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(Hypertension. 2005;45:e15.)
© 2005 American Heart Association, Inc.

Hypertension Electronic Pages

Blood Pressure Monitoring in Clinical Trials in the Absence of Ambulatory Blood Pressure Recording: Where Is the Stand?

Cardiovascular Pharmacology and Clinical Research Center, Sundaram Nagar, Thanjavur, India

An extract of the first 250 words of the full text is provided, because this article has no abstract.

To the Editor:

The American Heart Association position statement on blood pressure (BP) measurements¹ will be useful for clinicians and academicians alike in arriving at a consensus. The BP recordings reported in clinical trials have an important bearing on the future clinical practice. Although ambulatory BP monitoring is recommended, it may not be possible in all settings because of many factors like patient discomfort, unavailability, or cost. In this situation, BP measurements in the office will still remain as a method to assess efficacy of antihypertensives.

In this context, many clinical trials report the BP lowering at the end of study, which is considered the efficacy endpoint. Can this one-time office reading at endpoint accurately describe the efficacy of an antihypertensive? It is obvious that BP recordings performed at one time point do not offer conclusive evidence of antihypertensive efficacy of a drug. Many factors affect office-based BP measurements. However, the International Conference on Harmonization guideline or American Heart Association position statement does not give adequate importance to this criterion. The International Conferrence on Harmonization guideline for clinical evaluation of antihypertensives² states, "in general, the effect on blood pressure at the end of the study is the primary endpoint, but the time course of the onset of the effect is also of interest; this can be defined by examining trough response each week or every 2 weeks in some studies." This statement does not reflect the point that for meaningful evaluation of the efficacy of an antihypertensive drug, in the . . . [Full Text of this Article]

Thomas G. Pickering

Behavioral Cardiovascular Health and Hypertension Program, Columbia Presbyterian Medical Center, New York, NY