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VIEWPOINT AND COMMENTARY

Efficacy and Safety in Clinical Trials in Cardiovascular Disease

Cardiovascular Division, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota.

Manuscript received October 1, 2005; revised manuscript received January 20, 2006, accepted January 25, 2006.

^_* Reprint requests and correspondence: Dr. Jay N. Cohn, Cardiovascular Division, Mayo Mail Code 508, University of Minnesota Medical School, 420 Delaware Street SE, Minneapolis, Minnesota 55455. (Email: cohnx001{at}umn.edu).

Mortality and morbid events are insensitive guides to the efficacy and safety of interventions in chronic cardiovascular disease (CVD). To enhance the ability to find new and effective long-term treatments, especially for the early stages of CVD, a revised strategy for clinical trials should emphasize efficacy on disease progression while monitoring symptoms and quality of life as guides to clinical benefit. Mortality, which is uncommon except in acute or advanced disease, provides at best a crude guide to net efficacy and safety. It must be monitored to support demonstrated efficacy on disease progression without adverse safety effects. This revised approach, made possible by our enhanced ability to monitor the progression of disease, should make it possible to study earlier disease and to improve cardiovascular health while reducing health care costs.

Abbreviations and Acronyms   CVD = cardiovascular disease   HF = heart failure   LV = left ventricle/ventricular   MI = myocardial infarction

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