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Surrogate End Points, Health Outcomes, and the Drug-Approval Process for the Treatment of Risk Factors for Cardiovascular Disease
Bruce M. Psaty, MD, PhD;
Noel S. Weiss, MD, DrPH;
Curt D. Furberg, MD, PhD;
Thomas D. Koepsell, MD, MPH;
David S. Siscovick, MD, MPH;
Frits R. Rosendaal, MD, PhD;
Nicholas L. Smith, PhD, MPH;
Susan R. Heckbert, MD, PhD;
Robert C. Kaplan, MS;
Danyu Lin, PhD;
Thomas R. Fleming, PhD;
Edward H. Wagner, MD, MPH
JAMA. 1999;282:786-790.
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Data on surrogate end points such as blood pressure or body weight have often been used to support the approval of new pharmacologic treatments for cardiovascular risk factors. In small, short-term studies, a new drug reduces the level of a risk factor, and the changes in risk factor levels are interpreted as if the health benefits expected on the basis of those changes will necessarily follow. An editorial on the pharmacotherapy of obesity illustrates the argument1: in the context of discussing the association between appetite suppressant drugs and primary pulmonary hypertension,2 the editorialists . . . [Full Text of this Article]Cardiovascular Risk Factors as Surrogate End Points
Author Affiliations: The Cardiovascular Health Research Unit, the Departments of Medicine (Drs Psaty, Koepsell, Siscovick, and Smith), Epidemiology (Drs Psaty, Weiss, Koepsell, Siscovick, and Heckbert, and Mr Kaplan), Health Services (Drs Psaty, Koepsell, and Wagner), and Biostatistics (Drs Lin and Fleming), University of Washington, Seattle; the Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC (Dr Furberg); the Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands (Dr Rosendaal); and the Center for Health Studies, Group Health Cooperative of Puget Sound, Seattle (Dr Wagner).
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