Problems in the evaluation of antihypertensive therapy using the trough/peak ratio

In 1988, the U.S. Food and Drug Administration proposed guidelines for the clinical evaluation of new antihypertensive drugs. According to these guidelines, the drug effect at trough (measured as the difference in blood pressure values from placebo) should be no less than one half to two thirds of t...

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Bibliographic Details
Published in:Cardiovascular drugs and therapy 1997-07, Vol.11 (3), p.459-463
Main Authors: PRATTICHIZZO, F. A, GALETTA, F, SIMONETTI, I
Format: Article
Language:English
Subjects:
Aged
Antihypertensive agents
Antihypertensive Agents - administration & dosage
Antihypertensive Agents - pharmacokinetics
Antihypertensive Agents - therapeutic use
Biological and medical sciences
Blood Pressure - drug effects
Blood Pressure Monitoring, Ambulatory - economics
Cardiovascular system
Clinical trial. Drug monitoring
Drug Evaluation
General pharmacology
Guidelines as Topic
Heart Rate - drug effects
Humans
Hypertension - blood
Hypertension - drug therapy
Hypertension - economics
Medical sciences
Pharmacology. Drug treatments
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Summary:In 1988, the U.S. Food and Drug Administration proposed guidelines for the clinical evaluation of new antihypertensive drugs. According to these guidelines, the drug effect at trough (measured as the difference in blood pressure values from placebo) should be no less than one half to two thirds of the peak effect. Unfortunately, calculation of the trough/peak ratio suffers the consequences of many methodological, interpretative, practical, and epidemiological problems. When taking readings at short time intervals, noninvasive ambulatory blood pressure monitoring allows evaluation of blood pressure variability by means of several statistical parameters. Blood pressure variability, measured as the standard deviation of the overall 24-hour blood pressure measurements, has been demonstrated to be significantly correlated with target-organ damage in hypertensive patients. Blood pressure variability may not change with long-acting antihypertensive agents, but it may increase with short-acting ones. Therefore, assessment of the trough/peak ratio may be overcome by the evaluation of drug-induced changes in the standard deviation of the mean 24-hour blood pressure.
ISSN:0920-3206
1573-7241
DOI:10.1023/A:1007749522688