Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease

Figures & data

Table 1 Patients’ baseline characteristics (safety population)

Variables	Values
N	27
Age (years)
Mean (SD)	62.7 (8.6)
Median (range)	62 (48–81)
Sex, n (%)
Male	21 (78)
Female	6 (22)
Race, n (%)
Caucasian	24 (89)
Asian	3 (11)
Weight (kg)
Mean (SD)	84.5 (14.8)
Median (range)	85 (51–120)
Age at PD onset (years)
Mean (SD)	52.3 (8.7)
Median (range)	50 (36–74)
“Off” time (h/day)
Mean (SD)	5.9 (2.2)
Median (range)	5.7 (2.0–11.0)
Hoehn & Yahr stage,a n (%)
2	13 (48)
3	10 (37)
4	4 (15)
Levodopa IR dosage (mg/day)
Mean (SD)	815.7 (249.7)
Median (range)	800 (500–1,250)
Levodopa IR dosing frequency (doses/day)
Mean (SD)	5.4 (1.6)
Median (range)	5 (4–10)
Finger-tapping score (taps/min)
“On” state
Mean (SD)	170.4 (64.6)
Median (range)	163 (73–327)
“Off” state
Mean (SD)	117.9 (44.1)
Median (range)	116 (44–229)
UPDRS Part III score
“On” state
Mean (SD)	17.6 (8.5)
Median (range)	17 (1–32)
“Off” state
Mean (SD)	35.9 (9.4)
Median (range)	36 (20–51)

Note:

a During “on” time.

Abbreviations: IR, immediate release; PD, Parkinson’s disease; SD, standard deviation; UPDRS, Unified Parkinson’s Disease Rating Scale.

Figure 1 Mean time to onset (top graphs) and mean duration (bottom graphs) for an “on” state, finger-tapping score improvement, and UPDRS Part III score improvement after single doses of ER CD-LD vs IR CD-LD.^a

Notes: *P<0.05, **P<0.01, ***P<0.001 (ANCOVA). ^aEach analysis includes only the patients who reached each outcome.
Abbreviations: ANCOVA, analysis of covariance; CD-LD, carbidopa-levodopa; ER, extended release; IR, immediate release; SE, standard error; UPDRS, Unified Parkinson’s Disease Rating Scale.

Figure 2 Mean plasma levodopa levels after single doses of ER CD-LD vs IR CD-LD.^a

Notes: ^aFor each treatment, n=27. However, for six patients who required ER CD-LD redosing and for ten who required IR CD-LD redosing, data are included only until the redosing (see Pharmacokinetic Analyses in the Methods section and Dosing in the Results section).
Abbreviations: CD-LD, carbidopa-levodopa; ER, extended release; IR, immediate release; LD, levodopa; SE, standard error.