Scottsdale, Arizona (UroToday.com) EMPOWUR evaluated the efficacy and safety of vibegron, a new β3-agonist, vs placebo with tolterodine (active control) in adults with overactive bladder (OAB). Vibegron had statistically significant adjusted mean reductions from baseline (P<0.001) in daily micturition and urge urinary incontinence (UUI) episodes vs placebo from Week 2 through Week 12. Patient-reported quality of life (QOL) data are presented here.
Patients aged ≥18 years with OAB (≥8 micturition/day) for ≥3 months, and OAB wet (≥1 UUI episodes/day) or OAB dry (≥3 urgency and <1 UUI episode/day) were randomized 5:5:4 to vibegron 75 mg, placebo, or tolterodine extended-release 4 mg. The Overactive Bladder Questionnaire Long Form (OAB-q LF) for a 1-week recall period was administered at baseline and Week 12 to assess QOL. A repeated measured-mixed effects model was used for analyses. Covariates included treatment, visit, sex, region, OAB type, baseline score, and treatment by study visit interaction.
There were 1518 patients randomized (vibegron,547; placebo,540; tolterodine,431). Groups were well-balanced: mean age was ~60 years, with ~85% women/15% men in each group. Vibegron 75 mg demonstrated statistically significant improvements in adjusted mean change from baseline on the Coping, Concern, Sleep, total HRQL, and Symptom Bother scores (Table 1). The P values include the missing item imputation (Table 1). Vibegron results were numerically better than tolterodine results for all scales. Treatment-emergent adverse events (>placebo and >2%) were headache (vibegron, placebo, tolterodine;4.0%,2.4%,2.6%; respectively), nasopharyngitis (2.8%,1.7%,2.6%), diarrhea (2.2%,1.1%,2.1%),and nausea (2.2%,1.1%,1.2%). Notably, hypertension was 1.7% for vibegron and placebo, and 2.6% for tolterodine.
This study demonstrated that vibegron 75 mg improves the symptoms of OAB (urgency, frequency, UUI) and increases the QOL of patients suffering from OAB.
Table 1. Vibegron Significantly Improved Quality of Life at Week 12
Second efficacy analysis with missing item imputationa
aMissing imputation rule: the mean scale of non-missing items are used if <50% of the scale items are missing; if ≥50% of the items are missing the scale score is set to missing. bResults for the Coping subscale comprised a key secondary endpoint. HRQL, Health-Related quality of life. Table 14.2.8.1.4 Full analysis set. The n for each treatment group varied for each OAB-q score.
Presented by: Jeffrey Frankel, MD1
Co -Authors: David Staskin, MD,2 Susann Varano, MD,3 Denise Shortino, MS,4 Rachael Jankowich, RN,4 Paul N Mudd Jr, PharmD4
1Seattle Urology Research Center, Seattle, WA,2Tufts University School of Medicine, Boston, MA,3Clinical Research Consulting, Milford, CT,4Urovant Sciences, Inc.,Irvine, CA
Written by: Bilal Farhan, MD, Assistant Professor, Division of Urology, University of Texas, Medical Branch, Texas; @BilalfarhanMD, at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting, SUFU 2020, February 25 - February 29, 2020, Scottsdale, Arizona