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A fresh approach to the evaluation of antihypertensive agents
Abstract:
Clinical studies on the use and activity of drugs often rely on data generated from a relatively small number of patients, and definitive conclusions are drawn that are assumed to represent the population at large. Similarly, interpretation and comparison of studies are made difficult when end points of effectiveness, particularly with antihypertensive agents, are arbitrarily chosen. The results from a clinical study of more than 1400 hypertensive patients after indapamide therapy for 3 months, alone or in combination with a beta blocker, are presented using a different graphic approach. This is based on the assumption that the magnitude of the fall in blood pressure after hypertensive therapy is dependent on initial blood pressure. Diastolic and systolic pressures were plotted as a scattergram against the change in blood pressure. Predetermined response lines were drawn with a slope of 1 and intercepts on the initial blood pressure axis of 90 mm Hg for diastolic and 140 mm Hg for systolic pressures with tolerance limits of +/- 10 mm Hg drawn about it. Subdivisions of response can be achieved by counting the number of patients above and below these lines. This allows a drug to be "finger-printed" in terms of its pattern of activity in all degrees of severity of hypertension and, more relevant, direct comparisons with other drugs can be made. Similarly, the potential activity of the drug can be determined by computing the slope and intercept of the actual regression line through the data points.(ABSTRACT TRUNCATED AT 250 WORDS)