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Mirabegron

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https://www.readbyqxmd.com/read/28621388/first-direct-isolation-of-stable-%C3%AE-form-crystals-of-mirabegron-a-selective-%C3%AE-3-adrenoceptor-agonist
#1
G Dattatray Deshmukh, N Mukund Bangal, C Anil Mali, J Vijay Medhane, T Vijayavitthal Mathad
An efficient and scalable method for the direct isolation of stable α-form crystals of Mirabegron (1) is developed. The developed method negates transformation of metastable β-form crystals into α-form crystals thereby overcoming the limitations of reported methods and avoids additional processing steps during its manufacture. The developed method directly provides stable α-form crystals of Mirabegron (1) with yield of around 84% and purity of >99.77% by HPLC in a single step.
June 2017: Acta Chimica Slovenica
https://www.readbyqxmd.com/read/28620791/a-prospective-double-blind-randomized-two-period-crossover-multicenter-study-to-evaluate-tolerability-and-patient-preference-between-mirabegron-and-tolterodine-in-patients-with-overactive-bladder-prefer-study
#2
David Staskin, Sender Herschorn, Jonathan Fialkov, Le Mai Tu, Terry Walsh, Carol R Schermer
INTRODUCTION AND HYPOTHESIS: The objective of this study was to assess the tolerability and treatment preference in patients with overactive bladder (OAB) treated with mirabegron or tolterodine. METHODS: This was a two-period, 8-week crossover, double-blind, phase IV study (PREFER; NCT02138747) in treatment-naive adults with OAB for 3 months or longer randomized to one of four treatment sequences in a 5:5:1:1 ratio (mirabegron/tolterodine, tolterodine/mirabegron, mirabegron/mirabegron, or tolterodine/tolterodine), separated by a washout period of 2 weeks...
June 15, 2017: International Urogynecology Journal
https://www.readbyqxmd.com/read/28618007/an-exploratory-study-in-healthy-male-subjects-of-the-mechanism-of-mirabegron-induced-cardiovascular-effects
#3
Marcel van Gelderen, Matthias Stölzel, John Meijer, Virginie Kerbusch, Christiane Collins, Cees Korstanje
To explore the role of β1 -adrenoceptors (ARs) in the heart rate response to the selective β3 -adrenoceptor agonist mirabegron, 12 young male volunteers received single oral doses of the nonselective β1/2 -AR antagonist propranolol (160 mg), the selective β1 -AR antagonist bisoprolol (10 mg), or placebo on days 1 and 5 of each period in a 3-period crossover study. On day 5, dosing was followed by a supratherapeutic dose of mirabegron (200 mg). Vital signs, impedance cardiography, and plasma renin activity were collected...
June 15, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28588652/efficacy-and-safety-of-daily-mirabegron-50-mg-in-male-patients-with-overactive-bladder-a-critical-analysis-of-five-phase-iii-studies
#4
Andrea Tubaro, José E Batista, Victor W Nitti, Sender Herschorn, Christopher R Chapple, Mary Beth Blauwet, Emad Siddiqui, Moses Huang, Matthias Oelke
BACKGROUND: Oral pharmacotherapies to treat overactive bladder (OAB) are used less in men despite a similar prevalence of storage symptoms as women. The efficacy and safety of once-daily mirabegron 50 mg was evaluated in male OAB patients from five phase III studies that included placebo or antimuscarinic (tolterodine ER 4 mg or solifenacin 5 mg) as a comparator. METHODS: Three pooled 12-week placebo-controlled studies (mirabegron 50 mg versus placebo) and one 12-week non-inferiority phase IIIb study (BEYOND; mirabegron 50 mg versus solifenacin 5 mg) were used for efficacy (daily micturition frequency, urgency and incontinence episodes) and safety analyses...
December 2017: Therapeutic Advances in Urology
https://www.readbyqxmd.com/read/28574581/the-%C3%AE-3-adrenoceptor-agonist-mirabegron-increases-human-atrial-force-through-%C3%AE-1-adrenoceptors-an-indirect-mechanism
#5
Weilan Mo, Martin C Michel, Xiang Wen Lee, Alberto J Kaumann, Peter Molenaar
BACKGROUND AND PURPOSE: Mirabegron has been classified as a β3 -adrenoceptor agonist approved for overactive bladder syndrome. We investigated possible cardiac effects of mirabegron in the absence or presence of β-adrenoceptor subtype antagonists. In view of its phenylethanolamine structure we investigated whether mirabegron has indirect sympathomimetic activity by using neuronal uptake blockers. EXPERIMENTAL APPROACH: Right atrial trabeculae, from non-failing hearts, were paced and contractile force measured at 37°C...
June 2, 2017: British Journal of Pharmacology
https://www.readbyqxmd.com/read/28515812/cost-effectiveness-of-mirabegron-compared-to-tolterodine-er-4-mg-for-overactive-bladder-in-canada
#6
Sender Herschorn, Jameel Nazir, Barbara Ramos, Zalmai Hakimi
INTRODUCTION: This analysis compared the cost-effectiveness of once-daily regimens of mirabegron 50 mg and generic tolterodine ER 4 mg in a hypothetical cohort of previously treated patients with overactive bladder (OAB) in Canada. METHODS: A Markov model was developed to represent different health states according to OAB symptoms (frequency, incontinence), presence/absence of adverse events (AEs; dry mouth, constipation, blurred vision), and treatment status (on-treatment, discontinue treatment, restart previous treatment)...
March 2017: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
https://www.readbyqxmd.com/read/28487215/micturition-dysfunction-in-four-month-old-ovariectomized-rats-effects-of-testosterone-replacement
#7
Sandra M Bonilla-Becerra, Mariana G de Oliveira, Fabiano B Calmasini, Julio A Rojas-Moscoso, Angelina Zanesco, Edson Antunes
AIMS: Androgen deficiency has been implicated in urological complications of postmenopausal women. This study examined the effects of testosterone replacements on the lower urinary tract dysfunction in 4-month old ovariectomized (OVX) rats. MAIN METHODS: Sprague-Dawley female rats were OVX bilaterally. Three months later, rats received single intramuscular injections of testosterone undecanoate. Cystometric study, and bladder and urethra smooth muscle reactivities were evaluated...
May 6, 2017: Life Sciences
https://www.readbyqxmd.com/read/28478755/-mirabegron-a-breakthrough-in-overactive-bladder-syndrome
#8
Almudena Maestro Nombela, María José Almodóvar Carretón, Virginia Saavedra Quirós, Carlos Barreda Velázquez, Lucía Jamart Sánchez
Overactive bladder syndrome is a condition with high prevalence, which has a negative impact on patients' quality of life. A drug with a novel mechanism of action has been recently approved: mirabegron. The objective of this study is to review the scientific evidence available on mirabegron, with the aim to analyze its efficacy, safety and cost, and thus estimate its role within current pharmacotherapy. Methods: The effectiveness and safety of mirabegron were analyzed through an evaluation of scientific evidence...
May 1, 2017: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/28458369/evaluation-of-maltose-induced-chemical-degradation-at-the-interface-of-bilayer-tablets
#9
Naoya Matsuzaki, Yousuke Yamamoto, Daisuke Murayama, Yoshifumi Katakawa, Hisashi Mimura, Shin-Ichiro Kimura, Yasunori Iwao, Shigeru Itai
Fixed dose combination tablets consisting of mirabegron (MB) and solifenacin succinate (SS) were developed and formulated into bilayer tablets in the current study. The results of a chemical stability study showed that the original formulation for the tablets led to a significant increase of unknown degradants in the SS layer. Two compatibility studies were conducted to simulate the interface between the MB and SS layers, and the results revealed that the degradants only formed in the presence of both active pharmaceutical ingredients (APIs), and that the presence of maltose in the SS layer was critical to inducing degradation...
2017: Chemical & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28446460/inhibition-of-cholinergic-neurotransmission-by-%C3%AE-3-adrenoceptors-depends-on-adenosine-release-and-a1-receptors-activation-in-human-and-rat-urinary-bladders
#10
Isabel Silva, Ana Filipa Costa, Sílvia Moreira, Fátima Ferreirinha, Maria Teresa Magalhães-Cardoso, Isabel Calejo, Miguel Silva-Ramos, Paulo Correia-de-Sá
The direct detrusor relaxant effect of β3-adrenoceptor agonists as a primary mechanism to improve overactive bladder symptoms has been questioned. Among other targets, activation of β3-adrenoceptors down-modulate nerve-evoked acetylcholine (ACh) release, but there is insufficient evidence for the presence of these receptors on bladder cholinergic nerve terminals. Our hypothesis is that adenosine formed from the catabolism of cyclic AMP in the detrusor may act as a retrograde messenger via prejunctional A1 receptors to explain inhibition of cholinergic activity by β3-adrenoceptors...
April 26, 2017: American Journal of Physiology. Renal Physiology
https://www.readbyqxmd.com/read/28436145/comparisons-of-the-clinical-outcomes-and-urodynamic-effects-of-mirabegron-versus-tolterodine-treatment-for-female-overactive-bladder-syndrome-a-subgroup-analysis-of-a-controlled-randomised-prospective-study
#11
Sheng-Mou Hsiao, Ting-Chen Chang, Chi-Hau Chen, Wen-Yih Wu, Ho-Hsiung Lin
OBJECTIVES: The impact of mirabegron on clinical outcome and urodynamic parameters may be important for clinical practice. Thus, the aim of this study was to compare the clinical outcomes and urodynamic effects of mirabegron (Betmiga 50 mg) versus tolterodine (Detrusitol ER 4 mg) treatment for women with overactive bladder syndrome (OAB). METHODS: Women with OAB were randomized to receive 12 weeks of mirabegron 50 mg, tolterodine extended-release 4 mg or placebo treatment...
April 23, 2017: Lower Urinary Tract Symptoms
https://www.readbyqxmd.com/read/28434969/translational-science-approach-for-assessment-of-cardiovascular-effects-and-proarrhythmogenic-potential-of-the-beta-3-adrenergic-agonist-mirabegron
#12
Cees Korstanje, Masanori Suzuki, Koichiro Yuno, Shuichi Sato, Masashi Ukai, Marlowe J Schneidkraut, Gan X Yan
INTRODUCTION: Translational assessment of cardiac safety parameters is a challenge in clinical development of beta-3 adrenoceptor agonists. The preclinical tools are presented that were used for assessing human safety for mirabegron. METHODS: Studies were performed on electrical conductance at ion channels responsible for cardiac repolarization (IKr, IKs, Ito, INa, and ICa,L), on QT-interval, subendocardial APD90, Tpeak-end interval, and arrhythmia's in ventricular dog wedge tissue in vitro and on cardiovascular function (BP, HR, and QTc) in conscious dogs...
April 20, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/28419650/cardiovascular-safety-in-refractory-incontinent-patients-with-overactive-bladder-receiving-add-on-mirabegron-therapy-to-solifenacin-beside
#13
Marcus J Drake, Scott MacDiarmid, Christopher R Chapple, Adil Esen, Stavros Athanasiou, Javier Cambronero Santos, David Mitcheson, Sender Herschorn, Emad Siddiqui, Moses Huang, Matthias Stoelzel
AIMS/OBJECTIVES: In the BESIDE study, combination therapy (antimuscarinic [solifenacin] and β3 -adrenoceptor agonist [mirabegron]) improved efficacy over solifenacin monotherapy without exacerbating anticholinergic side effects in overactive bladder (OAB) patients; however, a potential synergistic effect on the cardiovascular (CV) system requires investigation. METHODS: OAB patients remaining incontinent despite daily solifenacin 5 mg during 4-week single-blind run-in, were randomised 1:1:1 to double-blind daily combination (solifenacin 5 mg/mirabegron 25 mg, increasing to 50 mg after week 4), solifenacin 5 or 10 mg for 12 weeks...
April 16, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28418102/efficacy-and-safety-of-combinations-of-mirabegron-and-solifenacin-compared-with-monotherapy-and-placebo-in-patients-with-overactive-bladder-synergy-study
#14
Sender Herschorn, Christopher R Chapple, Paul Abrams, Salvador Arlandis, David Mitcheson, Kyu-Sung Lee, Arwin Ridder, Matthias Stoelzel, Asha Paireddy, Rob van Maanen, Dudley Robinson
Overactive bladder (OAB) syndrome is characterized by urinary urgency, with or without urgency urinary incontinence, usually accompanied by increased daytime frequency and nocturia, in the absence of urinary tract infection (UTI) or other obvious pathology [1]. Urgency urinary incontinence is present in approximately one-third of cases [2], but is not a prerequisite. However, of all the OAB symptoms, it has the greatest impact on quality of life (QoL) [3, 4], and is associated with significantly lower productivity and higher healthcare resource utilization [5]...
April 18, 2017: BJU International
https://www.readbyqxmd.com/read/28400166/better-persistence-rates-with-mirabegron-questions-raised
#15
EDITORIAL
Alan J Wein
No abstract text is available yet for this article.
April 8, 2017: European Urology
https://www.readbyqxmd.com/read/28394529/-comprehensive-pharmacologic-management-of-overactive-bladder
#16
G G Krivoborodov, E I Tur
Overactive bladder (OAB) is a common and bothersome condition manifested by urgency, frequent urination, significantly impairing patients quality of life. The article presents an overview of the evidence on pharmacotherapy of neurogenic and idiopathic OAB. Selective M3 receptor blockers have been shown to be the medications of choice in treating these patients. Many studies have shown that solifenacin 10 mg is a starting dose for patients with OAB. Mirabegron (Betmiga) is the only 3-adrenergic receptor agonist approved for primary treatment of OAB patients refractory to anticholinergics or have their side effects...
April 2017: Urologii︠a︡
https://www.readbyqxmd.com/read/28371019/adherence-and-persistence-of-mirabegron-and-anticholinergic-therapies-in-patients-with-overactive-bladder-a-real-world-claims-data-analysis
#17
D Sussman, A Yehoshua, J Kowalski, W Lee, J Kish, S Chaudhari, B Murray
BACKGROUND: Adherence and persistence rates of anticholinergic (ACH) therapies have been well described. To date, few studies describe these metrics for mirabegron in patients with overactive bladder. METHODS: This retrospective analysis of MarketScan(®) database assessed adherence and persistence of patients receiving either mirabegron or ACH. Study eligibility required an index date (first prescription filled) between July 2012 and June 2013 with 12 months of continuous enrolment preindex date and 12 months of follow-up...
March 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28370541/a-prospective-study-of-elderly-initiating-mirabegron-versus-antimuscarinics-patient-reported-outcomes-from-the-overactive-bladder-satisfaction-scales-and-other-instruments
#18
Suvapun Bunniran, Cralen Davis, Rita Kristy, Daniel Ng, Carol R Schermer, Claudia Uribe, Brandon T Suehs
AIMS: To understand differences in patient reported outcomes (PRO) between patients initiating mirabegron or an antimuscarinic using a validated PRO instrument, OAB-Satisfaction (OAB-S). METHODS: This prospective observational study used real-time prescription claims from Humana to identify Medicare patients initiating mirabegron or an antimuscarinic to participate in a series of three phone surveys over ninety days. RESULTS: A total of 1897 mirabegron and 2444 randomly selected antimuscarinic initiators were identified; 174 mirabegron and 193 antimuscarinic initiators completed all three surveys...
March 31, 2017: Neurourology and Urodynamics
https://www.readbyqxmd.com/read/28361520/on-the-site-and-mechanism-of-action-of-%C3%AE-3-adrenoceptor-agonists-in-the-bladder
#19
REVIEW
Karl Erik Andersson
The clinical success of mirabegron as the first β3-adrenoceptor (AR) agonist for treatment of the overactive bladder (OAB) syndrome, has resulted in substantial interest in its site and mechanism of action. Even if the adrenergic innervation of the bladder and urethra has been well studied, the location(s) of β3-ARs in different structures within the bladder wall and urethra, and the mode(s) of action of β3-AR stimulation have still not been established. The recent demonstration of β3-ARs on cholinergic nerve terminals with no immunoreactivity in urothelium or detrusor smooth muscle, is not in agreement with previous morphological studies, and functional data strongly suggest that β3-ARs can be found these structures...
March 24, 2017: International Neurourology Journal
https://www.readbyqxmd.com/read/28322904/adding-mirabegron-to-solifenacin-to-treat-overactive-bladder-has-little-impact-on-postvoid-residual-volume-or-urinary-retention-risk
#20
Marcus J Drake, Scott MacDiarmid, Salman Al-Shukri, Jack Barkin, Aino Fianu-Jonasson, Sender Herschorn, Moses Huang, Matthias Stoelzel, Emad Siddiqui
No abstract text is available yet for this article.
March 16, 2017: Urology
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