Clinical efficacy and safety of mirabegron and imidafenacin in women with overactive bladder: A randomized crossover study (the MICRO study).
OBJECTIVE
We aimed to compare the efficacy and safety of mirabegron, a β3-adrenoceptor agonist, and imidafenacin, an anticholinergic agent, in overactive bladder patients.


METHODS
We conducted a multicenter, prospective randomized cross-over study at 5 hospitals in Japan from December 2012 to June 2015. We enrolled female patients with overactive bladder aged ≥50 years, who had never received treatment for the condition. The patients were assigned to Group A or B. Group A patients were administered mirabegron (50 mg per day) for 8 weeks, followed by a 2-week washout period, and then imidafenacin (0.2 mg per day) for 8 weeks. This order of drug administration was reversed in Group B.


RESULTS
A total of 33 and 18 patients in Group A and 37 and 26 patients in Group B continued to receive treatment at weeks 8 and 18, respectively. Mirabegron administration significantly improved overactive bladder symptom score (OABSS), the urinary frequency per 24 hr, voided volume per micturition, and number of nocturia episodes per night at week 8. Moreover, imidafenacin administration improved all these variables, except for the number of nocturia episodes per night at week 8. No significant difference was observed in the drug effects between mirabegron and imidafenacin. Although imidafenacin administration significantly increased the scores for dry mouth, blurred vision, and constipation, mirabegron administration did not.


CONCLUSIONS
Mirabegron and imidafenacin have the same efficacy. Imidafenacin administration is associated with a higher rate of dry mouth, blurred vision, and constipation as compared to mirabegron administration. Neurourol. Urodynam. 36:1097-1103, 2017. © 2016 Wiley Periodicals, Inc.
Nara Medical University, Nara, Japan.
Kazumasa
K
Torimoto
Saiseikai-Chuwa Hospital, Nara, Japan.|Tane General Hospital, Osaka, Japan.
Chie
C
Matsushita
Hirao Hospital, Nara, Japan.
Atsushi
A
Yamada
Hirao Hospital, Nara, Japan.
Daisuke
D
Goto
Nara Prefecture General Medical Center, Nara, Japan.
Yoshihiro
Y
Matsumoto
Tane General Hospital, Osaka, Japan.
Yukinari
Y
Hosokawa
Nara Medical University, Nara, Japan.
Makito
M
Miyake
Nara Medical University, Nara, Japan.
Katsuya
K
Aoki
Nara Hospital Kinki University Faculty of Medicine, Nara, Japan.
Akihide
A
Hirayama
Nara Medical University, Nara, Japan.
Nobumichi
N
Tanaka
Nara Medical University, Nara, Japan.
Kiyohide
K
Fujimoto
D000083:Acetanilides / Q000627:therapeutic use*; D058667:Adrenergic beta-3 Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D064804:Urological Agents / Q000009:adverse effects / Q000627:therapeutic use*
D000083:Acetanilides; D058667:Adrenergic beta-3 Receptor Agonists; D007093:Imidazoles; D018727:Muscarinic Antagonists; D013844:Thiazoles; D064804:Urological Agents; C520025:mirabegron; C120953:imidafenacin
anticholinergic agent; crossover; overactive bladder; β3-adrenoceptor agonist