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Volume 353:2319-2321 December 1, 2005 Number 22
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Observational Studies of Drugs and Mortality
Wayne A. Ray, Ph.D.

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 by Wang, P. S.
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Randomized controlled trials of therapies for the primary and secondary prevention of cardiovascular disease increasingly are powered to study overall mortality. The interventions frequently treat asymptomatic risk factors among high-risk patients and have a diverse spectrum of potential adverse effects. Thus, medications such as clofibrate or encainide that successfully alter surrogate end points but increase the rate of death are of little clinical interest. Many believe that a new preventive therapy for cardiovascular disease should be used sparingly, if at all, until clinical trials establish equivalence or even superiority to existing treatments in terms of mortality from all causes.

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Dr. Ray is a professor at the Center for Education and Research on Therapeutics, Department of Preventive Medicine, Vanderbilt University School of Medicine, and a research scientist at the Geriatric Research, Education and Clinical Center, Veterans Affairs Medical Center — both in Nashville.


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