Plenary: Next Frontier, Sunday
Plenary: Next Frontier
Presentation Authors: Christian Gratzke*, Munich, Germany, Rob van Maanen, Leiden, Netherlands, Christopher Chapple, Sheffield, United Kingdom, Paul Abrams, Bristol, United Kingdom, Sender Herschorn, Toronto, Canada, Dudley Robinson, London, United Kingdom, Arwin Ridder, Matthias Stoelzel, Asha Paireddy, Leiden, Netherlands, Elizabeth R. Mueller, Maywood, IL
Introduction: The objective of this Phase III study was to evaluate the safety and efficacy of long-term solifenacin and mirabegron combination (COMBN) treatment compared with solifenacin (SOLI) and mirabegron (MIRA) alone.
Methods: This was a randomized, double-blind, parallel-group study. Adult patients with symptoms of overactive bladder (OAB) for ≥3 m and ≥3 incontinence episodes in 7 d were eligible. After a 2-wk washout period, patients were randomized (4:1:1) to receive COMBN (SOLI 5 mg + MIRA 50 mg), SOLI (5 mg), or MIRA (50 mg) for a duration of 12 m. The primary safety variable was frequency of treatment-emergent adverse events (TEAEs). The change from Baseline to end of treatment (EoT) in mean number of incontinence episodes/24 h and micturitions/24 h were primary efficacy variables. Key secondary efficacy variables were change from Baseline to EoT in mean volume voided per micturition, OAB questionnaire Symptom Bother score, and treatment satisfaction-visual analog scale score. All efficacy variables were evaluated using analysis of covariance models.
Results: In total, 1,819 patients received COMBN (n=1,210), SOLI (n=303), or MIRA (n=306) and all groups had similar demographics. Overall, 856 (47.2%) patients experienced ≥1 TEAE (Table 1). A slightly increased frequency of TEAEs was observed in the COMBN group. The most common TEAEs in each group were dry mouth (COMBN and SOLI) and nasopharyngitis (MIRA). The changes from Baseline to EoT in the mean number of incontinence episodes and micturitions were significantly greater with COMBN treatment compared with SOLI and MIRA (Table 2). COMBN treatment was also significantly superior to SOLI and MIRA for all key secondary efficacy variables.
Conclusions: COMBN (SOLI + MIRA) treatment over 12 m was well tolerated and no new safety concerns were apparent. Clinically relevant improvements in efficacy were observed with COMBN treatment compared with each monotherapy over the 12 m study period.
Source Of Funding: This study was funded by Astellas Pharma Europe B.V.
LMU Munich, Department of Urology
Christian Gratzke is associate professor at the Department of Urology, Ludwig-Maximilians-University (LMU) in Munich, Germany (Director: Prof. C. G. Stief). After Medical School at the LMU Munich and University of Vienna, he completed a research fellowship at the Department of Anatomy, LMU Munich before starting residency at LMU Munich in 2004. Christian Gratzke underwent research fellowships between 2007-2008 at Wake Forest University, NC (Prof. Karl-Erik Andersson) and at Lund University, Sweden (Prof. Petter Hedlund) in clinical pharmacology. His main clinical interests include treatment of prostate and BPH / LUTS in addition to his basic and clinical research activities focusing on lower urinary tract and erectile dysfunction. Christian Gratzke is member of the EAU working group on BPH/male LUTS/BOO, member of the sub-committee (basic research) at the European Society for Sexual Medicine (ESSM), and member of the Urological Research Society (URS). He has published more than 200 articles in peer-reviewed journals, authored 15 book chapters and received multiple national and international awards for his basic and clinical research.
Friday, May 12
9:30 AM – 11:30 AM
Saturday, May 13
11:05 AM – 11:30 AM