Effect of rotigotine on sleep and quality of life in Parkinson's disease patients: post hoc analysis of RECOVER patients who were symptomatic at baseline

Expert Opin Pharmacother. 2011 Sep;12(13):1985-98. doi: 10.1517/14656566.2011.604031. Epub 2011 Jul 27.

Abstract

Objective: The aim of this research is to characterize further the potential motor and non-motor benefits of rotigotine reported in the double-blind, placebo-controlled RECOVER trial primary publication, by performing a post hoc exploratory analysis of patient status (symptom improvement/worsening).

Methods: Full RECOVER trial methodological details have already been reported. The post hoc analyses presented here are done on individual items of the PDSS-2 and PDQ-8 for all patients and two subgroups (baseline symptomatic and highly symptomatic patients).

Results: Ten PDSS-2 and five PDQ-8 items show significant mean treatment difference versus placebo. In the overall population, items that most favor rotigotine in percentage of patients with improvement are 'limb pain causes waking' and 'uncomfortable in bed due to immobility' for PDSS-2; for PDQ-8, rotigotine is most favored in 'difficulty dressing', 'felt depressed' and 'difficulty getting around in public'. Among symptomatic and highly symptomatic patients, the PDSS-2 items that most favor rotigotine are both indicators of pain. On the PDQ-8, the two items most favored in symptomatic patients are 'difficulty dressing' and 'embarrassed in public due to PD', and in the highly symptomatic subgroup 'difficulty dressing' and 'difficulty getting around in public'.

Conclusion: Though this trial was not powered for statistical subgroup analysis, these post hoc results indicate that treatment with rotigotine may benefit patients with sleep, pain, mood and quality-of-life issues.

Trial registration: ClinicalTrials.gov NCT00474058.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Dopamine Agonists / adverse effects
  • Dopamine Agonists / therapeutic use*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Parkinson Disease / drug therapy*
  • Parkinson Disease / physiopathology
  • Placebos
  • Quality of Life
  • Severity of Illness Index
  • Sleep / drug effects*
  • Tetrahydronaphthalenes / administration & dosage*
  • Tetrahydronaphthalenes / adverse effects
  • Thiophenes / administration & dosage*
  • Thiophenes / adverse effects
  • Transdermal Patch
  • Treatment Outcome

Substances

  • Dopamine Agonists
  • Placebos
  • Tetrahydronaphthalenes
  • Thiophenes
  • rotigotine

Associated data

  • ClinicalTrials.gov/NCT00474058