Are Branded and Generic Extended-Release Ropinirole Formulations Equally Efficacious? A Rater-Blinded, Switch-Over, Multicenter Study
Table 1
Results of tests measuring various motor and nonmotor symptoms.
Requip (Visit 2)
Ralnea (Visit 4)
Significance
Median
25th percentile
75th percentile
Median
25th percentile
75th percentile
UPDRS and HYS
UPDRS part I
2.0
2.0
4.0
3.0
2.5
5.0
0.566
UPDRS part II
15.0
12.0
17.0
15.0
9.5
19.0
0.928
UPDRS part III
27.0
20.5
31.0
28.0
23.0
33.5
0.505
UPDRS part IV
8.0
5.0
10.0
7.0
5.0
9.5
0.857
UPDRS total score
52.0
40.5
59.5
55.0
42.5
66.5
0.776
HYS
2.0
2.0
2.5
2.0
2.0
2.8
0.785
Tremor
FTMTRS part A
5.0
3.5
9.0
5.0
4.0
7.0
0.919
FTMTRS part B
10.0
9.0
10.5
12.0
9.5
13.0
0.502
FTMTRS part C
10.0
8.0
10.5
9.0
6.0
11.0
0.810
FTMTRS total score
25.0
21.0
29.0
25.0
22.0
28.5
0.918
Patient diary
ON time without dyskinesia (hours)
9.5
7.5
12.0
6.5
3.5
8.4
0.010
ON time with slight dyskinesia (hours)
1.0
0.0
2.5
3.5
0.5
4.5
0.041
“Good” time
10.5
7.5
13.5
10.0
8.0
13.0
0.670
ON time with severe dyskinesia (hours)
0.5
0.0
1.0
0.5
0.0
1.5
0.612
OFF time (hours)
4.5
3.5
7.5
4.5
1.5
11.5
0.778
Daytime sleeping hours
0.5
0.0
1.5
0.5
0.0
1.0
0.828
Nighttime sleeping hours
7.5
6.8
8.3
7.0
6.3
7.8
0.468
Nonmotor symptoms
NMS section I (cardiovascular subscore)
2.0
0.0
6.0
3.0
0.0
7.0
0.633
NMS section II (sleep subscore)
17.0
11.0
26.0
20.0
15.0
26.0
0.993
NMS section III (mood subscore)
11.0
3.5
20.0
12.0
4.5
25.0
0.907
NMS section IV (hallucinations subscore)
0.0
0.0
8.0
0.0
0.0
4.0
0.974
NMS section V (memory subscore)
10.0
3.0
18.5
12.0
6.0
21.0
0.523
NMS section VI (gastrointestinal subscore)
4.0
2.0
7.5
8.0
4.0
11.0
0.016
NMS section VII (urinary system subscore)
13.0
9.0
19.5
14.0
9.0
20.5
0.878
NMS section VIII (sexual subscore)
2.0
0.0
10.0
2.0
0.0
5.0
0.197
NMS section IX (miscellaneous subscore)
1.0
0.0
9.0
1.0
0.0
7.0
0.251
NMS total score
85.0
47.0
103.5
90.0
59.5
115.5
0.939
Sleep and sleepiness
PDSS-2 motor subscore
3.0
0.0
7.0
2.0
1.0
7.0
0.397
PDSS-2 Parkinsonian symptoms subscore
4.0
2.0
5.5
3.0
1.0
5.5
0.657
PDSS-2 disturbed sleep subscore
6.0
3.5
9.5
7.0
3.5
11.0
0.334
PDSS-2 total score
12.0
7.5
18.5
10.0
8.0
23.0
0.224
ESS Total
7.0
6.0
12.0
7.0
5.5
12.0
0.567
Depression
BDI total score
10.0
5.5
15.5
9.0
5.0
14.0
0.858
MADRS total score
10.0
5.5
15.0
11.0
7.5
15.5
0.623
QoL
EQ-5D
0.8
0.7
0.9
0.8
0.7
0.9
0.895
EQ-VAS
70.0
54.0
80.0
63.0
50.0
76.0
0.625
ADL (Schwab-England)
80.0
75.0
90.0
80.0
70.0
90.0
0.965
Clinical global impression-severity
3.0
2.0
4.0
3.0
1.5
3.5
0.647
Clinical global impression-improvement
4.0
4.0
4.0
4.0
4.0
5.0
0.199
ADL = activities of daily living (Schwab and England Scale). BDI = Beck Depression Inventory; ESS = Epworth Sleepiness Scale; EQ-5D = the EuroQol instrument for detecting health outcome; EQ-VAS = visual analogue scale included in EQ-5D; HYS = Hoehn-Yahr Stage; FTMTRS = Fahn-Tolosa-Marin Tremor Rating Scale; MADRS = Montgomery Asberg Depression Rating Scale; NMSS = Nonmotor Symptom Assessment Scale; PDSS-2 = Parkinson’s Disease Sleep Scale 2nd version; UPDRS = Unified Parkinson’s Disease Rating Scale. For calculating significance Kruskal-Wallis test was applied except for HYS and Clinical Global Impression scales where Chi-square test was used (because of being an ordinal variable).
