerosis • Overactive Bladder

Protocol for a multicenter randomized, double blind, controlled pilot trial of higher neural function in overactive bladder patients after anticholinergic, beta-3 adrenergic agonist, or placebo. (PubMed, Contemp Clin Trials Commun) - "Subjects are randomized to one of three interventions for 29 ± 1 day: AC (Solifenacin succinate, Teva), β3a (Mirabegron, Myrbetriq, Astellas), or placebo. Clinical cognitive assessments will be compared from baseline to post-intervention. All qualifying patients are properly consented before enrolling in this study that has been approved by the Institutional Review Board of participating institutions."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Depression • Mood Disorders • Overactive Bladder • Urinary Incontinence • MRI

[VIRTUAL] Can combination of OAB medication and intravesical botulinum toxin A prolong the therapeutic duration and effect in patients with overactive bladder syndrome (EAU-I 2020) - "They were randomly treated with solifenacin 5 mg QD in 29 patients (group 1), mirabegron 50 mg QD in 28 patients (group 2) and without medication in 27 patients (group 3). Adding beta-3 agonist can increase the therapeutic effect and duration in refractory OAB patients after receiving intradetrusor BoNT- A injection."

Clinical • Overactive Bladder

[VIRTUAL] Choosing medical treatment for overactive bladder based on bothersome symptoms: A network meta-analysis (EAU-I 2020) - " Oxybutynin 15mg/d was the most effective agent reducing incontinence episodes in comparison to placebo (mean change: -1.25 [-1.47, -1.02])...Fesoterodine 4 and 8mg/d as well as solifenacin 10mg/d were the most effective drugs reducing urgency episodes... Among different types, dosages and formulations of the included medications, only tolterodine 4mg/d, mirabegron 50mg/d and solifenacin 5mg/d were the frequently examined medications in the management of OAB with higher weight and lower confidence interval. However, taken together, there is only minimal difference in the efficacy of oral anti-muscarinics and β-adrenoceptor agonists between the multiple agents with regards to the different bothersome QOL endpoints. We cannot recommend an agent over another based on the current analysis."

Retrospective data • Overactive Bladder • Urinary Incontinence

Long-term safety and efficacy of mirabegron and solifenacin in combination compared with monotherapy in patients with overactive bladder: SYNERGY II study. (PubMed, Actas Urol Esp) - No abstract available

Clinical • Journal • Monotherapy • Overactive Bladder

[VIRTUAL] Trends in Mirabegron utilization in the United States (AUA 2020) - " The 2013-2017 Medicare Part D Public Use File was used to identify all prescribers of OAB medications including oxybutynin, tolterodine, trospium, darifenacin, solifenacin, fesoterodine, and mirabegron. Mirabegron utilization and the total expenditure has steadily increased each year since it was approved in 2012, making it one of most prescribed OAB medications among urologists. Oxybutynin continues to be the most prescribed OAB medication when considering all physicians. Source of Funding: None"

Overactive Bladder

Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes (clinicaltrials.gov) - P4; N=150; Not yet recruiting; Sponsor: National Taiwan University Hospital

New P4 trial • Biosimilar

Cardiovascular safety in refractory incontinent patients with overactive bladder receiving add-on mirabegron therapy to solifenacin (BESIDE). (PubMed) - Int J Clin Pract - "The comparable frequency of CV-related TEAEs, changes in vital signs and ECG parameters indicates no synergistic effect on CV safety outcomes when mirabegron and solifenacin are combined."

Journal • Biosimilar • Cardiovascular

The Receipt of Industry Payments is Associated with Prescribing Promoted Alpha-Blockers and Overactive Bladder Medications. (PubMed, Urology) - "There is a consistent association between receipt of industry payment and prescribing marketed alpha-blockers and OAB medications. Both the total value and number of transactions is associated with prescribing."

Journal • Biosimilar

[VIRTUAL] Comparison of mirabegron, solifenacin and tamsulosin for stent related symptoms: a double blinded randomized control trial (AUA 2020) - "Mirabegron has shown comparable benefit in alleviating SRSs and may be beneficial in cases where tamsulosin or solifenacin are contra-indicated or poorly tolerated. The MIRASOTA trial is first and only double blinded RCT comparing mirabegron with tamsulosin or solifenacin for SRSs. Source of Funding: None"

Clinical • Late-breaking abstract • Constipation • Pain

Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes (clinicaltrials.gov) - P4; N=150; Recruiting; Sponsor: National Taiwan University Hospital; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China (clinicaltrials.gov) - P=N/A; N=805; Completed; Sponsor: Astellas Pharma Singapore Pte. Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Overactive Bladder • Urology

Updating the evidence on drugs to treat overactive bladder: a systematic review. (PubMed, Int Urogynecol J) - "New evidence confirms small, but clinically uncertain, differences among monotherapies and also between combination and monotherapy, regardless of statistical significance. While drugs mainly differed in incidence of dry mouth or constipation, none provided improved efficacy without increased harms."

Journal • Review • Atrial Fibrillation • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Urinary Incontinence • Urology