A multicenter prospective study for overactive bladder patient treatment satisfaction with mirabegron after being unsatisfied with antimuscarinic therapy (FAVOR study)

Abstract

Aim: We investigated the satisfaction and efficacy of mirabegron in patients with overactive bladder (OAB) symptoms who were unsatisfied with previous antimuscarinic treatment. Methods: This was a 12-week, open-label study of adults with OAB who had been treated with antimuscarinics within 2 years of screening and expressed dissatisfaction over poor efficacy or adverse events of antimuscarinics. All enrolled patients have received mirabegron 50 mg once daily for 12 weeks. The primary outcome was the percentage of patients reporting treatment satisfaction questions (TSQ) at week 12 ("very satisfied" or "somewhat satisfied"). Patients completed voiding diaries, Overactive Bladder Questionnaire short form (OAB-q-SF), Overactive Bladder Symptom Score (OABSS), and the global response assessment (GRA) at baseline, Week 4, and Week 12. At 12-weeks, patients were assessed for willingness to continue treatment. Results: The response rate of treatment satisfaction at 12 weeks was 69.3% (275/397) (95% confidence interval 64.7-73.8). Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001). Both OAB-q-SF and OABSS were significantly improved compared to baseline. At 4 and 12 weeks, 27.5% and 41.8% of patients, respectively, responded to the GRA as being moderately or markedly improved. At 12 weeks, 80.8% of patients were willing to continue mirabegron. Conclusions: Mirabegron improved the rates of treatment satisfaction and symptoms in patients with OAB who were unsatisfied with prior antimuscarinic treatment.

Pharmacological Management of Urinary Incontinence: Current and Emerging Treatment

“… 36 A recent multicenter prospective study (the FAVOR study) concluded that mirabegron significantly improved the rates of treatment satisfaction and symptoms in patients with OAB who were unsatisfied with prior antimuscarinic treatment. 37 The response rate of treatment satisfaction at 12 weeks was 69.3% (275/397).…”

Clinical Utility of β3-Adrenoreceptor Agonists for the Treatment of Overactive Bladder: A Review of the Evidence and Current Recommendations

“… 26 In the FAVOR study, which included patients after withdrawal of AChs, there were no significant differences observed in mirabegron efficacy between those who discontinued AChs due to low efficacy and those who discontinued due to adverse effects. 27 Generally, the onset of effect in mirabegron recipients is usually observed within 1 month, reaching a maximum within 12–16 weeks after treatment initiation. The effect remains stable over 1 year if the drug is taken regularly.…”

Comment on “A multicenter prospective study for overactive bladder patient treatment satisfaction with mirabegron after being unsatisfied with antimuscarinic therapy (FAVOR study)”

“…Dear Editor, I read with great interest the article by Ko et al 1 published in a previous issue of the journal. They assessed the satisfaction and efficacy of mirabegron in patients with overactive bladder (OAB) who were unsatisfied with previous antimuscarinic therapy due to poor efficacy and/or adverse events.…”

“…Ko et al 1 should be congratulated for a well-designed study on this important topic. However, I would like to contribute to their study with the findings of our recent study investigating clinical responsiveness to antimuscarinics in postmenopausal women.…”

“…The importance of individualized therapy strategy has been emphasized for better clinical decision making and better outcomes, especially in refractory OAB. 5 According to Ko et al, 1 it is expected that an early switch to mirabegron in these patients may provide better therapeutic effects and satisfaction. However, patients who discontinued previous antimuscarinic therapy were not evaluated in terms of cardiovascular morbidity in their study.…”