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

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.

Figure 1.

Study design (the phase discussed in this manuscript is in the shaded box). T0, study entry; Y, year prior to study entry.

Figure 2.

Non-motor and motor symptoms of Parkinson’s disease (assessed by parts I/II of MDS-UPDRS). (A) part IA (physician assessed) nM-EDL; (B) part IB (patient assessed) nM-EDL; and (C) part II (patient assessed) motor experiences of daily living. MDS-UPDRS: Unified Parkinson’s Disease Rating Scale by the Movement Disorder Society; nM-EDL: non-motor experiences of daily living.

Figure 3.

Types of motor fluctuations in the 2 years (Y2 and Y1) prior to study entry (T0).

Figure 4.

Improvements in motor and non-motor symptoms of wearing-off fluctuations (as assessed by the WOQ-19). WOQ-19: 19-item Wearing-Off Questionnaire.

Figure 5.

Parkinson’s disease treatments 2 years prior (Y2 and Y1) to study entry (T0). (A) pharmacologic treatment (levodopa-carbidopa-entacapone was included in two classes - dopaminergic medications and COMT inhibitors); (B) dopaminergic medications (including concomitant use of >1 medication or combination); (C) dopamine agonists; (D) MAO-B inhibitors; and (E) COMT inhibitors (entacapone included levodopa-carbidopa-entacapone). COMT: catechol-O-methyltransferase enzyme; MAO-B: monoamine oxidase B enzyme.