Mirabegron is a novel, once-daily, orally active, first-in-class, potent β3-adrenoceptor agonist recently approved by Food and Drug Administration for overactive bladder therapy. Phase II studies and four large-scale phase III multinational randomized, controlled trials have supported the efficacy and tolerability of mirabegron in the clinical trial setting of patients with overactive bladder for up to 12 weeks of therapy and in the long term (12 months). The reported incidence and severity of treatment-emergent and serious adverse effects were similar to antimuscarinics, but with a more than threefold lower incidence of dry mouth compared with tolterodine. However, the effects on the cardiovascular system, pharmacokinetic interactions with other drugs, and increased incidence of new malignant events will require careful evaluation in the near future.

https://journals.sagepub.com/doi/pdf/10.1177/1756287212457114

Mirabegron: A review of recent data and its prospects in the management of overactive bladder

The lack of an alternative to antimuscarinics has led to the search for new drug targets for overactive bladder (OAB) symptoms. The presence of β-3 adrenoreceptors in the bladder has been confirmed, and they are known to have a role in bladder relaxation. Targeting these receptors improves bladder compliance on filling and increases bladder capacity. MEDLINE literature search on efficacy and safety of mirabegron was performed. The US Food and Drug Administration Web site, clinicaltrials.gov, and controlled-trials.com online trial registries were searched for English-language articles containing the term “mirabegron”. Finally, abstracts from recent International scientific meetings were searched for randomised controlled trials (RCTs). Studies show that mirabegron reduces the number of micturitions and incontinence episodes in a 24-h period compared with placebo. Dry mouth and gastrointestinal disturbances are the most common side effects, but these have been rated as mild to moderate. A small rise in mean heart rate and blood pressure has been shown. Further investigations are ongoing and results are awaited. Although mirabegron is metabolised by CYP2D6, it is also thought to inhibit the activity of this enzyme. Therefore, potential drug interactions with other CYP2D6 substrates need to be further studied. Mirabegron is a promising alternative to antimuscarinics. Further information on its long-term use in terms of efficacy, safety, and tolerability is awaited.

Use of mirabegron in treating overactive bladder

Overactive bladder is a common condition that significantly impacts overall quality of life. Antimuscarinics are the current main pharmacological option for treatment; however, many patients fail to adhere to therapy due to troublesome side effects. Mirabegron is a new beta-3 adrenoreceptor agonist which causes detrusor smooth muscle relaxation and has been proposed to be effective for treating overactive bladder symptoms. Mirabegron has been shown to be superior to placebo for reducing the mean number of incontinence episodes per 24 hours and the mean number of micturitions per 24 hours. Side effects such as dry mouth were observed at similar or lower rates than those seen for placebo and antimuscarinics. Higher doses of mirabegron were associated with minor increases in pulse rate and mean blood pressure. Mirabegron offers a new alternative for treating overactive bladder in patients for which antimuscarinics are either not tolerated or not appropriate.

/pdf/mirabegron-a-selective-b3-adrenoreceptor-agonist-for-the-4zn7kudybo.pdf

Mirabegron - a selective β3-adrenoreceptor agonist for the treatment of overactive bladder.

The medical management of refractory Overactive Bladder

Context Mirabegron, the selective β3-adrenoceptor agonist, heralds the latest development for the treatment of overactive bladder (OAB). Objective To present the evidence available on the efficacy and tolerability of mirabegron and to discuss this treatment's potential in our setting. Evidence acquisition We reviewed 11 studies conducted with mirabegron in patients with OAB (2 phase ii , 9 phase iii ), all studies were compared to placebo with 6 studies also including tolterodine as an additional arm. Greater emphasis shall be given to the main phase iii trials performed in Europe, the USA and Australia evaluating efficacy and safety after 12 weeks ( NCT00662909 , NCT00689104 , NCT00912964 ) and safety after 12 months ( NCT00688688 ). The combined analyses of these 12-week studies are also available, with emphasis on global efficacy (FAS), efficacy with regard to incontinence (FAS i ) and safety (SAF). More than 50% of patients had previously discontinued anticholinergics medication for OAB, thus allowing us to obtain data on the effectiveness of mirabegron in patients already treated with anticholinergics. Evidence synthesis Mirabegron is an efficacious drug which presents a statistically significant reduction in the number of incontinence episodes and in urinary frequency as of 4 weeks, with a higher percentage of dry patients and a higher percentage of patients with reduction ≥50% in the number of incontinence episodes than placebo. The efficacy of mirabegron 50 and 100 mg in the reduction of incontinence episodes occurs in de novo patients and who have received antimuscarinics, with adjusted mean difference and improvement in urinary frequency greater in treated patients. Its tolerability is very similar to placebo particularly for the adverse effects of the antimuscarinics (dry mouth, constipation and blurred vision). A minimal, non-clinically significant change is observed in systolic and diastolic blood pressure and pulse. Its efficacy is long-term. Mirabegron at the doses of 50 and 100 mg presents an improvement versus placebo in patient satisfaction, health-related quality of life (HRQoL), symptom bother and patient's perception of bladder condition (PPBC). In the 12-week phase III European study tolterodine deliverred a lesser degree of improvement than mirabegron versus placebo in patient satisfaction, HRQoL, symptom bother and PPBC. Conclusions Mirabegron is the first of a new class of compounds with a novel mechanism of action that is different to the antimuscarinics. It presents significant and clinically important efficacy in the treatment of the symptoms of OAB. It has advantages with regard to the results described by the patient in treatment satisfaction. Studies on its combined use with anticholinergics are ongoing.

Evidence available on the use of the selective β3-adrenoceptor agonist mirabegron for the treatment of overactive bladder.

1958 THE SELECTIVE β3-ADRENORECEPTOR AGONIST MIRABEGRON IS EFFECTIVE AND WELL TOLERATED IN PATIENTS WITH OVERACTIVE BLADDER SYNDROME

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1958 THE SELECTIVE β3-ADRENORECEPTOR AGONIST MIRABEGRON IS EFFECTIVE AND WELL TOLERATED IN PATIENTS WITH OVERACTIVE BLADDER SYNDROME