A Response to “Holding GUSTO Up to the Light”

  1. Paul M. Ridker, MD;
  2. Christopher J. O'Donnell, MD;
  3. Victor J. Marder, MD; and
  4. Charles H. Hennekens, MD
  1. From the Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; the University of Rochester, Rochester, New York. Requests for Reprints: Paul M. Ridker, MD, Department of Medicine, Brigham and Women's Hospital, 900 Commonwealth Avenue East, Boston, MA 02215-1204. Acknowledgments: The authors acknowledge their participation in the International Studies of Infarct Survival (ISIS) (where Drs. Ridker and Hennekens are members of the Steering Committee) and their participation in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial (where Dr. Marder is a member of the Steering Committee).

    Abstract

    Open and informed evaluation of study results is essential to advancing scientific understanding, particularly in large-scale trials (such as the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries [GUSTO] trial), which may affect clinical treatment and public health.

    In this article, we discuss alternative interpretations of the GUSTO findings, the problems inherent in any unblinded trial, and the need for more complete analysis and reporting of data so that the four different thrombolytic regimens tested in GUSTO can be adequately compared with one another.We conclude that, based on all the available evidence, any differences among individual drugs in terms of efficacy or safety are small and are less clinically important than is the wider use and more rapid delivery of thrombolytic therapy with any of the available agents.

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