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Media type:
E-Article
Title:
Results of a randomized, double‐blind, active‐controlled clinical trial with propiverine extended release 30 mg in patients with overactive bladder
Description:
<jats:sec><jats:title>Objective</jats:title><jats:p>To compare the efficacy and safety of the 30 mg extended release (<jats:styled-content style="fixed-case">ER</jats:styled-content>) formulation of propiverine hydrochloride with the 4 mg <jats:styled-content style="fixed-case">ER</jats:styled-content> formulation of tolterodine tartrate in patients with overactive bladder (<jats:styled-content style="fixed-case">OAB</jats:styled-content>) in a non‐inferiority trial.</jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p>Eligible patients, aged 18–75 years and with symptoms of <jats:styled-content style="fixed-case">OAB</jats:styled-content>, were enrolled in this multicentre, randomized, double‐blind, parallel‐group, active‐controlled study. After a 2‐week screening period, patients were randomized at a 1:1 ratio to receive either propiverine <jats:styled-content style="fixed-case">ER</jats:styled-content> 30 mg or tolterodine <jats:styled-content style="fixed-case">ER</jats:styled-content> 4 mg daily during the 8‐week treatment period. Efficacy was assessed using a 3‐day voiding diary and patient's self‐reported assessment of treatment effect. Safety assessment included recording of adverse events, laboratory test results, measurement of post‐void residual urine and electrocardiograms.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 324 patients (244 female and 80 male) were included in the study. Both active treatments improved the variables included in the voiding diary and in the patient's self‐reported assessment. The change from baseline in the number of voidings per 24 h was significantly greater in the propiverine <jats:styled-content style="fixed-case">ER</jats:styled-content> 30 mg group compared with the tolterodine <jats:styled-content style="fixed-case">ER</jats:styled-content> 4 mg group after 8 weeks of treatment (full analysis set [<jats:styled-content style="fixed-case">FAS</jats:styled-content>] −4.6 ± 4.1 vs −3.8 ± 5.1; <jats:italic>P</jats:italic> = 0.005). Significant improvements were also observed for the change of urgency incontinence episodes after 2 weeks (<jats:italic>P</jats:italic> = 0.026) and 8 weeks (<jats:italic>P</jats:italic> = 0.028) of treatment when comparing propiverine <jats:styled-content style="fixed-case">ER</jats:styled-content> 30 mg with tolterodine <jats:styled-content style="fixed-case">ER</jats:styled-content> 4 mg. Both treatments were well tolerated, with a similar frequency of adverse drug reactions in both the propiverine <jats:styled-content style="fixed-case">ER</jats:styled-content> 30 mg and tolterodine <jats:styled-content style="fixed-case">ER</jats:styled-content> 4 mg groups (<jats:styled-content style="fixed-case">FAS</jats:styled-content> 40.7 vs 39.5%; <jats:italic>P</jats:italic> = 0.8). More patients treated with tolterodine <jats:styled-content style="fixed-case">ER</jats:styled-content> 4 mg discontinued the treatment because of adverse drug reactions compared with propiverine <jats:styled-content style="fixed-case">ER</jats:styled-content> 30 mg (7.4 vs 3.1%).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Propiverine <jats:styled-content style="fixed-case">ER</jats:styled-content> 30 mg was confirmed to be an effective and well‐tolerated treatment option for patients with <jats:styled-content style="fixed-case">OAB</jats:styled-content> symptoms. This first head‐to‐head study showed non‐inferiority of propiverine <jats:styled-content style="fixed-case">ER</jats:styled-content> 30 mg compared with tolterodine <jats:styled-content style="fixed-case">ER</jats:styled-content> 4 mg.</jats:p></jats:sec>