Laird Harrison

May 20, 2016

LONG BEACH, California — The treatment of hypertensive patients 75 years and older to a systolic blood pressure target of 120 mm Hg reduces the overall risk for mortality by one-third, according to new data from SPRINT.

"It's a game-changer," said researcher Mark Supiano, MD, from the School of Medicine at the University of Utah in Salt Lake City.

And this low blood pressure target does not appear to increase the risk for adverse events, including falls, as some experts had feared, he told Medscape Medical News.

The study results were presented by Dr Supiano and one of his colleagues, first author Jeff Williamson, MD, from the Wake Forest School of Medicine in Winston-Salem, North Carolina, here at the American Geriatrics Society 2016 Annual Scientific Meeting, and published online simultaneously in JAMA.

Overall results from SPRINT — the Systolic Blood Pressure Intervention Trial — were released previously, as reported by Medscape Medical News.

Many previous trials have shown that most people with hypertension live longer if their condition is controlled, but a target blood pressure has not been definitively established.

A systolic blood pressure target below 150 mm Hg for patients 60 years and older was recently recommended by the Eighth Joint National Committee, although a minority of committee members argued for a target of 140 mm Hg.

 
It's a game-changer.
 

Results from studies of the aggressive lowering of blood pressure in older people have been conflicting. Some observational studies have suggested that blood pressure medications increase the risk for falls, but some small randomized controlled trials have suggested the opposite, Dr Williamson reported.

The researchers conducted their analysis to see "how low you can go," Dr Supiano explained.

They assessed 2636 SPRINT participants who were 75 years and older, a subpopulation considered to be at high risk for adverse events from antihypertensive medication. All were at elevated risk for cardiovascular disease.

The 1317 people randomly assigned to intensive treatment had a target systolic blood pressure of 120 mm Hg or less, and the 1319 assigned to standard treatment had a target of 140 mm Hg or less.

At a median follow-up of 3.14 years, mean pressure achieved was lower with intensive treatment than with standard treatment (123.4 vs 134.8 mm Hg).

Mortality rates were significantly lower with intensive treatment than with standard treatment, as were rates of cardiovascular disease, defined as a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from all cardiovascular causes.

The overall rate of serious adverse events did not differ between the two groups.

The researchers calculated that they would need to intensively treat 27 patients to prevent one cardiovascular event and 41 patients to prevent one death.

Table. Outcomes in SPRINT Patients 75 Years and Older

Outcome Intensive Treatment, n = 1317 Standard Treatment, n = 1319 Hazard Ratio 95% Confidence Interval
Death, n 73 107 0.67 0.49–0.91
Cardiovascular event, n 102 148 0.66 0.51–0.85
Serious adverse event, % 48.4 48.3 0.99 0.89–1.11

 

There was no statistically significant difference in the number of people injured in falls between the two groups, or in the prevalence of orthostatic hypotension.

There were also no differences between the two groups when the researchers refined their analysis to look at particularly frail participants and those with slow gaits.

About the same number of patients in the two groups dropped out of the study, but those numbers were small.

"This is encouraging news," Dr Williamson told Medscape Medical News. "Yes, it comes at a price of one more medication per day. But you can safely lower the blood pressure even in older people and significantly lower the risk of complications of hypertension."

The researchers acknowledge that the exclusion criteria they used in their analysis is a weakness. They excluded people with type 2 diabetes, a history of stroke, symptomatic heart failure in the previous 6 months or reduced left ventricular ejection fraction, a clinical diagnosis of or treatment for dementia, an expected survival of less than 3 years, unintentional weight loss during the previous 6 months, a systolic blood pressure below 110 mm Hg after 1 minute of standing, and residency in a nursing home.

Whether these patients would benefit from the same intensive treatment remains unresolved.

One person in the audience asked whether he should treat hypertension differently in his patients with diabetes.

"We'll let the guidelines committees wrestle with that," said Dr Williamson.

"I'm on one such guideline committee," the questioner shot back, and "I don't know what to do."

The same man wanted to know if intensive treatment affected the quality of life of these older people. Dr Williamson said his team is preparing a report on that, but overall, the effect was "not a lot."

 
Clinicians should take heed of these results.
 

The strong evidence for a target systolic blood pressure of 120 mm Hg in most patients impressed session moderator Laurence Rubenstein, MD, MPH, from the University of Oklahoma College of Medicine in Oklahoma City.

"This is quite a surprise," he told Medscape Medical News. "It's been controversial for quite some time."

SPRINT seems to have been better designed than previous studies that have examined target blood pressures, he said. "I'm still not sure in my practice whether I'm going to aim for 120," he said. "But this is moving me to a more aggressive approach."

"Clinicians should take heed of these results," Aram Chobanian, MD, from the Boston University Medical Center, writes in an editorial accompanying the JAMA publication.

He recommends a "stepwise approach to treatment," starting with a target of 140 mm Hg. If patients tolerate that level well, clinicians could then aim for a target of 130 mm Hg.

However, achieving that lower goal could prove challenging because it could require "additional medications, more careful monitoring, and more frequent clinic visits," he noted.

This study was funded by the National Institutes of Health, the Department of Veterans Affairs, and the National Center for Advancing Translational Sciences. Takeda Pharmaceuticals International provided the medications. Dr Supiano, Dr Williamson, Dr Rubenstein, and Dr Chobanian have disclosed no relevant financial relationships.

American Geriatrics Society (AGS) 2016 Annual Scientific Meeting. Presented May 19, 2016.

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