SPRINT protocols achieved similar or lower therapeutic inertia for patients, regardless of race

In clinical practice, the use of highly standardized blood pressure measurement and treatment protocols similar to those used in clinical trials may help clinicians reduce racial and ethnic disparities that may exist in the control of hypertension, according to results from an analysis of the Systolic Blood Pressure Intervention Trial (SPRINT) published in JAMA Network Open.

Researchers found that the prevalence of therapeutic inertia—defined as no antihypertensive medication intensification at each study visit in which BPs were above the target goal—were similar or lower in non-Hispanic Black and Hispanic patients with BP above the target goals compared with non-Hispanic White patients.

“Our take-home message is that with a standardized approach to blood pressure measurement and intensification, differences in therapeutic inertia can be eliminated, with similar treatment intensification by race/ethnicity. This can hopefully help to reduce the disparities we have seen in blood pressure control. Ideally, clinicians will ensure that they are intensifying antihypertensive medication appropriately for all patients,” Alexander R. Zheutlin, MD, MS, of the University of Utah School of Medicine, Salt Lake City, told BreakingMED in an e-mail correspondence.

In this secondary analysis of the SPRINT trial, Zheutlin and colleagues sought to assess whether an association exists between race and ethnicity and therapeutic inertia in BP control.

“Therapeutic inertia, the act of not intensifying antihypertensive medication despite indication, has been identified as a key actionable item to improve blood pressure control and is common in clinical practice. Additionally, recent evidence has demonstrated that despite similar awareness and treatment rates, non-Hispanic Black and Hispanic adults have lower rates of blood pressure control. It may be that the intensity of treatment is insufficient. SPRINT offers a unique research setting in which there was a standardized approach to blood pressure measurement and treatment intensification, as well as parity in blood pressure control among all participants. We wanted to determine if therapeutic inertia differed by race/ethnicity in SPRINT,” Zheutlin explained.

Original SPRINT researchers compared intensive (˂120 mmHg) vs standard (˂140 mmHg) systolic BP treatment goals. Between November 8, 2010 and March 15, 2013, 8,556 subjects aged ≥50 years who were at high risk for cardiovascular disease were included. Patients did not have diabetes, previous stroke, or heart failure.

“The SPRINT protocol required intensification of antihypertensive medication if SBP was not at goal. This design allowed for a quasinatural experimental comparison of therapeutic inertia by race and ethnicity in a randomized clinical trial in which BP management was standardized across racial and ethnic groups, including access, measurement, and treatment,” explained Zheutlin and colleagues.

For their secondary analysis of SPRINT, they included 8,556 patients with visits in which BP was above the target goal, with 4,141 comprising the standard treatment group (median age: 67 years; 35.4% women) and 4,415 the intensive treatment group (median age: 67 years; 35.9% women).

In non-Hispanic Black patients compared with non-Hispanic White patients, adjusted odds ratios (aORs) for therapeutic inertia were 0.85 (95% CI: 0.79-0.92) in the standard treatment groups, compared with 0.94 (95% CI: 0.88-1.01) in the intensive therapy groups. Corresponding aORs in comparisons of Hispanic with non-Hispanic White patients were 1.00 (95% CI: 0.90-1.13) and 0.89 (95% CI: 0.79-1.00), respectively.

In patients who were non-Hispanic White, the overall prevalence of therapeutic inertia was 59.8% (95% CI: 58.9%-60.7%) in the standard treatment group, compared with 56.0% (95% CI: 55.2%-56.7%) in the intensive treatment group. Corresponding prevalence rates in non-Hispanic Black patients were 56.8% (95% CI: 54.4%-59.2%) vs 54.5% (95% CI: 52.4%-56.6%), respectively; and in Hispanic patients, 59.7% (95% CI: 56.5%-63.0%) vs 51.0% (95% CI: 47.4%-54.5%).

“We found that therapeutic inertia was fairly similar between non-Hispanic Black and Hispanic participants and non-Hispanic white participants. I think these results were not surprising overall in the clinical trial context, and reassuring that a standardized approach to blood pressure measurement and management can help address the disparities we see in blood pressure control,” said Zheutlin.

In an accompanying editorial, Matthew B. Rivara, MD, of the University of Washington, Seattle, and fellow editorialists agreed with Zheutlin.

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

But, explained Zheutlin, these incidence rates are even lower than those in the real-world setting.

“Overall, the prevalence of therapeutic inertia was lower than that in routine clinical practice, which has been seen up to 90% in some settings. It may be that as the trial continued, the number of participants with blood pressure above goal were more difficult to control or had other barriers to achieving blood pressure control that we could not capture. The number of participants decreased over time, and that may be the reason as to why. However, the absolute reason is unclear,” he added.

When asked about the ease or difficulty of clinician adoption of standardized approaches to BP management, such as that used in SPRINT, in daily clinical practice, Zheutlin responded: “A standardized approach to blood pressure measurement and management has been implemented in clinical practice in various practice settings. The AMA’s Measure Accurately, Act Rapidly, and Partner with Patients [BP Improvement Program] has demonstrated success in providing a standardized approach to blood pressure management which has reduced therapeutic inertia. Further, certain integrated healthcare systems have applied a blood pressure management protocol which has also reduced therapeutic inertia. I think infrastructure investment (e.g., automated blood pressure cuffs, medical assistants to measure blood pressure in a calm environment, affordable antihypertensive medication on formulary, routine follow-up) are necessary, however.”

According to Rivara and colleagues, the effective treatment of hypertension will involve shared decision-making with patients, clinician education and support on current clinical practice guidelines and in managing the possible adverse effects of intensified antihypertensive treatments (including acute kidney injury and electrolyte abnormalities. They also called on health care systems to improve patient activation and support, as well as further research on the causes of therapeutic inertia.

“There is much work to be done to improve outcomes for patients with hypertension—time to get moving!” the editorialists concluded.

Coincidentally, one of the patients from the original SPRINT study published an article detailing his experience in the premier issue of NEJM Evidence, a new monthly online journal. Moses Taylor, of Rocklin, CA, was 64 years old at the time of his enrollment, had hypertension and impaired kidney function due to cancer at the age of 58, which in turn resulted in the loss of one kidney and part of the other. He recounts the importance of his personal physician in his decision to participate in this trial.

“My primary reason for considering participation in the SPRINT trial was my personal physician’s involvement and my trust in his judgment that had developed during his care of my condition. His explanation of the potential benefits and risks of my participation and the details of the trial were comprehensive and reassuring,” wrote Taylor.

His experience was positive, and indeed, he had “no suggestions for improvement.” Taylor detailed the highlights of his experience. Interestingly, the first of these was that his personal physician—who also became his trial physician—suggested that he enroll in the trial.

Taylor also had positive things to say about the ease with which he complied with trial protocols and monitoring appointments, the clarity and accessibility of risks, goals, and results of the trial, the professionalism and kindness of the trial staff, and the results of the trial overall.

“I was left with the impression that the trial results would have a positive impact on how physicians treat patient over 50 with hypertension and at least one additional risk factor for heart disease,” wrote Taylor.

“God has blessed me with access to the best available medical care for my condition. I expect that level of care is available, at least in part, due to previous clinical trials in which volunteers participated. My participation in the SPRINT trial allowed me to play some small part in paying that blessing forward,” he concluded.

  1. A standardized approach to management of hypertension, as implemented in the SPRINT clinical trial, may help ensure equitable care is provided to all patients and reduce the contribution of therapeutic inertia to disparities in uncontrolled BP.

  2. Standardized BP management protocols in BP measurement, medication initiation, and intensification may overcome disparities in care caused by therapeutic inertia.

Liz Meszaros, Deputy Managing Editor, BreakingMED™

The Systolic Blood Pressure Intervention Trial (SPRINT) was funded with federal funds from the NIH, including the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke. It was also supported, in part, with resources and use of facilities through the Department of Veterans Affairs. The SPRINT investigators acknowledge the contribution of study medications (azilsartan and azilsartan combined with chlorthalidone) from Takeda Pharmaceuticals International, Inc. Researchers also received support from the Clinical and Translational Science Awards funded by the National Center for Advancing Translational Sciences.

Zheutlin reported receiving grants from National Institutes of Health (NIH) during the conduct of the study.

Rivara reported no disclosures.

Cat ID: 6

Topic ID: 74,6,585,730,6,127,410,192,916