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CAST
About the Trial
The Cardiac Arrhythmia Suppression Trial tested whether suppressing ventricular premature beats after heart attack prevented death. Encainide and flecainide superbly suppressed the ectopy on ECG, yet patients on them died at 2 to 3 times the rate of placebo: 56 deaths versus 22. The trial was stopped early in 1989 and shocked cardiology. Surrogate endpoints, the PVC, had misled a whole field. CAST became the canonical lesson that drugs must be judged by clinical outcomes, not intermediate markers. It triggered FDA reforms, influenced approval standards, and is still taught as the prime example of why mechanism based reasoning can fail catastrophically.
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