3. OVERACTIVE BLADDER SYNDROME (OAB) - BESER
International Continence Society (ICS) definition:
Overactive bladder (OAB, urgency) syndrome
• Urinary urgency, usually accompanied by increased daytime frequency and/or nocturia, with urinary
incontinence (OAB-wet) or without (OAB- dry), in the absence of urinary tract infection (UTI) or other
detectable disease
ICS, International Continence Society; OAB, overactive bladder; UTI, urinary
tract infection.
Urinary
urgency
Urinary
incontinence
+/
+
UTI or other
detectable
disease
Daytime Frequency
Nocturia
and/or
D’Ancona, et al. Neurology and Urodymaics 2019. 38:433-477
4. CURRENT ICS TERMINOLOGY
Urgency
• Complaint of a sudden, compelling desire to pass urine which is difficult to defer
Increased daytime frequency
• Complaint that voiding occurs more frequently during waking hours than previously deemed normal
by the individual (or caregivers)
Nocturia
• The number of times urine is passed during the main sleep period. Having woken to pass urine for
the first time, each urination must be followed by sleep or the intention to sleep. This should be
quantified using a bladder diary
Urinary incontinence
• Complaint of involuntary loss of urine
ICS, International Continence Society.
D’Ancona, et al. Neurology and Urodymaics 2019. 38:433-477
5. OAB REPRESENTS A COLLECTION OF SYMPTOMS1
OAB, overactive bladder; OABSS, Overactive Bladder Symptom Score.
1. Ouslander JG, et al. N Engl J Med 2004;350:786
Nocturia
(≥2 awakenings per night)
“Waking to pass urine during
the main sleep period”
Urinary urgency
“Complaint of a sudden,
compelling desire to pass urine
which is difficult to deter”
Urination frequency
(≥8 voidings per 24 hours)
“Complaint that voiding occurs
more frequently than deemed
normal”
Urge incontinence
“Complaint of involuntary loss of urine
associated with urgency”
Although older patients have significantly more underlying comorbidities than younger patients,
no significant differences in OABSS exist between them at baseline1
6. YOUNGER AND OLDER PATIENTS WITH OAB EXPERIENCE
MULTIPLE COMORBIDITIES1
OAB, overactive bladder.
1. Lee YK, et al. Geriatr Gerontol Int. 2018;18(9):1330-1333
7. OAB, Overactive bladder; HRQoL, Health-related quality of life.
1. Stewart WF, et al. World J Urol. 2003:20;327-336. 2. Potts JM, et al. Gerontol. 2018;64:541-550. 3. Chiu AF, et al. Tzu Chi Medical Journal. 2012, 24 (2), 56-60. 4. Herschorn S, et al. BJU int. 2008, 101:52-8. 5.
Eapen RS and Radomski SB. Res Rep Urol. 2016;8:71. 6. Lloyd S, et al. Journal of Clinical Urology. 2017;10:513-522.
OAB PRESENTS DIFFERENTLY IN FEMALES AND
REQUIRES SPECIAL CONSIDERATION
Have a similar or
slightly higher
prevalence of OAB
symptoms.1,3,4
Develop incontinence
(wet OAB) at a much
earlier age.1,2
Are more likely to be
bothered by urinary
frequency.5
Experiences statistically
significantly worse
HRQoL than men.6
Compared to men, women:
8. OAB symptoms were found to affect 1 in 5 individuals aged ≥40 years in China,Taiwan, and South Korea, becoming more
common with increasing age. The results suggest that many more individuals with OAB could benefit by consulting
healthcare professionals.
1. Rochani, Mochtar CA, Rahardjo HE, Yunisaf, Santoso BI, Setiati S, et al. Prevalence of urinary incontinence,
risk factors and its impact: multivariate analysis from Indonesian nation-wide survey. Acta Med Indones.
2014. Jul;46(3):175-8
2. Chuang, et al. Lower Urinary Tract Symptoms. 2019.11:48–55
Prevalence of OAB increases with age:
40-44
45-49
50-54
55-59
≥60 27.9%
24.5%
20.0%
15.3%
10.8%
PREVALENCE OF OAB IN INDONESIA - ASIA1,2
• INDONESIA (2014)1 :
- About 2765 completed questionnaires were obtained (from six teaching hospitals in various regions of Indonesia ). The
overall UI prevalence was 13.0% , there was no significant difference of UI prevalence in male and female subjects.
- The prevalence of UI in Indonesia is nearly similar to other Asian countries. It increases with age and is not affected by
gender.
• ASIA2
9. 54% of individuals with
OAB are not receiving
the most effective
available treatment for
their condition
Likelihood of seeking healthcare for urinary symptoms
according to overactive bladder (OAB) status and severity
Chuang YC et al. Low. Urin. Tract Symptoms. 2017;11:48-55
OAB, overactive bladder
OAB REMAINS LARGELY UNTREATED
10. OAB IS UNDERTREATED DUE TO UNDERDIAGNOSIS
of the global population
have OAB1,2
of patients with
symptoms don’t seek
treatment2
is how long female patients
wait before consulting a
physician3
Prevalence is similar
in both males and
females and
increases with age2
Commonly occurs with other
comorbidities:2
OAB, overactive bladder.
1. Irwin DE, et al. BJU international. 2011;108(7):1132-1138. 2. Chuang YC, et al. Low Urin Tract Symptoms. 2019;11:48-55. 3. Dmochowski RR,
et al. Curr Med Res Opin. 2007;23:65-76.
Diabetes
mellitus
Neurological
disease
11. PATIENTS TEND TO ADAPT TO THE DIFFICULTY OF
LIVING WITH OAB AND MAY AVOID SEEKING HELP1
1. Ricci J, et al. Clin Ther. 2001;23:1245-1259. 2. Nicholson P, et al. Br J Health Psychol. 2008;13:343-359.
Constant planning ahead2
Scanning surroundings
for bathrooms2
Adaptive behaviours may lead to a delay in diagnosis and treatment:
Emergency kit preparation2
Hinders diagnostic process1,2
Discussing symptoms can be challenging
Reduces understanding of potential
treatment improvements1,2
Prevents reassessment of treatments
due to embarrassment1,2
12. UNTREATED OAB HAS A DETRIMENTAL IMPACT ON
PATIENTS’ QOL1-3
OAB, overactive bladder.
1. Nicolson P, et al. Br J Health Psychol. 2008;13:343-359. 2. Ouslander JG, et al. N Engl J Med 2004;350:786. 3. Tubaro A, et al. Urology.
2004;64:2-6.
Leads to
patients
feeling:
OAB can
negatively
impact
patients’:
Relationships Financial situations
Quality of life Mental health
Intimacy Work and productivity
Physical health Sleep
13. OAB HAS A CONSIDERABLE FINANCIAL IMPACT ON
PATIENTS
Direct costs are defined as treatment, routine care and diagnosis. Indirect costs are defined as health-related and lost productivity.
OAB, overactive bladder.
1. Hu TW, et al. Urology. 2003;61:1123-8.
Annual costs associated with OAB for patients in the community setting are estimated to be:
Lost
Productivity
Diagnosis
Treatment
Routine Care
Health-Related
USD$841.24
million dollars
USD$2,798.99
million dollars
USD$77.98
million dollars
USD$1,562.64
million dollars
USD$3,887.74
million dollars
49% of annual
costs are direct1
51% considered
indirect costs1
14. DRUG ACQUISITION HAS A LESSER FINANCIAL IMPACT
THAN OTHER COST COMPONENTS
1. Reeves P, et al. Eur Urol. 2006;50:1050-1057.
Compared with other cost components, drugs acquisition costs 6x less than pads and 2x less than physician consultations1
20%
63%
10%
Proportion of Annual Cost Components
Physician
Consultations
Pads
Drug
Acquisitions
16. Misdiagnosis may occur owing to shared symptomatology with recurrent UTIs and BPH
OAB HAS SHARED SYMPTOMATOLOGY WITH OTHER
COMMON UROLOGIC CONDITIONS1
BPH, benign prostatic hyperplasia; OAB, overactive bladder; UTI, urinary tract infection.
1. Nik-Ahd F, et al. Current Urology Reports. 2018;19(11):94
OAB
BPH
UTI
Discrete symptoms:
o Dysuria
o Haematuria
NOTE:
Unlike in OAB, all UTI symptoms tend to be acute
Shared symptoms (OAB/UTI):
o Urgency
o Frequency
o Nocturia
Discrete symptoms:
o Hesitancy
o Intermittency
o Sensation of incomplete voiding
Shared symptoms (OAB/BPH):
o Urgency
o Frequency
17. EAU GUIDELINES:
APPROPRIATE SCREENING TOOLS
1. EAU Guidelines. Edn. presented at the EAU Annual Congress Amsterdam, 2020. ISBN 978-94-92671-07-3.
The following methods and tools are recommended by the EAU guidelines as part of the OAB diagnostic evaluation:1
Patient history and
physical examination
including comorbidities
Post-void residual volume
Patient questionnaires
Urodynamics
Voiding diaries
Pad testing
Urinalysis and urinary
tract infection
Imaging
18. OABSS: A SIMPLE, RELIABLE DIAGNOSTIC TOOL
OAB, overactive bladder.
1. Homma Y, et al. Urology. 2006;68(2):318-323.
A self-reported symptom assessment questionnaire designed to quantify four OAB symptoms into a single score,
with higher score:1
Night-time
frequency
Urgency
Daytime frequency
Urge incontinence
If the total score is over 3 points and the Q3 score over 2 points, OAB is diagnosed.
If the total score is 5 or less: Mild, 6‒11: Moderate, 12 or more: Severe
19. To overcome treatment challenges during the COVID-19 pandemic, the EAU developed additional guidance based on
current EAU guidelines to support urologists:1
DIAGNOSING OAB DURING THE COVID-19 PANDEMIC
1. Ribal MJ, et al. Eur Urol. 2020;78(1):21-28.
Imaging of the urinary tract is not
recommended when evaluating patients
with incontinence
Remote consultations and
diagnostics utilising current guidelines
are recommended
Resources from primary care can be
used i.e. monitoring of blood tests
Symptom scores and bladder diaries
can be emailed to patients
Remote follow-up of existing patients
with urinary incontinence is
recommended
Urodynamic investigations and
supplementary investigations should
be deferred
20. To cope with symptoms of OAB, many patients employ
elaborate behaviours to hide and manage symptoms
Ricci, et al. Clin Ther 2001. 23:1245
Use absorbent
products
Medication Restrict fluid
intake
Wear special
clothing to conceal
accidental urine loss
Regular
schedule for
urination
Bathroom
mapping
COMMON PATIENT COPING BEHAVIOURS
22. AUA/SUFU and EAU guidelines recommend mirabegron as first- or second-line therapy, in combination therapy for
patients refractory to monotherapy or if conservative treatment fails:
GUIDELINES ON MANAGING URINARY INCONTINENCE
(AUA/SUFU AND EAU)1,2
*Long-term antimuscarinic treatment should be used with caution in the elderly
1. Gormley EA, et al. J Urol. 2015; 193:1572–80. 2. EAU. Guidelines on urinary incontinence. Presented at the European Association of Urology (EAU) Annual Congress; 15-19 Mar
2019. Barcelona, Spain. Available at: https://uroweb.org/guideline/urinary-incontinence/. Accessed 14 Sept 2021.
1ST-LINE
Behavioural
therapies
± monotherapy
with an antimuscarinic
or mirabegron or
individualised
behavioural and
physical therapies
including pelvic floor
muscle training
2ND-LINE
Pharmacological
management
Antimuscarinics or oral
B3-adrenoreceptor
For patients refractory
to monotherapy:
Combination therapy with
antimuscarinic and B3
adrenereceptors
3RD-LINE
PTNS and
neuromodulation
(BoNT-A) or posterior
tibial nerve stimulation
(PTNS) or sacral
neuromodulation
(SNM) or mid-urethral
sling
4TH-LINE
(If other
options fail)
Bladder augmentation
or urinary diversion
23. GUIDELINE RECOMMENDATION
EAU: European Association of Urology
1. EAU Guidelines. Edn. presented at the EAU Annual Congress Amsterdam, 2020. ISBN 978-94-92671-07-3.
Recommendations from the 2020 EAU Guidelines on urinary incontinence in adults
Oxybutynin may worsen cognitive function in elderly patients.
Mirabegron has been shown to be efficacious and safe in elderly patients.
2
Long-term antimuscarinic treatment should be used with caution in elderly patients
especially those who are at risk of, or have, cognitive dysfunction.
EAU 2020 recommendation for use of antimuscarinic drugs for urinary incontinence in the elderly.1
1b
Summary of evidence for use of antimuscarinics in the elderly Evidence level
Long-term antimuscarinic treatment should be used with caution in elderly
patients especially those who are at risk of, or have, cognitive dysfunction
Strong
Summary of evidence for use of antimuscarinics in the elderly Evidence level
24. EAU guidelines recommend mirabegron if conservative treatment fails:1
GUIDELINES ON MANAGING MALE LUTS1
*Or prostate volume >40 mL when long-term treatment is not indicated.
PDE5i, Phosphodiesterase type 5 inhibitors.
1. EAU. Guidelines on management of non-neurogenic male LUTS. Presented at the European Association of Urology (EAU) Annual Congress; 15-19 Mar 2019. Barcelona, Spain. Available at:
https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts/.Accessed 14 Sept 2021.
Residual storage symptoms1
following α-blocker/ PDE5i
monotherapy
(prostate volume <40ml)*
Predominant storage
symptoms1
Education and
lifestyle advice
Mirabegron or
antimuscarinics
Education and
lifestyle advice
Add on mirabegron
or antimuscarinics
to α-blocker or PDE5i
25. GUIDELINES ON MANAGING OAB IN THE ELDERLY1-4
AGS, American Geriatrics Society; AUA/SUFU, American Urological Association/Society of Urodynamics, Female Pelvic Medicine and Urogenital
Reconstruction; CUA, Canadian Urology Association; EAU, European Association of Urology.
1. EAU. Guidelines on urinary incontinence. Presented at the European Association of Urology (EAU) Annual Congress; 15-19 Mar 2019. Barcelona, Spain. Available at: https://uroweb.org/guideline/urinary-incontinence/.
Accessed 14 Sept 2021. 2. Corcos J et al. CUA guideline on adult overactive bladder. Can Urol Assoc J 2017; 11: E142–73. 3. Nishtala PS, et al. Exp Opin Drug Safety. 2016;15:753–68. 4. Shah D, Badlani G. Rev Urol. 2002;
4(Suppl.4); S38–43. 5. Macdiarmid SA. Rev Urol. 2008;10: 6–13.
AUA/SUFU, EAU, CUA and the AGS recommend that long-term antimuscarinic
treatment be used with caution due to potential cumulative effects on cognitive
function and the associated increase in risk for falls and fractures1-4
Concurrent medications should be evaluated as up to 50% of medications often
prescribed to older patients have anticholinergic activity, and can contribute to
patients’ anticholinergic burden, or aggravate urinary symptoms3,4
Urinary retention may result from anticholinergics, narcotics, antidepressants,
sedatives, and alpha-adrenergic agonists5
26. GUIDELINE RECOMMENDATIONS ON MANAGEMENT OF
INCONTINENCE IN FEMALES WITH OAB
AUA, American Urology Association; SUFU, Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction; EAU, European Association of Urology; BoNT-A, Onabotulinum toxin-A;
PTNS, Peripheral tibial nerve stimulation
1. Gormley EA, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. 2019. Available at: https://www.auanet.org/guidelines/overactive-bladder-(oab)-
guideline. Accessed 09 Sep 2021. 2. EAU Guidelines. Edn. presented at the EAU Annual Congress Amsterdam, 2020. ISBN 978-94-92671-07-3.
1st-line 2nd-line 3rd-line
Behavioural therapies with
or without monotherapy of
an antimuscarinic or a beta
3-adrenoceptor agonist
such as mirabegron1
Conservative management:
individualised behavioural and
physical therapies including
pelvic floor muscle training2
For patients refractory to
monotherapy, combination
therapy with an antimuscarinic
and beta 3-adrenoceptor
agonist such as mirabegron1
Mirabegron or an antimuscarinic
(extended release if possible).
Long-term antimuscarinic
treatment should be used with
caution in elderly patients2
Intradetrusor BoNT-A, PTNS,
or sacral nerve modulation1
Mid-urethral sling, PTNS,
BoNT-A, or sacral nerve
modulation2
Mirabegron can be recommended as first-line pharmacological treatment with or after behavioural therapy
in management of incontinence in female patients with OAB.
AUA/
SUFU
EAU
27. GUIDELINES ON FEMALE INCONTINENCE1
OAB, Overactive bladder.
1. Harding CK (Chair) et al. EAU Guidelines on Management of Non-Neurogenic Female Lower Urinary Tract Symptoms (LUTS). European Association of
Urology 2021.
Mirabegron is recommended as an alternative to anticholinergics in women
with overactive bladder who fail conservative treatment.
Long-term anticholinergic treatment should be used with caution in elderly
women, especially those who are at risk of, or have pre-existing cognitive
dysfunction
Anticholinergic burden and associated co-morbidities should be assessed in
patients being considered for anticholinergic therapy for OAB
32. Key considerations of OAB management1-3
OAB, overactive bladder.
1. European Association of Urology. EAU guidelines on urinary incontinence in adults 2018. 2. Dhaliwal P, et al. Clin Interv Aging. 2016;11:755-
760. 3. Schabert VF, et al. Am J Manag Care. 2009;15:S118-122.
OAB should be managed
from a long-term perspective
To achieve the best treatment
outcomes with chronic
diseases, adherence to
prescribed treatment and
long-term medication
persistence are needed
Encourage lifestyle and
behavioural modifications
Lifestyle modifications and
behavioural interventions may
be necessary to enhance
patient adherence to medication
Patient education is crucial
for treatment persistence
Medical adherence support and
patient education may help
address unmet treatment
expectations
33. OAB, overactive bladder.
1. Kim TH, et al. ICUrology. 2016;57:84-93. 2. Wagg A, et al. BJU Int. 2012;110:1767-74.
ADHERENCE AND PERSISTENCE: THE KEY IN OAB
MANAGEMENT
Persistence with therapy is key to sustained symptom control and improved quality of life2
Considerations in OAB management1
Common and chronic condition
impacting quality of life
Severity progresses dynamically
over long time periods
Requires long-term treatment
for reliable symptom control
Consequences of poor
treatment
persistence and
adherence:1
Higher risk of morbidity and
mortality
Higher risk for increased
healthcare costs
Increased healthcare resource
use
34. OAB, overactive bladder.
1. Kim TH, et al. ICUrology. 2016;57:84-93. 2. Chapple CR. et al. European urology. 2017 Sep 1;72:389-99. 3. Yeowell G, et al. BMJ open. 2018;8:e021889.
PERSISTENCE WITH ANTIMUSCARINICS IS LOW
Persistence with antimuscarinics in OAB is markedly poorer than other types of chronic medication such as statins and
antihypertensive medication1
Percentage of Patients Remaining on Each Antimuscarinic Over 12 Months2
Patients with OAB should
receive therapy combining a
good efficacy-tolerability
profile with evidence of
persistence and adherence3
35. CHALLENGES WITH ANTIMUSCARINIC THERAPY
OAB, overactive bladder.
1. Chancellor MB, et al. Int Urol Nephrol. 2016;48:1029-1036. 2. Nambiar AK, et al. Eur Urol. 2018;73:596-609. 3. Wagg A, et al. Eur Urol. 2020;77:211-20.
Antimuscarinic cycling1
Discontinuation of an antimuscarinic is followed by a
switch to another antimuscarinic.
Patient can cycle from 1 to 6 antimuscarinics with
out addition benefit, leading to sub-optimal care.
Polypharmacy and anticholinergic burden2,3
Antimuscarinics can increase the anticholinergic burden in
patients.
Elderly patients have higher risk of cognitive dysfunction,
alteration in CNS metabolism, and association with brain
atrophy with prolonged antimuscarinic use.
Poor Persistence1
Adherence to antimuscarinic therapy is reportedly
low (18%) and almost half discontinue their first
prescribed antimuscarinic.
Most discontinue within the first year due to lack of
efficacy, adverse events, and/or cost.
36. MIRABEGRON: A FIRST-IN-CLASS BETA-3 AGONIST
QoL, Quality of life.
1. Nitti VW, et al. J Urol. 2013;189:1388-1395. 2. Kelleher C, et al. European urology. 2018;74(3):324-333. 3. Chapple C, et al. European
urology. 2015;67(1):11-4. 4. Drake MJ, et al. European urology. 2016;70(1):136-45. 5. Lozano-Ortega G, et al. Drugs Aging. 2020;37:801-816. 6. Nazir J, et al.
Pharmacoecon Open. 2017;1:25-36. 7. Kato D, et al. Low Urin Tract Symptoms. 2019;11:O152-O161. 8. Soda T, et al. Neurourol Urodyn. 2020;39:2527-2534. 9. Andersson KE, et al.
Ther Adv Urol. 2018;10:243-256. 10. Chapple CR, et al. Int Urogynecol J. 2013;24:1447-1458. 11. Freeman R, et al. Curr Med Res Opin. 2018;34:785-793.
MIRABEGRON
Proven efficacy1‒4 Favourable safety profile5
Improved QoL10,11 Cost-effectiveness6
Quick onset of action9 Better persistence7,8
As monotherapy and in
combination with solifenacin
Does not contribute to anticholinergic burden
Clinically meaningful improvements
in QoL and health status
Low healthcare utilisation
Reported as early as 2 weeks,
similar to antimuscarinics
Observed up to 3 years, significantly longer
when administered in first‐ or second‐line
37. MIRABEGRON IS SUPPORTED BY A WEALTH OF DATA1,2
1. Sacco E, et al. Ther Adv Urol. 2012;4:315-324. 2. Astellas Data on File.
Since its launch,
mirabegron has
garnered a wealth
of data in:1
Male
Combination
Elderly
Neoplasm Real-World
Evidence
Pediatrics
Cardiovascular
Safety
83 countries2
Approved in
65 countries2
Marketed in
18,500,000
patients treated2 international
guidelines2
Recommended by
38. MIRABEGRON IS ASSOCIATED WITH A FAVOURABLE
TOLERABILITY IN PATIENTS WITH OAB
1. Kelleher C, et al. Eur Urol. 2018;74:324-333.
According to a meta-analysis of randomised
control trials from 2000–2017, mirabegron
was significantly better tolerated regarding:
Dry Mouth
(21/22 active comparators)
Constipation
(9/20 active comparators)
Urinary Retention
(7/10 active comparators)
Mirabegron is as effective as antimuscarinic therapy with fewer bothersome side effects
39. MIRABEGRON HAS SIMILAR CARDIOVASCULAR
SAFETY WHEN COMPARED WITH ANTIMUSCARINICS
AMI, acute myocardial infarction; CI, confidence interval; CV, cardiovascular; MACE, major adverse cardiovascular event; Ref, reference group.
1. Hoffman V, et al. Drug Safety. 2021;44:899-915
In a real-world observational post-marketing
safety study, rates of:
• MACE
• AMI
• Stroke
were no higher with mirabegron versus
antimuscarinics.1
Comparison of cardiovascular and mortality outcomes
during current use of mirabegron or antimuscarinics1
40. MIRABEGRON DELIVERS CLINICALLY MEANINGFUL REDUCTION IN OAB
SYMPTOMS1
References:
1. Nitti VW, Auerbach S, Martin N, et al. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol 2013;189:1388-95.
2. Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a β(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian
phase 3 trial. Eur Urol 2013;63:283-295.
Mirabegron significantly reduced the number of
incontinence episodes per 24 hours vs placebo2
Mirabegron significantly reduced the number
of micturitions per 24 hours vs placebo2
Mirabegron relieves frequency and urinary incontinence in OAB2
41. MIRABEGRON DELIVERS SUSTAINED IMPROVEMENTS IN OAB SYMPTOMS
OVER 12 MONTHS OF TREATMENT1,2
At 12 months of Mirabegron 50mg treatment1 :
Real-world Mirabegron 50 mg data showed
that at 12 months2 :
References:
1. Chapple CR, Kaplan SA, Mitcheson D, et al. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β(3)-adrenoceptor agonist, in overactive bladder.
Eur Urol 2013;63:296-305.
2. Yamaguchi O, Ikeda Y, Ohkawa S. Phase III Study to Assess Long-Term (52-Week) Safety and Efficacy of Mirabegron, a β3 -Adrenoceptor Agonist, in Japanese Patients with Overactive Bladder. Low Urin Tract
Symptoms 2015;9:38-45.
42. MIRABEGRON IS ASSOCIATED WITH A FAVOURABLE
TOLERABILITY IN PATIENTS WITH OAB
1. Kelleher C, et al. Eur Urol. 2018;74:324-333.
According to a meta-analysis of randomised
control trials from 2000–2017, mirabegron
was significantly better tolerated regarding:
Dry Mouth
(21/22 active comparators)
Constipation
(9/20 active comparators)
Urinary Retention
(7/10 active comparators)
Mirabegron is as effective as antimuscarinic therapy with fewer bothersome side effects
43. FSFI, Female sexual function index
Athanasiou S, et al. Eur J Obstet Gynecol Reprod Biol. 2020, 251, 73-82.
META-ANALYSIS: EFFICACY OF MIRABEGRON IN
FEMALES
After 12 weeks of mirabegron usage, pooled results from 120 female patients showed statistically significant
improvement in sexual health:
FSFI Mean difference (95% CI) p-value
Desire 1.02 (0.04, 2) 0.04
Lubrication 0.81 (0.55, 1.08) <0.001
Orgasm 0.61 (0.35, 0.88) <0.001
Satisfaction 0.7 (0.3, 1.1) <0.001
Total Score 4.75 (1.32, 8.18) 0.007
44. MIRABEGRON IS ASSOCIATED WITH HIGHER LEVELS
OF TREATMENT PERSISTENCE
OAB, Overactive bladder
1. Kato D, et al. Low Urin Tract Symptoms. 2019;11:O152-O161. 2. Dhaliwal P, et al. Clin Interv Aging. 2016;11:755-760. 3. Soda T, et al. Neurourol Urodyn. 2020;39:2527-2534.
• OAB is a chronic
condition requiring
long-term treatment
and persistence1
• 65%–86% of patients
under antimuscarinics
discontinue treatment
after one year2
65.8% 52.9% 46.7%
1 year 2 years 3 years
Post-marketing survey1
Persistence rates with mirabegron were:
Retrospective review3
“Treatment persistence with
mirabegron was significantly longer
than that with antimuscarinics when
administered as either the first‐ or
second‐line medication”
45. META-ANALYSIS: EFFICACY OF MIRABEGRON IN
FEMALES
Athanasiou S, et al. Eur J Obstet Gynecol Reprod Biol. 2020, 251, 73-82.
Systematic review and meta-analysis of 21
studies indicated that 12 weeks of
mirabegron use in female patients led to
significant decrease in:
Micturition
frequency/24h
2.04 – 2.33
Urgency
episodes/24h
1.3 – 2.2
Incontinence/24h
0.9 – 1.04
Nocturia/24h
0.42 – 0.5
46. MIRABEGRON HAS SIMILAR CARDIOVASCULAR
SAFETY WHEN COMPARED WITH ANTIMUSCARINICS
AMI, acute myocardial infarction; CI, confidence interval; CV, cardiovascular; MACE, major adverse cardiovascular event; Ref, reference group.
1. Hoffman V, et al. Drug Safety. 2021;44:899-915
In a real-world observational post-marketing
safety study, rates of:
• MACE
• AMI
• Stroke
were no higher with mirabegron versus
antimuscarinics.1
Comparison of cardiovascular and mortality outcomes
during current use of mirabegron or antimuscarinics1
47. TS-VAS, Treatment Satisfaction-Visual Analog Scale.
1. Freeman R, et al. Curr Med Res Opin. 2018;34:785-93. 2. Foley S, et al. Int J Urol. 2019;26:890-6. 3. Petrossian RA, et al. Can J Urol. 2020;27:10106-7.
TREATMENT WITH MIRABEGRON IS ASSOCIATED WITH
IMPROVEMENTS IN QUALITY OF LIFE
Reduced symptom bother
• 52.5% of patients reported
meaningful improvements1
Improved health-related
quality of life
• 45.5% of patients reported
meaningful improvements in
health-related quality of life1
Improved treatment
satisfaction
• Increase in TS-VAS scores
indicating good treatment
satisfaction with mirabegron1,2
Sleep improvement
• Improvements in nocturia and
significant improvement in
sleep disturbance and urinary
symptoms associated with
disordered sleep3
48. Chapple CR, et al. Eur Urol 2020;77:119-28.
MIRABEGRON IS ASSOCIATED WITH FAVOURABLE
SAFETY OUTCOMES
More drug-related adverse events are reported for the antimuscarinic group (21.4%) versus the Mirabegron group (17%)
According to pooled data analysed from 10 phase 2-4, double-blind, 12-week mirabegron monotherapy studies in adults with OAB
who had received one or more doses of study drug.
Analysis of safety endpoints
49. 1. Marinkovic SP. Ther Adv Urol 2019;11:1756287219844669. 2. Yehoshua A, et al. J Manag Care Spec Pharm 2016;22:406-13. 3. Griebling TL, et al. BMC geriatrics 2020;20:1-0.
4. Yeowell G, et al. BMJ open. 2018 Nov 1;8:e021889. 5. Arlandis GS, et al. Arch Esp Urol 2020;73:509-22.
MIRABEGRON IS ASSOCIATED WITH GREATER COST-
EFFECTIVENESS FOR PATIENTS
OAB patients incur a psychologic and economic costs predicted to be in excess of US$82 billion in the US and Europe.
Treatments include behavioural, pharmacological and surgical management.1
Anticholinergics are associated with:1,2
Reduced
persistence
Impact on
cognitive function
Risk of falls
or fractures
Depression
or anxiety
Use of more
healthcare resources
Mirabegron is associated with:3,4
Higher
persistence rates
No impact on
cognitive function
Treatment with Mirabegron has the
potential to save 80.74 ±4.61 € per
patient per year compared with
antimuscarinics5
versus
50. Take Home Message
• OAB is a condition in which the bladder (Detrusor Muscle) becomes very active
• This symptom does not cause death, but it will impact patient’s daily activity and quality of life
• OAB is a prevalent condition and is still mainly undertreated
• Diagnosis of OAB is based on history, physical examination and laboratory investigation
• Key Consideration of OAB Management : OAB should be managed from a long-term perspective;
Encourage lifestyle and behavioural modifications; Patient education is crucial for treatment
persistence.
• Step by step management starting from non-invasive strategy are recommended for OAB
• OAB is a chronic condition requiring long-term treatment and persistence
• Mirabegron is a new type of OAB treatment, the first of ß 3-adrenoceptor agonist to treat OAB
• Mirabegron study supports the efficacy, safety and tolerability in treatment of OAB patients
• Mirabegron associated with higher levels of treatment persistence
Notas do Editor
Prevalensi OAB di Indonesia dan di Asia
Indonesia :
Wawancara pasien yang berobat ke 6 RS di Indonesia (2765 pasien), Angka kejadian inkontinensia urin : 13% (perempuan 16,1% laki-laki 11,4%)
Prevalensi inkontinensia urin di Indonesia menyerupai hasil penelitian pada negara-negara Asia lainnya.
Prevalensi meningkat seiring pertambahan usia , dan tidak dipengaruhi jenis kelamin.