Validation of LC–MS/MS methods for the determination of mirabegron and eight metabolites in human plasma in a paediatric population
Publication date: Available online 7 February 2019Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): John Meijer, Tom van den Berg, Robert Huls, Vincent Hofstede, Willem Niesing, Cas van den Beld, Walter KrauwinkelAbstractMirabegron is the first registered β3-adrenoceptor agonist for treatment of overactive bladder as an alternative to antimuscarinics. Previously four liquid chromatography-tandem mass spectrometry assays were published to determine mirabegron and eight metabolites (M5, M8, M11-M16) in human plasma. In order to support paediatric development, the assays were further optimized to reduce the required blood volume and increase the sensitivity. The assays were miniaturized by using 96-well supported liquid extraction plates (mirabegron, M5, M16) or 96-well mixed-mode cation exchange solid phase extraction plates (M8, M11-M15) and a more sensitive MS-system was used. For the analytes, up to fivefold increase in assay sensitivity was achieved. The required blood sample volume was reduced from 10 to 2 mL for each timepoint. Validation demonstrated that the assays were accurate, precise and selective in the determination of mirabegron and metabolites. The assays were successfully applied to evaluate the pharmacokinetics of mirabegron in a paediatric population.
ConclusionsMirabegron efficacy, safety, and tolerability over 12 wk were confirmed in patients aged ≥65 yr with OAB and incontinence.Patient summaryWe examined the effect of mirabegron compared with placebo in people aged 65 yr or older with overactive bladder and incontinence. Mirabegron improved the symptoms of overactive bladder compared with placebo. Side effects were similar to those already known for mirabegron.
Review in-depth clinical information, latest medical news, and guidelines on urinary incontinence, urge incontinence, and adult incontinence. Read about overactive bladder (OAB) and overactive bladder treatment.
AbstractPurpose of ReviewNocturia is defined as awakening due to the desire to void during a period of intended sleep. The pathophysiology of nocturia is multifactorial and management remains a challenge. Herein, we provide an overview of the management strategies for nocturia and summarize the existing evidence for treatment of nocturia across the condition ’s broad etiologic categories: nocturnal polyuria, diminished bladder capacity, and global polyuria.Recent FindingsTreatment should begin with behavioral modification. A high level of evidence supports the efficacy of desmopressin in the treatment of nocturnal po...
In conclusion, significant in vitro permeability and in vivo absorption of Sol from the transdermal formulations were observed. PMID: 31685750 [PubMed - in process]
Authors: Tae BS, Park TY, Jeon BJ, Chung H, Lee YH, Park JY, Bae JH, Choi H Abstract Purpose: To evaluate seasonal variations of overactive bladder (OAB) symptoms in women who visited hospital clinics. Methods: Medical records of female patients treated for OAB symptoms from January 2011 to December 2017 were retrospectively reviewed. Patients with pyuria at the first visit, those who did not complete the questionnaire, and those with
The prevalence of overactive bladder syndrome (OAB) increases with age. Sleep disturbances in elderly individuals with OAB is a common problem. The purpose of this study was to examine the effects of a biofeed...
Condition: Overactive Bladder Intervention: Sponsor: TriHealth Inc. Not yet recruiting
Publication date: Available online 6 November 2019Source: European UrologyAuthor(s): Peter E.P. Petros
Cadence Neuroscience is moving to bring a neuromodulation therapy for patients with focal drug-resistant epilepsy to market. The Redmond, WA-based company has raised $15 million in a series A round to help with this goal. Cadenceâs financing round was led by JAZZ Venture Partners, with additional support being provided by Mayo Clinical Ventures, Mayo Benefactors Innovation Fund, and the Epilepsy Foundation of America (EFA). The device was developed by a Mayo Clinic, Rochester campus Neurology and Neurosurgery team. Cadence is licensing the technology from Mayo and said the device uses chronic subthreshold...