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 4
Overall summary of safety (TS).
Pramipexole SR (N = 49)
Pramipexole IR (N = 49)
Total (N = 98)
AEs by category, n (%)
Any AEs, n (%)
21 (42.9)
27 (55.1)
48 (49.0)
Severe AEs, n (%)
0 (0.0)
1 (2.0)
1 (1.0)
Drug-related AEs, n (%)
16 (32.7)
19 (38.8)
35 (35.7)
Serious AEs, n (%)
0 (0.0)
1 (2.0)
1 (1.0)
AEs leading to discontinuation, n (%)
1 (2.0)
1 (2.0)
2 (2.0)
AEs by PT,n (%)
Dizziness
3 (6.1)
3 (6.1)
6 (6.1)
Nausea
2 (4.1)
2 (4.1)
4 (4.1)
Dyskinesia
1 (2.0)
3 (6.1)
4 (4.1)
Somnolence
1 (2.0)
3 (6.1)
4 (4.1)
Constipation
2 (4.1)
1 (2.0)
3 (3.1)
Upper respiratory tract infection
2 (4.1)
1 (2.0)
3 (3.1)
Oedema peripheral
1 (2.0)
2 (4.1)
3 (3.1)
Headache
1 (2.0)
2 (4.1)
3 (3.1)
Compulsive sexual behaviour
2 (4.1)
0 (0.0)
2 (2.0)
Dermatitis allergic
2 (4.1)
0 (0.0)
2 (2.0)
Orthostatic hypotension
2 (4.1)
0 (0.0)
2 (2.0)
Chest pain
0 (0.0)
2 (4.1)
2 (2.0)
Bradykinesia
0 (0.0)
2 (4.1)
2 (2.0)
Cough
0 (0.0)
2 (4.1)
2 (2.0)
A patient may be counted in more than one seriousness criterion. AE, adverse event; IR, immediate release; PT, preferred term; SR, sustained release; TS, treated set. With frequency >2% in either pramipexole groups; listed in descending order for total pramipexole.
