BOSTON, MA – The intensive blood-pressure management performed in the Systolic Blood Pressure Intervention Trial (SPRINT) trial was cost-effective in simulation models and also well tolerated, as measured by patient-reported outcomes, compared with the standard BP-management approach, according to two new reports based on patients and data from the trial[1,2].
The results may persuade some naysayers to change their mind about intensive BP-lowering therapy like that in SPRINT, which aimed for systolic pressures <120 mm Hg, the study authors hope.
“Here are two articles showing that intensive treatment is cost-effective and that patients tolerate it. So if patients don’t feel miserable on therapy and the therapy is cost-effective, and on top of that, it lowers cardiovascular morbidity and mortality, the argument in favor of intensive treatment becomes very persuasive,” Dr Dan R Berlowitz (Bedford VA Hospital and Boston University, MA) told theheart.org | Medscape Cardiology.
Berlowitz is lead author of the SPRINT patient-reported outcomes analysis; it and the cost-effectiveness analysis, with lead author Dr Adam P Bress (University of Utah School of Medicine, Salt Lake City), were published August 23, 2017 in the New England Journal of Medicine.
As previously published and presented at meetings, SPRINT showed that, among people with hypertension and increased cardiovascular risk but no diabetes, the rates of cardiovascular events were lower in those assigned to a target systolic blood pressure <120 mm Hg (intensive treatment) than in those who were assigned to a target of <140 mm Hg (standard treatment).
“Yet a lot of people, including some of the guidelines committees, have not totally bought the results,” said Berlowitz.
“Recent guidelines published several months ago by the American College of Physicians are not recommending to go down to 140, so there’s still a lot of controversy,” he said.
“I think it is interesting that there is no consensus right now in the medical community on something as basic as what blood pressure we shouldstrive for in someone with hypertension.”
“These articles help add more information to SPRINT and put it in economic context,” Dr Harlan Krumholz (Yale University, New Haven, CT) said by email correspondence.
“The question remains how best to apply the results of SPRINT and to reconcile trials that did not find lower targets to be beneficial,” he said.
“Another question is how best to translate the totality of evidence into recommendations for an individual. In other words, should SPRINT trump all other studies, or do we still need to understand some of the heterogeneity of the evidence?”
Patient-Reported Outcomes
One objection has been the fear that intensive therapy will not be well tolerated by many people, according to Berlowitz. “That’s why this paper is so important. It really addresses that issue and shows that not only in the whole SPRINT population but also in subgroups, defined by older age, comorbidities, and frailty—in other words, the people you would be most concerned might not tolerate intensive therapy—that in fact it was well tolerated by all, and there was no difference in health status between the groups.”
He and his group assessed patient-reported outcomes in the SPRINT trial to determine whether patients who were assigned to the intensive group perceived their health status differently from those assigned to the standard group.
They also sought to see whether older patients with lower physical and cognitive function receiving intensive treatment had different patient-reported outcomes from similar patients who were on standard treatment and whether any adverse events from antihypertensive medications in intensive treatment affected patient-reported adherence to treatment.
Patient-reported outcome measures included the following:
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Scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-item Health Survey.
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The Patient Health Questionnaire 9-item depression scale (PHQ-9).
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Patient-reported satisfaction with blood-pressure care and medications.
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Patient-reported adherence to blood-pressure medications.
Patients on intensive treatment received an average of one additional antihypertensive medication. Their systolic blood pressure was a mean of 14.8-mm-Hg lower than in the standard-management group.
After a median follow up of 3 years, mean PCS, MCS, and PHQ scores were stable, with no differences between the two groups.
Similarly, patient-reported outcomes did not differ among older, more vulnerable patients, and both groups were similarly satisfied with their treatment and reported that they were adherent with their medication.
“We looked at the things that are important to people—how they feel while they are on treatment, what their mood is like, how much fatigue or how much energy they have, can they do things they want to do. It’s great to lower cardiovascular morbidity and mortality, but if it comes at the expense of people feeling miserable, well, that’s not a good idea. But there was no difference,” Berlowitz said.
“There was a slight statistical difference in satisfaction with care, the folks receiving the intensive therapy were actually more satisfied, but the percent difference was very small and not clinically meaningful,” he said.
Intensive Therapy Is Cost-effective
The second study reported that intensive blood-pressure control was cost-effective and very high value compared with standard blood-pressure control in patients at high risk for cardiovascular disease.
“We know that treating people more intensively will require more office visits to doctors, pharmacists, and nurses to initiate and titrate more medications and that more medications means more risk of side effects, some of which are serious,” Bress said in an interview.
“So we determined with our simulation model whether the expected health gains from intensive treatment outweighed the implementation costs and side-effect risks.”
Bress and his team used a microsimulation model to apply SPRINT treatment effects and healthcare costs from national sources to a hypothetical cohort of SPRINT-eligible adults.
The model projected lifetime costs of treatment and monitoring in patients with hypertension; cardiovascular disease events and subsequent treatment costs; treatment-related risks of serious adverse events and subsequent costs; and quality-adjusted life-years (QALYs) gained for intensive vs standard blood-pressure control.
Longer Life With Intensive Treatment
Bress and his group found that in their simulation study, intensive control prevented CVD events and prolonged life at a cost that was below common willingness-to-pay thresholds, regardless of whether the benefits were reduced after 5 years or persisted for the remaining lifetime of the patient.
When factoring in the impacts of intensive treatment vs standard treatment on both the quality and length of life, the model projected that patients treated intensively would live 0.27 QALYs longer than those receiving standard treatment.
The cost of intensive treatment ranged from 51% to 79% below $50,000 per QALY and 76% to 93% below $100,000 per QALY, regardless of length of treatment.
“Our analysis is a comprehensive one because we looked at over 36 separate scenario analyses and found that the cost-effectiveness was robust among all of them. In addition, all of the inputs for the model are grounded in very high-quality studies, including randomized trials and meta-analyses of randomized trials. We also took great care to look at the uncertainty of those values with probabilistic analyses,” Bress said.
“It’s a conservative model, and it has wide breadth and looks at many scenarios. But the collective message is that intensive treatment is cost-effective compared with standard treatment.”
Both studies were funded by the National Institutes of Health. Berlowitz reported no relevant financial relationships; disclosures for the coauthors are listed in the paper. Bress reported no relevant financial relationships; disclosures for the coauthors are listed in the paper. Krumholz reported no relevant financial relationships.
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