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Parkinson Treatment Approval
JAMA. 1999;282:1995.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The FDA has approved entacapone (COMTAN, Orion Corp, Scotch Plains, NJ), a new catechol-O-methyltransferase (COMT) inhibitor, as an adjunct to levodopa/carbidopa for patients with Parkinson disease who experience end-of-dose worsening. Entacapone's ability to inhibit COMT, one of the enzymes responsible for the metabolism of dopamine, results in greater and more sustained plasma levels of dopamine than levodopa/carbidopa when the latter is given alone. One 200-mg entacapone tablet is administered concomitantly with each dose of levodopa/carbidopa, up to a maximum of 8 doses per day (1600 mg/d).
The drug's effectiveness as an adjunct to levodopa/carbidopa was established in three placebo-controlled trials with 677 patients that included individuals whose Parkinson disease was characterized by fluctuations, ie, "on" periods (relatively good functioning) alternating with "off" periods (relatively poor functioning) despite optimum levodopa therapy. The double-blind portion of each trial was 6 months long.
In two of the trials, effectiveness was determined . . . [Full Text of this Article]
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