Importance of various methods of blood pressure measurement in clinical trials.

Ambulatory blood pressure (ABP) monitoring and self-measurement of blood pressure (BP) are more reproducible than clinic BP measurement, minimize the white coat effect, and can reduce the sample size necessary to demonstrate the efficacy of a drug in clinical trials. For many years, the trough:peak ratio has been considered the key index for demonstrating the efficacy of antihypertensive agents. However, several potential problems are associated with the use of this index, and ABP monitoring makes it possible to examine changes in BP over the entire 24-hour period, not only at a preset time of peak effect and at the end of the dosing interval. The smoothness index provides more comprehensive information on the 24-hour BP control with treatment and avoids part of the problems encountered with the trough:peak ratio. One simple way to summarize the results of ABP monitoring in clinical trials is to provide the mean 24-hour BP difference from placebo and the BP decrease at trough. The numerous advantages summarized above make ABP monitoring an accepted method of BP measurement in hypertension therapy trials. Self-measurement of BP may be a valid and less expensive alternative to ABP monitoring.