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June 7, 1995

Clinical Pharmacology

Author Affiliations

Cornell University Medical College, New York, NY

JAMA. 1995;273(21):1664-1665. doi:10.1001/jama.1995.03520450034017

One of the principal themes of clinical pharmacology is the scientific study of drug effects in humans. The issue of what drug effects to measure, surrogate end points, has been emphasized by two recent clinical trials: the Cardiac Arrhythmia Suppression Trial1 reported in 1993 and the CONCORDE trial2 reported in 1994.

The Cardiac Arrhythmia Suppression Trial was designed to test the hypothesis that giving antiarrhythmic drugs that suppress premature ventricular beats would prolong survival in patients who recovered from myocardial infarctions. The patients were randomized to receive placebo or one of three antiarrhythmic drugs. The patients receiving active drugs had a higher 1-year mortality than those receiving placebo, and the trial was stopped.1 The investigators concluded that suppressing asymptomatic ventricular premature beats with these antiarrhythmic drugs was not beneficial and appeared to be harmful. This was clearly contrary to the conventional wisdom that assumed that any intervention

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