Abstract
A beneficial effect or an adverse effect of drug therapy on death is difficult to assess in patients with cardiovascular diseases because the death rate is moderate (<10% per year) in most patient groups that are the target of treatment assessment. Since the death rate is modest, studies must be large, long-lasting, and expensive if they are to establish either benefit or harm of a drug in terms of mortality. The realization that the answer to questions about a drug’s effect on mortality will be slow in coming and expensive to get naturally raises the issue of surrogate endpoints that may provide reasonable predictions of mortality effects at less effort and cost than full-scale controlled, randomized clinical trials with mortality as an end point. This discussion will focus on the question: what surrogate endpoints are valid and sufficient to establish benefit of an antiarrhythmic drug on mortality.
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© 1990 Kluwer Academic Publishers
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Bigger, J.T. (1990). Are there Valid Surrogate Endpoints for Mortality that can be Used to Evaluate the Effects of Antiarrhythmic Drug Therapy?. In: Morganroth, J., Moore, E.N. (eds) Use and Approval of Antihypertensive Agents and Surrogate Endpoints for the Approval of Drugs Affecting Antiarrhythmic Heart Failure and Hypolipidemia. Developments in Cardiovascular Medicine, vol 112. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-1505-6_12
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DOI: https://doi.org/10.1007/978-1-4613-1505-6_12
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