Analysis of Therapeutic Inertia and Race and Ethnicity in the Systolic Blood Pressure Intervention Trial: A Secondary Analysis of a Randomized Clinical Trial

Abstract

IMPORTANCE Therapeutic inertia may contribute to racial and ethnic differences in blood pressure (BP) control.OBJECTIVE To determine the association between race and ethnicity and therapeutic inertia in the Systolic Blood Pressure Intervention Trial (SPRINT). DESIGN, SETTING, AND PARTICIPANTSThis cross-sectional study was a secondary analysis of data from SPRINT, a randomized clinical trial comparing intensive (<120 mm Hg) vs standard (<140 mm Hg) systolic BP treatment goals. Participants were enrolled between November 8, 2010, and March 15, 2013, with a median follow-up 3.26 years. Participants included adults aged 50 years or older at high risk for cardiovascular disease but without diabetes, previous stroke, or heart failure. The present analysis was restricted to participant visits with measured BP above the target goal. Analyses for the present study were performed in from October 2020 through March 2021.EXPOSURES Self-reported race and ethnicity, mutually exclusively categorized into groups of Hispanic, non-Hispanic Black, or non-Hispanic White participants. MAIN OUTCOMES AND MEASURESTherapeutic inertia, defined as no antihypertensive medication intensification at each study visit where the BP was above target goal. The association between self-reported race and ethnicity and therapeutic inertia was estimated using generalized estimating equations and stratified by treatment group. Antihypertensive medication use was assessed with pill bottle inventories at each visit. Blood pressure was measured using an automated device. RESULTSA total of 8556 participants, including 4141 in the standard group (22 844 participant-visits; median age, 67.0 years [IQR, 61.0-76.0 years]; 1467 women [35.4%]) and 4415 in the intensive group (35 453 participant-visits; median age, 67.0 years [IQR, 61.0-76.0 years]; 1584 women [35.9%]) with at least 1 eligible study visit were included in the present analysis. Among non-Hispanic White, non-Hispanic Black, and Hispanic participants, the overall prevalence of therapeutic inertia in the standard vs intensive groups was 59.8% (95% CI, 58.9%-60.7%) vs 56.0% (95% CI, 55.2%-56.7%), 56.8% (95% CI, 54.4%-59.2%) vs 54.5% (95% CI, 52.4%-56.6%), and 59.7% (95% CI, 56.5%-63.0%) vs 51.0% (95% CI, 47.4%-54.5%), respectively. The adjusted odds ratios in the standard and intensive groups for therapeutic inertia associated with non-Hispanic Black vs non-Hispanic White participants were 0.85 (95% CI, 0.79-0.92) and 0.94 (95% CI, 0.88-1.01), respectively. The adjusted odds ratios for therapeutic inertia comparing Hispanic vs non-Hispanic White participants were 1.00 (95% CI, 0.90-1.13) and 0.89 (95% CI, 0.79-1.00) in the standard and intensive groups, respectively.

Therapeutic Inertia and Racial Differences in Blood Pressure Control—Time to Get Moving

“…A critically important finding in the study by Zheutlin et al 4 is the extremely high degree of therapeutic inertia observed in all SPRINT participants, despite and across groups defined by selfidentified race or ethnicity. The unadjusted prevalence of therapeutic inertia at 36 months ranged from 50% to 85% depending on assigned treatment group.…”

“…The somewhat surprising results of the study by Zheutlin et al should not be taken to mean that racial and ethnic differences in therapeutic inertia in hypertension treatment are absent in everyday clinical practice. Care delivered in a clinical trial environment is different in a number of important ways from care delivered outside of a research study.…”

“…Elsewhere in JAMA Network Open , Zheutlin et al present the results of a secondary analysis of the landmark Systolic Blood Pressure Intervention Trial (SPRINT) in which they aimed to investigate the association of self-identified race and ethnicity with therapeutic inertia, which they defined as no antihypertensive medication intensification by study clinicians at study visits when measured BP was above the target. SPRINT was a highly influential multicenter randomized clinical trial in which adults with hypertension but without diabetes aged 50 years and older with high cardiovascular disease risk were randomized to a standard systolic BP goal of less than 140 mm Hg or an intensive systolic BP goal of less than 120 mm Hg .…”

“…SPRINT was a highly influential multicenter randomized clinical trial in which adults with hypertension but without diabetes aged 50 years and older with high cardiovascular disease risk were randomized to a standard systolic BP goal of less than 140 mm Hg or an intensive systolic BP goal of less than 120 mm Hg . In their study, the authors leveraged the high degree of protocol standardization inherent in a clinical trial to robustly assess the association of race and ethnicity with therapeutic inertia, while accounting for important potential confounders, such as sociodemographic characteristics, comorbid depression, and specific antihypertensive medication classes prescribed. Change in the intensity of the antihypertensive medication regimen was quantified using a modified therapeutic intensity score (mTIS) which incorporates the number of antihypertensive medications along with the relative dose of age mediation represented as a proportion of the maximum therapeutic dose.…”

Correction in Article Information

“…In the Original Investigation titled “Analysis of Therapeutic Inertia and Race and Ethnicity in the Systolic Blood Pressure Intervention Trial: A Secondary Analysis of a Randomized Clinical Trial,” published January 10, 2022, a disclaimer was missing to note that author Olugbenga Ogedegbe is an Associate Editor of JAMA Network Open . This article has been corrected …”