Advanced Parkinson's disease treatment patterns in Italy: an observational study interim analysis

Ann Med. 2024 Dec;56(1):2315226. doi: 10.1080/07853890.2024.2315226. Epub 2024 Feb 21.

Abstract

Background: Oral levodopa remains the mainstay of treatment for Parkinson's disease (PD). However, as PD progresses, response to treatment may fluctuate. Managing fluctuations can be demanding for clinicians and patients. There is a paucity of real-world studies reporting on PD management in patients with fluctuations in treatment response, especially in patients with advanced stages of PD. The multicentre, observational Parkinson's Disease Fluctuations treatment PAthway (PD-FPA) study describes the real-life management of response fluctuations in Italian patients with advanced PD.

Patients and methods: PD-FPA had a retrospective and prospective phase; herein, retrospective results are presented. Ten Italian centres enrolled patients with a PD diagnosis from 10-15 years prior to study entry (T0) and who had ≥2-year history of fluctuations. Data on patient demographics, medical history, PD stage, fluctuation characteristics, symptoms, and prescribed treatments were collected at T0 and retrospectively (2 years prior to T0) via patient chart review/interview.

Results: Overall, 296 patients (60% male, mean age 68 years, 84% with Hoehn and Yahr scores 2-3) were enrolled. At T0, most patients (99.3%) were on oral levodopa therapy. All patients used dopaminergic medications; adjunctive medications included dopamine agonists (56%) and monoamine oxidase B (60%) and catechol-O-methyltransferase enzyme inhibitors (41%). At T0, 51% of patients had changed therapy, with response fluctuations being the most common reason (74%); wearing-off was the most common fluctuation (83%).

Conclusion: This interim analysis of PD-FPA suggests that adequate levodopa dosing and adjunctive medications can stabilize advanced PD and provide patients with a good quality of life.

Keywords: COMT inhibitor; MAO-B inhibitor; levodopa; motor/non-motor fluctuations; parkinson disease.

Plain language summary

Patients with Parkinson’s disease (PD) often exhibit fluctuations in their response to oral levodopa; however, real-world studies on the management of these fluctuations are lacking. This planned interim analysis of the real-world, multicentre, observational PD Fluctuations treatment Pathway (PD-FPA) study found that adequate levodopa dosing and adjunctive medications can stabilize Italian patients with advanced PD and improve their quality of life.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Antiparkinson Agents / adverse effects
  • Antiparkinson Agents / therapeutic use
  • Catechol O-Methyltransferase / therapeutic use
  • Catechol O-Methyltransferase Inhibitors / therapeutic use
  • Female
  • Humans
  • Levodopa / therapeutic use
  • Male
  • Parkinson Disease* / drug therapy
  • Parkinson Disease* / epidemiology
  • Prospective Studies
  • Quality of Life
  • Retrospective Studies

Substances

  • Levodopa
  • Antiparkinson Agents
  • Catechol O-Methyltransferase
  • Catechol O-Methyltransferase Inhibitors

Grants and funding

Bial Italy funded the study, data analysis and medical writing support. The funder had no role in data interpretation or in the decision to submit the manuscript for publication.