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Course of Parkinson Disease Apparently Modified by Rasagiline
Patients may ask about a report from the New England Journal of Medicine that rasagiline could have a disease-modifying effect in Parkinson disease. The study was supported by the drug's manufacturer. (Rasagiline inhibits monoamine oxidase type B.)
Researchers used a double-blind, delayed-start trial design in some 1200 patients with untreated disease. In the 72-week trial, half started rasagiline immediately (either 1 or 2 mg daily), while the other half took placebo. At the 36-week mark, those initially on placebo began receiving one of the two active-treatment doses.
On the basis of disease severity scoring, the 1-mg dose showed a disease-modifying effect at the 72-week mark. The 2-mg dose did not.
The authors say they "cannot definitively conclude" that the 1-mg dose has disease-modifying effects, given their inability to explain the difference in success rates between the two doses.
(The issue includes an explanation of delayed-start trial designs.)
LINK(S):
NEJM article (Free abstract; full text requires subscription)
NEJM Statistics in Medicine article (Subscription required)
Published in Physician's First Watch September 24, 2009
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