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it doesn't seem like the researchers asked - which is more disabling after 6 years -- sleepiness or dyskinesia. They should look at quality of life too. i'd take the sleepiness over dyskinesias any day

linda
www.pdpipeline.org

---------- Original Message ----------
From: mschild <[log in to unmask]>
To: [log in to unmask]
Subject: Long-Term Results of Initial Pramipexole vs. Levodopa Therapy
Date: Fri, 13 Mar 2009 16:00:47 +0100

another version:

Patients initiating dopaminergic therapy with pramipexole have less dyskinesia 
but greater sleepiness than those initiating with levodopa after 6 years, 
leading study authors to conclude "there is no strong evidence favoring either 
of these initial treatment strategies over the other." These are the latest 
results from follow-up of patients in the CALM-PD study, first reported by E-
MOVE in 2000. ?http://www.wemove.org/emove/article.asp?ID=223

Following the blinded phase of the CALM-PD study, patients were invited to 
enroll in an open-label observational phase (the "cohort"). Of the 151 
patients in CALM-PD receiving initial pramipexole, 83 completed the trial and 
108 entered the cohort. Of the 150 initially receiving levodopa, 100 completed 
the trial and 114 entered the cohort. Patients not entering the cohort were 
older, and had more severe disease and lower quality of life. 

Of patients entering the cohort, those initially on pramipexole had lower 
quality of life compared to those initially on levodopa, a difference seen at 
the beginning of the CALM-PD study. More than 90% of patients in each group 
were receiving levodopa. More initial-pramipexole patients were receiving 
dopamine agonist therapy than initial-levodopa patients, more of whom instead 
used other anti-PD medications.

After a mean of 6 years of follow-up, there was no significant difference 
between the two groups in any of the following measures:
--self-reported activities of daily living (Schwab and England) scores
--mean change from baseline in disease severity (UPDRS parts I-III)
--freezing
--percent of the waking day spent in the on state
--disability due to dyskinesias
--functionally significant edema

There were significant differences in these measures:

????????initial pramipexole?????initial levodopa????????P value
edema???27.10%?? ? ? ? ? ? ? ? ? ? ? 14.40%????? ? ? ? ? ? ? ? ? ? ? 0.04
Dopaminergic motor complications 
(wearing off, on-off effects, or dyskinesias)50%???????? ? 68.40%???????0.02
Epworth Sleepiness
Scale Score?????11.3????8.6????? ? ? ? ? ? ? ? ? ? ? 0.001

"The policies of initial pramipexole and initial levodopa use followed by 
open-label levodopa use resulted in similar self-reported disability 6 years 
after randomization," the authors conclude. "Persistent differences favoring 
initial pramipexole were seen in the rates of dopaminergic motor 
complications, with less severe somnolence favoring initial levodopa.. The 
differences seen in favor of pramipexole (fewer dopaminergic events) or 
levodopa (less somnolence and edema) argue for an individualized approach. 
Over the long-term, there is no strong evidence favoring either of these 
initial treatment strategies over the other."


Long-term Effect of Initiating Pramipexole vs Levodopa in Early Parkinson 
Disease
Parkinson Study Group CALM-PD Investigators
Arch Neurol. 2009;66(5):(doi:10.1001/archneurol.2009.32)

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