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

Figures & data

Figure 1. Study design (the phase discussed in this manuscript is in the shaded box).

T0, study entry; Y, year prior to study entry.

Table 1. Patient demographic and clinical characteristics.

Characteristics	Patients (N = 296)
	n (%)	Mean (± SD)
Sex
Male	178 (60.1)	–
Female	118 (39.9)	–
Age, years
At T0	–	68.0 (9.7)
At diagnosis	–	55.3 (9.8)
At first fluctuation	–	62.6 (10.6)
Disease duration, years	–	12.6 (4.4)
Oral levodopa dose
Yes	294 (99.3)	–
Total daily dose, mg	–	662.2 (271.5)
Number of daily administrations	–	5.6 (1.9)
Time from last administration, min	130	–
LCIG use	13 (4.4)	–
Hoehn and Yahr Stage^a
0	1 (0.3)	–
1	8 (2.7)	–
2	127 (42.9)	–
3	120 (40.5)	–
4	33 (11.1)	–
5	6 (2.0)	–
Motor examination score^b MDS-UPDRS, Part III
All	–	37.6 (16.2)
NMSS	–	59.1 (43.2)
PDQ-39	–	35.0 (14.7)
Presence of comorbidities	139 (47.0)	–
Comorbidities affecting ≥5% of patients^c
Hypertension	63 (21.3)	–
Anxiety/Depression	29 (9.8)	–
Heart disease^d	25 (8.5)	–
Benign prostatic hyperplasia	20 (6.8)	–
Dyslipidemia/Hypercholesterolemia	19 (6.5)	–
Gastritis/Gastroesophageal reflux	19 (6.5)	–
Diabetes	18 (6.0)	–
Osteoporosis	15 (5.0)	–

LCIG: levodopa-carbidopa intestinal gel; MDS-UPDRS: Unified Parkinson’s Disease Rating Scale by the Movement Disorder Society; NMSS: Non-Motor Symptom Scale; PD: Parkinson’s disease; PDQ-39: 39-item Parkinson’s Disease Questionnaire; SD: standard deviation; T0: study entry; –: not available.

^a PD stages according to the Hoehn and Yahr Scale: 0, Asymptomatic; 1, Unilateral involvement only; 2, Bilateral involvement without impairment of balance; 3, Mild-to-moderate involvement and some postural instability but physically independent. Needs assistance to recover from pull test; 4, Severe disability, still able to walk or stand unassisted; 5, Wheelchair bound or bedridden unless aided [16].

^b Score according to MDS-UPDRS, Part III (range 0–108).

^c Based on patient recall of comorbidities.

^d Angina, arrythmia, hypertensive heart disease, ischemic heart disease, atrial fibrillation, heart failure and valvular heart disease.

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.

Antonini A, Martinez-Martin P, Chaudhuri RK, et al. Wearing-off scales in Parkinson’s disease: critique and recommendations. Mov Disord. 2011;26(12):2169–2175. doi: 10.1002/mds.23875.

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Data availability statement

The data supporting the findings of this study are available from the study sponsor (Bial Italy) upon reasonable request ([email protected]).