Recently published patient-perception data point to significantly more patients with overactive bladder (OAB) deriving meaningful benefit from treatment with vibegron (Gemtesa) vs placebo.1,2
Vibegron was approved by the FDA in December of 2020 based on data from the phase 3 EMPOWUR trial. In the primary study analysis, at 12 weeks, vibegron showed a mean change from baseline in the average daily number of micturitions of -1.8 compared with -1.3 for placebo and -1.6 for tolterodine (P <.001).3 The mean change from baseline in urge urinary incontinence (UUI) episodes was -2.0, -1.4, and -1.8, respectively.
Treatment with vibegron also led to a statistically significant improvement in the key secondary outcome measures of number of urgency episodes, volume per micturition, and proportion of incontinent patients with at least a 75% reduction in UUI episodes (P <.01 for all).
For the current study, the investigators utilized what they described as “an anchor-based approach using Patient Global Impression of Change (PGI-C) applied to phase 2 data allowed predefining phase 3 responder definitions.” This anchor-based approach was used to assess the meaningfulness of reduction in micturitions, urgency episodes, and UUI episodes. The investigators also conducted qualitative patient interviews in order to identify responder-based end points reflecting clinically meaningful improvement. Based on PGI-C results applied to phase 2 and phase 3 data along with the patient interviews, the investigators were able to establish responder-based definitions of clinically meaningful improvement in reducing micturitions, urgency episodes, and UUI episodes.
According to a news release regarding the findings, the investigators found “that significantly more patients receiving vibegron vs placebo achieved meaningful responder definitions: ≥15% reduction in micturitions (56.3% vs 44.6%, respectively) (post hoc), ≥50% reduction in urgency episodes (39.5% vs 32.8%), ≥75% reduction in UUI episodes (49.3% vs 32.8%), and ≥90% reduction in UUI episodes (35.2% vs. 23.5%) (post hoc) at week 12 (P < 0.05 each).”
“Our findings suggest that the statistically significant improvements in bothersome symptoms of OAB seen in the 12-week EMPOWUR trial are indeed clinically relevant in terms of patient perceptions,” said lead author Jeffrey Frankel, MD, of Seattle Urology Research Center, Washington, in the release. “These significantly higher proportions of patients achieving pre-defined patient-perceived symptom improvements are likely to inform patients and providers in establishing realistic treatment goals.”
“The patient-centered analysis further supports that Gemtesa is an important treatment option with meaningful clinical benefit for patients with OAB,” said Cornelia Haag-Molkenteller, MD, PhD, executive vice president and Chief Medical Officer of Urovant Sciences in the release. “The publication in a peer-reviewed journal is another example of Urovant’s commitment to informing the scientific-medical community about meaningful effects of Gemtesa.”
1. Frankel J, Staskin D, Varano S, et al. Interpretation of the meaningfulness of symptom reduction with vibegron in patients with overactive bladder: analyses from EMPOWUR. Adv Ther. Published online December 18, 2021. Accessed December 20, 2021. doi:10.1007/s12325-021-01972-8
2. Urovant Sciences announces publication in advances in therapy of analyses of patient-perceived meaningfulness of improvement in symptom reduction for overactive bladder patients treated with Gemtesa (vibegron) 75 mg. Press release. Urovant Sciences. December 20, 2021. Accessed December 20, 2021. https://bwnews.pr/3sl4GW1
3. Staskin D, Frankel J, Varano S, et al. 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