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Critical analysis of phase II and III randomised control trials ( RCTs ) evaluating efficacy and tolerability of a β 3 ‐adrenoceptor agonist ( M irabegron) for overactive bladder ( OAB )
Author(s) -
Rossanese Marta,
Novara Giacomo,
Challacombe Ben,
Iannetti Alessandro,
Dasgupta Prokar,
Ficarra Vincenzo
Publication year - 2015
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.12730
Subject(s) - mirabegron , tolerability , overactive bladder , medicine , discontinuation , placebo , urology , randomized controlled trial , adverse effect , clinical trial , alternative medicine , pathology
To critically analyse available phase II and III randomised control trials ( RCTs ) reporting clinical data about the efficacy and tolerability of M irabegron (a β 3 ‐adrenoceptor agonist) in the treatment of overactive bladder ( OAB ) syndrome. A review of the literature was performed in S eptember 2013 using the MEDLINE database. A ‘free text’ protocol was used for the search strategy using ‘overactive bladder’ and ‘ M irabegron’ as keywords. Subsequently, the searches were pooled and limited to phase II and III RCTs . Two phase II and five phase III RCTs were selected and analysed. The available phase II studies showed the efficacy and tolerability of different doses of M irabegron compared with placebo. Moreover, a dose‐ranging study showed that 50 mg once daily should be considered the most promising dose for clinical use. The 12‐week phase III studies confirmed the effectiveness of M irabegron to significantly reduce the mean number of incontinence episodes/24 h and the mean number of micturitions/24 h compared with placebo. A post hoc analysis confirmed that favourable results with M irabegron were reported both in patients with OAB who were antimuscarinic naïve and in those who had discontinued prior antimuscarinic therapy. Moreover, a phase III trial showed the safety and tolerability of 12‐month treatment of M irabegron. Discontinuation due to adverse events was low both using the 50 and 100 mg dose of M irabegron. M irabegron is the first of a new class of drugs for the treatment of OAB able to influence non‐voiding activity and produce an increased storage capacity and inter‐void interval. Recently published phase II and III RCTs have shown that the β 3 ‐adrenoceptor‐selective agonist, M irabegron, is an effective and safe drug for the symptomatic treatment of OAB syndrome. M irabegron represents a valid medical option both for patients with OAB who are antimuscarinic naïve, as well as in those where antimuscarinics are ineffective or not tolerated.