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Discover the benefits of GEMTESA for long-term care (LTC) residents with overactive bladder (OAB)
GEMTESA (vibegron) offers symptom improvement, simple dosing, and a demonstrated safety and tolerability profile for patients with OAB1
No overall differences in safety or effectiveness of GEMTESA have been observed between patients aged 65+ and younger adult patients2
PROVEN EFFICACY
IN OLDER ADULTS
First and only beta-3 agonist with proven urgency reduction data in its label1
Statistically significant reduction in all 3 key OAB symptoms* vs placebo at 12 weeks—including urgency1,3†
Reductions in 3 key OAB symptoms* at 12 weeks in patients aged 65+ and 75+2
ONE
CRUSHABLE DOSE
First and only beta-3 agonist with a once-daily 75-mg dose with no titration, to be taken with or without food, and swallowed whole with a glass of water1
Crushability. In adults, GEMTESA tablets may be crushed, mixed with a tablespoon (~15 mL) of applesauce and taken immediately with a glass of water1
ESTABLISHED SAFETY
FOR OLDER ADULTS
First and only beta-3 agonist with no blood pressure warning in its label1
First and only beta-3 agonist with no drug interaction with CYP2D6 substrates (medications commonly taken by LTC residents)1
Digoxin drug interaction was identified with GEMTESA. Measure serum digoxin concentrations before initiating GEMTESA. Monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. Continue monitoring digoxin concentration upon discontinuation of GEMTESA and adjust digoxin dose as needed1
No known association with cognitive decline, including dementia, for the beta-3 agonist class4,5
*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI)/leakage.3
†The efficacy of GEMTESA was evaluated in a pivotal 12-week, double-blind, randomized, placebo- and active-controlled trial in patients with OAB (UUI, urgency, and urinary frequency). For study entry, patients had to have symptoms of OAB for at least 3 months, with an average of 8 or more micturitions per day and at least 1 UUI per day, or an average of 8 or more micturitions per day and an average of at least 3 urgency episodes per day. A total of 1515 patients received at least 1 daily dose of placebo (n=540), GEMTESA 75 mg (n=545), or an active-control treatment (n=430). The majority of patients were Caucasian (78%) and female (85%) with a mean age of 60 (range 18 to 93) years.1,5
GEMTESA was evaluated at 12 weeks and 52 weeks in the overall study population1,6,7
CHANGE FROM BASELINE AT
EFFICACY ANALYSIS Adjusted least squares mean decrease in frequency of:
12 WEEKS1,7
(pivotal study)
52 WEEKS6
(extension study)
URGE URINARY INCONTINENCE EPISODES (UUI)
GEMTESA 75 mg
(n=403) -2.0*
Placebo
(n=405) -1.4
GEMTESA 75 mg
(n=143) -2.2
Active Control
(n=106) -1.7
MICTURITION EPISODES
GEMTESA 75 mg
(n=526) -1.8†
Placebo
(n=520) -1.3
GEMTESA 75 mg
(n=176) -2.4
Active Control
(n=136) -2.0
URGENCY EPISODES
GEMTESA 75 mg
(n=526) -2.7‡
Placebo
(n=520) -2.0
GEMTESA 75 mg
(n=176) -3.4
Active Control
(n=136) -3.2
EXPLORATORY RESPONDER ANALYSIS % of patients achieving 100% reduction in UUI episodes4,6§
GEMTESA 75 mg
(n=403) 28.8%
Placebo
(n=405) 22.5%
GEMTESA 75 mg
(n=143) 40.8%
Active Control
(n=106) 34.2%
Efficacy analyses were performed using the FAS-EXT, except for incontinence episode endpoints, which used the FAS-EXT-I.7
*P<0.0001 vs placebo.1
†P<0.001 vs placebo.1
‡P=0.002 vs placebo.1
§Data were based on an exploratory endpoint analysis of patients with 100% reduction in UUI from baseline at week 52 (n=143).7
In the older adult subpopulation, reductions in all 3 key OAB symptoms* were consistent with the overall study population at 12 weeks1-3
No overall differences in safety or effectiveness of GEMTESA have been observed between patients aged 65+ and younger adult patients2
This post hoc subpopulation analysis was not powered to detect differences within subgroups and is therefore limited by the small sample sizes, particularly in the subgroup of patients aged ≥75 years
In patients aged 65+ years2
GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks (co-primary endpoint) vs placebo2†
*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI)/leakage.3
†P<0.001 vs placebo.2
Urge urinary incontinence (UUI)2
Values
LEAST SQUARES (LS) MEAN CHANGE FROM BASELINE
Week
2
4
8
12
Placebo (n=168)
-0.9
-1.1
-1.2
-1.2
GEMTESA 75 mg (n=192)
-1.5
-1.8
-1.8
-2.0
*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI)/leakage.3
†P<0.001 vs placebo.2
In patients aged 75+ years2
GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks (co-primary endpoint) vs placebo2*
*P<0.001 vs placebo.
Please see older adults data analysis above.
UUI2
Values
LS MEAN CHANGE FROM BASELINE
Week
2
4
8
12
Placebo (n=44)
-0.5
-0.6
-0.3
-0.4
GEMTESA 75 mg (n=59)
-1.6
-1.7
-1.8
-2.0*
*P<0.001 vs placebo.
In patients aged 65+ years2
GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo2*
*P<0.001 vs placebo.
Please see older adults data analysis above.
Micturition frequency2
Values
LS MEAN CHANGE FROM BASELINE
Week
2
4
8
12
Placebo (n=220)
-0.3
-0.5
-0.7
-1.0
GEMTESA 75 mg (n=242)
-1.1
-1.4
-1.8
-1.9*
*P<0.001 vs placebo.
In patients aged 75+ years2
GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks (co-primary endpoint) vs placebo2*
*P<0.05 vs placebo.
Please see older adults data analysis above.
Micturition frequency2
Values
LS MEAN CHANGE FROM BASELINE
Week
2
4
8
12
Placebo (n=57)
-0.7
-0.7
-1.0
-1.2
GEMTESA 75 mg (n=75)
-1.3
-1.8
-2.1
-2.1*
*P<0.05 vs placebo.
Urgency is the hallmark OAB symptom8,9
While urgency is a critical factor in the diagnosis of OAB, the symptom often remains unreported and undiagnosed8,9
In a recently published study:
Urgency progressed in severity in older patients
Identifying and treating urgency in female individuals with lower urinary tract symptoms could help delay or possibly prevent progression as they age8
GEMTESA is the first and only beta-3 agonist with urgency reduction data in its label1
In patients aged 65+ years2
GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks vs placebo2*
*P<0.01 vs placebo.
Please see older adults data analysis above.
Urgency episodes2
Values
LS MEAN CHANGE FROM BASELINE
Week
2
4
8
12
Placebo (n=220)
-0.9
-1.2
-1.3
-1.7
GEMTESA 75 mg (n=242)
-1.6
-2.1
-2.5
-2.7*
*P<0.01 vs placebo.
In patients aged 75+ years2
GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks vs placebo2*
*P<0.01 vs placebo.
Please see older adults data analysis above.
Urgency episodes2
Values
LS MEAN CHANGE FROM BASELINE
Week
2
4
8
12
Placebo (n=57)
-0.7
-0.8
-0.7
-0.9
GEMTESA 75 mg (n=75)
-1.3
-1.7
-2.2
-2.6*
*P<0.01 vs placebo.
Established safety of GEMTESA for older adults at 12 weeks1,2
Adverse events (AEs) with an incidence of ≥2% compared with and exceeding placebo up to 12 weeks1,2
OVERALL STUDY
POPULATION
PATIENTS 65+
PATIENTS 75+
GEMTESA
(n=545)
Placebo
(n=540)
GEMTESA
(n=246)
Placebo
(n=228)
GEMTESA
(n=75)
Placebo
(n=60)
URINARY TRACT
INFECTION
5.0%
6.1%
5.7%
7.9%
8.0%
6.7%
HEADACHE
4.0%
2.4%
4.5%
2.2%
2.7%
3.3%
NASOPHARYNGITIS
2.8%
1.7%
2.4%
2.2%
2.7%
3.3%
DIARRHEA
2.2%
1.1%
2.4%
0.9%
4.0%
3.3%
NAUSEA
2.2%
1.1%
2.0%
1.3%
2.7%
3.3%
UPPER RESPIRATORY
TRACT INFECTION
2.0%
0.7%
3.3%
0.9%
4.0%
1.7%
DRY MOUTH
1.7%
0.9%
3.3%
0.9%
1.3%
1.7%
RASH
0.7%
0.7%
1.2%
0.4%
2.7%
1.7%
DYSPNEA
0.7%
0.2%
1.6%
0%
4.0%
1.7%
URINARY RETENTION
0.6%
0.4%
1.2%
0.4%
2.7%
0%
FLATULENCE
0.4%
0.6%
0.8%
0.9%
2.7%
0%
SOMNOLENCE
0.4%
0.4%
0.8%
0.4%
2.7%
0%
Safety results to consider for older adults assessed at 12 weeks2
No overall differences in safety or effectiveness of GEMTESA have been observed between patients aged 65+ or 75+ and younger adult patients
Incidence of cardiovascular-associated AEs, including hypertension (1.3%) and increased blood pressure (0%), was low for elderly patients aged 75+ taking GEMTESA vs placebo (3.3% and 1.7%, respectively)
Rates of discontinuation due to AEs were low for patients aged 65+ and 75+ (1.6% and 4%, respectively)
Less than 2% of patients aged 65+ and 75+ taking GEMTESA experienced hypertension (1.2% and 1.3%, respectively) vs placebo (3.1% and 3.3%, respectively)2
Want to know more about efficacy in the overall study population?
A 12-week, Phase 3, randomized, double-blind, placebo- and active-controlled multicenter study evaluated the safety and efficacy of GEMTESA in 1500+ patients with symptoms of overactive bladder (OAB).
In a post hoc subpopulation analysis, efficacy and safety with GEMTESA was assessed in 647 patients aged 65+ and 75+ years (a subset of the population aged 65+ years). This analysis was not powered to detect differences within subgroups and is therefore limited by the small sample sizes, particularly in the subgroup of patients aged ≥75 years.
Change from baseline in average daily number of urge urinary incontinence (UUI) episodes
Change from baseline in average daily number of micturitions
Key secondary endpoint
Change from baseline in average daily number of urgency episodes
GEMTESA PATIENT DEMOGRAPHICS1,2
OVERALL POPULATION
(n=526)
85.4%
FEMALE
76.6% OAB WET§
≥65†
YEARS OLD
(n=242)
84.3%
FEMALE
79.3% OAB WET§
≥75‡
YEARS OLD
(n=75)
78.7%
FEMALE
78.7% OAB WET§
Prior therapy and treatment naïve
Symptoms of OAB ≥3 months with an average ≥8 micturitions/day and ≥1 UUI/day, or an average ≥8 micturitions/day, ≥3 urgency episodes/day2§
*The 75+ population is a subset of the 65+ patient population.2
†Percentage calculated from the subset of patients aged ≥65 years in each treatment group.2
‡Percentage calculated from the subset of patients aged ≥75 years in each treatment group.2
§OAB wet=average of ≥1 UUI episode per day. OAB dry=average of ≥3 urgency episodes and average of <1 UUI episode per day.7
Urge urinary incontinence (UUI)2
†P<0.001 vs placebo.
UUI2
*P<0.001 vs placebo.
Micturition frequency2
*P<0.001 vs placebo.
Micturition frequency2
*P<0.05 vs placebo.
Urgency episodes2
*P<0.01 vs placebo.
Urgency episodes2
*P<0.01 vs placebo.
EXTENSION STUDY DESIGN
More than 500 patients were studied
in the 40-week extension period1
Study design description
A 12-week, phase 3, randomized, double-blind, placebo- and active-controlled, multicenter study evaluated the safety and efficacy of GEMTESA in 1500+ patients with symptoms of overactive bladder (OAB).2,3
A 40-week, phase 3, randomized, double-blind, active-controlled, multicenter extension study evaluated the safety and efficacy of GEMTESA in 505 patients with symptoms of OAB.1*
Values
40-WEEK, DOUBLE-BLIND EXTENSION PERIOD
2-week run-in period2,3
12-week, double-blind treatment period2,3
40-week, double-blind extension study1
Randomization
Placebo group rolled into an active teartment arm1
Placebo
Placebo (n=540)
Gemtesa 75 mg (n=545)
Gemtesa 75 mg (n=273)
Active Control (n=430)
Active Control (n=232)
Week 0
Week 12
Week 52
*A limitation of this study is the potential for selection bias for patients who elected to enter the EMPOWUR extension.1
Study endpoints1-3
Efficacy at 12 weeks
Safety at 52 weeks
PRIMARY ENDPOINT
PRIMARY ENDPOINT
Change from baseline in average daily number of micturitions and urge urinary incontinence (UUI) episodes (wet OAB)
Incidence of treatment-emergent adverse events
At 12 weeks
(key secondary endpoint)
At 52 weeks
SECONDARY ENDPOINT
SECONDARY ENDPOINT
Change from baseline in average daily number of urgency episodes
Change from baseline at Week 52 in average daily number of:
Micturitions
UUI episodes (wet OAB)
Urgency episodes
At 12 weeks
At 52 weeks
100% REDUCTION IN UUI EPISODES
100% REDUCTION IN UUI EPISODES
Secondary endpoint
Exploratory endpoint
Efficacy analyses were performed using the FAS-EXT, except for incontinence episode endpoints, which used the FAS-EXT-I.3
52-week patient demographics1-3
61
YEARS OLD
MEAN AGE
78%
FEMALE
22%
MALE
78% OAB WET†
22% OAB DRY†
Treatment naïve or had prior ACh or beta-3 agonist use 12 months before study
Inclusion criteria: symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day2†
†OAB wet=average of ≥1 UUI episode per day. OAB dry=average of ≥3 urgency episodes and average of <1 UUI episode per day.3
‡UUI was defined as leakage of urine of any amount because the patient felt an urge or need to urinate immediately.2
ACh=anticholinergic; FAS-EXT=full analysis set extension; FAS-EXT-I=full analysis set extension for incontinence.
12-WEEK STUDY DESIGN
12-week, double-blind treatment period
Studied in more than 1500 patients with overactive bladder1,2
A 12-week, phase 3, randomized, double-blind, placebo- and active-controlled multicenter study to evaluate the safety and efficacy of GEMTESA in 1500+ patients with symptoms of OAB.1,2
Values
2-week run-in period2
12-week, double-blind treatment period2
RANDOMIZATION
Placebo
Placebo (n=540)
GEMTESA 75 mg (n=545)
Active control (n=430)
Week 0
Week 12
GEMTESA met efficacy endpoints1
Co-primary endpoints1,2
CFB in average daily number of micturitions and UUI episodes
Key secondary endpoints1,2
CFB in average daily number of urgency episodes
Percent of OAB-wet patients at week 12 with ≥75% reduction in total number of UUI episodes in 24 hours*
Percent of all OAB patients at week 12 with 50% reduction in total number of urgency episodes per 24 hours*
Efficacy analyses were performed using the FAS, except for incontinence episode endpoints, which used the FAS-I.
*Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.2
12-week patient demographics1,2
60
YEARS OLD
MEAN AGE
85%
FEMALE
15%
MALE
Treatment naïve or had prior ACh or beta-3 agonist use in 12 months before study
77% OAB WET†
23% OAB DRY†
Symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day1‡
†OAB wet=average of ≥1 UUI episode per day. OAB dry=average of ≥3 urgency episodes and average of <1 UUI episode per day.2
‡UUI was defined as leakage of urine of any amount because the patient felt an urge or need to urinate immediately.1
ACh=anticholinergic; CFB=change from baseline; FAS=full analysis set; FAS-I=full analysis set for incontinence.
References: 1. GEMTESA [prescribing information]. Irvine, CA: Urovant Sciences; 2020. 2. Varano S, Staskin D, Frankel J, Shortino D, Jankowich R, Mudd PN Jr. Efficacy and safety of once-daily vibegron for treatment of overactive bladder in patients aged ≥65 and ≥75 years: subpopulation analysis from the EMPOWUR randomized, international, phase III study. Drugs Aging. 2021;38(2):137-146. doi:10.1007/s40266-020-00829-z 3. Edmondson SD, Zhu C, Kar NF, et al. Discovery of vibegron: a potent and selective β3 adrenergic receptor agonist for the treatment of overactive bladder. J Med Chem. 2016;59(2):609-623. doi:10.1021/acs.jmedchem.5b01372 4. Welk B, McArthur E. Increased risk of dementia among patients with overactive bladder treated with an anticholinergic medication compared to a beta-3 agonist: a population-based cohort study. BJU Int. 2020;126(1):183-190. doi:10.1111/bju.15040 5. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. J Urol. 2020;204(2):316-324. doi:10.1097/JU.0000000000000807 6. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. Once-daily vibegron 75 mg for overactive bladder: long-term safety and efficacy from a double-blind extension study of the international phase 3 trial (EMPOWUR). J Urol. 2021;205(5):1421-1429. doi:10.1097/JU.0000000000001574 7. Data on file. Urovant Sciences. 8. Zhou F, Newman DK, Palmer MH. Urinary urgency in working women: what factors are associated with urinary urgency progression? J Womens Health (Larchmt). 2018;27(5):575-583. doi:10.1089/jwh.2017.6555 9. Salvatore S, Espuña-Pons M, Tubaro A. Urinary urgency: a symptom in need of a cure. Res Rep Urol. 2019;11:327-331. doi:10.2147/RRU.S216757
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