Calculation of trough-to-peak ratio in the research unit setting. Advantages and disadvantages.

The trough-to-peak ratio for the response to an antihypertensive drug is a clinically meaningful parameter but only when the calculation has been derived from an appropriate and scientifically robust study. Since the methodological details have not been defined by any regulatory authority, several possible approaches have developed. The major apparent advantages of the intensive study of individual patients in the research unit setting are that the conditions of measurement can be standardized and an accurate account can be taken of the circadian variations in the responses to placebo and active drug treatment. The principal disadvantage is that it is an "artificial" environment that may, or may not, be directly relevant to routine clinical circumstances. Nevertheless, the values obtained with this approach to date are directly comparable to values obtained by the alternative approaches, such as ambulatory blood pressure measurements (provided that those are also well-conducted studies). Thus, using the trough-to-peak ratio not only appears valid but also permits the detailed study of individual patients and also lends itself to the incorporation of additional and confirmatory clinical pharmacological assessments.