title: Blood pressure responder rates versus goal rates: which metric matters?
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 > or = 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.
authors.affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC, USA. Jan.Basile@med.va.gov
authors.forename: Jan
authors.initials: J
authors.lastname: Basile
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001794:Blood Pressure / Q000187:drug effects*; D006040:Goals; D006973:Hypertension / Q000188:drug therapy*; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents