Long-term safety, efficacy, and tolerability of imidafenacin in the treatment of overactive bladder: a review of the Japanese literature

Figures & data

Table 1 Changes in incontinence episodes as a primary endpoint in a randomized, double-blind, placebo-controlled and propiverine-controlled trial of imidafenacin in Japan

Incontinence episodes per week, mean ± SD	Placebo	Imidafenacin 0.1 mg twice daily	Propiverine 20 mg once daily
Full analysis set population
Patients (n)	143	318	305
Baseline	17.55 ± 11.18	18.56 ± 14.81	18.00 ± 14.90
Week 12 or at discontinuation	8.88 ± 11.93	6.89 ± 11.55	5.36 ± 10.67
% change from baseline	−49.50 ± 57.22	−68.24 ± 36.90	−73.09 ± 43.62
95% CI of difference versus placebo	–	−27.62, −9.85	−33.40, −13.77
P value (versus placebo)†	–	<0.0001	<0.0001
Per protocol set population
Patients (n)	131	300	278
Baseline	17.79 ± 11.49	18.59 ± 14.88	17.93 ± 14.83
Week 12 or at discontinuation	8.53 ± 11.70	6.82 ± 11.59	5.35 ± 10.53
% change from baseline	−52.31 ± 55.71	−68.54 ± 36.58	−73.08 ± 43.15
95% CI of difference versus propiverine	–	−1.98, 11.06	–
P value (noninferiority to propiverine)‡	–	0.0014	–

Notes:

† t-test, two-sided;

‡ t-test with noninferiority margin of Δ = 14.5%, one-sided.

Copyright © 2009. John Wiley and Sons. Modified and adapted with permission from Homma Y, Yamaguchi O. A randomized, double-blind, placebo- and propiverine-controlled trial of the novel antimuscarinic agent imidafenacin in Japanese patients with overactive bladder. Int J Urol. 2009;16: 499–506.¹¹

Abbreviation: CI, confidence interval.

Table 2 Changes from baseline in the efficacy endpoints during 52 weeks of imidafenacin treatment in a long-term, open-label, uncontrolled study in Japan (per protocol set, n = 364)

	Baseline	Week 4	Week 12	Week 28	Week 40	Week 52	Week 52 or at discontinuation
Incontinence episodes per week
Mean ± SD	14.53 ± 14.47	7.26 ± 10.83	5.53 ± 9.62	4.03 ± 8.39	2.97 ± 7.05	2.88 ± 7.22	2.84 ± 7.14
% change from baseline	–	−48.58 ± 57.08*	−55.92 ± 73.52*	−70.83 ± 50.56*	−81.30 ± 40.74*	−83.59 ± 35.54*	−83.51 ± 35.48*
% of incontinence- free patients	0	23.5	33.5	43.1	56.8	59.9	59.8
Urgency incontinence episodes per week
Mean ± SD	11.88 ± 11.59	5.76 ± 8.55	4.23 ± 7.19	3.20 ± 7.25	2.15 ± 5.60	2.13 ± 5.43	2.11 ± 5.38
% change from baseline	–	−49.58 ± 71.35*	−58.91 ± 76.07*	−71.56 ± 61.24*	−83.54 ± 39.89*	−84.44 ± 38.57*	−84.21 ± 38.71*
Micturition per day
Mean ± SD	11.56 ± 2.81	10.35 ± 2.46	9.92 ± 2.43	9.52 ± 2.34	9.02 ± 2.29	9.22 ± 2.38	9.21 ± 2.36
% change from baseline	–	−1.21 ± 1.84*	−1.65 ± 2.12*	−2.05 ± 2.26*	−2.55 ± 2.31*	−2.34 ± 2.15*	−2.35 ± 2.14*
Urgency episodes per day
Mean ± SD	4.84 ± 3.18	3.14 ± 3.02	2.53 ± 2.79	2.11 ± 2.64	1.46 ± 2.26	1.56 ± 2.46	1.54 ± 2.43
% change from baseline	–	−35.01 ± 48.51*	−45.81 ± 53.37*	−55.67 ± 48.65*	−71.54 ± 37.85*	−70.39 ± 38.67*	−70.53 ± 38.37*
Urine volume voided per micturition (mL)
Mean ± SD	145.77 ± 49.43	173.48 ± 59.54	179.52 ± 57.68	178.26 ± 58.27	169.06 ± 59.40	179.91 ± 58.78	174.49 ± 58.37
Change from baseline	–	27.87 ± 33.45*	34.10 ± 35.70*	33.08 ± 39.08*	24.09 ± 41.23*	29.67 ± 39.77*	28.99 ± 40.09*

Notes:

* P < 0.05; paired t-test, two-sided. Copyright © 2008. John Wiley and Sons. Modified and adapted with permission from Homma Y, Yamaguchi O. Long-term safety, tolerability, and efficacy of the novel anti-muscarinic agent imidafenacin in Japanese patients with overactive bladder. Int J Urol. 2008;15:986–991.⁴⁸

Abbreviation: SD, standard deviation.

Figure 1 Changes from baseline in the efficacy endpoints during 52 to 64 weeks of imidafenacin treatment.

Notes: Open and closed circles indicate 0.2 mg/day and 0.4 mg/day imidafenacin, respectively. Circles and vertical bars indicate mean and upper limit of 95% confidence interval, respectively. *Week 52 or at discontinuation of 0.2 mg/day imidafenacin, week 64, or at discontinuation of 0.4 mg/day imidafenacin. Copyright © 2009. Japanese Pharmacology and Therapeutics. Modified and adapted with permission from Yamaguchi O, Homma Y. Long-term efficacy and safety of dose increase study of imidafenacin in patients with overactive bladder. Jpn Pharmacol Ther. 2009;37:909–930.⁴⁹

HommaYYamaguchiOA randomized, double-blind, placebo- and propiverine-controlled trial of the novel antimuscarinic agent imidafenacin in Japanese patients with overactive bladderInt J Urol20091649950619389083

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HommaYYamaguchiOLong-term safety, tolerability, and efficacy of the novel anti-muscarinic agent imidafenacin in Japanese patients with overactive bladderInt J Urol20081598699118761536

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YamaguchiOHommaYLong-term efficacy and safety of dose increase study of imidafenacin in patients with overactive bladderJpn Pharmacol Ther200937909930

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