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Claims of efficacy and safety based on open-label extensions of clinical trials create misinformation and unrealistic expectations about important treatments, can undermine otherwise compelling trials evidence, and have no place in academic journals. The evidence for the efficacy and safety of memantine rests on the well-conducted and methodologically sound randomized controlled trials as summarized by the Cochrane meta-analysis.¹ Open label extension studies are essentially case series of the survivors of these trials who then choose to take the medications openly. These studies by design cannot contribute either safety or efficacy evidence no matter how we choose to analyze them.

The report by Reisberg and colleagues² continues the tradition set by cholinesterase inhibitors of using open-label extension studies to make unwarranted efficacy claims (references on request). Without any evidentiary support, the authors state that (1) their study "provides further efficacy and safety data"; (2) "treatment initiation with memantine was effective"; (3) . . . [Full Text of this Article]

AUTHOR INFORMATION

Lon S. Schneider, MD

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