A noninterventional study evaluating the effectiveness of rotigotine and levodopa combination therapy in younger versus older patients with Parkinson's disease

Expert Opin Pharmacother. 2018 Jun;19(9):937-945. doi: 10.1080/14656566.2018.1480721. Epub 2018 Jun 19.

Abstract

Background: PD0013 was a 6-month noninterventional study in clinical practice comparing effectiveness/tolerability of rotigotine+levodopa in younger (<70 years) vs. older (≥70 years) Parkinson's disease (PD) patients.

Methods: Patients previously received levodopa for ≥6 months as monotherapy/in combination with another dopamine-agonist (DA). Primary variable: Unified PD Rating Scale (UPDRS) Part-II change from baseline to end-of-observation-period (EOP).

Results: 91 younger/99 older patients started rotigotine; 68 younger/62 older patients completed the study. Most switched from levodopa+another DA. Addition of rotigotine as first DA was more common in older patients (20.2% vs.15.4%). Mean ± SD rotigotine-exposure: 6.1 ± 3.4 mg/24h younger vs. 4.9 ± 2.4 mg/24h older. Eleven patients changed levodopa dose. At EOP, improvement in mean UPDRS-II was greater in younger patients (p = 0.0289). UPDRS-II responder-rate (≥20% decrease in UPDRS-II score) was higher in younger patients (42.3% vs. 25.9%). Improvement across age groups was similar on PD Sleep Scale-2 and Clinical Global Impressions-Improvement Scale. Adverse drug reactions (ADRs), and discontinuations because of ADRs, were more common among older patients. There were no new safety signals.

Conclusions: Despite low rotigotine doses, when added to levodopa/switched from levodopa+another DA, rotigotine led to greater improvement in UPDRS-II in younger patients (<70 years). Individual patient data revealed clinically meaningful improvements in UPDRS-II in both groups.

Keywords: Add-on therapy; Parkinson’s disease; UPDRS II; dopamine agonist; levodopa; noninterventional study; rotigotine.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Dopamine Agonists / adverse effects
  • Dopamine Agonists / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Levodopa / adverse effects
  • Levodopa / therapeutic use*
  • Male
  • Middle Aged
  • Parkinson Disease / drug therapy*
  • Parkinson Disease / pathology
  • Severity of Illness Index
  • Sleep / physiology
  • Tetrahydronaphthalenes / adverse effects
  • Tetrahydronaphthalenes / therapeutic use*
  • Thiophenes / adverse effects
  • Thiophenes / therapeutic use*
  • Treatment Outcome

Substances

  • Dopamine Agonists
  • Tetrahydronaphthalenes
  • Thiophenes
  • Levodopa
  • rotigotine