title: Clinical relevance of ambulatory versus clinic blood pressure when evaluating antihypertensive therapy.
abstract: REVIEW IN DEPTH: The evaluation of the effect of antihypertensive drugs over time has led to the increasing popularity of noninvasive ambulatory monitoring of blood pressure in the drug development process. Although not mandated by the Food and Drug Administration of the USA, from a practical standpoint new drug applications for antihypertensive agents typically include one or more studies that have used ambulatory blood pressure recordings. Ambulatory blood pressure monitoring is now used in several phases of drug development, including phase II dose-ranging studies, phase III efficacy studies, and phase IV comparative trials. The perceived benefit of the ambulatory blood pressure methodology during drug development is that it avoids observer bias, markedly reduces the effect of placebo, and may economize on sample size, especially in cross-over-designed trials. Furthermore, there is a clinical benefit of ambulatory blood pressure monitoring in the assessment of antihypertensive drugs because it allows evaluation of the effect and duration of effect of a drug during activities of daily living, including sleep.
authors.affiliation: Section of Hypertension and Vascular Disease, University of Connecticut Health Center, Farmington, Connecticut, USA.
authors.initials: WB
authors.lastname: White