Efficacy

GO with efficacy for incontinence
and micturition frequency1

Study Design: Monotherapy

Myrbetriq was evaluated in three 12‑week, double‑blind, randomized, placebo‑controlled, parallel‑group, multicenter clinical trials in adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency (Studies 1, 2, and 3).

MYRBETRIQ (mirabegron) Study Design details

Clinical Studies: Monotherapy

Efficacy demonstrated in three 12-week, double-blind, placebo-controlled Phase III studies1

Drop of water

Fewer episodes of
incontinence

Clock showing hours between events

Reduced micturition
frequency

Beaker

Greater volume
voided

Reduced Incontinence

Myrbetriq significantly reduced incontinence episodes per 24 hours1

Co-primary Endpoint

Mean change from baseline to end treatment (Week 12) in number of incontinence episodes per 24 hours (Full Analysis Set-Incontinence [FAS-I])1-5*†‡

MYRBETRIQ (mirabegron) Clinical Study Results: Reduced Incontinence

Myrbetriq was effective in treating the symptoms of overactive bladder (OAB):

  • Myrbetriq 25 mg: Within 8 weeks
  • Myrbetriq 50 mg: Within 4 weeks

The efficacy of Myrbetriq 25 mg and 50 mg was maintained through the 12-week treatment period.1

*For incontinence episodes per 24 hours, the analysis population is restricted to patients with ≥1 episode of incontinence at baseline.
Adjusted mean for baseline, gender, and geographic region.
This population includes patients randomized to placebo and Myrbetriq 50 mg in Studies 1 and 2.
§Statistically significant vs placebo at the 0.05 level with multiplicity adjustment.
Reduced Micturition Frequency

Myrbetriq significantly reduced micturition frequency per 24 hours1

Co-primary Endpoint

Mean change from baseline to end of treatment (Week 12) in number of micturitions per 24 hours1-5*

MYRBETRIQ (mirabegron) Clinical Study Results: Reduced Micturition Frequency

Myrbetriq was effective in treating the symptoms of overactive bladder (OAB):

  • Myrbetriq 25 mg: Within 8 weeks
  • Myrbetriq 50 mg: Within 4 weeks

The efficacy of Myrbetriq 25 mg and 50 mg was maintained through the 12-week treatment period.1

*Adjusted mean for baseline, gender, and geographic region.
Statistically significant vs placebo at the 0.05 level with multiplicity adjustment.
Increased Volume Voided

Myrbetriq increased the mean volume of urine voided per micturition1

Secondary Endpoint

Mean change from baseline to end of treatment (Week 12) in volume of urine (mL) voided per micturition1-5*

MYRBETRIQ (mirabegron) Clinical Study Results: Increased Volume Voided
Study 1: Increased Volume Voided Data Over Time
Study 2: Increased Volume Voided Data Over Time
Study 3: Increased Volume Voided Data Over Time

*Adjusted mean for baseline, gender, and geographic region.
Statistically significant vs placebo at the 0.05 level with multiplicity adjustment.
Myrbetriq 25 mg did not demonstrate statistical significance for change in volume voided per micturition.

Elderly Patient Subgroup Analysis

Overactive bladder (OAB) Prevalence

  • The prevalence of OAB symptoms increases with age in both men and women6
  • OAB has a prevalence of ~15% among those aged ≥65 and 30–40% among those aged ≥757

Myrbetriq Monotherapy in Elderly Patient Populations

Pie chart showing percent of elderly on MYRBETRIQ (mirabegron) by age group
  • Magnifying glass
    No overall differences in safety or effectiveness were observed between patients <65 years and those ≥65 years of age in the Phase II and III studies of Myrbetriq1*
  • Wave
    The pharmacokinetics of Myrbetriq were similar in elderly and younger volunteers1†

*Of 5648 patients who received Myrbetriq monotherapy in the Phase II and III studies for OAB, 2029 (35.9%) were 65 years of age or older, and 557 (9.9%) were 75 years of age or older. All patients were ≥18 years of age.1

The Cmax and area under curve (AUC) of Myrbetriq following multiple oral doses in elderly volunteers (≥65 years) were similar to those in younger volunteers (18 to 45 years).1

To see the safety results, including a subset analysis of elderly patients, click here

Study Design: PILLAR, the First Prospective Study of Myrbetriq in Adults ≥65

Efficacy demonstrated in a double-blind, randomized, placebo-controlled, parallel-group, multicenter Phase IV study8

Entry Criteria

  • Male and female community-dwelling patients ≥65 years of age
  • Wet OAB symptoms (defined as urgency, urinary frequency, and urinary incontinence) for ≥3 months
  • ≥8 micturition episodes per 24 hours
  • ≥3 urgency episodes
  • ≥1 urinary incontinence episode

Efficacy Endpoints

  • Co-primary Endpoint: Change from baseline to end of treatment (EoT) in the mean number of urinary incontinence episodes per 24 hours
  • Co-primary Endpoint: Change from baseline to EoT in the mean number of micturitions per 24 hours
  • Secondary Endpoint: Change from baseline to EoT in mean volume voided per micturition

Treatment Arms and Timeline

After a 2-week placebo run-in period, those who entered the 12-week treatment period were randomized to Myrbetriq 25 mg or placebo and were given the option to increase to 50 mg at Week 4 or Week 8 based on individual efficacy, tolerability, and investigator discretion.

This study was designed to detect a difference between placebo and total mirabegron groups and not for each individual mirabegron dosing group.

EoT = End of Treatment

PILLAR Efficacy Results

Reduced Incontinence

Myrbetriq significantly reduced the mean number of incontinence episodes per 24 hours in patients ≥65 years of age8

Co-primary Endpoint

Change from baseline to end of treatment (EoT) in mean number of urinary incontinence episodes per 24 hours8

  • 38% of elderly patients receiving Myrbetriq achieved zero incontinence vs 30% in the placebo group (OR 1.50, 95% CI 1.09, 2.06).
  • 38% of elderly patients receiving Myrbetriq achieved zero incontinence vs 30% in the placebo group (OR 1.50, 95% CI 1.09, 2.06).
Reduced Micturition Frequency

Myrbetriq significantly reduced the mean number of micturitions per 24 hours in patients ≥65 years of age8

Co-primary Endpoint

Change from baseline to EoT in the mean number of micturitions per 24 hours8

Increased Volume Voided

Myrbetriq increased the mean volume of urine voided per micturition in patients ≥65 years of age8

Secondary Endpoint

Change from baseline to EoT in mean volume voided per micturition8

To see PILLAR safety results in patients ≥65 years of age, click here

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Important Safety Information,
Indications and Usage

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INDICATIONS AND USAGE

MYRBETRIQ® (mirabegron extended-release tablets), either alone or in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.

IMPORTANT SAFETY INFORMATION

MYRBETRIQ® (mirabegron extended-release tablets) is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet.

MYRBETRIQ monotherapy or in combination with solifenacin succinate can increase blood pressure in adults. Periodic blood pressure determinations are recommended, especially in hypertensive patients. MYRBETRIQ is not recommended for use in patients with severe uncontrolled hypertension (defined as systolic blood pressure ≥ 180mm Hg and/or diastolic blood pressure ≥ 110mm Hg). Worsening of pre-existing hypertension was reported infrequently in patients taking MYRBETRIQ.

In patients taking MYRBETRIQ, urinary retention has been reported in patients with bladder outlet obstruction (BOO) and in patients taking muscarinic antagonist medications for the treatment of OAB. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with mirabegron; however, MYRBETRIQ should still be administered with caution to patients with clinically significant BOO. For example, monitor these patients for signs and symptoms of urinary retention. MYRBETRIQ should also be administered with caution to patients taking muscarinic antagonist medications for the treatment of OAB, including solifenacin succinate.

Angioedema of the face, lips, tongue and/or larynx has been reported with MYRBETRIQ. In some cases, angioedema occurred after the first dose. Cases have been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue MYRBETRIQ and initiate appropriate therapy and/or measures necessary to ensure a patent airway.

Since MYRBETRIQ is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates is increased when co‐administered with MYRBETRIQ. Therefore, appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6.

In clinical trials, the most commonly reported adverse reactions in adults (> 2% and > placebo) for MYRBETRIQ 25mg and 50mg versus placebo, respectively, were hypertension (11.3%, 7.5% vs. 7.6%), nasopharyngitis (3.5%, 3.9% vs. 2.5%), urinary tract infection (4.2%, 2.9% vs. 1.8%), and headache (2.1%, 3.2% vs. 3.0%).

In clinical trials, the most commonly reported adverse reactions in adults (> 2% and > placebo and > comparator) for MYRBETRIQ in combination with solifenacin succinate 25mg + 5mg and 50mg + 5mg versus MYRBETRIQ 25mg, MYRBETRIQ 50mg, solifenacin succinate 5mg, and placebo, respectively, were dry mouth (9.3%, 7.2% vs. 3.8%, 3.6%, 6.5%, 2.2%), urinary tract infection (7.0%, 4.0% vs. 4.0%, 4.2%, 3.6%, 5.3%), constipation (4.2%, 3.9% vs. 1.2%, 2.8%, 2.4%, 1.2%), and tachycardia (2.2%, 0.9% vs. 1.6%, 1.6%, 0.7%, 0.8%).

In postmarketing experience with mirabegron, the following events have also occurred: atrial fibrillation, nausea, diarrhea, and dizziness.

Please refer to prescribing information for solifenacin succinate when prescribing MYRBETRIQ in combination with solifenacin succinate.

Please click here for complete Prescribing Information for Myrbetriq® (mirabegron extended-release tablets)

References

1. Myrbetriq [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 2. Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol 2013;63(2):283-95. 3. Nitti VW, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol 2013;189(4):1388-95. 4. Astellas. Myrbetriq. Data on File. 5. Herschorn S, Barkin J, Castro-Diaz D, et al. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the β3 adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology 2013;82(2):313-20. Erratum in: Urology 2013;82(6):1457. 6. Coyne KS, Sexton CC, Vats V, Thompson C, Kopp ZS, Milsom I. National community prevalence of overactive bladder in the United States stratified by sex and age. Urology 2011;77(5):1081-7. 7. Wagg A, Cardozo L, Nitti VW, et al. The efficacy and tolerability of the β3-adrenoceptor agonist mirabegron for the treatment of symptoms of overactive bladder in older patients. Age Ageing 2014;43(5):666-75. 8. Wagg A, Staskin D, Engel E, Herschorn S, Kristy RM, Schermer CR. Efficacy, safety, and tolerability of mirabegron in patients aged ≥65yr with overactive bladder wet: a phase IV, double-blind, randomised, placebo-controlled study (PILLAR). Eur Urol 2020;77(2):211-20.