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European Heart Journal 1988 9(2):203-206;
Copyright © 1988 by the European Society of Cardiology.
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© 1988 The European Society of Cardiology

Clinical trials: A practical tool in cardiology

M. E. KITLER

CH-1181 Gilly, Switzerland

Abstract

A number of major clinical trials have addressed the issue of the management of hypertension, but only a few have looked exclusively at elderly patients. While these trials have brought about new approaches to the chronic management of hypertension, they have failed to answer several important questions, partly because the methodologies employed in individual trials do not permit inter-trial comparability. Other questions that have not yet been answered involve the use of non-pharmacologic approaches, in particular dietary means of controlling elevated blood pressure, the specificity of end-points (how much does blood pressure have to be lowered to avoid cardiovascular and cerebrovascular sequelae?), and how results from large-scale trials can be related to the practice of the individual practitioner. Importantly, quality-of-life issues, often still tested by means developed for young patients, have assumed great import and their study should be pursued vigorously. As far as trial methodology is concerned, there is a need to differentiate between ‘intention-to-treat’ analysis and ‘on-treatment’ analysis. Subgroup analysis should be considered and more attention should probably be paid to patient selection, goal specificity, and size of study population, particularly in chronic studies.

Key Words: Clinical trials • clinical trial methodology • hypertension • elderly


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