Patient-reported outcomes in patients with overactive bladder treated with mirabegron and tolterodine in a prospective, double-blind, randomized, two-period crossover, multicenter study (PREFER)

Abstract

BackgroundThe PREFER study was an assessment of medication tolerability, treatment preference and symptom improvement during treatment with mirabegron (M) and tolterodine (T) extended release (ER) in patients with overactive bladder (OAB). In this analysis of PREFER, patient-reported outcomes (PROs) were assessed during treatment.MethodsPREFER was a two-period, 8-week crossover, double-blind, phase IV study (NCT02138747) of treatment-naïve adults with OAB ≥3 months randomized to 1 of 4 treatment sequences (M/T; T/M; M/M; T/T), separated by a 2-week washout. Tolterodine ER was dosed at 4 mg for 8 weeks and mirabegron was dosed at 25 mg for 4 weeks then increased to 50 mg for the next 4 weeks. At each visit, PROs related to treatment satisfaction, quality of life and symptom bother were assessed using the OAB Satisfaction (OAB-S; 3 independent scales/5 single-item overall assessments), OAB-q (total health-related QoL [HRQoL] and subscales [Sleep, Social, Coping, Concern] and Symptom Bother scale) and Patient Perception of Bladder Condition (PPBC) questionnaires. Responder rates were reported for OAB-q subscales based on a minimal important difference (MID; ≥ 10-point improvement) and OAB-S Medication Tolerability score ≥ 90.ResultsIn total, 358 randomized patients received ≥1 dose of double-blind study medication and completed ≥1 post-baseline value (OAB-S scale, OAB-q, PPBC): M/T (n = 154), T/M (n = 144), M/M (n = 30) or T/T (n = 30). At end of treatment (EoT), mirabegron and tolterodine ER were associated with similar mean improvements in 7 of the 8 OAB-S scores investigated, OAB-q scales and PPBC. A higher percentage of patients achieved clinically relevant improvements (MID) in OAB-q scales and OAB-S Medication Tolerability score during treatment with mirabegron than tolterodine ER.ConclusionsOn average, patients with OAB experienced improvements in treatment satisfaction, HRQoL and symptom bother that were of a similar magnitude during treatment with mirabegron or tolterodine ER. However, during mirabegron treatment, patients were more likely to achieve clinically relevant improvements in tolerability and HRQoL (as measured by the MID for the OAB-q or an OAB-S Medication Tolerability score ≥ 90) than during tolterodine ER treatment.Trial registrationNCT02138747; registered May 13, 2014.

Factors Associated with Improvements in Patient-Reported Outcomes During Mirabegron or Antimuscarinic Treatment of Overactive Bladder Syndrome: A Registry Study (PERSPECTIVE)

“…A two-period crossover study (PREFER), during which patients were randomized to receive mirabegron or tolterodine in one of four sequences (mirabegron–tolterodine, tolterodine–mirabegron, mirabegron–mirabegron, or tolterodine–tolterodine), reported similar mean OAB-q SF improvements for each of the treatments. However, patients were more likely to achieve clinically relevant improvements in HRQoL during mirabegron treatment [21]. Moreover, the PREFER study demonstrated improved tolerability for mirabegron compared with tolterodine.…”

Role of Mirabegron in the Treatment of Overactive Bladder: A Prospective Study

“…16 Herschorn et al conducted a double blind randomized multicenter trial for the efficacy of Mirabegron in the patients of OAB (PREFER) and found Mirabegron to be effective in relieving the symptoms of urgency in the patients with OAB. 17 We similarly found mirabegron to be effective in the treatment of nocturia and urge incontinence.…”

FAP Beige Adipogenesis in Volumetric Muscle Loss

“…In this study, we demonstrated that Amibegron treatment signi cantly improved muscle regeneration and hindlimb function after VML. Mirabegron, a β3 adrenergic receptor agonist, with a similar structure to Amibegron, has been approved by the FDA for treating over-reactive bladders [43,44]. Though it may mildly increase heart rate and blood pressure in patients, Mirabegron could be considered as a potential novel treatment for VML in the future.…”