Is it possible to file and approve a new antihypertensive without ambulatory blood pressure monitoring?.
Clinical research into the efficacy and safety of antihypertensives has used non-invasive automated ambulatory blood pressure monitoring (ABPM) for the last two decades. Different national validation requirements have standardized the equip;ment and the clinical use thereof. The European Standardization for Medical Devices (CEN/CENELEC) organization has recently approved requirements for new ABPM devices in most European countries. For the approval process of new antihypertensive drugs, ABPM today has a supportive role to play in the documentation. Increasingly, national regulatory bureaux demand ABPM data. For the US Food and Drug Administration (FDA) ABPM is still not a prerequisite for approval but the value of peak: trough evaluation has recently been debated by major advisory boards. A US-based Cooperative Research and Development Agreement (CRADA) has been established to evaluate ABPM data from controlled trials with versus without placebo controls. In major clinical trials it has been documented that the ABPM technique reduces sample size, reduces the number of placebo-controlled trials, provides detailed information concerning the first-dose effect, documents the duration of action and dose-response relationship and allows documentation of antihypertensive therapy throughout 24 h, including the night-time period. ABPM data are recommended to support the documentation of 24 h efficacy and safety of new antihypertensive dose regimens. ABPM has been discussed for the documentation of new drugs to treat angina pectoris, heart failure and arrhythmia.
Meyer-Sabellek
WA
Department of Internal Medicine, Universitätsklinikum Benjamin Franklin, Berlin, Germany.