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

Abstract

IntroductionPatient-reported outcomes (PROs) provide valuable insights about the effectiveness of overactive bladder (OAB) treatments. The aim of PERSPECTIVE (a Prospective, non-intErventional Registry Study of PatiEnts initiating a Course of drug Therapy for overactIVE bladder) was to provide real-world evidence from the USA and Canada on patient-perceived effectiveness and safety of mirabegron and antimuscarinics for treating OAB symptoms.MethodsThis prospective, non-interventional registry followed adult patients with OAB who were starting treatment with mirabegron or antimuscarinics. All treatment decisions were made at the discretion of the treating healthcare provider with no mandatory visits after enrollment. The primary objective was to identify factors associated with improved treatment effectiveness from a patient perspective mainly using the OAB Questionnaire Short-Form (OAB-q SF). The form was sent to patients via email link at baseline and months 1, 3, 6, and 12. Treatment-emergent adverse event (TEAE) data were collated from investigator reports.ResultsOverall, 1514 patients were included (female 73.5%, mean age 62.2 years). Mirabegron was initiated by 613 patients and antimuscarinics by 901 patients. A PRO response rate of approximately 60% was achieved (575 patients did not complete baseline PROs). Similar improvements in OAB-q SF symptom bother score and health-related quality of life (HRQoL) total score were observed for mirabegron and antimuscarinic initiators. Covariate-adjusted models demonstrated that worse baseline PRO score, Hispanic ethnicity, being treatment naïve, and use of complementary/supportive OAB therapies at baseline were significantly associated with greater improvements in both scores. The most frequent TEAEs were gastrointestinal disorders (dry mouth, constipation, and nausea) and nervous system disorders (headache, somnolence, and dizziness).ConclusionThere are no differences between mirabegron and antimuscarinics in terms of patient-reported OAB symptom bother and HRQoL.Trial RegistrationClinicalTrials.gov identifier, NCT02386072.FundingAstellas Pharma Global Development, Inc.Plain Language SummaryPlain language summary available for this article.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-019-00994-7) contains supplementary material, which is available to authorized users.

Persistence with mirabegron or antimuscarinic treatment for overactive bladder syndrome: Findings from the PERSPECTIVE registry study

“…This finding was potentially due to the study design as there was no requirement for patients to attend scheduled visits during the follow‐up period. The lack of statistically significant differences in persistence may explain why similar patient‐reported OAB symptom bother and HRQoL results were observed for both treatments in the present study 31 …”

“…The study population data have been reported previously 31 . In brief, a total of 1514 patients were included in PERSPECTIVE (613 mirabegron initiators and 901 antimuscarinic initiators).…”

“…The study population data have been reported previously. 31 In brief, a total of 1514 patients were included in PERSPECTIVE (613 mirabegron initiators and 901 antimuscarinic initiators). The most frequently initiated antimuscarinics were oxybutynin (423 [46.9%] patients), solifenacin (298 [33.1%] patients), and tolterodine (90 [10.0%] patients).…”

“…PERSPECTIVE (a Prospective, Non‐interventional Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder) is the first large, prospective, non‐interventional study that involves patients with OAB being prescribed mirabegron or antimuscarinics in North American clinical practice 30 . The primary analysis from the PERSPECTIVE registry found that there were no differences between mirabegron and antimuscarinics in terms of patient‐reported OAB symptom bother and health‐related quality of life (HRQoL) and investigated the safety of both types of therapeutic 31 . As persistence with different types of OAB pharmacotherapies is not well examined in prospective clinical practice, this secondary analysis of PERSPECTIVE was conducted to evaluate treatment persistence with mirabegron or antimuscarinics over the 12‐month study period.…”

“… 30 The primary analysis from the PERSPECTIVE registry found that there were no differences between mirabegron and antimuscarinics in terms of patient‐reported OAB symptom bother and health‐related quality of life (HRQoL) and investigated the safety of both types of therapeutic. 31 As persistence with different types of OAB pharmacotherapies is not well examined in prospective clinical practice, this secondary analysis of PERSPECTIVE was conducted to evaluate treatment persistence with mirabegron or antimuscarinics over the 12‐month study period.…”