Randomized, double‐blind, placebo‐ and propiverine‐controlled trial of the once‐daily antimuscarinic agent solifenacin in Japanese patients with overactive bladder

Abstract

* See Appendix for complete list of contributors.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. CONCLUSIONSolifenacin 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. KEYWORDSoveractive bladder, solifenacin succinate, propiverine hydrochloride, efficacy, tolerability, quality of life Study Type -Therapy (RCT) Level of Evidence 1b OBJECTIVESTo 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 METHODSA multicentre, 12-week, double-blind phase III trial randomized men and women aged ≥ 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. RESULTSOf 1593 patients randomized, 1584 were treated; at the endpoint there were greater

Efficacy and safety of once‐daily oxybutynin patch versus placebo and propiverine in Japanese patients with overactive bladder: A randomized double‐blind trial

“…15,16 Yet the incidence of dry mouth in the oxybutynin patch group was significantly lower than that in the propiverine group (6.5% vs 13.2%, P = 0.0001). Constipation was also significantly less frequent in the oxybutynin patch group than the propiverine group (0.7% vs 5.0%, P < 0.0001).…”

“…The non-inferiority margin was set at 0.37 (50% of the difference between the propiverine and placebo groups) using data from phase III studies of similar drugs. 15,16 The standard deviation was set at 2.00 for all groups.…”

The Forefront for Novel Therapeutic Agents Based on the Pathophysiology of Lower Urinary Tract Dysfunction: Ameliorative Effect of Solifenacin Succinate (Vesicare®), a Bladder-Selective Antimuscarinic Agent, on Overactive Bladder Symptoms, Especially Urgency Episodes

“…Against this background, Astellas Pharma, Inc. instituted a program with the aim of discovering bladder-selective antimuscarinic agents, which resulted in the discovery of solifenacin succinate in 1996. The beneficial effect of solifenacin (Vesicare ® ) on the symptoms of OAB has been confirmed in a number of clinical studies, and the product was launched for the indication of OAB in Europe in 2004, the USA in 2005, and Japan in 2006 (6,7). This review summarizes the pharmacological profile of solifenacin for muscarinic receptors, voiding function, bladder selectivity, and bladder afferent pathways and attempts to relate this to clinical data in OAB patients, in which the urgency episodes were used as the primary endpoint.…”

Efficacy and Safety of Propiverine Hydrochloride for Overactive Bladder in Adult: a Systematic Review and Meta-analysis

“…However, the ability of propiverine to decrease the number of nocturia episodes remains controversial. Some people think propiverine can decrease the number of nocturia episodes more effectively than placebo [8,9,11]. Others do not think that [6].…”

“…Based on the inclusion and exclusion criteria, 70 articles were excluded after simply reading the titles and abstracts of the articles and two articles were excluded because they lacked a full text. In all, 10 articles with 9 RCTs were included in the analysis, with 5 RCTs [6,[8][9][10][11] for propiverine hydrochloride for overactive bladder (Figs. 2, 3, and 4) and 4 RCTs [12][13][14][15] for propiverine hydrochloride for overactive bladder and in adult with lower urinary tract symptoms (Fig.…”