25 novembre 2015

Auteurs : E. Chartier-Kastler, V. Nitti, D. De Ridder, D. Sussman, P. Sand, K. Sievert, C. Chapple, J. Charmaine, A. Magyar, S. Radomski
Référence : Prog Urol, 2015, 13, 25, 739
Objectives

Here we present the final results from an extension study assessing long-term onabotulinumtoxinA treatment (3.5 years) in patients with idiopathic overactive bladder.

Methods

Patients who completed either of 2 Phase III trials were eligible to enter a 3-year extension study in which they received multiple onabotulinumtoxinA (100 U) treatments. Data were analyzed for the overall population of patients who received 100 U in any treatment cycle (n =829) and within discrete subgroups of patients who received exactly 1 (n =105), 2 (n =118), 3 (n =117), 4 (n =83), 5 (n =46), or 6 (n =33) treatments of the 100 U dose throughout the study (n =502).

Results

Of the 829 patients enrolled, 51.7 % completed the study. Discontinuations due to AEs/lack of efficacy were low (5.1/5.7 %); other reasons were not treatment-related. Mean reductions from baseline in urinary incontinence (UI) episodes/day (week 12; co-primary endpoint) were consistent among discrete subgroups who received 1 (–3.1), 2 (–2.9, –3.2), 3 (–4.1 to –4.5), 4 (–3.4 to –3.8), 5 (–3.0 to –3.6), or 6 (–3.1 to –4.1) treatments. A consistently high proportion of patients reported improvement/great improvement on the Treatment Benefit Scale (week 12; co-primary endpoint) in the discrete subgroups across all treatments (70.0–93.5 %). Median time to request retreatment was ≤6 months for 34.2 %, >6–12 months for 37.2 %, and >12 months for 28.5 % of patients. Most common AE was UTI, with no changes in safety profile over time.

Conclusion

Long-term onabotulinumtoxinA treatment resulted in consistent reductions in UI and high proportions of patients reporting improvement after each treatment, with no new safety findings.




 




Disclosure of interest


The authors have not supplied their declaration of conflict of interest.






© 2015 
Publié par Elsevier Masson SAS.