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Effects of vibegron on ambulatory blood pressure in patients with overactive bladder: results from a double-blind, placebo-controlled trial
Abstract
Objectives: To characterize the blood pressure (BP) profile of the new β 3-adrenergic receptor agonist, vibegron, in patients with overactive bladder. Methods: Patients were randomized to once-daily vibegron 75 mg or placebo for 28 days and underwent ambulatory BP monitoring. The primary endpoint was change from baseline (CFB) to day 28 in mean daytime ambulatory systolic BP (SBP). Secondary endpoints were CFB in mean 24-h SBP and in mean daytime and mean 24-h ambulatory diastolic BP (DBP) and heart rate (HR). Safety was assessed through adverse event reporting. Results: Of 214 patients randomized, 96 receiving vibegron and 101 receiving placebo had evaluable baseline and day 28 measurements. Overall, 39.6 and 30.7% of patients receiving vibegron and placebo, respectively, had preexisting hypertension. The least squares mean difference (LSMD; 90% confidence interval) between vibegron and placebo in CFB in mean daytime SBP was 0.8 (–0.9, 2.5) mmHg. LSMD in CFB in mean daytime DBP and HR was 0.0 mmHg and 0.9 bpm, respectively. No significant differences between treatments were seen in CFB in mean 24-h SBP (LSMD, 0.6 mmHg), DBP (–0.2 mmHg) or HR (1.0 bpm). The most common treatment-emergent adverse event was hypertension, with rates comparable between groups [vibegron: n = 5 (4.7%); placebo: n = 4 (3.7%)]. One patient receiving vibegron took a prohibited medication (phentermine) known to increase BP. Conclusions: Once-daily vibegron had no statistically significant or clinically relevant effects on BP or HR.
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Cited by 14
Research works printed but not linked: 15
- Coyne, 2011, National community prevalence of overactive bladder in the United States stratified by sex and age., Urology, 77, 1081, 10.1016/j.urology.2010.08.039 · DOI · Paper page
- Arana, 2018, Variation in cardiovascular risk related to individual antimuscarinic drugs used to treat overactive bladder: a UK cohort study., Pharmacotherapy, 38, 628, 10.1002/phar.2121 · DOI
- Rosa, 2013, Cardiovascular effects of antimuscarinic agents in overactive bladder., Expert Opin Drug Saf, 12, 815, 10.1517/14740338.2013.813016 · DOI
- Staskin, 2020, 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, 204, 316, 10.1097/JU.0000000000000807 · DOI · Paper page
- Staskin, 2021, 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, 205, 1421, 10.1097/JU.0000000000001574 · DOI · Paper page
- Otsuka, 2008, Expression and functional role of β-adrenoceptors in the human urinary bladder urothelium., Naunyn Schmiedebergs Arch Pharmacol, 377, 473, 10.1007/s00210-008-0274-y · DOI
- Yamaguchi, 2002, β3-adrenoceptors in human detrusor muscle., Urology, 59, 25, 10.1016/S0090-4295(01)01635-1 · DOI
- Wachter, 2012, Beta-adrenergic receptors, from their discovery and characterization through their manipulation to beneficial clinical application., Cardiology, 122, 104, 10.1159/000339271 · DOI
- Andersson, 2010, Cardiovascular morbidity, heart rates and use of antimuscarinics in patients with overactive bladder., BJU Int, 106, 268, 10.1111/j.1464-410X.2009.09073.x · DOI
- Asche, 2012, Presence of central nervous system, cardiovascular and overall co-morbidity burden in patients with overactive bladder disorder in a real-world setting., BJU Int, 109, 572, 10.1111/j.1464-410X.2011.10436.x · DOI
- D’Agostino, 2008, General cardiovascular risk profile for use in primary care: the Framingham Heart Study., Circulation, 117, 743, 10.1161/CIRCULATIONAHA.107.699579 · DOI · Paper page
- Psaty, 2001, Association between blood pressure level and the risk of myocardial infarction, stroke, and total mortality: the cardiovascular health study., Arch Intern Med, 161, 1183, 10.1001/archinte.161.9.1183 · DOI · Paper page
- Stewart, 2003, Prevalence and burden of overactive bladder in the United States., World J Urol, 20, 327, 10.1007/s00345-002-0301-4 · DOI · Paper page
- Ganz, 2016, Real-world characteristics of elderly patients with overactive bladder in the United States., Curr Med Res Opin, 32, 1997, 10.1080/03007995.2016.1226167 · DOI
- Varano, 2021, 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, 38, 137, 10.1007/s40266-020-00829-z · DOI
Metadata
- Authors
- Weber, M. A., Haag-Molkenteller, C., King, J., Walker, A., Mudd, P. N., & White, W. B.
- Venue
- Blood Pressure Monitoring
- Published
- 2021-10-25
- Volume
- 27
- Issue
- 2
- Pages
- 128-134
- ISSN
- 1359-5237
- Cited by
- 14
- Language
- en
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- Weber, M. A., Haag-Molkenteller, C., King, J., Walker, A., Mudd, P. N., & White, W. B. (2022). Effects of vibegron on ambulatory blood pressure in patients with overactive bladder: results from a double-blind, placebo-controlled trial. Blood Pressure Monitoring. https://doi.org/10.1097/mbp.0000000000000572
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