The effects of transdermal rotigotine on non-motor symptoms of Parkinson's disease: a multicentre, observational, retrospective, post-marketing study

Int J Neurosci. 2018 Apr;128(4):369-375. doi: 10.1080/00207454.2017.1387111. Epub 2017 Dec 17.

Abstract

Aim: This study evaluated the effect of ≥6 months of transdermal rotigotine on non-motor and motor symptoms of patients with advanced Parkinson's disease.

Materials and methods: The study was conducted in Spain between September 2011 and December 2012 (ClinicalTrials.gov: NCT01504529). The primary efficacy variable was the change from baseline in non-motor symptoms, as assessed by changes in Parkinson's Disease Non-Motor Symptoms Questionnaire total scores at 6 months. Secondary endpoints included the assessment of motor symptoms by Unified Parkinson's Disease Rating Scale III scores.

Results: Data from 378 patients (mean age: 70.2 years; 56.9% male) with Parkinson's disease receiving rotigotine from were collected. Mean disease duration was 6.1 years, and mean rotigotine treatment duration was 45.6 months. Rotigotine reduced non-motor symptoms by 14.6% (mean change from baseline in Parkinson's Disease Non-Motor Symptoms Questionnaire: -1.5 ± 3.4; p < 0.0001). The majority of patients (58.2%) had improved non-motor symptoms at 6 months. Comparing the baseline versus study end, fewer patients experienced events in the urinary (78.6% vs. 73.3%; p = 0.0066), sleep (82.8% vs. 72.8%; p < 0.0001) and mood/cognition (77.3% vs. 66.4%; p < 0.0001) domains of the Parkinson's Disease Non-Motor Symptoms Questionnaire. Mean motor symptoms were reduced from baseline by 8.0% (mean change from baseline in Unified Parkinson's Disease Rating Scale III: -2.6 ± 8.0; p < 0.0001).

Conclusions: In clinical practice in Spain, rotigotine may be an effective treatment to reduce the non-motor and motor symptoms in patients with advanced Parkinson's disease.

Keywords: Parkinson's disease; clinical practice; non-motor symptoms; rotigotine.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Administration, Cutaneous
  • Aged
  • Aged, 80 and over
  • Cognition Disorders / drug therapy*
  • Cognition Disorders / etiology
  • Dopamine Agonists / administration & dosage*
  • Female
  • Humans
  • Male
  • Parkinson Disease / complications*
  • Parkinson Disease / drug therapy
  • Product Surveillance, Postmarketing
  • Retrospective Studies
  • Sleep Wake Disorders / drug therapy*
  • Sleep Wake Disorders / etiology
  • Spain
  • Surveys and Questionnaires
  • Tetrahydronaphthalenes / administration & dosage*
  • Thiophenes / administration & dosage*
  • Treatment Outcome
  • Urination Disorders / drug therapy*
  • Urination Disorders / etiology

Substances

  • Dopamine Agonists
  • Tetrahydronaphthalenes
  • Thiophenes
  • rotigotine

Associated data

  • ClinicalTrials.gov/NCT01504529