Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder in a Real-World Clinical Setting: A Japanese Post-Marketing Study
TL;DR: To provide real‐world data on Japanese patients with overactive bladder initiating treatment with the β3‐adrenoceptor agonist, mirabegron, this study examined prescribing patterns, adverse drug reaction (ADR) incidence, and treatment effectiveness.
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Abstract: Objectives
To provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with the β3-adrenoceptor agonist, mirabegron. This study examined prescribing patterns, adverse drug reaction (ADR) incidence, and treatment effectiveness.
Methods
Full medical histories, including prior/concomitant drug use, were collected before initiating mirabegron treatment. After 12 weeks mirabegron, physicians assessed ADR incidence and treatment effectiveness. Residual urine volume was assessed and patients completed the Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score-Quality of Life (I-PSS QoL) surveys at Baseline and 12 weeks. Data were collected between April 2012 and July 2014.
Results
Of 9795 OAB patients (46.8% male; 80.8% ≥65 years), 71.7% had coexisting disease [notably benign prostatic hyperplasia (BPH, 32.4%), hypertension (31.9%), and diabetes mellitus (9.4%)] and 53.4% reported concomitant drug use (27.8% α1-antagonists, 6.3% anticholinergics). The incidence of total ADRs was 6.07% [including constipation (0.97%), thirst (0.47%), and dysuria (0.44%)], of serious ADRs, 0.21%, of cardiovascular ADRs, 0.48% and of urinary retention, 0.31%. Incidence of total ADRs in patients with concomitant cardiovascular disease was 10.09% and of those related to urinary retention in men with untreated BPH, 0.88%. After 12 weeks treatment, physicians judged mirabegron as “effective” in 80.7% of patients, 63.6% of patients achieved the three-point minimal clinically important change from Baseline in the mean OABSS, and the I-PSS QoL decreased significantly from Baseline (−2.1 ± 1.77; P < 0.001).
Conclusions
In the clinical setting, mirabegron is well tolerated, with no unanticipated ADRs, and is an effective treatment for Japanese patients with OAB.
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Citations
Mirabegron: A Review in Overactive Bladder Syndrome.
TL;DR: Urinary and HR-QOL benefits of mirabegron were sustained over up to 52 weeks of treatment and the drug was generally well tolerated, with a numerically lower incidence of dry mouth than antimuscarinics.
64
Mirabegron for the treatment of overactive bladder: a review of efficacy, safety and tolerability with a focus on male, elderly and antimuscarinic poor-responder populations, and patients with OAB in Asia.
TL;DR: A growing body of evidence suggests that mirabegron represents a new treatment option for a broad range of patients with OAB, and has a favorable safety and tolerability profile, particularly compared with antimuscarinics for dry mouth, constipation, and many CNS effects.
37
Rotator cuff tear degeneration and the role of fibro-adipogenic progenitors
Obiajulu Agha,Obiajulu Agha,Agustin Diaz,Agustin Diaz,Michael R. Davies,Michael R. Davies,Hubert T. Kim,Hubert T. Kim,Xuhui Liu,Xuhui Liu,Brian T. Feeley,Brian T. Feeley +11 more
TL;DR: The aim of this review is to summarize the current rotator cuff degeneration assessment tools, the effects of poor muscle quality on patient outcomes, the role of fibro‐adipogenic progenitors in mediating muscle pathology, and how these cells could be leveraged for potential therapeutics to augment current rotators cuff surgical and rehabilitative strategies.
31
Mirabegron improves quality-of-life, treatment satisfaction, and persistence in patients with overactive bladder: a multi-center, non-interventional, real-world, 12-month study.
Robert Freeman,Steve Foley,José Rosa Arias,E. Vicente,Robert Grill,Zuzana Kachlirova,Anny Stari,Moses Huang,Nurul Choudhury +8 more
TL;DR: Patients receiving mirabegron in a real-world setting reported meaningful improvements in QoL and health status, with a persistence rate of 53.8% at 12 months for the FAS.
25
Cardiovascular effects of antimuscarinic agents and beta3-adrenergic receptor agonist for the treatment of overactive bladder.
Gian Marco Rosa,Danilo Baccino,Alberto Valbusa,Carolina Scala,Fabio Barra,Claudio Brunelli,Simone Ferrero +6 more
TL;DR: Antimuscarinic drugs (AMs) are considered to have good CV safety profile but, however, they may cause undesirable adverse events, such as dry mouth, constipation, and mirabegron has similar efficacy and tolerability to AMs but causes less adverse events.
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