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PDF Statement on Rasagiline (Azilectģ) and Early Parkinson's Treatment

The long-awaited publication of the results of an important clinical trial, known as ADAGIO, were printed in the New England Journal of Medicine on September 24, 2009.  

A multicenter study group examined the effects of rasagiline (Azilect (R)) on the progression of clinical signs of PD over 18 months.  The group aimed to test whether early introduction of rasagiline provided better long-term benefit than a later introduction of the drug.  Specifically one group of patients received rasagiline for 18 months and the other group received a placebo or inactive tablet for the first nine months of the study and then received rasagiline like the other group for the remaining nine months.  The concept being tested was whether the early use of rasagiline had long-term benefits that were different than the benefit obtained if patients waited initially and then took the same drug.  Two doses of rasagiline were tested, one mg and two mg daily. 

The results were different with the two doses.  In the group receiving one mg/rasagiline/day, outcome was superior if early treatment was initiated.  This finding is comfortably compatible with the idea that early treatment with this drug alters disease outcome in a positive way in comparison to holding off on treatment in the early phase of PD.  On the other hand, the positive results seen with one mg were NOT seen with the two mg treatment.  This puzzling outcome of different results with differing doses needs to be followed with further studies.   

"The results have been fairly reported with appropriate caution on interpretation," says Christopher Goetz, M.D., Director of the PDF Parkinson's Disease Research Center at Rush University Medical Center in Chicago.  "Clearly, if one focuses on the one mg results, we would want to recommend early intervention as opposed to holding off on treatment to reserve it for later.  If one focuses on the two mg results, we would not have any reason to promote early treatment, since the outcomes achieved with the extra duration of treatment did not meet the outcome measures predicted.  More research is needed and a longer follow-up on these patients since PD lasts far longer than 18 months." 

PDF is committed to keeping its members and readership up to date on developing results in this and all other important clinical trials in PD.  For a view of other clinical trial information, see the website of PDtrials, www.PDtrials.org, an initiative led by PDF in collaboration with several other Parkinson's organizations.

To read previous statements about the ADAGIO trial, please use the links below.

Read PDF's August 29, 2009 Statement about this Trial

Source Date: Sep 24 2009