In patients aged ≥65 years3
GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks3†
*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI)/leakage.2
†P<0.001 vs placebo.3
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No overall differences in safety or effectiveness of GEMTESA have been observed between patients 65 years of age and older and younger adult patients
*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI)/leakage.2
†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.1,4
‡Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the EMPOWUR trial. Unadjusted placebo percentage was 38.3%.4
CHANGE FROM BASELINE AT | ||
---|---|---|
EFFICACY ANALYSIS Adjusted least squares mean decrease in frequency of: |
12 WEEKS1,4 (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.4
*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).4
No overall differences in safety or effectiveness of GEMTESA have been observed between patients 65 years of age and older and younger adult patients
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 years3
GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks3†
*The 3 key symptoms of OAB are urgency, micturition frequency, and urge urinary incontinence (UUI)/leakage.2
†P<0.001 vs placebo.3
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.2
†P<0.001 vs placebo.3
In patients ≥75 years3
GEMTESA demonstrated significant reductions in average daily UUI episodes at 12 weeks3*
*P<0.001 vs placebo.
Please see elderly data analysis above.
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 years3
GEMTESA demonstrated significant reductions in average daily micturition frequency at 12 weeks3*
*P<0.001 vs placebo.
Please see elderly data analysis above.
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 years3
GEMTESA demonstrated significant reductions in average micturition frequency at 12 weeks3*
*P<0.05 vs placebo.
Please see elderly data analysis above.
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.
In patients aged ≥65 years3
GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks3*
*P<0.01 vs placebo.
Please see elderly data analysis above.
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 years3
GEMTESA demonstrated significant reductions in average daily urgency episodes—need to urinate immediately—at 12 weeks3*
*P<0.01 vs placebo.
Please see elderly data analysis above.
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.
Adverse events (AEs) with an incidence of ≥2% compared with and exceeding placebo up to 12 weeks1,3*
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) |
|
HEADACHE | 4.0% | 2.4% | 4.5% | 2.2% | 2.7% | 3.3% |
DRY MOUTH | 1.7% | 0.9% | 3.3% | 0.9% | 1.3% | 1.7% |
UPPER RESPIRATORY TRACT INFECTION |
2.0% | 0.7% | 3.3% | 0.9% | 4.0% | 1.7% |
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% |
URINARY TRACT INFECTION |
5.0% | 6.1% | 5.7% | 7.9% | 8.0% | 6.7% |
DYSPNEA | 0.7% | 0.2% | 1.6% | 0% | 4.0% | 0% |
URINARY RETENTION | 0.6% | 0.4% | 1.2% | 0.4% | 2.7% | 0% |
RASH | 0.7% | 0.7% | 1.2% | 0.4% | 2.7% | 1.7% |
SOMNOLENCE | 0.4% | 0.4% | 0.8% | 0.4% | 2.7% | 0% |
FLATULENCE | 0.4% | 0.6% | 0.8% | 0.9% | 2.7% | 0% |
*Includes all AEs occurring in ≥2% of the GEMTESA group and more frequently than placebo.
ELDERLY PATIENT STUDY DESIGN
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 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.
2-week run-in period | 12-Week, double-blind treatment period |
---|---|
Randomization | |
Placebo | Placebo 65+ (n=330) 75+ (m=57)* |
Gemtesa 75 mg 65+ (n=242) 75+ (n=75)* | |
Active Control 65+ (n=166) 75+ (n=47)* | |
Week 0 | Week 12 |
Co-primary endpoints
Key secondary endpoints
OVERALL POPULATION
(n=526)
85.4%
FEMALE
≥65†
YEARS OLD (n=242)
84.3%
FEMALE
≥75‡
YEARS OLD (n=75)
78.7%
FEMALE
76.6% OAB WET
79.3% OAB WET
78.7% OAB WET
*The 75+ population is a subset of the 65+ patient population.3
†Percentage calculated from the subset of patients aged ≥65 years in each treatment group.3
‡Percentage calculated from the subset of patients aged ≥75 years in each treatment group.3
OAB=overactive bladder; UUI=urge urinary incontinence.
†P<0.001 vs placebo.
*P<0.001 vs placebo.
*P<0.001 vs placebo.
*P<0.05 vs placebo.
*P<0.01 vs placebo.
*P<0.01 vs placebo.
EXTENSION STUDY DESIGN
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 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*
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
Efficacy at 12 weeks | Safety at 52 weeks | |
---|---|---|
PRIMARY ENDPOINT | ||
PRIMARY ENDPOINT | Change from baseline in average daily number of micturitions and 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 in average daily number of:
|
Efficacy analyses were performed using the FAS-EXT, except for incontinence episode endpoints, which used the FAS-EXT-I.3
61
YEARS OLD
MEAN AGE
78%
FEMALE
22%
MALE
78% OAB WET
22% OAB DRY
†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; OAB=overactive bladder; UUI=urge urinary incontinence.
12-WEEK STUDY DESIGN
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
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 |
Co-primary endpoints1,2
Key secondary endpoints1,2
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
60
YEARS OLD
MEAN AGE
85%
FEMALE
15%
MALE
77% OAB WET†
23% OAB DRY†
†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
‡Urge urinary incontinence 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; UUI=urge urinary incontinence.
References: 1. GEMTESA [prescribing information]. Irvine, CA: Urovant Sciences; 2020. 2. 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 3. 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 4. Data on file. Urovant Sciences. 5. 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 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. 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
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