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Mirabegron

Mirabegron, also known by brand names like Betmiga, Myrbetriq, and Betanis, is a medication being studied in clinical trials for the treatment of overactive bladder (OAB) and related conditions. These trials aim to evaluate its effectiveness, safety, and how it works in the body across different patient groups, including adults and children. The research explores various aspects such as quality of life improvements, long-term effects, and comparisons with other treatments.

Table of Contents

What is Mirabegron?

Mirabegron is a medication primarily used to treat overactive bladder (OAB). It was developed by Astellas Pharma and approved by the United States Food and Drug Administration (FDA) in July 2012[1]. Mirabegron belongs to a class of drugs called β3 adrenergic receptor agonists, which means it works by activating certain receptors in the bladder to help it function better[2].

What Conditions Does Mirabegron Treat?

Mirabegron is primarily used to treat the following conditions:

  • Overactive Bladder (OAB): A condition characterized by sudden urges to urinate that are difficult to control, frequent urination, and sometimes involuntary loss of urine[3].
  • Urgency Incontinence: A type of urinary incontinence where you suddenly feel the need to urinate and may leak urine before reaching the toilet[3].
  • Neurogenic Detrusor Overactivity (NDO): A condition where the bladder contracts involuntarily due to nerve problems, often seen in patients with neurological disorders[4].

How Does Mirabegron Work?

Mirabegron works differently from other OAB medications. It activates β3 adrenergic receptors in the bladder muscle, which helps the bladder relax and increases its capacity to hold urine. This action can reduce the frequency of urination and the sudden urges to urinate that are common in OAB[2].

Brand Names and Forms

Mirabegron is marketed under several brand names worldwide:

  • Myrbetriq
  • Betmiga
  • Betanis
  • Bladogra

It is available in different forms, including:

  • Extended-release tablets (usually 25 mg or 50 mg)
  • Oral suspension (for children or adults who have difficulty swallowing tablets)[4]

Effectiveness of Mirabegron

Clinical studies have shown that Mirabegron can be effective in improving symptoms of OAB. Researchers use various measures to assess its effectiveness, including:

  • Overactive Bladder Questionnaire (OAB-q): This measures the patient’s quality of life related to bladder symptoms[1].
  • Patient Perception of Bladder Control (PPBC): This assesses how patients perceive their bladder control[1].
  • Urinary Distress Inventory (UDI): This measures how bothered patients are by urinary symptoms[1].

These measures help doctors understand how well the medication is working for individual patients.

Potential Side Effects

Like all medications, Mirabegron can cause side effects. Common side effects may include:

  • Increased blood pressure
  • Urinary tract infections
  • Headache
  • Constipation

It’s important to note that not everyone experiences side effects, and your doctor will monitor you closely while you’re taking this medication[5].

Usage in Children

Mirabegron is also being studied for use in children with overactive bladder or neurogenic detrusor overactivity. A special oral suspension form has been developed for children who may have difficulty swallowing tablets. However, its use in children is still under investigation to determine the appropriate dosage and safety profile[4].

Combination Therapy

In some cases, Mirabegron may be used in combination with other medications to treat OAB, particularly in men who also have benign prostatic hyperplasia (enlarged prostate). For example, it may be combined with drugs called alpha-blockers like Tamsulosin. This combination therapy aims to address multiple aspects of urinary symptoms and may provide better symptom relief for some patients[6].

Aspect Details
Drug Name Mirabegron (also known as Betmiga, Myrbetriq, Betanis, YM178)
Primary Conditions Studied Overactive Bladder (OAB), Neurogenic Detrusor Overactivity (NDO), Urgency Incontinence
Age Groups Adults and children (including studies on children as young as 6 months)
Administration Methods Oral tablets, oral suspension, intravenous (IV) infusion
Key Outcome Measures Quality of life, bladder capacity, urgency episodes, pharmacokinetics, safety profile
Study Designs Randomized controlled trials, open-label studies, bioequivalence studies, long-term safety studies
Duration of Studies Ranging from single-dose studies to long-term studies up to 52 weeks

FAQ

  • What is Mirabegron used for? Mirabegron is primarily used to treat overactive bladder (OAB) and related conditions like urgency incontinence and neurogenic detrusor overactivity (NDO). It helps control frequent urination, urgency, and accidental urine leakage.
  • How does Mirabegron work? Mirabegron works by relaxing the bladder muscles, which helps increase the bladder's capacity to hold urine. This can reduce symptoms of overactive bladder such as frequent urination and urgency.
  • What are the common side effects of Mirabegron? While specific side effects aren't detailed in the provided trials, clinical studies generally monitor for adverse events. Common side effects of Mirabegron may include headache, increased blood pressure, and urinary tract infections. However, the safety profile is being closely studied in these trials.
  • Is Mirabegron being studied in children? Yes, several clinical trials are investigating the use of Mirabegron in children, including those as young as 6 months old with conditions like neurogenic detrusor overactivity (NDO). These studies aim to determine appropriate dosing, safety, and effectiveness in pediatric populations.
  • How is the effectiveness of Mirabegron measured in clinical trials? The effectiveness of Mirabegron is measured through various means, including changes in bladder capacity, reduction in urgency episodes, improvements in quality of life scores, and changes in urodynamic parameters like maximum cystometric capacity (MCC). Researchers also track patient-reported outcomes and use questionnaires to assess symptom improvement.

Ongoing Clinical Trials on Mirabegron

  • Study on Solifenacin, Mirabegron, and Their Combination for Treating Overactive Bladder and Daytime Urinary Incontinence in Children Aged 5 to 14 Years

    Recruiting

    1 1 1 1
    Investigated drugs:
    Denmark

  • Study on Stopping Solifenacin and Mirabegron for Children with Daytime Urinary Incontinence

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Denmark

  • Study on the Safety and Effectiveness of Mirabegron for Children Aged 6 Months to Under 3 Years with Neurogenic Detrusor Overactivity

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Germany Poland

Glossary

  • Overactive Bladder (OAB): A condition characterized by frequent, sudden urges to urinate that may be difficult to control, often accompanied by involuntary loss of urine.
  • Neurogenic Detrusor Overactivity (NDO): A bladder dysfunction caused by a neurological condition, resulting in involuntary contractions of the detrusor muscle during the filling phase of the bladder.
  • Urgency Incontinence: A sudden, intense urge to urinate followed by an involuntary loss of urine.
  • Maximum Cystometric Capacity (MCC): The volume of fluid in the bladder when the patient feels a strong desire to void or experiences discomfort.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Quality of Life (QoL): A measure of an individual's overall well-being and satisfaction with life, often used to assess the impact of medical treatments.
  • Clean Intermittent Catheterization (CIC): A technique used to empty the bladder regularly using a catheter, which is then removed after each use.
  • Urodynamics: A series of tests that evaluate how well the bladder, sphincters, and urethra store and release urine.
  • Bioequivalence: The absence of a significant difference in the rate and extent at which the active ingredient in pharmaceutical equivalents becomes available at the site of drug action when administered at the same dose under similar conditions.

References

  1. https://clinicaltrials.gov/study/NCT02495389
  2. https://clinicaltrials.gov/study/NCT06124066
  3. https://clinicaltrials.gov/study/NCT02320773
  4. https://clinicaltrials.gov/study/NCT02526979
  5. https://clinicaltrials.gov/study/NCT01901120
  6. https://clinicaltrials.gov/study/NCT02279615