The use of ambulatory blood pressure monitoring to evaluate antihypertensive drugs for drug approval.
So far, the contribution of clinical studies using ambulatory blood pressure monitoring in the registration of a new antihypertensive agent for marketing authorization purposes has been limited. However, pre-registration studies can be particularly useful, especially to study dose and dose interval in relation to peak: trough ratio during phase II and to facilitate comparison with other antihypertensive agents during phase III of the development of a new antihypertensive agent. More attention should be paid to their design and implementation as high standards are recommended. If properly studied, ambulatory blood pressure monitoring could fulfil a major role in the registration process of a new antihypertensive agent.
de Graeff PA
Department of Internal Medicine, University of Groningen, Groningen, The Netherlands.
Hoppe
U