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Science of ABPM

dabl ABPM automatically interpreted plot
  • Ambulatory Blood Pressure Monitoring (ABPM) is a non-invasive technique by which multiple indirect blood pressure readings can be obtained automatically over a 24-hour period with minimal intrusion into a patient's daily activities.

  • Historically used in the development of hypertension and cardiovascular drug therapies, ABPM is now increasingly used to assess the cardiovascular/cardiac safety of investigational compounds in several (non-cardiovascular), therapeutic areas.

  • As blood pressure (BP), is characterized by high variability, a single reading taken at a given time, or even multiple readings obtained on different days, will only partially reflect a subject's mean blood pressure over a whole day (1,2). In contrast, by providing a profile of BP behavior over the 24-hour period rather than the single snapshot provided by clinic BP, ABPM offers several advantages including the detection of white coat responders, elimination of operator variability and absence of placebo response (3).

  • The 24-hour profile allows the effect of investigational drugs to be assessed, not only over the entire 24-hour period but during specific windows such as daytime, postprandial (or siesta), vesperal (evening), nocturnal and matinal (early morning) windows (4,5). As the mechanisms involved in determining BP at different times may vary, drugs can induce different effects in different windows of the BP circadian rhythm (6,7).

  • The average BP over 24 hours is three times more reproducible than are clinic BP values which allows the number of subjects required in parallel and crossover design studies to be reduced without loss of statistical power (6).

  • dabl's scientific leaders have pioneered many of the measurement and analytical techniques that have become standard practice for 24-hour ABPM. In recognition of our unmatched expertise in the ABPM field, dabl scientific leaders have acted as authors of the European Society of Hypertension International Protocols for the validation of blood pressure measuring devices.

  • We are uniquely positioned to provide practical and feasible projects that reduce research time, optimize trial operations and fulfil regulatory requirements.

  • dabl's scientific leaders are actively involved in the consideration of such important questions as the definition of the end point of primary interest and the degree of BP change that should be of concern. If you would like to discuss these scientific and regulatory issues with us, please click here.

References

1. Mancia G, Ferrari A, Gregorini L, Parati G, Pomidossi G, Grassi G, Zanchetti A. BP and heart rate variabilities in normotensive and hypertensive human beings. Circ Res 1983; 53:96-104.

2. Mancia G, Parati G, Di Rienzo M, Zanchetti A. Blood pressure variability. In: Zanchetti A, Mancia G (editors): Handbook of hypertension, vol 17: pathophysiology of hypertension. Amsterdam: Elsevier Science BV; 1997, pp.117-169.

3. O'Brien, E. Why ABPM should be mandatory in all trials of blood pressure lowering drugs. Drug Inf J. 2011;45:233-239.

4. O'Brien, E. The circadian nuances of hypertension: a reappraisal of 24-h ambulatory blood pressure measurement in clinical practice. Ir J Med Sci. 2007; 176:55-63.

5. O'Brien, E. Ambulatory blood pressure monitoring: 24-hour blood pressure control as a therapeutic goal for improving cardiovascular prognosis. Medicographia. 2010; 32:241-249.

6. O'Brien, E. The value of 24-hour blood pressure monitoring to assess the efficacy of antihypertensive drug treatment. Hot topics Hypertens. 2011;4:6-23.

7. Bilo G, Parati G. Temporal blood pressure patterns and cardiovascular events: "good night" or "good morning"? J Hypertens. 2006;24:1703-1705.