Mirabegron 50 mg once daily, long-term treatment maximizes benefit in middle-aged and older people with overactive bladder syndrome: a systematic review and meta-analysis
The International Continence Society (ICS) defines overactive bladder (OAB) as a bladder storage symptom syndrome: “urgency, with or without urgency urinary incontinence, usually with increased daytime frequency and nocturia” (1). Urgency is a sudden and strong urge to urinate that is difficult to postpone, and sometimes there is involuntary urinary leakage, called urgency urinary incontinence. Urinating more than eight times in a 24 h period is recognized as frequent in clinical practice. If a person wakes up over once during the nighttime to urinate from asleep, the condition is known as nocturia (2). In 2008, the prevalence of OAB was approximately 10.7% of the global population of 4.3 billion. It was previously estimated that by 2018, 546 million people would be affected by OAB (20.1%) (3). As a highly prevalent disease, the prevalence and severity of OAB increase with age (4, 5). As the world is expected to enter an aging society, OAB results in adverse effects on patients’ health-related quality of life and a significant financial burden, on the one hand, and may put increasing pressure on healthcare resources, on the other hand (6–9). The myogenic and urothelial-neurogenic hypotheses are the two most frequently recognized explanations for OAB, which is caused by multiple underlying pathophysiologic mechanisms and should be viewed as a complex, multifactorial symptomatic syndrome (10). Current treatment options for OAB include behavioral therapy, pharmacotherapy, minimally invasive surgery, and other surgical options (11). Clinical guidelines identified behavioral therapy with or without pharmacotherapy as the first-line treatment and pharmacotherapy alone as the second-line therapy for OAB (12). This evaluation's focus is solely on pharmaceutical care.
One of the main pharmacologic treatments for OAB is to block the binding of acetylcholine to muscarinic receptors in the bladder wall with anticholinergic drugs; the intestines, salivary glands, eyes, brain, and other areas of the body do, however, have muscarinic receptors. Consequently, this category of medications can have negative effects on several physiological systems, such as constipation, dry mouth, blurred vision, and cognitive dysfunction (13–15). These side effects cause some patients to become intolerant and discontinue treatment, and they particularly hinder the durability of treatment for middle-aged and elderly OAB patients whose base medication is in this class. Mirabegron is a β3-adrenergic receptor agonist that selectively stimulates bladder β3-adrenergic receptors, mediates relaxation of the detrusor, and modulates sensory pathways, bladder afferent neural activity, and neurotransmitter release, from the urothelium, thereby increasing bladder capacity and decreasing bladder sensitivity to alleviate the storage-phase symptom syndrome—OAB (10, 16, 17). At the same time, it has been shown that mirabegron has a concentration-dependent diastolic effect on the detrusor, which results from a combination of action through agonism of β3-adrenergic receptors and antagonism of α1-adrenergic receptors (18). It was approved by the US Food and Drug Administration in 2012 for the treatment of OAB symptoms and is an alternative treatment regimen for antimuscarinic treatment of OAB (19). To support and further define the reported efficacy and safety of adult patients receiving mirabegron monotherapy, we included evidence from the most recent extant global clinical trials of 12-week placebo-controlled randomized studies in patients with OAB. We aimed to integrate these existing high-level studies and conduct a meta-analysis of these studies to explore mirabegron for OAB efficacy and safety.
Objectives
To evaluate the efficacy of mirabegron in the treatment of overactive bladder syndrome in comparison to a placebo. We will address the following assumption: mirabegron is more effective than a placebo in managing overactive bladder syndrome.
Mirabegron 50 mg once daily, long-term treatment maximizes benefit in middle-aged and older people with overactive bladder syndrome: A systematic review and meta-analysis of nine phase II/III, randomized, double-blind, parallel-design, placebo-controlled, multicenter, and multinational trials. (2024). Frontiers in Surgery, 11. https://doi.org/10.3389/fsurg.2024.1372175
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