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Astellas Reports Results of Mirabegron in P-IV PLUS Study to Reduce Overactive Bladder Symptoms in Men

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Astellas Reports Results of Mirabegron in P-IV PLUS Study to Reduce Overactive Bladder Symptoms in Men

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  • 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

Ref: PRNewsWire | Image: Astellas

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