Parkinson’s Disease

Review Article

A Systematic Review and Meta-Analysis of the Efficacy and Safety of Rasagiline or Pramipexole in the Treatment of Early Parkinson’s Disease

Table 2

The main characteristics of the pramipexole studies included in the systematic review.


Study, year	Intervention	Dose (mg/day)^a	Duration	Population (n)	Number of withdrawals	Mean age ± SD (yr.)	Males (%)	Duration of PD (yr.)	H&Y stage	Country	Other PD medications in entire population (%)

Barone et al. 2010	PPX vs. PBO	0.375–3 (2.18 ± 0.83)	12 wk	152	19	66.6 ± 9.9	51.3	4.5 ± 3.9	2.1 ± 0.6	12 European countries, South Africa	LD and derivatives^b (74.7), AM (23.3), MAOB-I (13.2), AC (7.8), other (5.4)^c
Barone et al. 2010	PPX vs. PBO	0.375–3 (2.18 ± 0.83)	12 wk	144	20	67.4 ± 9.0	43.1	4.0 ± 4.5	2.2 ± 0.6	12 European countries, South Africa

Hauser et al. 2010	PPX ER or PPX IR vs. PBO	0.375–4.5	18 wk	50	4	63.2 ± 8.7	46.0	0.8 ± 1.1	1–3	14 countries, Europe, US, South America, Asia	MAOB-I, AM, AC, β-blockers. Rescue LD 14.0 (PBO), 2.9 (ER), 1.0 (IR)
		3.05 ± 1.37 (ER)		106	21	61.6 ± 9.4	58.5	1.1 ± 1.3	1–3
		3.03 ± 1.39 (IR)		103	15	62.0 ± 8.3	57.3	0.9 ± 1.2	1–3

Parkinson Study Group 2000	PPX vs. LD	300–600 (LD)^e (LD: 427 ± 112)	48 mo.	150	49	60.8 ± 9.8	68.0	1.8 ± 1.7	1.8 ± 0.4	US, Canada	Open-label LD 59.3 (LD) and 72.2 (PPX), EL (35.5), AM (25.2), AC (9.6), COMT-I (2.3)^f
Parkinson Study Group 2004^d	PPX vs. LD	0.75–4.5 (PPX) (PPX: 2.8 ± 1.1)	48 mo.	151	67	61.1 ± 9.6	60.2	1.5 ± 1.4	1.9 ± 0.4	US, Canada

Kieburtz et al. 1997	PPX vs. PBO	1.5–6.0	10 wk	51	0	60.4 ± 12.0	62.7	1.7 ± 1.5	1.8 ± 0.5	US	AC, AM, and SE were permitted with stable dose for 30 days prior to the study. SE use 55.6–68.0%
				54	10	60.3 ± 10.5	64.8	1.8 ± 1.5	1.8 ± 0.6
				50	2	62.2 ± 11.1	62.0	2.0 ± 1.6	1.9 ± 0.5
				54	4	62.8 ± 10.5	63.0	1.9 ± 1.5	1.8 ± 0.5
				55	9	62.8 ± 11.4	69.1	2.2 ± 1.8	1.9 ± 0.6

Poewe et al. 2011	PPX ER or PPX IR vs. PBO	0.375–4.5	33 wk	103	12	62.0 ± 9.6	49.5	0.9 ± 1.0	2.1 ± 0.6	14 countries Europe, US, South America, Asia	In each group AM (29.6%–31.5%) MAOB-I (25.2%–29.1%), AC (20.2%–21.5%), rescue LD (7.0 ER, 4.3 IR, 21.4 PBO)
		2.9 ± 1.4 (ER)		223	49	61.3 ± 9.8	57.0	1.0 ± 1.2	1.6 ± 0.6
		2.9 ± 1.4 (IR)		213	37	61.7 ± 9.6	56.8	1.1 ± 1.4	2.1 ± 0.6

Schapira et al. 2013	PPX vs. PBO	1.5	15 mo.	274	60^g	62.9 ± 9.9	61	4.5 ± 5.9 mo.	1.5 ± 0.5	10 countries Europe, US, Asia	Other PD medications were not permitted
Schapira et al. 2013	PPX vs. PBO	1.5	15 mo.	261	40	62.1 ± 10.1	68	4.4 ± 6.3 mo.	1.5 ± 0.4	10 countries Europe, US, Asia	Other PD medications were not permitted

Shannon et al. 1997	PPX vs. PBO	0.375–4.5 (3.8)	31 wk	171	34	62.7 (PBO + PPX)	60.6 (PBO + PPX)	1.8 (PBO + PPX)	1–3	NR	SE with stable dosage (about two-thirds in each group)
Shannon et al. 1997	PPX vs. PBO	0.375–4.5 (3.8)	31 wk	164	28	62.7 (PBO + PPX)	60.6 (PBO + PPX)	1.8 (PBO + PPX)	1–3	NR	SE with stable dosage (about two-thirds in each group)

Thomas et al. 2006	PPX vs. RR	2.1–4.2	24 mo.	30	3	57.1 ± 2.0^h	56.0	1.2 ± 0.5 (PPX + RR)	1.6 ± 0.6	Italy	Patients had never received any PD treatment
Thomas et al. 2006	PPX vs. RR	15–24	24 mo.	30	5	55.3 ± 2.0	55.6	1.2 ± 0.5 (PPX + RR)	1.4 ± 0.6	Italy	Patients had never received any PD treatment

Viallet et al. 2013	PPX vs. RA	1.5 (PPX)	15	56	14	62.1 ± 6.2	55.4	4.3 ± 7.3 mo.	≤3ⁱ	France	All PD treatments were discontinued
Viallet et al. 2013	PPX vs. RA	1 (RA)	15	53	3	63.2 ± 7.3	69.8	2.5 ± 3.8 mo.	≤3ⁱ	France	All PD treatments were discontinued

Wong et al. 2003	PPX vs. PBO	0.375–4.5	15	77	8	60.9 ± 1.1	72.7	4.3 ± 0.4	2.2 ± 0.1	Hong Kong, Taiwan	Stable LD, SE, AC, AM
Wong et al. 2003	PPX vs. PBO	0.375–4.5	15	73	9	58.8 ± 1.3	65.8	4.5 ± 0.4	2.2 ± 0.1	Hong Kong, Taiwan	Stable LD, SE, AC, AM

AC = anticholinergics, AM = amantadine, COMT-I = Catechol-O-methyl transferase inhibitors, EL = eldepryl, ER = extended release, IR = immediate release, H&Y = Hoehn and Yahr stage, LD = levodopa, MAOB-I = monoamine oxidase B inhibitors, mo = months, NR = not reported, PBO = placebo, PD = Parkinson’s disease, PPX = pramipexole, RA = rasagiline, RCT = randomized controlled trial, RR = ropinirole, SE = selegiline, US = the United States of America, wk = weeks, and yr = years. ^aIn most studies, doses were titrated at the beginning of the study. Mean values in brackets. ^bLevodopa with or without carbidopa, levodopa plus carbidopa plus entacapone, or levodopa plus benserazide. ^cEntacapone or budipine. ^dThe first 2 yr. are reported in Parkinson Study Group [34] and whole 4 yr. study is reported in Parkinson Study Group [35]. ^eCarbidopa and levodopa preparation. First value is the amount of carbidopa and the second one is the amount of levodopa. ^fValues reported of the whole study population (n = 301). ^gAll subjects that discontinued the study before active treatment at 9 months. This study had a delayed-start design that used placebo until 9 months when patients were switched to placebo. We are reporting the data before the switch to an active treatment. PBO group means in this table the delayed-start pramipexole group. ^hThe results are reported of patients that completed the study. ⁱ94% of study subjects had a H&Y score of ≤2.