Results of a randomized, double‐blind, active‐controlled clinical trial with propiverine extended release 30 mg in patients with overactive bladder

Abstract

ObjectiveTo compare the efficacy and safety of the 30 mg extended release (ER) formulation of propiverine hydrochloride with the 4 mg ER formulation of tolterodine tartrate in patients with overactive bladder (OAB) in a non-inferiority trial. Patients and MethodsEligible patients, aged 18-75 years and with symptoms of OAB, were enrolled in this multicentre, randomized, doubleblind, parallel-group, active-controlled study. After a 2-week screening period, patients were randomized at a 1:1 ratio to receive either propiverine ER 30 mg or tolterodine ER 4 mg daily during the 8-week treatment period. Efficacy was assessed using a 3-day voiding diary and patient's selfreported assessment of treatment effect. Safety assessment included recording of adverse events, laboratory test results, measurement of post-void residual urine and electrocardiograms. ResultsA 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 ER 30 mg group compared with the tolterodine ER 4 mg group after 8 weeks of treatment (full analysis set [FAS] À4.6 AE 4.1 vs À3.8 AE 5.1; P = 0.005). Significant improvements were also observed for the change of urgency incontinence episodes after 2 weeks (P = 0.026) and 8 weeks (P = 0.028) of treatment when comparing propiverine ER 30 mg with tolterodine ER 4 mg. Both treatments were well tolerated, with a similar frequency of adverse drug reactions in both the propiverine ER 30 mg and tolterodine ER 4 mg groups (FAS 40.7 vs 39.5%; P = 0.8). More patients treated with tolterodine ER 4 mg discontinued the treatment because of adverse drug reactions compared with propiverine ER 30 mg (7.4 vs 3.1%). ConclusionsPropiverine ER 30 mg was confirmed to be an effective and well-tolerated treatment option for patients with OAB symptoms. This first head-to-head study showed noninferiority of propiverine ER 30 mg compared with tolterodine ER 4 mg.

Efficacy and safety of propiverine in patients with overactive bladder and neurogenic detrusor overactivity

“…37 In the study in which 324 patients using propiverine (30 mg/day) ER and tolterodine (4 mg/day) ER for 8 weeks, the improvement in symptoms was found to be 88.9% in the propiverine group and 77.8% in the tolterodine group, and the rate of discontinuation of treatment due to side effects is also reported to be lower in the propiverine slowrelease (ER 30 mg) group compared to tolterodine 4 mg ER group. 38 However, in different studies comparing propiverine (30 mg/day) and tolterodine ER (4 mg/day), the frequency of adverse events was observed to be comparable in both treatment groups (Figure 1). 34,40 In two studies comparing propiverine and oxybutynin, dry mouth and severe dry mouth were observed less frequently in the propiverine administration.…”

Asiri Aktif Mesane Tedavisinde Karma Etkili Ajanların Etki Mekanizmasi ve Avantajlari

“…Propiverinin klinik etkinliği 2 haftadan itibaren başlamakta olup 4. haftada optimum düzeye yükselmektedir. Son yapılan çalışmalarda uzun etkili propiverinin 8. haftada en yüksek klinik etkinliğe ulaştığı bildirilmiştir (25).…”