BETMIGA (mirabegron), urinary antispasmodic
UROLOGY - Update
Opinions on drugs - Posted on Mar 29 2018
Reason for request
Re-assessment of the actual benefit
Insufficient clinical benefit to justify its inclusion on the list of reimbursable products for overactive bladder syndrome due to a poorly established efficacy/adverse effects ratio.
- BETMIGA has Marketing Authorisation in the symptomatic treatment of urinary urgency and increased urinary frequency and/or urge incontinence that may occur in adults with overactive bladder syndrome (OAB).
- Its efficacy is low compared with placebo. A study was unable to demonstrate the non-inferiority of BETMIGA compared with VESICARE (solifenacin) in terms of mean number of micturitions per day.
- The cardiovascular tolerance of BETMIGA is still being monitored.
Évaluation des médicaments