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Blood pressure responder rates versus goal rates: which metric matters?

Blood pressure responder rates versus goal rates: which metric matters? Reducing blood pressure (BP) to guideline-recommended goals associated with reductions in cardiovascular risk is central to effective hypertension management. In addition to measuring BP reduction, clinical trials of antihypertensive agents should assess the percentage of patients responding to treatment. The Food and Drug Administration's defined rate of response required for drug approval is a reduction in diastolic BP (DBP) to <90 mmHg and/or a DBP reduction of ≥10 mmHg. Consequently, some patients may be counted as responders even if they have not reached DBP <90 mmHg. An antihypertensive agent's effectiveness may be better assessed by the proportion of patients who achieve recommended BP goals. This article analyzes the frequency of response rates versus goal rates as endpoints in randomized trials since January 2001. Data showed that goal rates, especially combined systolic BP (SBP)/DBP goal rates, are consistently lower than response rates in studies evaluating both endpoints. Goal rates incorporating both SBP and DBP, or having a focus on SBP for individuals >50 years of age, provide the most clinically relevant information and are a more clinically relevant metric of an agent's ability to reduce BP than DBP alone. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Therapeutic Advances in Cardiovascular Disease SAGE

Blood pressure responder rates versus goal rates: which metric matters?

Therapeutic Advances in Cardiovascular Disease , Volume 3 (2): 18 – Apr 1, 2009

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References (114)

Publisher
SAGE
Copyright
Copyright © by SAGE Publications
ISSN
1753-9447
eISSN
1753-9455
DOI
10.1177/1753944708101552
pmid
19299428
Publisher site
See Article on Publisher Site

Abstract

Reducing blood pressure (BP) to guideline-recommended goals associated with reductions in cardiovascular risk is central to effective hypertension management. In addition to measuring BP reduction, clinical trials of antihypertensive agents should assess the percentage of patients responding to treatment. The Food and Drug Administration's defined rate of response required for drug approval is a reduction in diastolic BP (DBP) to <90 mmHg and/or a DBP reduction of ≥10 mmHg. Consequently, some patients may be counted as responders even if they have not reached DBP <90 mmHg. An antihypertensive agent's effectiveness may be better assessed by the proportion of patients who achieve recommended BP goals. This article analyzes the frequency of response rates versus goal rates as endpoints in randomized trials since January 2001. Data showed that goal rates, especially combined systolic BP (SBP)/DBP goal rates, are consistently lower than response rates in studies evaluating both endpoints. Goal rates incorporating both SBP and DBP, or having a focus on SBP for individuals >50 years of age, provide the most clinically relevant information and are a more clinically relevant metric of an agent's ability to reduce BP than DBP alone.

Journal

Therapeutic Advances in Cardiovascular DiseaseSAGE

Published: Apr 1, 2009

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