- Email: [email protected]
PD36-01 IMPROVED PATIENT-REPORTED OUTCOMES (PROS) WITH MIRABEGRON ADD-ON TREATMENT IN A RANDOMIZED, DOUBLE-BLIND, PHASE 3B STUDY IN INCONTINENT OVERACTIVE BLADDER (OAB) PATIENTS WITH AN INADEQUATE RESPONSE TO SOLIFENACIN
THE JOURNAL OF UROLOGYâ
Vol. 195, No. 4S, Supplement, Monday, May 9, 2016
e849
Urodynamics/Lower Urinary Tract Dysfunction/ Female Pelvic Medicine: Female Incontinence: Therapy I Podium Monday, May 9, 2016
8:00 AM-10:00 AM
PD36-01 IMPROVED PATIENT-REPORTED OUTCOMES (PROS) WITH MIRABEGRON ADD-ON TREATMENT IN A RANDOMIZED, DOUBLE-BLIND, PHASE 3B STUDY IN INCONTINENT OVERACTIVE BLADDER (OAB) PATIENTS WITH AN INADEQUATE RESPONSE TO SOLIFENACIN Scott MacDiarmid*, Greensboro, NC; Salman Al-Shukri, Saint Petersburg, Russian Federation; Jack Barkin, Toronto, Canada; Aino Fianu-Jonasson, Huddinge Stockholm, Sweden; Philippe Grise, Rouen, France; Sender Herschorn, Toronto, Canada; Moses Huang, €lzel, Leiden, Emad Siddiqui, Chertsey, United Kingdom; Matthias Sto Netherlands; Claire Hemsted, Chertsey, United Kingdom; Marcus Drake, Bristol, United Kingdom INTRODUCTION AND OBJECTIVES: Quality of life (QoL) and treatment satisfaction are important determinants of successful long-term outcomes in patients with OAB. This study (NCT01908819) assessed PROs during treatment with a combination (COMBN) of the b3-adrenoceptor agonist, mirabegron (MIRA) 50mg and the antimuscarinic, solifenacin (SOLI) 5mg vs SOLI 5mg or 10mg monotherapy, in incontinent patients with OAB and an inadequate response to SOLI 5mg monotherapy. METHODS: In a pre-specified analysis, incontinent adults with OAB symptoms for 3 mo entered a 2-wk wash-out followed by 4 wks single-blind daily SOLI 5mg. Patients still reporting 1 incontinence episode(s) during a 3-day micturition diary were randomized (1:1:1) to daily double-blind treatment with COMBN (SOLI 5mg + MIRA 25mg, increasing to MIRA 50mg at 4 wks), SOLI 5mg, or SOLI 10mg for 12 wks. At Baseline (BL), 4 wks, 8 wks and end of treatment (EoT), patients completed an OAB-specific questionnaire (OAB-q) evaluating Symptom Bother and total/subscale health-related QoL (HRQoL, subscales: Concern, Coping, Sleep and Social). PRO instruments Treatment Satisfaction-Visual Analog Scale (TS-VAS) and Patient Perception of Bladder Condition (PPBC) were completed at BL, 4 wks, 8 wks and EoT. Patient/Clinician’s Global Impression of Change (PGIC/ CGIC) were only completed at EoT. RESULTS: Baseline characteristics were similar between groups (COMBN, n¼707; SOLI 5mg, n¼705; SOLI 10mg, n¼698). At EoT, COMBN was superior to SOLI 10mg for OAB-q Symptom Bother, total HRQoL and all subscales, and superior to SOLI 5mg for all OAB-q scores, except Sleep. PPBC was improved for COMBN vs SOLI 5mg and 10mg (Table). Significant differences in favor of COMBN vs SOLI 5mg were reported in TS-VAS (p¼0.001). For CGIC, “very much improved” patients at EoT were reported by 26.0%, 16.7% and 20.2% of clinicians for COMBN and SOLI 5mg and 10mg, respectively. For PGIC, “very much improved” was reported by 32.1%, 21.6% and 24.5% of patients for COMBN and SOLI 5mg and 10mg, respectively. CONCLUSIONS: In incontinent patients with OAB and an inadequate response to solifenacin, daily add-on mirabegron resulted in improved HRQoL and treatment satisfaction.
Source of Funding: This work was funded by Astellas.
PD36-02 MIRABEGRON ADD-ON TREATMENT TO SOLIFENACIN IN INCONTINENT OVERACTIVE BLADDER (OAB) PATIENTS: A RESPONDER ANALYSIS OF A RANDOMIZED, DOUBLE BLIND, PHASE 3B STUDY Scott MacDiarmid*, Greensboro, NC; Salman Al-Shukri, Saint Petersburg, Russian Federation; Jack Barkin, Toronto, Canada; Aino Fianu-Jonasson, Huddinge Stockholm, Sweden; Philippe Grise, Rouen, France; Sender Herschorn, Toronto, Canada; Moses Huang, €lzel, Leiden, Emad Siddiqui, Chertsey, United Kingdom; Matthias Sto Netherlands; Claire Hemsted, Chertsey, United Kingdom; Marcus Drake, Bristol, United Kingdom INTRODUCTION AND OBJECTIVES: Incontinence is detrimental to health-related quality of life (HRQoL) in patients with OAB. This study (NCT01908829) assessed responder rates for efficacy and patient-reported outcomes (PROs), after treatment with a combination (COMBN) of the b3-adrenoceptor agonist, mirabegron (MIRA) and the antimuscarinic, solifenacin (SOLI), in incontinent patients with OAB and an inadequate response to SOLI 5mg monotherapy. METHODS: In this pre-specified analysis, incontinent adults with OAB symptoms for 3 mo entered a 2-wk wash-out period followed by 4 wks single-blind daily SOLI 5mg. Patients still reporting 1 incontinence episodes during a 3-day micturition diary were randomized (1:1:1) to daily double-blind treatment with COMBN (SOLI 5mg + MIRA 25mg, increasing to MIRA 50mg at 4 wks), SOLI 5mg, or SOLI 10mg for 12 wks. At end of treatment, responder rates for incontinence (zero incontinence episodes post-Baseline [‘dry rate’] and 50% decrease in incontinence episodes/24 h); micturition reduction to <8 micturitions/ 24h; and PROs (exceeding threshold of minimally important differences [MID] in Patient Perception of Bladder Condition [PPBC], and OABquestionnaire [OAB-q] Symptom Bother and total HRQoL scores) were evaluated individually or as double/triple responder analyses (50% reduction in incontinence plus OAB-q and/or PPBC). RESULTS: Baseline characteristics were similar between groups (COMBN, n¼707; SOLI 5mg, n¼705; SOLI 10mg, n¼698). The odds for achieving full continence were 47% and 28% higher for COMBN vs SOLI 5mg or 10mg respectively; improvements in OAB-q outcomes were statistically significant (Table). Responder rates for
Vol. 195, No. 4S, Supplement, Monday, May 9, 2016
e849
Urodynamics/Lower Urinary Tract Dysfunction/ Female Pelvic Medicine: Female Incontinence: Therapy I Podium Monday, May 9, 2016
8:00 AM-10:00 AM
PD36-01 IMPROVED PATIENT-REPORTED OUTCOMES (PROS) WITH MIRABEGRON ADD-ON TREATMENT IN A RANDOMIZED, DOUBLE-BLIND, PHASE 3B STUDY IN INCONTINENT OVERACTIVE BLADDER (OAB) PATIENTS WITH AN INADEQUATE RESPONSE TO SOLIFENACIN Scott MacDiarmid*, Greensboro, NC; Salman Al-Shukri, Saint Petersburg, Russian Federation; Jack Barkin, Toronto, Canada; Aino Fianu-Jonasson, Huddinge Stockholm, Sweden; Philippe Grise, Rouen, France; Sender Herschorn, Toronto, Canada; Moses Huang, €lzel, Leiden, Emad Siddiqui, Chertsey, United Kingdom; Matthias Sto Netherlands; Claire Hemsted, Chertsey, United Kingdom; Marcus Drake, Bristol, United Kingdom INTRODUCTION AND OBJECTIVES: Quality of life (QoL) and treatment satisfaction are important determinants of successful long-term outcomes in patients with OAB. This study (NCT01908819) assessed PROs during treatment with a combination (COMBN) of the b3-adrenoceptor agonist, mirabegron (MIRA) 50mg and the antimuscarinic, solifenacin (SOLI) 5mg vs SOLI 5mg or 10mg monotherapy, in incontinent patients with OAB and an inadequate response to SOLI 5mg monotherapy. METHODS: In a pre-specified analysis, incontinent adults with OAB symptoms for 3 mo entered a 2-wk wash-out followed by 4 wks single-blind daily SOLI 5mg. Patients still reporting 1 incontinence episode(s) during a 3-day micturition diary were randomized (1:1:1) to daily double-blind treatment with COMBN (SOLI 5mg + MIRA 25mg, increasing to MIRA 50mg at 4 wks), SOLI 5mg, or SOLI 10mg for 12 wks. At Baseline (BL), 4 wks, 8 wks and end of treatment (EoT), patients completed an OAB-specific questionnaire (OAB-q) evaluating Symptom Bother and total/subscale health-related QoL (HRQoL, subscales: Concern, Coping, Sleep and Social). PRO instruments Treatment Satisfaction-Visual Analog Scale (TS-VAS) and Patient Perception of Bladder Condition (PPBC) were completed at BL, 4 wks, 8 wks and EoT. Patient/Clinician’s Global Impression of Change (PGIC/ CGIC) were only completed at EoT. RESULTS: Baseline characteristics were similar between groups (COMBN, n¼707; SOLI 5mg, n¼705; SOLI 10mg, n¼698). At EoT, COMBN was superior to SOLI 10mg for OAB-q Symptom Bother, total HRQoL and all subscales, and superior to SOLI 5mg for all OAB-q scores, except Sleep. PPBC was improved for COMBN vs SOLI 5mg and 10mg (Table). Significant differences in favor of COMBN vs SOLI 5mg were reported in TS-VAS (p¼0.001). For CGIC, “very much improved” patients at EoT were reported by 26.0%, 16.7% and 20.2% of clinicians for COMBN and SOLI 5mg and 10mg, respectively. For PGIC, “very much improved” was reported by 32.1%, 21.6% and 24.5% of patients for COMBN and SOLI 5mg and 10mg, respectively. CONCLUSIONS: In incontinent patients with OAB and an inadequate response to solifenacin, daily add-on mirabegron resulted in improved HRQoL and treatment satisfaction.
Source of Funding: This work was funded by Astellas.
PD36-02 MIRABEGRON ADD-ON TREATMENT TO SOLIFENACIN IN INCONTINENT OVERACTIVE BLADDER (OAB) PATIENTS: A RESPONDER ANALYSIS OF A RANDOMIZED, DOUBLE BLIND, PHASE 3B STUDY Scott MacDiarmid*, Greensboro, NC; Salman Al-Shukri, Saint Petersburg, Russian Federation; Jack Barkin, Toronto, Canada; Aino Fianu-Jonasson, Huddinge Stockholm, Sweden; Philippe Grise, Rouen, France; Sender Herschorn, Toronto, Canada; Moses Huang, €lzel, Leiden, Emad Siddiqui, Chertsey, United Kingdom; Matthias Sto Netherlands; Claire Hemsted, Chertsey, United Kingdom; Marcus Drake, Bristol, United Kingdom INTRODUCTION AND OBJECTIVES: Incontinence is detrimental to health-related quality of life (HRQoL) in patients with OAB. This study (NCT01908829) assessed responder rates for efficacy and patient-reported outcomes (PROs), after treatment with a combination (COMBN) of the b3-adrenoceptor agonist, mirabegron (MIRA) and the antimuscarinic, solifenacin (SOLI), in incontinent patients with OAB and an inadequate response to SOLI 5mg monotherapy. METHODS: In this pre-specified analysis, incontinent adults with OAB symptoms for 3 mo entered a 2-wk wash-out period followed by 4 wks single-blind daily SOLI 5mg. Patients still reporting 1 incontinence episodes during a 3-day micturition diary were randomized (1:1:1) to daily double-blind treatment with COMBN (SOLI 5mg + MIRA 25mg, increasing to MIRA 50mg at 4 wks), SOLI 5mg, or SOLI 10mg for 12 wks. At end of treatment, responder rates for incontinence (zero incontinence episodes post-Baseline [‘dry rate’] and 50% decrease in incontinence episodes/24 h); micturition reduction to <8 micturitions/ 24h; and PROs (exceeding threshold of minimally important differences [MID] in Patient Perception of Bladder Condition [PPBC], and OABquestionnaire [OAB-q] Symptom Bother and total HRQoL scores) were evaluated individually or as double/triple responder analyses (50% reduction in incontinence plus OAB-q and/or PPBC). RESULTS: Baseline characteristics were similar between groups (COMBN, n¼707; SOLI 5mg, n¼705; SOLI 10mg, n¼698). The odds for achieving full continence were 47% and 28% higher for COMBN vs SOLI 5mg or 10mg respectively; improvements in OAB-q outcomes were statistically significant (Table). Responder rates for