OnabotulinumtoxinA is Effective in Patients with Urinary Incontinence due to Neurogenic Detrusor Activity Regardless of Concomitant Anticholinergic Use or Neurologic EtiologyReportar como inadecuado




OnabotulinumtoxinA is Effective in Patients with Urinary Incontinence due to Neurogenic Detrusor Activity Regardless of Concomitant Anticholinergic Use or Neurologic Etiology - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Advances in Therapy

, Volume 30, Issue 9, pp 819–833

First Online: 27 September 2013Received: 15 July 2013DOI: 10.1007-s12325-013-0054-z

Cite this article as: Ginsberg, D., Cruz, F., Herschorn, S. et al. Adv Ther 2013 30: 819. doi:10.1007-s12325-013-0054-z

Abstract

IntroductionTo evaluate the efficacy and safety of onabotulinumtoxinA for the treatment of neurogenic detrusor overactivity NDO in subpopulations of etiology multiple sclerosis MS or spinal cord injury SCI and concomitant anticholinergics use-non-use.

MethodsData were pooled from two double-blind, placebo-controlled, pivotal, phase 3 studies including a total of 691 patients with ≥14 urinary incontinence UI episodes-week due to MS n = 381 or SCI n = 310. Patients received intradetrusor injections of onabotulinumtoxinA 200U n = 227, 300U n = 223, or placebo n = 241. Change from baseline at week 6 in UI episodes-week primary endpoint, urodynamics, quality of life QOL, and adverse events AEs were assessed.

ResultsSignificant and similar reductions in UI episodes were observed regardless of etiology or anticholinergic use: at week 6, mean weekly decreases of −22.6 and −19.6 were seen in MS and SCI patients, respectively, and −20.3 and −22.5 in anticholinergic users and non-users, respectively, treated with onabotulinumtoxinA 200U. The 300U dose did not add to the clinical efficacy in any subpopulation. Similar proportions of patients achieved ≥50% or 100% reductions in UI episodes in all subgroups. Improvements in maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction, and QOL were significant in both etiologies and were independent of anticholinergic use. The most common AEs in all groups were urinary tract infection and urinary retention.

ConclusionRegardless of concomitant anticholinergic use or etiology, onabotulinumtoxinA significantly improved UI symptoms, urodynamics, and QOL in patients with UI due to NDO. OnabotulinumtoxinA was well tolerated in all groups.

KeywordsBotulinum toxin Multiple sclerosis OnabotulinumtoxinA Spinal cord injury Urinary incontinence ClinicalTrials.gov identifiers: NCT00311376 and NCT00461292.

An erratum to this article can be found at http:-dx.doi.org-10.1007-s12325-014-0103-2.

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Autor: David Ginsberg - Francisco Cruz - Sender Herschorn - Angelo Gousse - Véronique Keppenne - Philip Aliotta - Karl-Dietrich S

Fuente: https://link.springer.com/







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