Clinical Study

Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease

Table 1

Demographic baseline characteristics of the 246 randomized and treated subjects who had ophthalmologic data.

Randomized and treated set Pramipexole Ropinirole

Age in years, mean ± SD57.5 ± 9.359.1 ± 8.7
 Range35–8035–7836–80
Age group, n (%)
 <5040 (16.3)23 (19.0)17 (13.6)
 50 to <65145 (58.9)71 (58.7)74 (59.2)
 65 to <7551 (20.7)21 (17.4)30 (24.0)
 ≥7510 (4.1)6 (5.0)4 (3.2)
Men, n (%)157 (63.8)79 (65.3)78 (62.4)
Women, n (%)89 (36.2)42 (34.7)47 (37.6)
Race, n (%)
 Asian2 (0.8)1 (0.8)1 (0.8)
 African American10 (4.1)7 (5.8)3 (2.4)
 Caucasian234 (95.1)113 (93.4)121 (96.8)
Time in years since PD diagnosis, mean ± SD1.13 ± 1.460.97 ± 1.151.29 ± 1.70
 Median0.510.460.58
 Range0.0–9.40.0–5.20.0–9.4
Hoehn–Yahr stage, n (%)
 0000
 151 (20.7)28 (23.1)23 (18.4)
 1.530 (12.2)11 (9.1)19 (15.2)
 2142 (57.7)71 (58.7)71 (56.8)
 2.513 (5.3)8 (6.6)5 (4.0)
 310 (4.1)3 (2.5)7 (5.6)
 4000
 5000
Sum of the UPDRS part II and part III total scores, mean ± SD30.4 ± 12.728.8 ± 11.631.9 ± 13.4
Alcohol history, n (%)
 Does not drink95 (38.6)46 (38.0)49 (39.2)
 Number of patients with average consumption (not regarded as problematic by investigators)151 (61.4)75 (62.0)76 (60.8)
 Fulfils criteria for abuse/dependence000
Most common concomitant diagnoses (>10%), n (%)
 Hypertension93 (37.8)42 (34.7)51 (40.8)
 Depression74 (30.1)38 (31.4)36 (28.8)
 Constipation56 (22.8)23 (19.0)33 (26.4)
 Drug hypersensitivity56 (22.8)25 (20.7)31 (24.8)
 Hypercholesterolemia49 (19.9)27 (22.3)22 (17.6)
 Anxiety48 (19.5)20 (16.5)28 (22.4)
 Back pain48 (19.5)26 (21.5)22 (17.6)
 Gastroesophageal reflux disease37 (15.0)19 (15.7)18 (14.4)
 Arthralgia36 (14.6)15 (12.4)21 (16.8)
 Insomnia36 (14.6)16 (13.2)20 (16.0)
 Headache32 (13.0)13 (10.7)19 (15.2)
 Osteoarthritis30 (12.2)11 (9.1)19 (15.2)
 Erectile dysfunction29 of 157 men (18.5)11 of 79 men (13.9)18 of 78 men (23.1)
 Pollakiuria28 (11.4)9 (7.4)19 (15.2)
 Arthritis25 (10.2)15 (12.4)10 (8.0)
 Hyperlipidemia25 (10.2)9 (7.4)16 (12.8)

PD: Parkinson’s disease; SD: standard deviation; UPDRS: Unified Parkinson’s Disease Rating Scale.