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Stephen B. Hulley, MD, MPH; Thomas B. Newman, MD, MPH; Deborah Grady, MD, MPH; Robert B. Baron, MS, MD; Warren S. Browner, MD, MPH
University of California San Francisco

Alan M. Garber, MD, PhD
Stanford (Calif) University School of Medicine

JAMA. 1993;270(8):937-938.

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In Reply.

—We agree with Dr Tobert that the small number of deaths in the EXCEL trial precludes firm conclusions about the impact of lovastatin on mortality, but we take little comfort from his comments on cause of death. The fact is that a higher proportion of lovastatin-treated patients died. It is disturbing that this large study funded by Tobert's employer had only 1 year of follow-up, and that it is the only randomized trial of this drug with published disease event outcomes. This leaves us in the position of hoping that other trials will show that death rates decrease and keeping our fingers crossed in the meantime. Such uncertainty about a new class of drugs that is already widely used seems unacceptable, raising questions about the use of surrogate end points by Food and Drug Administration advisory panels to recommend long-term drug treatment for healthy people.

As to Dr . . . [Full Text PDF of this Article]

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