Demonstrated safety and tolerability with GEMTESA
Adverse reactions at 12 weeks and at 52 weeks with an incidence of
≥2% compared with and exceeding control arm1-3*
| AT 12 WEEKS1,2 | AT 52 WEEKS3 | |||
|---|---|---|---|---|
| GEMTESA n=545 |
Placebo n=540 |
GEMTESA n=273 |
Active Control n=232 |
|
| HYPERTENSION | 1.7% | 1.7% | 8.8% | 8.6% |
| HEADACHE | 4.0% | 2.4% | 5.5% | 3.9% |
| NASOPHARYNGITIS | 2.8% | 1.7% | 4.8% | 5.2% |
| DIARRHEA | 2.2% | 1.1% | 4.8% | 1.7% |
| CONSTIPATION | 1.7% | 1.3% | 3.7% | 2.6% |
| NAUSEA | 2.2% | 1.1% | 3.7% | 3.0% |
| UPPER RESPIRATORY TRACT INFECTION | 2.0% | 0.7% | 3.7% | 0.4% |
| BRONCHITIS | 2.9% | 1.3% | ||
*Includes all AEs with an incidence of ≥2% in the GEMTESA group and greater than in the placebo group.1,3
†The total number of patients in the GEMTESA arm of the extension trial included in this safety assessment was 273 (safety set extension).3
GEMTESA is the first and only beta-3 agonist with no clinically significant impact on blood pressure1,5
The prevalence of hypertension increases with age. By age 45, nearly half of women and men have hypertension6‡
Hypertension and increased BP rates for GEMTESA compared with placebo for up to 12 weeks2
| GEMTESA n (%) |
PLACEBO n (%) |
|
|---|---|---|
| NUMBER OF PATIENTS | 545 | 540 |
| HYPERTENSION | 9 (1.7) | 9 (1.7) |
| BP INCREASE | 4 (0.7) | 5 (0.9) |
In a 4-week, randomized, placebo-controlled, ambulatory BP study in overactive bladder (OAB) patients (n=200), daily treatment with GEMTESA 75 mg was not associated with clinically significant changes in blood pressure. Subjects enrolled in this study had a mean age of 59 years and 75% were female. Thirty-five percent of subjects had preexisting hypertension at baseline and 29% of all subjects were taking at least 1 concomitant antihypertensive medication.1
‡Based on NHANES data conducted from 2011 to 2014, including 9623 participants.6
AE=adverse event; BP=blood pressure.
But wait, there’s more!
GEMTESA is the first and only beta-3 agonist without a blood pressure warning in its label1,5
Learn about resources to help patients start and stay on GEMTESA
See access and resources
References: 1. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2023. 2. Data on file. Sumitomo Pharma America, Inc. 3. 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 4. 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 5. Weber MA, Haag-Molkenteller C, King J, Walker A, Mudd PN, White WB. Effects of vibegron on ambulatory blood pressure in patients with overactive bladder: results from a double-blind, placebo-controlled trial. Blood Press Monit. 2022;27:128-134. 6. Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circ. 2020;141(9):e139-e596. doi:10.116/CIR0000000000000757