Methodological considerations in calculation of the trough: peak ratio

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AimThe Food and Drug Administration in the United States has published guidelines which indicate that a minimum trough: peak ratio of 50–66% is required for the efficacy of an antihypertensive drug to be considered satisfactory in relation to its proposed dosage interval. However, these guidelines do not give any definition of the most appropriate methodology, and published data contain widely disparate values which often reflect methodological inconsistencies. This article attempts to define the principal methodological requirements for the accurate and reproducible measurement of trough and peak antihypertensive effects and for calculation of the trough: peak ratio.ConclusionsProvided there is an adequate placebo run-in period (of not less than 4 weeks) and individual patients are studied under carefully standardized conditions, with multiple blood pressure recordings throughout the dose interval, it is possible by means of a sequential, placebo-active treatment design to calculate the trough: peak ratio with acceptable accuracy and reproducibility.

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