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                                                                                          Dott. Carlo Sebastiano Tadeo
                                                                                                Specialista Neurologia

Pramipexole Versus Levodopa per il Parkinson

 

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Pramipexole Versus Levodopa For Early Parkinson's

A DGReview of :"Pramipexole vs Levodopa as Initial Treatment for Parkinson Disease. A Randomized Controlled Trial"
JAMA

10/18/2000
By Elda Hauschildt


Pramipexole, as initial therapy in patients with early Parkinson's disease, reduces risk of developing certain dopaminergic motor complications compared to initiation with levodopa therapy.

The drug, however, is not as effective as levodopa in improving total features of the disease as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), researchers from the Parkinson Study Group report.

They note that the absolute risk reduction seen from initial pramipexole therapy over levodopa is 23 percent. This means doctors would have to treat four of five Parkinson's disease patients with pramipexole, instead of levodopa, over two years to prevent one additional dopaminergic complication.

Researchers used a multi-centre, parallel-group, randomised trial at 22 sites in the United States and Canada to compare dopaminergic motor complications after initial treatment with either of the two drugs. A total of 301 patients with early Parkinson's were enrolled in the double-blind, controlled study between October 1996 and August 1997.

A total of 151 patients were randomly assigned to receive 0.5 mg of pramipexole three times a day, with levodopa placebo. Another 150 patients were assigned 25/100 mg carbidopa/levodopa three times per day, with pramipexole placebo.

Dosages were escalated during the first 10 weeks for patients with residual disability. Investigators could add open-label levodopa from week 11 to month 23.5 to treat continuing or emerging disability.

Initial pramipexole therapy resulted in significantly less development of wearing off, dyskinesias or on-off motor fluctuation (28 percent) compared to levodopa (51 percent). Mean improvement in total UPDRS score to 23.5 months was greater for the levodopa patients (9.2 points) than the pramipexole patients (4.5 points).

"UPDRS scores remained worse in the pramipexole group despite the use of open-label levodopa for treating emerging or continuing disability," the researchers point out.

They suggest that further studies are needed to assess a variety of questions, include whether the trade off between motor complications and efficacy favours levodopa or dopamine-receptor agonists such as pramipexole.

Editorialist Dr. Caroline M. Tanner of the Parkinson's Institute at Sunnyvale, California agrees. She points out that few clinical trials extend beyond one year, yet Parkinson's patients commonly live decades after treatment is initiated.

"As the proportion of the US population at risk for Parkinson's disease increases, a long-term approach to therapy assumes increasing importance," says Dr. Tanner. "Understanding the relationship between initial treatment and outcomes such as morbidity, mortality and responsiveness to therapies for advanced disease will be needed."


JAMA, 2000; 284: 1931-1938; (editorial) 1971-1973. "Pramipexole vs Levodopa as Initial Treatment for Parkinson Disease. A Randomized Controlled Trial"

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Aggiornato il: 27 February 2001