mirabegron and Stroke

To evaluate the neurological safety and clinical efficacy of darifenacin and mirabegron in patients with a history of cerebrovascular accident (CVA) who had overactive bladder (OAB) symptoms.. This prospective randomized study, approved by the institute's ethics committee, was carried out at a tertiary care center from December 2018 to June 2020. Treatment naïve adult patients with a past history of CVA with stable neurological status for atleast past 3 months with symptoms of OAB for 3 or more months were included. Eligible patients received either darifenacin or mirabegron for a period of 3 months and various parameters on the 3-day International Consultation on Incontinence Questionnaire (ICIQ) bladder diary, the Montreal Cognitive Assessment-Basic score (MoCA-B), and the adverse events at 3 months posttreatment were compared to that at the baseline.. A total of 60 patients were included, 30 in each arm. After 3 months of treatment with darifenacin or mirabegron, the majority of the ICIQ bladder diary parameters improved and there was no deterioration in the cognitive function as noted on the MoCA-B score in either of the arms. On intergroup comparison, the mean change in bladder diary parameters and the MoCA-B scores was similar between the two groups.. Darifenacin and mirabegron, in the short term, do not adversely affect the cognitive function in patients with a history of CVA with OAB symptoms. Both are safe and effective treatment options in patients with OAB post-CVA.

Topics: Acetanilides; Adult; Benzofurans; Humans; Prospective Studies; Pyrrolidines; Stroke; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urological Agents

During clinical trials, mirabegron, a β3-adrenoreceptor agonist, was associated with increased vital signs vs placebo in patients with overactive bladder.. The purpose of this study was to compare incidence rates of adverse cardiovascular (CV) outcomes following mirabegron or antimuscarinic use.. We conducted an observational post-marketing safety study utilising real-world data. The study population was identified within five sources: Danish and Swedish National Registers, Clinical Practice Research Datalink (UK), Optum (USA) and Humana (USA). Episodes of time when patients were new users of mirabegron or antimuscarinics (October 2012-December 2018) were sourced from prescriptions and matched on propensity scores. Occurrences of major adverse cardiovascular events (MACE), acute myocardial infarction (AMI), stroke, CV mortality and all-cause mortality were identified. Outcome incidence rates and hazard ratios from Cox models were estimated.. Overall, 152,026 mirabegron and 152,026 antimuscarinic episodes were matched. The population consisted of 63.1% women and 72.6% were ≥ 65 years old. There were no appreciable differences in the incidence rates of MACE, AMI or stroke between users of mirabegron and antimuscarinics. Incidence rates of CV mortality (hazard ratio 0.83, 95% confidence interval 0.73-0.95) and all-cause mortality (hazard ratio 0.80, 95% confidence interval 0.76-0.84) were no higher with mirabegron vs antimuscarinics. Results restricted to episodes at high risk for CV events or stratified by age (< 65 years, ≥ 65 years) or prior overactive bladder medication use were consistent with overall findings.. This large, multinational study found no higher risk of MACE, AMI, stroke, CV mortality or all-cause mortality among users of mirabegron relative to users of antimuscarinics.. During clinical trials, mirabegron, which is a treatment for overactive bladder, was associated with small increases in heart rate and blood pressure. This study was conducted to compare the frequency of cardiac events following the use of mirabegron or antimuscarinics, a group of treatments also used to treat overactive bladder. We obtained the data for this study from four countries: Denmark, Sweden, the UK and the USA. We identified people who were new users of mirabegron or antimuscarinics from 2012 to 2018 using prescription or dispensing records. Occurrences of major cardiac events, heart attack, stroke, death due to cardiac events and death from any cause were evaluated. Overall, we identified 152,026 times when mirabegron or antimuscarinics were each used as new treatments. Most of the people in the study were women (63.1%) and at least 65 years old (72.6%). There were no notable differences between the treatment groups with regard to how often major cardiac events, heart attack or stroke occurred. Further, death due to cardiac events and death from any cause were no higher with mirabegron compared with antimuscarinics. We obtained similar results when the data were assessed for patients who were at high risk for cardiac events or split by age (less than 65 years or at least 65 years) or a history of overactive bladder medication use. In conclusion, this large study involving data from several countries found no higher risk of major cardiac events, heart attack, stroke or death among people prescribed mirabegron compared with antimuscarinics.

Topics: Acetanilides; Aged; Cardiovascular Diseases; Cohort Studies; Female; Heart Disease Risk Factors; Humans; Male; Muscarinic Antagonists; Risk Factors; Stroke; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive

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.. Patients with CVA, PD, dementia, and OAB symptoms were consecutively enrolled in the study group, and mirabegron 25 mg q.d. was prescribed. Clinical effects, evaluated using the Overactive Bladder Symptom Score (OABSS), Urinary Sensation Scale (USS), International Prostate Symptom Score (IPSS), and Patient Perception of Bladder Condition (PPBC), as well as urodynamic parameters and adverse events were assessed at baseline and 4 and 12 weeks after treatment.. In all, 44 patients (mean [± SD] age 77.7 ± 9.49 years) with OAB due to CVA (n = 27), PD (n = 6), and dementia (n = 11) were included in the present prospective study. Mirabegron resulted in significant improvements in symptom scores on the OABSS (P = .02), USS (P = .009), total IPSS (P = .002), Storage and Voiding domains of the IPSS (P = .001 and .017, respectively), and PPBC (P = .001). No significant changes were noted in post-void residual, maximum flow rate, and voided volume after treatment. Only 5 patients dropped out due to poor therapeutic efficacy and shifted to antimuscarinics. Three patients complained of adverse effects, including dizziness and dysuria. No patient complained of urine retention or constipation.. Mirabegron 25 mg once daily effectively decreased urgency symptoms in elderly OAB patients with CNS lesions after the 12-week treatment period. The adverse events were mild and only noted in a few cases.

Topics: Acetanilides; Aged; Central Nervous System Diseases; Dementia; Female; Humans; Male; Parkinson Disease; Stroke; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urological Agents

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Humans; Hypertension; Stroke; Thiazoles; Urinary Incontinence