- The P-IV PLUS study involves assessing of Mirabegron(25mg,50mg) vs PBO in 715 men patients with overactive bladder (OAB) symptoms receiving tamsulosin for lower urinary tract symptoms (LUTS) due to underlying benign prostatic hyperplasia (BPH) aged ≥40 yrs.
- The P-IV PLUS study results: @12wks. reduction in no. of micturition/day, increment in mean volume voided (MVV)/micturition, reduction in urgency episodes/day, improvements in total urgency and frequency score, TEAEs (25.9% vs 31.4%), no difference in IPSS score is observed
- Mirabegron is a beta‐3 adrenergic agonist targeting CYP2D6 and has received FDA’s approval as monothx. or in combination with solifenacin succinate for the treatment of OAB symptoms, marketed as Myrbetriq in the US
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