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Randomized, double-blind, placebo- and propiverine-controlled trial of the once-daily antimuscarinic agent solifenacin in Japanese patients with overactive bladder.
BJU Int. 2007 Sep; 100(3):579-87.BI

Abstract

OBJECTIVES

To compare solifenacin succinate (5 and 10 mg once-daily) to placebo and propiverine hydrochloride (20 mg once-daily), respectively, in Japanese patients with overactive bladder syndrome (OAB).

PATIENTS AND METHODS

A multicentre, 12-week, double-blind phase III trial randomized men and women aged > or = 20 years with OAB to solifenacin 5 or 10 mg, propiverine 20 mg, or placebo. Changes at endpoint in number of voids/24 h, urgency, incontinence, urgency incontinence and nocturia episodes, volume voided/void, restoration of continence and quality of life (QoL) were examined.

RESULTS

Of 1593 patients randomized, 1584 were treated; at the endpoint there were greater reductions in mean (sd) voids/24 h with solifenacin 5 mg, at -1.93 (1.97), and 10 mg, at -2.19 (2.09), and propiverine 20 mg, at -1.87 (2.70), than with placebo, at -0.94 (2.29) (P < 0.001 for all). Solifenacin (5 and 10 mg) was superior to placebo, and no worse than propiverine 20 mg, for this variable. There were significantly fewer mean (sd) urgency, incontinence and urgency incontinence episodes with solifenacin and propiverine than with placebo, with respective changes on placebo of - 1.28 (2.90), - 0.72 (1.95) and - 0.69 (2.00); solifenacin 5 mg, - 2.41 (2.88), -1.59 (2.12) and -1.45 (1.89) (P < 0.001 for all), and 10 mg, -2.78 (2.82), - 1.60 (1.81) and - 1.52 (1.77) (P < 0.001 for all), and propiverine 20 mg, -2.30 (3.08), -1.25 (2.79) and - 1.19 (2.20) (P < 0.001, = 0.002 and = 0.002 respectively). All active treatments vs placebo improved the volume voided (P < 0.001 for all) and QoL; solifenacin 10 mg reduced nocturia episodes (P = 0.021) and significantly improved urgency episodes (P = 0.012) and volume voided (P = 0.009) vs propiverine 20 mg, and solifenacin 5 mg caused less dry mouth (P = 0.003). Solifenacin 10 mg caused more dry mouth (P = 0.012) and occurrences of constipation (P = 0.004) than propiverine 20 mg, but discontinuation rates between both treatment groups were similar. Continence was restored at endpoint in more than half of the patients on active treatment.

CONCLUSION

Solifenacin 5 and 10 mg once daily significantly improved the symptoms of OAB compared with placebo. Solifenacin therapy at 5 mg once daily is well-tolerated; 10 mg can be given if additional efficacy is required.

Authors+Show Affiliations

Department of Urology, Fukushima Medical University School of Medicine, Fukushima, Japan. yamaosa@cc.fmu.ac.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17669143

Citation

Yamaguchi, Osamu, et al. "Randomized, Double-blind, Placebo- and Propiverine-controlled Trial of the Once-daily Antimuscarinic Agent Solifenacin in Japanese Patients With Overactive Bladder." BJU International, vol. 100, no. 3, 2007, pp. 579-87.
Yamaguchi O, Marui E, Kakizaki H, et al. Randomized, double-blind, placebo- and propiverine-controlled trial of the once-daily antimuscarinic agent solifenacin in Japanese patients with overactive bladder. BJU Int. 2007;100(3):579-87.
Yamaguchi, O., Marui, E., Kakizaki, H., Itoh, N., Yokota, T., Okada, H., Ishizuka, O., Ozono, S., Gotoh, M., Sugiyama, T., Seki, N., & Yoshida, M. (2007). Randomized, double-blind, placebo- and propiverine-controlled trial of the once-daily antimuscarinic agent solifenacin in Japanese patients with overactive bladder. BJU International, 100(3), 579-87.
Yamaguchi O, et al. Randomized, Double-blind, Placebo- and Propiverine-controlled Trial of the Once-daily Antimuscarinic Agent Solifenacin in Japanese Patients With Overactive Bladder. BJU Int. 2007;100(3):579-87. PubMed PMID: 17669143.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind, placebo- and propiverine-controlled trial of the once-daily antimuscarinic agent solifenacin in Japanese patients with overactive bladder. AU - Yamaguchi,Osamu, AU - Marui,Eiji, AU - Kakizaki,Hidehiro, AU - Itoh,Naoki, AU - Yokota,Takashi, AU - Okada,Hiroshi, AU - Ishizuka,Osamu, AU - Ozono,Seiichiro, AU - Gotoh,Momokazu, AU - Sugiyama,Takahide, AU - Seki,Narihito, AU - Yoshida,Masaki, AU - ,, PY - 2007/8/3/pubmed PY - 2007/10/5/medline PY - 2007/8/3/entrez SP - 579 EP - 87 JF - BJU international JO - BJU Int VL - 100 IS - 3 N2 - OBJECTIVES: To compare solifenacin succinate (5 and 10 mg once-daily) to placebo and propiverine hydrochloride (20 mg once-daily), respectively, in Japanese patients with overactive bladder syndrome (OAB). PATIENTS AND METHODS: A multicentre, 12-week, double-blind phase III trial randomized men and women aged > or = 20 years with OAB to solifenacin 5 or 10 mg, propiverine 20 mg, or placebo. Changes at endpoint in number of voids/24 h, urgency, incontinence, urgency incontinence and nocturia episodes, volume voided/void, restoration of continence and quality of life (QoL) were examined. RESULTS: Of 1593 patients randomized, 1584 were treated; at the endpoint there were greater reductions in mean (sd) voids/24 h with solifenacin 5 mg, at -1.93 (1.97), and 10 mg, at -2.19 (2.09), and propiverine 20 mg, at -1.87 (2.70), than with placebo, at -0.94 (2.29) (P < 0.001 for all). Solifenacin (5 and 10 mg) was superior to placebo, and no worse than propiverine 20 mg, for this variable. There were significantly fewer mean (sd) urgency, incontinence and urgency incontinence episodes with solifenacin and propiverine than with placebo, with respective changes on placebo of - 1.28 (2.90), - 0.72 (1.95) and - 0.69 (2.00); solifenacin 5 mg, - 2.41 (2.88), -1.59 (2.12) and -1.45 (1.89) (P < 0.001 for all), and 10 mg, -2.78 (2.82), - 1.60 (1.81) and - 1.52 (1.77) (P < 0.001 for all), and propiverine 20 mg, -2.30 (3.08), -1.25 (2.79) and - 1.19 (2.20) (P < 0.001, = 0.002 and = 0.002 respectively). All active treatments vs placebo improved the volume voided (P < 0.001 for all) and QoL; solifenacin 10 mg reduced nocturia episodes (P = 0.021) and significantly improved urgency episodes (P = 0.012) and volume voided (P = 0.009) vs propiverine 20 mg, and solifenacin 5 mg caused less dry mouth (P = 0.003). Solifenacin 10 mg caused more dry mouth (P = 0.012) and occurrences of constipation (P = 0.004) than propiverine 20 mg, but discontinuation rates between both treatment groups were similar. Continence was restored at endpoint in more than half of the patients on active treatment. CONCLUSION: Solifenacin 5 and 10 mg once daily significantly improved the symptoms of OAB compared with placebo. Solifenacin therapy at 5 mg once daily is well-tolerated; 10 mg can be given if additional efficacy is required. SN - 1464-4096 UR - https://www.unboundmedicine.com/medline/citation/17669143/Randomized_double_blind_placebo__and_propiverine_controlled_trial_of_the_once_daily_antimuscarinic_agent_solifenacin_in_Japanese_patients_with_overactive_bladder_ L2 - https://doi.org/10.1111/j.1464-410X.2007.07031.x DB - PRIME DP - Unbound Medicine ER -