Selegiline, or the problem of early termination of clinical trials

BMJ 1998;316:1182-1183 ( 18 April )

Editorials

Selegiline, or the problem of early termination of clinical trials

The clinical questions are not well answered, and probably never will be

The first 150 words of the full text of this article appear below.

Parkinson's disease is the second most common neurodegenerative disorder, after dementia. About 1.4% of people aged 55 yearsor over have Parkinson's disease,¹ and because of the agingof Western populations the absolute number of patients is rapidlyincreasing. Until now, treatment has been mainly symptomatic,but much effort is being put into developing neuroprotective agentsthat may stop progression or even cure the disease. Clearly, unrecognisedadverse effects of such treatments may potentially affect largenumbers of patients and any suggestion of such effects needs thoroughinvestigation.

Selegiline has probably become the most controversial drug in Parkinson's disease during the past decade. Its presumed efficacywas initially ascribed to neuroprotection due to inhibition ofmonoamine oxidase-B, then to a symptomatic effect, and more recentlyagain to neuroprotection, this time due to inhibition of apoptosis.The greatest controversy, however, occurred because selegilinecaused the early termination of the intervention arms of . . . [Full text of this article]

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Investigation by Parkinson's Disease Research Group of United Kingdom into excess mortality seen with combined levodopa and selegiline treatment in patients with early, mild Parkinson's disease: further results of randomised trial and confidential inquiry: Y Ben-Shlomo, A Churchyard, J Head, B Hurwitz, P Overstall, J Ockelford, and A J Lees
BMJ 1998 316: 1191-1196. [Abstract] [Full Text] [PDF]

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