mirabegron and Parkinson-Disease

The goal of this meta-analysis was to determine the efficacy and safety of medication for treating overactive bladder (OAB) in patients with Parkinson's disease (PD).. Papers containing predefined key terms were searched in the PubMed, Embase, Web of Science, and Cochrane Library databases up to December 2021 to collect randomized double-blind placebo-controlled trials (RCTs). The review process followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements. Two reviewers independently assessed the risk of bias using the modified Jadad scale and Cochrane risk-of-bias tool. The GRADEpro GDT was employed to evaluate the strength of evidence based on the findings of this meta-analysis.. We eventually included four RCTs involving 313 patients (163 patients in the medication group and 150 patients in the placebo group). Of these, the therapeutic agent in two RCTs was mirabegron (121 and 106 patients and controls, respectively, representing 3/4 -2/3 of the patients). The results showed that the number of micturition episodes per 24 h (MD -1.33; 95% CI -2.30 to -0.36; p = 0.007), the number of nocturia episodes per 24 h (MD -0.33; 95% CI -0.58 to -0.08; p = 0.009) and the number of urinary incontinence episodes per 24 h (MD -0.72; 95% CI -1.32 to -0.12; p = 0.02) were significantly lower in the medication group than in the placebo group. The OAB symptom score (MD -2.84; 95% CI -4.67 to -1.00; p = 0.002) and quality of life score (MD 15.15; 95% CI 12.33 to 17.96; p < 0.0001) of the medication group were significantly improved compared with those of the placebo group. However, no significant difference in the daily frequency of urinary urgency episodes was identified between the medication group and the placebo group (MD -0.79; 95% CI -1.71 to 0.14; p = 0.09). There were no significant differences between the two groups in terms of drug-related adverse events (OR 1.69; 95% CI 0.41 to 6.99; p = 0.47), especially in PD patients receiving mirabegron therapy.. Medication was effective for OAB symptoms in patients with PD, and patients tolerated adverse events well.

Topics: Acetanilides; Double-Blind Method; Humans; Parkinson Disease; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome; Urinary Bladder, Overactive

To assess the safety and effectiveness of mirabegron in patients with PD complaining of overactive bladder (OAB).. From January 2017 to November 2020, we performed a prospective randomized, double-blind, placebo-controlled trial that enrolled PD patients with symptoms of OAB. The total duration of the study was 13 weeks, comprising a 1-week screening period and a 12-week treatment period. A total of 110 patients were randomized in one of two groups: treatment group (mirabegron 50 mg) or placebo group. The primary outcomes of our study were the change from baseline in OAB symptom score (OABSS) and the overactive bladder questionnaire short form (OAB-q SF) score. The secondary outcomes were the change from baseline in the mean number of micturitions/24 hours, the mean number of urgency episodes/24 hours, the mean number of urgency incontinence episodes/24 hours and the mean number of nocturia episodes/night, volume voided/micturition (ml) as recorded on a 3-day bladder diary. Safety assessments included adverse events, electrocardiogram, QT corrected for heart rate using Fridericia's correction (QTcF) interval and blood pressure and pulse rate measurements.. There was a significant improvement in the primary outcome and secondary outcome measures in the treatment group compared to the placebo group. Adverse events were mild and the same in the two groups. The cardiovascular safety profile was high. This study is limited by its sample size and its short follow-up period.. Mirabegron is a promising drug to control OAB symptoms in patients with PD with an excellent safety profile.

Topics: Acetanilides; Double-Blind Method; Humans; Parkinson Disease; Prospective Studies; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urological Agents

This study aimed to investigate the efficacy and safety of mirabegron for Parkinsonism patients with overactive bladder (OAB) symptoms in a randomized, placebo-controlled, multicenter study.. Inclusion criteria are Parkinsonism with OAB symptoms for 4 weeks or more, OAB symptom score (OABSS) questionnaire scores greater than 2, and OABSS urgency question scores greater than 1. After a 2-week wash-out period, the patients were randomized into placebo and mirabegron groups at visit 2. Visit 3 was performed after 4 weeks of medication. Mirabegron was prescribed to the two groups for the rest of the study period at visit 4.. The mean age was 68.1 ± 8.1 years and 72 males and 64 females were included. A total of 136 patients were screened, 117 patients were randomized, and 25 patients dropped out. The OABSS scores were significantly different between the two groups at Weeks 4 and 8. The OABSS scores became the same in the two groups at Week 12 (visit 5). The postvoid residual urine volume showed a mild increase to 64 ml in the mirabegron group compared to the placebo group at visit 4. Adverse events occurred in 27 patients (23.1%). The degree was mild in 26 cases (78.8%), moderate in five (15.2%), and severe in two (6.1%). Only 13 cases (39.4%) showed medication-related adverse events. Acute urinary retention occurred in a single case. The treatment satisfaction questionnaires showed no significant differences between the two groups.. Mirabegron was effective in treating OAB symptoms in patients with Parkinsonism with acceptable adverse events.

Topics: Acetanilides; Aged; Double-Blind Method; Female; Humans; Male; Parkinson Disease; Surveys and Questionnaires; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urological Agents

Overactive bladder (OAB) is a common non-motor symptom of Parkinson disease (PD), often treated with antimuscarinics or beta-3 agonists. There is lack of evidence to guide OAB management in PD.. To assess the comparative safety of antimuscarinics versus beta-3 agonists for OAB treatment in PD.. We employed a new-user, active-comparator cohort study design. We included Medicare beneficiaries age ≥65 years with PD who were new users of either antimuscarinic or beta-3 agonist. The primary outcome was any acute care encounter (i.e., non-elective hospitalization or emergency department visit) within 90 days of OAB drug initiation. The main secondary outcome was a composite measure of acute care encounters for anticholinergic related adverse events (AEs). Matching on high-dimensional propensity score (hdPS) was used to address potential confounding. We used Cox proportional hazards models to examine the association between OAB drug category and outcomes. We repeated analyses for 30- and 180-day follow-up periods.. We identified 27,091 individuals meeting inclusion criteria (mean age: 77.8 years). After hdPS matching, antimuscarinic users had increased risks for any acute care encounter (hazard ratio [HR] 1.23, 95% confidence interval [CI] 1.12-1.37) and encounters for anticholinergic related AEs (HR 1.18, 95% CI 1.04-1.34) compared to beta-3 agonist users. Similar associations were observed for sensitivity analyses.. Among persons with PD, anticholinergic initiation was associated with a higher risk of acute care encounters compared with beta-3 agonist initiation. The long-term safety of anticholinergic vs. beta-3 agonist therapy in the PD population should be evaluated in a prospective study.

Topics: Acetanilides; Aged; Cholinergic Antagonists; Cohort Studies; Humans; Medicare; Muscarinic Antagonists; Parkinson Disease; Prospective Studies; Treatment Outcome; United States; Urinary Bladder, Overactive; Urological Agents

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

This study aimed to assess the outcomes of mirabegron for the treatment of overactive bladder (OAB) symptoms in patients with Parkinson disease (PD).. A retrospective study was conducted including patients with PD who received mirabegron 50 mg once daily for OAB symptoms between 2012 and 2017. The primary endpoint was clinical success defined as any improvement in overactive bladder symptoms self-assessed by the patients 6 weeks after mirabegron initiation. Secondary endpoints included number of pads per day, number of nocturia episodes and adverse events.. Fifty patients (mean 74 years old) were included. Before being treated with mirabegron, 56% had failed prior anticholinergic therapy. After 6 weeks of mirabegron 50 mg, five patients (11.4%) had a complete resolution of their OAB symptoms; 25 patients (50%) reported improvement, 23 (46%) reported no change and 2(4%) reported worsening of their OAB symptoms. The number of pads per day decreased from 1.5 to 0.9 (p = 0.01) and so did the number of nocturia episodes (from 3 to 2.6/night; p = 0.02). Only 2 adverse events were reported during mirabegron treatment (4%): one dizziness and one diaphoresis, that disappeared after mirabegron discontinuation. After a median follow-up of 19 months, 23 patients (46%) persisted on mirabegron. Persistence rates were 51.5%, 44.6% and 36.4% at 1, 2 and 3 years respectively.. Mirabegron has an excellent safety profile and appears to be an effective treatment for overactive bladder symptoms in patients with PD. Further prospective randomized trials are needed to properly assess mirabegron in PD patients.

Topics: Acetanilides; Aged; Cohort Studies; Female; Humans; Male; Middle Aged; Parkinson Disease; Retrospective Studies; Thiazoles; Treatment Outcome; Urinary Bladder, Overactive; Urological Agents

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Aged; Deep Brain Stimulation; Dyskinesia, Drug-Induced; Female; Humans; Parkinson Disease; Recurrence; Thiazoles