Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder in Japanese patients

Mineo Takei, Yukio Homma, Hironobu Akino, Shiro Baba, Atsunobu Esa, Takuji Fujinaga, Junnosuke Fukui, Eitetsu Gon, Momokazu Gotoh, Takahiro Haginaka, Kiyotaka Hoshinaga, Takahito Ikeuchi, Hirohide Iriguchi, Toshiya Ishida, Yoshio Ishida, Yasunori Ishii, Osamu Ishiko, Shinji Kageyama, Hiroshi Kajikawa, Yoshiyuki KakehiTetsuo Katsumi, Kazuki Kawabe, Mutsushi Kawakita, Takeshi Kawamura, Kazuo Kitami, Shinya Kobayashi, Kenjiro Kohri, Hideki Komatsu, Hitoshi Masuda, Shigeki Matsuo, Hisashi Matsushima, Shigeyoshi Morimoto, Hajime Morita, Kouei Muguruma, Haruo Nakagawa, Yosuke Nakjima, Mikio Namiki, Takashige Namima, Osamu Nishizawa, Kazumi Noguchi, Ryosuke Noguchi, Hiroya Oka, Yasutada Onodera, Seiichirou Ozono, Masafumi Sahashi, Shigeo Sakashita, Shoji Samma, Masayoshi Shimamura, Naotake Shimoda, Atsushi Sone, Takahide Sugiyama, Kouji Suzuki, Yasushi Suzuki, Masashi Takaiwa, Hitoshi Takamoto, Masayuki Takeda, Ikumasa Takenaka, Shigeo Taketa, Hideo Takeuchi, Toshiro Terachi, Takashi Tominaga, Keiichi Tozawa, Sadamu Tsukamoto, Osamu Ueki, Toyoko Yamato, Kousaku Yasuda, Teruhiko Yokoyama, Masaki Yoshida

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22 Citations (Scopus)

Abstract

Aim: To evaluate the long-term safety, tolerability and efficacy of extended-release (ER) tolterodine in Japanese patients completing 12-week treatment in a randomized, double-blind trial comparing tolterodine ER 4 mg once daily, oxybutynin 3 mg three times daily or placebo in patients with overactive bladder. Methods: Of 293 Japanese patients completing the 12-week study, 188 continued in the open-label trial and received tolterodine ER 4 mg once daily for 12 months, irrespective of previous treatment. The primary objective was to assess the safety of tolterodine ER for up to 52 weeks of treatment and at post-treatment follow-up. Secondary endpoints included changes in micturition diary variables, patient perception of bladder condition and urgency and treatment benefit. Results: Overall, 77% of patients completed 12 months of open-label treatment. Tolterodine ER was well tolerated and the most common adverse event was dry mouth (33.5%). In general, there was no increase in adverse event frequency with long-term treatment compared with short-term treatment. The efficacy of tolterodine ER was maintained over the 12-month period. The complete analysis showed a median reduction in incontinence episodes/week (-92.9%; mean reduction, -77.2%), a mean reduction in micturitions/24 h (-21.3%) and a mean increase in volume voided per micturition (19.6%). Of patients completing the 12-month study, 78.6% reported improvement in patient perception of bladder condition, 52.4% reported improvement in perception of urgency and 89.7% reported treatment benefit. Conclusions: Favorable safety, tolerability and efficacy of once-daily tolterodine ER was maintained over 12 months in a Japanese overactive bladder patient population.

Original languageEnglish
Pages (from-to)456-464
Number of pages9
JournalInternational Journal of Urology
Volume12
Issue number5
DOIs
Publication statusPublished - 2005 May

Keywords

  • Efficacy
  • Overactive bladder
  • Safety
  • Tolerability
  • Tolterodine

ASJC Scopus subject areas

  • Urology

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    Takei, M., Homma, Y., Akino, H., Baba, S., Esa, A., Fujinaga, T., Fukui, J., Gon, E., Gotoh, M., Haginaka, T., Hoshinaga, K., Ikeuchi, T., Iriguchi, H., Ishida, T., Ishida, Y., Ishii, Y., Ishiko, O., Kageyama, S., Kajikawa, H., ... Yoshida, M. (2005). Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder in Japanese patients. International Journal of Urology, 12(5), 456-464. https://doi.org/10.1111/j.1442-2042.2005.01066.x