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Mirabegron

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https://www.readbyqxmd.com/read/29164523/identification-of-uridine-5-diphosphate-glucuronosyltransferases-responsible-for-the-glucuronidation-of-mirabegron-a-potent-and-selective-%C3%AE-3-adrenoceptor-agonist-in-human-liver-microsomes
#1
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
https://www.readbyqxmd.com/read/29134621/replication-of-mini-sentinel-study-assessing-mirabegron-and-cardiovascular-risk-in-non-mini-sentinel-databases
#2
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
https://www.readbyqxmd.com/read/28986184/no-353-treatments-for-overactive-bladder-focus-on-pharmacotherapy-an-addendum
#3
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...
October 3, 2017: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
https://www.readbyqxmd.com/read/28954464/meta-analysis-of-the-efficacy-and-safety-of-mirabegron-add-on-therapy-to-solifenacin-for-overactive-bladder
#4
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
https://www.readbyqxmd.com/read/28916436/treating-overactive-bladder-in-older-patients-with-a-combination-of-mirabegron-and-solifenacin-a-prespecified-analysis-from-the-beside-study
#5
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
https://www.readbyqxmd.com/read/28906080/persistence-and-adherence-with-mirabegron-vs-antimuscarinics-in-overactive-bladder-retrospective-analysis-of-a-uk-general-practice-prescription-database
#6
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
https://www.readbyqxmd.com/read/28901041/safety-and-effectiveness-of-mirabegron-in-patients-with-overactive-bladder-aged-%C3%A2-75%C3%A2-years-analysis-of-a-japanese-post-marketing-study
#7
Masaki Yoshida, Yumiko Nozawa, Daisuke Kato, Hiromi Tabuchi, Kentarou Kuroishi
OBJECTIVES: A 12-week post-marketing study was conducted to provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with mirabegron. This post-hoc analysis focused on safety and effectiveness of mirabegron in patients aged ≥75 versus <75 years. METHODS: Incidence of adverse drug reactions (ADR) was assessed following 12 weeks' mirabegron treatment. Overactive Bladder Symptom Score (OABSS) and International-Prostate Symptom Score Quality of Life (I-PSS QoL) were completed at baseline and at the end of treatment (EoT)...
September 12, 2017: Lower Urinary Tract Symptoms
https://www.readbyqxmd.com/read/28889761/safety-issues-associated-with-using-medication-to-treat-overactive-bladder
#8
REVIEW
George Araklitis, Linda Cardozo
The mainstay of overactive bladder treatment is the use of anticholinergic medication with its common side effects well known. This review focused on three less well-known safety issues when treating OAB. Areas covered: Patients with increased anticholinergic load are at risk of cognitive decline, dementia or even death. The elderly are particularly at risk due to polypharmacy. Botulinum toxin carries the risk of high urinary residuals, urinary tract infection and need to self catheterise. The use of vaginal oestrogens may improve OAB symptoms, but there is concern in those with a history of breast cancer...
November 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28833621/persistence-and-adherence-to-overactive-bladder-medications-in-japan-a-large-nationwide-real-world-analysis
#9
Daisuke Kato, Satoshi Uno, James Van Schyndle, Alan Fan, Tomomi Kimura
OBJECTIVES: To evaluate persistence and adherence to mirabegron and antimuscarinics in Japan using data from two administrative databases. METHODS: The present retrospective study evaluated insurance claims for employees and dependents aged ≤75 years, and pharmacy claims for outpatients. From October 2012 to September 2014, new users of mirabegron or five individual antimuscarinics indicated for overactive bladder in Japan (fesoterodine, imidafenacin, propiverine, solifenacin and tolterodine) were identified and followed for 1 year...
August 22, 2017: International Journal of Urology: Official Journal of the Japanese Urological Association
https://www.readbyqxmd.com/read/28814193/sirolimus-and-mirabegron-interaction-in-a-hematopoietic-cell-transplant-patient
#10
Jeff A Engle, Christina Fair
Purpose Hematopoietic cell transplant patients are exposed to numerous classes of medications. Transplant practitioners must vigilantly monitor for drug interactions especially involving immunosuppressants. We report a hematopoietic cell transplant patient receiving sirolimus who developed supratherapeutic serum concentrations after initiating mirabegron. Summary A 31-year-old, 98 kg female received a second umbilical cord blood transplant four years after the first transplant for relapsed acute myeloid leukemia...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28805473/the-impact-of-persistence-with-mirabegron-usage-vs-switching-to-onabotulinumtoxina-on-healthcare-costs-and-resource-utilization-in-patients-with-overactive-bladder-in-the-united-states
#11
Daniel Bin Ng, Robert Espinosa, Scott J Johnson, David Walker, Katherine Gooch
AIMS: To compare healthcare costs and resource utilization in patients with overactive bladder (OAB) in the US who switch from mirabegron to onabotulinumtoxinA (onabotA) with those who persist on mirabegron. MATERIALS AND METHODS: A retrospective observational claims analysis of the OptumHealth Administrative Claims database conducted between April 1, 2012 and September 30, 2015 used medical and pharmacy claims to identify patients with at least one OAB diagnosis who switched from mirabegron to onabotA (onabotA group) or persisted on mirabegron for at least 180 days (mirabegron persisters)...
September 4, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28762672/safety-efficacy-and-persistence-of-long-term-mirabegron-treatment-for-overactive-bladder-in-the-daily-clinical-setting-interim-1-year-report-from-a-japanese-post-marketing-surveillance-study
#12
Daisuke Kato, Hiromi Tabuchi, Satoshi Uno
OBJECTIVES: To report interim 1-year results from a 3-year surveillance study evaluating safety, efficacy, and persistence of long-term mirabegron for overactive bladder (OAB). METHODS: Patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years. Data were collected on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations...
August 1, 2017: Lower Urinary Tract Symptoms
https://www.readbyqxmd.com/read/28715189/diamine-tethered-bis-thiourea-organocatalyst-for-asymmetric-henry-reaction
#13
Jan Otevrel, Pavel Bobal
We have developed a novel multifunctional C2-symmetric biphenyl-based diamine-tethered bis(thiourea) organocatalyst, which was tested in the asymmetric Henry reaction. Under thoroughly optimized conditions, the catalyst provided exceptionally high yields and excellent enantioselectivities especially for electron-deficient aromatic and heterocyclic substrates. Due to a high affinity of the catalyst to silica gel, a simple chromatography-free nitroaldol isolation procedure was feasible. Preliminary kinetic and spectroscopic experiments were performed in order to complete the mechanistic picture of the organocatalyzed nitroaldolization process...
July 31, 2017: Journal of Organic Chemistry
https://www.readbyqxmd.com/read/28705713/sn003-a-crf1-receptor-antagonist-attenuates-depressive-like-behavior-and-detrusor-overactivity-symptoms-induced-by-13-cis-retinoic-acid-in-rats
#14
Andrzej Wróbel, Urszula Doboszewska, Ewa Rechberger, Piotr Wlaź, Tomasz Rechberger
Overactive bladder (OAB) often co-exists with depression in women. The corticotropin-releasing factor (CRF) system participates in the pathophysiology of both disorders. Therefore, we tested the effects of acute treatment with a reversible CRF receptor type-1 (CRF1) antagonist, SN003 (1mg/kg, i.v.), representatives of first (solifenacin, 0.03mg/kg, i.v.) and second (mirabegron, 1mg/kg, i.v.) line treatments for OAB as well as an antidepressant imipramine (30mg/kg, i.p.) on changes in depressive-like behavior and detrusor overactivity (DO) symptoms induced by a 6-week administration of 13-cis-retinoic acid (13-cis-RA, 1mg/kg/day, i...
July 10, 2017: European Journal of Pharmacology
https://www.readbyqxmd.com/read/28704584/patient-reported-outcomes-from-synergy-a-randomized-double-blind-multicenter-study-evaluating-combinations-of-mirabegron-and-solifenacin-compared-with-monotherapy-and-placebo-in-oab-patients
#15
Dudley Robinson, Con Kelleher, David Staskin, Elizabeth R Mueller, Christian Falconer, Jianye Wang, Arwin Ridder, Matthias Stoelzel, Asha Paireddy, Rob van Maanen, Zalmai Hakimi, Sender Herschorn
AIMS: To evaluate patient-reported outcomes (PROs) of combinations of solifenacin and mirabegron compared with solifenacin and mirabegron monotherapy and with placebo in patients with overactive bladder (OAB) from the SYNERGY trial. METHODS: Following a 4-week placebo run-in, period patients (≥18 years) with OAB were randomized 2:2:1:1:1:1 to receive solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg + mirabegron 50 mg, (combination 5 + 50 mg), solifenacin 5 mg, mirabegron 25 mg, mirabegron 50 mg or placebo for 12 weeks, followed by a 2-week washout period...
July 13, 2017: Neurourology and Urodynamics
https://www.readbyqxmd.com/read/28695920/pharmacology-cardiovascular-effects-of-mirabegron
#16
Karl-Erik Andersson
No abstract text is available yet for this article.
October 2017: Nature Reviews. Urology
https://www.readbyqxmd.com/read/28681036/additional-low-dose-antimuscarinics-can-improve-overactive-bladder-symptoms-in-patients-with-suboptimal-response-to-beta-3-agonist-monotherapy
#17
Jung Hyun Shin, Aram Kim, Myung-Soo Choo
PURPOSE: We aimed to assess the patient-reported outcome (PRO) and efficacy of add-on low-dose antimuscarinic therapy in over-active bladder (OAB) patients with suboptimal response to 4-week treatment with beta 3 agonist monotherapy (mirabegron, 50 mg). MATERIALS AND METHODS: We enrolled OAB patients with 4-week mirabegron (50 mg) treatment if the patients' symptoms improved, but not to a satisfactory extent (patient perception of bladder condition [PPBC] ≥4)...
July 2017: Investigative and Clinical Urology
https://www.readbyqxmd.com/read/28673067/expected-next-generation-drugs-under-development-in-relation-to-voiding-symptoms
#18
REVIEW
Kyung Jin Chung, Benjamin I Chung
New drug development is a high-risk venture, but if successful, will bring great revenues to those willing to accept the risk. In the field of urology, in particular for lower urinary tract symptoms (LUTS), the recent successful landing of drugs (e.g., mirabegron, botulinum toxin A, and tadalafil) has resulted in increased interest in new drug development. Benign prostatic hyperplasia and overactive bladder syndrome, representative LUTS diseases, are attractive targets because of their prevalence and market size in the field of urology...
June 2017: International Neurourology Journal
https://www.readbyqxmd.com/read/28670786/comparative-assessment-of-the-efficacy-of-onabotulinumtoxina-and-oral-therapies-anticholinergics-and-mirabegron-for-overactive-bladder-a-systematic-review-and-network-meta-analysis
#19
REVIEW
Marcus J Drake, Victor W Nitti, David A Ginsberg, Benjamin M Brucker, Zsolt Hepp, Rachael McCool, Julie M Glanville, Kelly Fleetwood, Daniel James, Christopher R Chapple
OBJECTIVES: To compare the efficacy of onabotulinumtoxinA, mirabegron, and anticholinergics in adults with idiopathic overactive bladder (OAB) using network meta-analysis (NMA). PATIENTS AND METHODS: Information sources were searched for blinded randomised controlled trials (RCTs), of ≥2 weeks duration, comparing any dose of onabotulinumtoxinA, eligible oral/transdermal anticholinergics, or mirabegron, with each other or placebo, in adults with OAB. Bayesian random-effects models were used to synthesise the results at week 12: NMA for responder analyses and network meta-regression (NMR) for change from baseline analyses...
November 2017: BJU International
https://www.readbyqxmd.com/read/28646416/assessing-preference-based-outcome-measures-for-overactive-bladder-an-evaluation-of-patient-reported-outcome-data-from-the-beside-clinical-trial
#20
REVIEW
Mike Herdman, Jameel Nazir, Zalmai Hakimi, Emad Siddiqui, Moses Huang, Marco Pavesi, Scott MacDiarmid, Marcus J Drake, Nancy Devlin
OBJECTIVES: The aim of this study was to compare outcomes using two preference-based measures of health status (EQ-5D-5L and OAB-5D) in patients with overactive bladder (OAB) treated with solifenacin plus mirabegron or solifenacin monotherapy in the BESIDE trial. METHODS: Patients with OAB who remained incontinent after 4 weeks' treatment with solifenacin 5 mg were randomized 1:1:1 to combination treatment (solifenacin 5 mg plus mirabegron [25 mg for the first 4 weeks/50 mg for the last 8 weeks]), solifenacin 5 mg, or solifenacin 10 mg...
December 2017: Patient
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