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Gian Marco Rosa, Danilo Baccino, Alberto Valbusa, Carolina Scala, Fabio Barra, Claudio Brunelli, Simone Ferrero
Overactive bladder (OAB) syndrome is common in the general population, particularly in elderly patients. Antimuscarinic drugs (AMs) are considered the mainstay pharmaceutical treatment of OAB whereas β3-adrenoceptor agonists, such as mirabegron, represent a good alternative. Owing to the important role of muscarinic and β3 receptors in cardiovascular (CV) tissue and to the fact that OAB patients often have CV comorbidities, the safety-profile of these drugs constitute an important challenge. Area covered: The aim of this review is to evaluate the CV effects of AMs and mirabegron in OAB...
March 15, 2018: Expert Opinion on Drug Safety
Tomohiro Matsuo, Yasuyoshi Miyata, Tatsufumi Nakamura, Katsuya Satoh, Hideki Sakai
OBJECTIVE: Mirabegron is widely considered as an effective and safe drug for patients with overactive bladder (OAB). However, there is no evidence regarding the efficacy of mirabegron in human T cell lymphotropic virus-1 (HTLV-1)-associated myelopathy/tropical spastic paraparesis (HAM/TSP) patients with OAB symptoms. The aim of the present study was to clarify the efficacy of mirabegron in HAM/TSP patients with OAB symptoms. METHODS: The present study evaluated the efficacy of mirabegron treatment (50 mg, once daily) in nineteen HAM/TSP patients with OAB symptoms by assessing subjective symptoms using the overactive bladder symptom score (OABSS) and International Prostate Symptom Score (IPSS) before and 12 weeks after administration...
February 22, 2018: Lower Urinary Tract Symptoms
Jameel Nazir, Malin Berling, Charles McCrea, Francis Fatoye, Sally Bowditch, Zalmai Hakimi, Adrian Wagg
PURPOSE: Our objective was to estimate the economic outcomes of using mirabegron versus antimuscarinics in the treatment of patients with overactive bladder (OAB) from a societal perspective in the UK. MATERIALS AND METHODS: A Markov model was developed using Microsoft Excel ® . The time horizon and cycle length are 12 and 1 months, respectively; and the hypothetical cohort size 100 patients. Antimuscarinic comparators are fesoterodine, oxybutynin extended release (ER) and immediate release (IR), solifenacin, tolterodine ER/IR, trospium ER/IR, darifenacin and flavoxate...
March 2017: PharmacoEconomics Open
Barbara Mintzes, Swestika Swandari, Alice Fabbri, Quinn Grundy, Ray Moynihan, Lisa Bero
OBJECTIVES: To investigate patterns of industry-sponsored educational events that focus on specific health conditions for which there are concerns about overdiagnosis and overtreatment. DESIGN AND SETTING: This retrospective cohort study examines publicly reported industry-sponsored events in Australia from October 2011 to September 2015 for three conditions potentially subject to overdiagnosis and overtreatment: depression, osteoporosis and overactive bladder. We used a database of transparency reports to identify events with a focus on depression, osteoporosis and overactive bladder and compared these with other sponsored events...
February 13, 2018: BMJ Open
Sheng-Fu Chen, Hann-Chorng Kuo
OBJECTIVE: The incidence of overactive bladder (OAB) increases with age, especially in patients with central nervous system (CNS) disorders such as cerebrovascular accident (CVA) and Parkinson's disease (PD). Mirabegron is a novel medication for the treatment of OAB. The present study investigated the therapeutic effect of mirabegron on OAB patients with CNS diseases. METHODS: Patients with CVA, PD, dementia, and OAB symptoms were consecutively enrolled in the study group, and mirabegron 25 mg q...
January 30, 2018: Lower Urinary Tract Symptoms
G R Kasyan, S O Sukhikh, D Yu Pushkar
Currently, a wide range of different drugs is available for te management of overactive bladder. This creates problems when it comes to drug selection and personalized care for each patient. Mirabegron is the only 3-adrenomimetic agent for the treatment of urinary disorders, which, after careful long-term multi-center randomized trials, has been approved for use in Europe and North America. Mirabegron has proven to be very effective in patients who had previously received anticholinergic drugs and discontinued them because of the insufficient therapeutic effect or pronounced adverse reactions...
December 2017: Urologii︠a︡
Jan Krhut, Alois Martan, Roman Zachoval, Tomas Hanus, Lukas Horcicka, Kamil Svabík, Peter Zvara
PURPOSE: To evaluate the feasibility of discontinuing treatment with mirabegron once symptoms have subsided in patients with overactive bladder (OAB). METHODS: The present study evaluated a total of 159 female OAB patients (age 62.9 ± 12.36), each of which were prescribed 50 mg/day mirabegron (Time point 1-T1). Data obtained from voiding diaries and patient-reported outcome variables were assessed during follow-up visits at months 1, 3, 6, 12, 18 (T2), and 21 (T4)...
January 10, 2018: International Urology and Nephrology
Mina Tadrous, Dean Elterman, Wayne Khuu, Muhammad M Mamdani, David N Juurlink, Tara Gomes
INTRODUCTION: Medication is an important option for patients with overactive bladder (OAB), with four different drugs approved over the last 10 years including the first non-anticholinergic treatment, mirabegron. We set out to describe the number and rate of users of medication for the management of OAB over the last 15 years among residents of Ontario, Canada covered by the public drug programs. METHODS: We conducted a population-based, repeated cross-sectional study examining quarterly publically-funded prescription claims for OAB medications from January 2000 to June 2016 in Ontario, Canada...
December 22, 2017: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Alan C Kinlaw, Michele Jonsson Funk, Mitchell M Conover, Virginia Pate, Alayne D Markland, Jennifer M Wu
BACKGROUND: Despite several new medications being Food and Drug Administration-approved for overactive bladder (OAB) and new prescription drug payment programs, there are limited population-based data regarding OAB medication use among older adults. OBJECTIVES: To examine: (1) impacts of new medications and $4 generic programs on time trends for OAB-related medication dispensing for older adults in the United States; (2) differences by age and sex; and (3) temporal changes in OAB-related medication payments...
December 28, 2017: Medical Care
Michael Di Lena, Victoria Tolls, Kerri-Lynn Kelly, J Curtis Nickel
INTRODUCTION: Interstitial cystitis/bladder pain syndrome (IC/BPS) patients represent a heterogeneous group with pain and urinary storage symptoms and varying responses to current treatment options. The novel beta-3 agonist, mirabegron, has been shown to improve storage symptoms of patients with bladder overactivity; however, its effect on symptoms in the IC/BPS population has yet to be studied. METHODS: Patients diagnosed at a single IC centre with IC/BPS undergoing standard therapy were treated with additional daily mirabegron 25 mg and seen in followup post-treatment...
December 22, 2017: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Athanasios Zachariou, Maria Filiponi, Dimitrios Baltogiannis, John Giannakis, Fotios Dimitriadis, Panagiota Tsounapi, Atsushi Takenaka, Nikolaos Sofikitis
INTRODUCTION: Multiple sclerosis (MS) is the commonest progressive neurological disease affecting young people. With advancing disease, management of neurogenic detrusor overactivity (NDO) based on antimuscarinics may prove inadequate and if based on botulinum toxin, may necessitate clean intermittent self-catheterization. The aim of the study was to evaluate the effectiveness of combined mirabegron and desmopressin administration in the treatment of NDO in patients with MS. MATERIALS AND METHODS: Sixty patients diagnosed with MS and NDO were evaluated...
December 2017: Canadian Journal of Urology
Nodi Dehvari, Edilson Dantas da Silva Junior, Tore Bengtsson, Dana S Hutchinson
The ®3 -adrenoceptor was initially an attractive target by several pharmaceutical companies due to its high expression in rodent adipose tissue, where its activation resulted in decreased adiposity and improved metabolic outputs (such as glucose handling) in animal models of obesity and type 2 diabetes. However, several drugs acting at the β3 -adrenoceptor failed in clinical trials. This was thought to be due to their lack of efficacy at the human receptor. Recently mirabegron, a ®3 -adrenoceptor agonist with human efficacy, was approved in North America, Europe, Japan and Australia for the treatment of overactive bladder syndrome...
December 15, 2017: British Journal of Pharmacology
Arcangelo Sebastianelli, Giorgio I Russo, Steven A Kaplan, Kevin T McVary, Ignacio Moncada, Stavros Gravas, Christopher Chapple, Giuseppe Morgia, Sergio Serni, Mauro Gacci
A systematic review and meta-analysis was carried out to evaluate the efficacy and safety of mirabegron 50 mg and 100 mg in the treatment of storage lower urinary tract symptoms/overactive bladder in comparison with a placebo and tolterodine 4 mg. A total of 491 articles were collected and eight randomized studies were identified as eligible for this meta-analysis. Overall, eight trials were included in the meta-analysis evaluating 10 248 patients. Mirabegron at both doses of 50 mg and 100 mg, and and tolterodine 4 mg were significantly associated with the reduction of incontinence episodes per 24 h, reduction of mean number of micturitions per 24 h, increase of voided volume and reduction of urgency episodes per 24 h, compared to a placebo...
December 3, 2017: International Journal of Urology: Official Journal of the Japanese Urological Association
Evan R Sirls, Kim A Killinger, Judith A Boura, Kenneth M Peters
OBJECTIVE: To examine the outcomes and compliance with percutaneous tibial nerve stimulation (PTNS) for overactive bladder (OAB) symptoms. METHODS: Adults who had PTNS from June 30, 2011, to October 8, 2015, were retrospectively reviewed for demographics, copay, travel distance, employment status, history, symptoms, and treatments used before, during, and after PTNS. Pearson chi-square test, Fisher exact test, Wilcoxon rank and paired t test were performed. RESULTS: Of 113 patients (mean age 75 ± 12 years), most were women (65...
November 28, 2017: Urology
Kentaro Konishi, Daisuke Tenmizu, Shin Takusagawa
BACKGROUND AND OBJECTIVES: Mirabegron is cleared by multiple mechanisms, including drug-metabolizing enzymes. One of the most important clearance pathways is direct glucuronidation. In humans, M11 (O-glucuronide), M13 (carbamoyl-glucuronide), and M14 (N-glucuronide) have been identified, of which M11 is one of the major metabolites in human plasma. The objective of this study was to identify the uridine 5'-diphosphate (UDP)-glucuronosyltransferase (UGT) isoform responsible for the direct glucuronidation of mirabegron using human liver microsomes (HLMs) and recombinant human UGTs (rhUGTs)...
November 21, 2017: European Journal of Drug Metabolism and Pharmacokinetics
Jason C Simeone, Beth L Nordstrom, Kwame Appenteng, Samuel Huse, Milbhor D'Silva
BACKGROUND: In 2014, the US Food and Drug Administration (FDA) initiated a prospective routine surveillance using the Mini-Sentinel (M-S) program to assess potential signals of acute myocardial infarction (AMI) and stroke with use of mirabegron, indicated for the treatment of overactive bladder (OAB), compared with oxybutynin. PURPOSE: To replicate the FDA M-S analysis of mirabegron using datasets that did not contribute to the M-S program. METHODS: IMS PharMetrics Plus and Truven MarketScan claims data from 2012-2015 were converted to the M-S Common Data Model...
November 13, 2017: Drugs—Real World Outcomes
Roxana Geoffrion
OBJECTIVE: This technical update addendum reviews success rates and comparative evidence of the anticholinergic fesoterodine, as well as mechanism of action, safety profile, success rates, and comparative evidence of the β3 agonist mirabegron in the treatment of non-neurogenic overactive bladder syndrome (OAB). This adds to OAB pharmacotherapy recommendations initially published in 2012. INTENDED USERS: Residents and other trainees, primary care practitioners, gynaecologists, urologists, urogynaecologists, and other health care providers who assess, counsel, and treat women with OAB...
December 2017: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
Yankai Xu, Ruihua Liu, Chu Liu, Yuanshan Cui, Zhenli Gao
PURPOSE: We performed a meta-analysis to evaluate the efficacy and safety of mirabegron add-on therapy to solifenacin for patients with overactive bladder (OAB). METHODS: We conducted a systematic literature review to identify all randomized, double-blind, controlled trials (RCTs) of this combination (mirabegron and solifenacin) for OAB. Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials were searched. A manual search was also performed to investigate relevant references from the retrieved studies...
September 2017: International Neurourology Journal
William Gibson, Scott MacDiarmid, Moses Huang, Emad Siddiqui, Matthias Stölzel, Nurul Choudhury, Marcus J Drake
BACKGROUND: The BESIDE study demonstrated that combination therapy (mirabegron and solifenacin 5mg) improved overactive bladder symptoms versus solifenacin 5mg or 10mg, and was well tolerated. OBJECTIVE: To ensure efficacy and safety is maintained in older patients (>65 yr), who usually experience greater symptom severity and comorbidities, a prespecified subanalysis stratified by age group was conducted. DESIGN, SETTING, AND PARTICIPANTS: Patients remaining incontinent (≥1 episode during 3-d diary) following 4-wk single-blind daily solifenacin 5mg were randomized 1:1:1 to a daily double-blind combination (solifenacin 5mg and mirabegron 25mg, increased to 50mg at wk 4), solifenacin 5mg or 10mg for 12 wk...
September 12, 2017: European Urology Focus
Adrian S Wagg, Steve Foley, John Peters, Jameel Nazir, Leanne Kool-Houweling, Ludmila Scrine
INTRODUCTION AND OBJECTIVES: Persistence with antimuscarinic (AM) drugs prescribed for overactive bladder (OAB) is poor. This study aimed to compare persistence and adherence with the beta-3-adrenoceptor agonist mirabegron (MIR) vs AMs over 12 months. PATIENTS AND METHODS: This retrospective cohort analysis included patients aged ≥18 years who were prescribed MIR, or any AM. A 12-month look-back was used to assess inclusion eligibility. The primary end-point was persistence, defined as time to first discontinuation of index drug, during 1 year follow-up...
October 2017: International Journal of Clinical Practice
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