Proposals for European Commission guidelines in the use of ambulatory blood pressure monitoring to evaluate antihypertensive drugs.

Different national authorities have different requirements before antihypertensive drugs can be approved for clinical use. Traditionally, antihypertensive treatment is evaluated by blood pressure measurements made by standardized casual readings. Twenty-four-hour ambulatory blood pressure monitoring provides additional information on the antihypertensive profile of a drug. In antihypertensive drug studies, this technique reduces the sample size required, has no placebo effect and provides more detailed information on first-dose effects, the duration of action and dose-response relationships. Accordingly, proposals are being made that might form the basis of European Commission (EC) guidelines for ambulatory blood pressure monitoring, thus standardizing the present different national requirements.