New possibilities in the treatment of overactive bladder
IUGA Academy. Sharvadze G. Jun 30, 2018; 212822; 384 Topic: Overactive Bladder
Dr. Georgy Sharvadze
Dr. Georgy Sharvadze

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384

New possibilities in the treatment of overactive bladder

Sharvadze, G1; Mukhametshina, E1; Samsonov, M1

1: R-pharm

Introduction and Objective: Overactive bladder (OAB) is among the ten most common diseases. The results of epidemiological studies showed that the symptoms of OAB are detected 9-58% of cases in women. The first lines in the treatment of OAB are of the anticholinergic group drugs. In order to expand the potential for the therapy of an OAB, a new m-anticholinergic - imidafenacin, has been studied.

Methods: This study is a multicenter, open-label, randomized, comparative product Imidafenacin and tolterodine study in 300 male and female patients aging from 18 to 65 years with the diagnosis of OAB for ≥ 3 months at the screening visit and randomization visit. Patients were randomized into two groups: a twice-daily 0.1 mg imidafenacin, or twice-daily 2 mg tolterodine were administered for 12 weeks. The primary efficacy end-point was the difference in DMVF at 12 weeks. The secondary efficacy end-points were differences in daily mean: incontinence frequency, incontinence frequency during daytime, incontinence frequency during nighttime, incontinence frequency per week, changes in overactive bladder symptoms assessment parameters according to OAB Awareness Tool Questionnaire and quality of life assessment using EQ-5D questionnaire. The variables for safety analysis were adverse events, vital signs, residual urine volume and clinical laboratory tests. An efficacy analysis was conducted in per-protocol patients and the safety analysis was conducted in all randomized patients.

Results: In both groups, dominated by female patients: the share of women amounted to 124 (83.8%) in the group of drug imidafenacin and 121 (81.8%) in group tolterodine. The differences in mean daily number of urination episodes at 12 weeks were -3.7 ± 3.1 and -3.5 ± 2.4 in the imidafenacin and tolterodine groups, respectively, and the difference was not significant between the two groups. Imidafenacin was non-inferior to tolterodine, and the lower limit of 95% two-sided confidence intervals was -0.46. Imidafenacin showed a statistically significantly higher efficacy of in mean daily number of urinary incontinence episodes at 12 weeks (p = 0,0008), in daily number of urinary incontinence episodes during daytime (p = 0,0099), in nighttime (? < 0,0001) and week compared with tolterodine. The differences in overactive bladder symptoms assessment parameters according to Overactive bladder Awareness Tool Questionnaire were - 14,2 ± 8,5 in the imidafenacin group and -14,5 ± 8,0 tolterodine group (? = 0,5321). The differences in quality of life assessment using EQ-5D questionnaire were - 0,1 in the imidafenacin and tolterodine groups (? = 0.3743). The most frequent side effect of both drugs was dry mouth 26% in the imidafenacin group and 30% tolterodine group (? = 0,440).

Conclusion: During the treatment of patients with OAB has been demonstrated the clinical effectiveness of the drug imidafenacin, not worse than of the drug tolterodine, to reduce the frequency of urination. However, it is worth noting the statistically significant higher efficacy of the imidafenacin in reducing the number of incontinence episodes per day, daytime, at night and per week compared to the tolterodine. In patients with OAB treatment with investigational drugs shown good results and a similar safety profile and tolerability of the imidafenacin and the comparison drug.

Disclosure:

Work supported by industry: yes, by R-pharm. A consultant, employee (part time or full time) or shareholder is among the authors (R-pharm).

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