Efficacy and Safety of Pramipexole Sustained Release versus Immediate Release Formulation for Nocturnal Symptoms in Chinese Patients with Advanced Parkinson’s Disease: A Pilot Study
Table 3
Adjusted mean changes in primary and secondary efficacy endpoints at week 18 from baseline (FAS).
Pramipexole SR
Pramipexole IR
SR vs IR
N
Baseline, mean (SD)
Week 18, mean (SD)
Change, mean (SE); 95% CI
N
Baseline, mean (SD)
Week 18, mean (SD)
Change, mean (SE); 95% CI
Adjusted mean difference (SE)
95% CI, value
PDSS-2 total score
45
28.0 (6.47)
14.6 (7.27)
–13.7 (1.16); –16.0 to –11.4
43
29.3 (8.32)
14.3 (9.19)
–14.4 (1.20); –16.8 to –12.0
0.7 (1.68)
–2.7 to 4.0;
PDSS-2 total score—disturbed sleep
45
13.1 (3.18)
7.8 (3.54)
–5.4 (0.55); –6.5 to –4.3
43
13.8 (3.54)
7.6 (4.25)
–5.9 (0.57); –7.0 to –4.7
0.4 (0.79)
–1.1 to 2.0;
PDSS-2 total score—motor symptoms at night
45
8.3 (3.52)
3.7 (3.23)
–4.7 (0.45); –5.6 to –3.8
43
8.9 (4.02)
3.8 (3.34)
–4.8 (0.47); –5.7 to –3.9
0.1 (0.65)
–1.2 to 1.4;
PDSS-2 total score—PD symptoms at night
45
6.7 (2.51)
3.0 (2.52)
–3.7 (0.39); –4.4 to –2.9
43
6.7 (2.79)
2.9 (3.17)
–3.7 (0.41); –4.6 to –2.9
0.1 (0.57)
–1.0 to 1.2;
NHQ by patient
45
5.6 (1.70)
3.7 (2.50)
–1.9 (0.35); –2.6 to –1.2
43
5.9 (1.84)
4.1 (2.66)
–1.7 (0.36); –2.4 to –0.9
–0.2 (0.51)
–1.2 to 0.8;
NHQ by caregivers
13
5.2 (2.09)
4.0 (2.58)
–1.4 (0.61); –2.7 to –0.2
11
6.1 (1.81)
5.3 (2.10)
–0.6 (0.67); –2.0 to 0.8
–0.8 (0.91)
–2.7 to 1.1;
SCOPA—night-time
45
7.9 (3.03)
4.2 (2.89)
–3.8 (0.46); –4.7 to –2.9
43
8.2 (2.85)
4.9 (3.46)
–3.2 (0.47); –4.1 to –2.2
–0.6 (0.66)
–1.9 to 0.7;
SCOPA —overall night-time sleep quality
45
4.7 (1.19)
3.0 (1.33)
–1.9 (0.20); –2.3 to –1.5
43
4.9 (1.23)
3.2 (1.46)
–1.6 (0.21); –2.0 to –1.2
–0.3 (0.29)
–0.8 to 0.3;
SCOPA —day time
45
3.7 (2.63)
2.4 (2.44)
–1.4 (0.34); –2.0 to –0.7
43
3.7 (2.51)
2.9 (3.19)
–0.9 (0.35); –1.6 to –0.2
–0.5 (0.49)
–1.4 to 0.5;
EMO
45
3.2 (0.77)
1.4 (1.10)
–1.8 (0.18); –2.1 to –1.4
43
3.3 (0.87)
1.8 (1.31)
–1.5 (0.18); –1.9 to –1.1
–0.3 (0.26)
(–0.8 to 0.2);
ESS
45
7.4 (3.52)
5.6 (3.84)
–2.4 (0.54); –3.5 to –1.3
43
9.4 (5.02)
6.4 (4.92)
–2.6 (0.56); –3.7 to –1.5
0.2 (0.79)
(–1.4 to 1.7);
PDQ-8
45
11.2 (5.04)
7.1 (5.03)
–4.1 (0.60); –5.3 to –2.9
43
10.5 (5.07)
7.1 (5.03)
–3.5 (0.62); –4.7 to –2.3
–0.6 (0.87)
(–2.3 to 1.2);
Unstructured covariance matrix, Kenward–Roger approximation for denominator degrees of freedom. Adjusted with factors treatment, maintenance period, and covariate baseline. CI, confidence interval; EMO, early morning off; ESS, Epworth Sleepiness Scale; FAS, full analysis set; IR, immediate release; NHQ, Nocturnal Hypokinesia Questionnaire; PDQ-8, Parkinson’s Disease Questionnaire-8; PDSS-2, Parkinson’s Disease Sleep Scale 2nd version; SCOPA-S, Scales for Outcomes in Parkinson’s Disease-Sleep Scale; SD, standard deviation; SE, standard error; SR, sustained release.
