For people age 75 and older, a blood pressure goal under 120 mm Hg systolic substantially lowered the risk of major cardiovascular events and death from any cause without increasing risks, a SPRINT sub-analysis showed.
Compared with a goal of less than 140 mm Hg, intensive treatment yielded a 34% relatively lower risk of the composite primary endpoint of nonfatal myocardial infarction or other acute coronary syndrome, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes (2.59% versus 3.85%, hazard ratio 0.66, 95% CI 0.51-0.85).
All-cause mortality likewise was 33% reduced by intensive treatment over a median follow-up of 3.14 years (73 versus 107 deaths, respectively; HR 0.67 [95% CI 0.49-0.91]).
The number needed to treat was 27 to prevent one composite endpoint event and 41 to forestall one death over that period, Jeff D. Williamson, MD, MHS, of Wake Forest School of Medicine in Winston-Salem, N.C., and colleagues reported online in the Journal of the American Medical Association and at the American Geriatrics Society meeting in Long Beach, Calif.
Although safety has been the major concern holding back aggressive treatment for older adults, SPRINT showed a nearly identical 48.4% versus 48.3% rate of serious adverse event rates between the intensive and standard treatment groups for the participants 75 and older.
“Small increases in incidence of hypotension, syncope, or acute changes in renal function were observed, but these appeared to be more than offset by the large benefits of treatment,” noted an accompanying editorial by Aram V. Chobanian, MD, of Boston University.
“Everybody is afraid of treating these people; they don’t want them to keel over or have some untoward event,” Joseph L. Izzo MD, of New York’s University at Buffalo, toldMedPage Today. The SPRINT data “pretty strongly refute that concept that these older people who have very high risk for debilitating strokes can’t be treated effectively. It is not a good idea to gauge therapy based on the age of the patient.”
Although the event rates were higher with increasing frailty across the board, the intervention improved outcomes in every frailty stratum (P=0.84 for interaction). Results were similar considering gait speed as a marker of frailty.
Likewise, serious adverse events were more common with greater frailty but did not differ significantly by treatment group across frailty strata. The analysis included 2,636 participants age 75 and older (mean of 79.9, and 37.9% were women), randomized to a systolic treatment goal of less than 120 or less than 140 mm Hg.
The high adverse effect rate in both groups was not surprising for this age group, John Bisognano, MD, PhD, of New York’s University of Rochester Medical Center and president of the American Society of Hypertension, told MedPage Today. “The incidence of adverse events is really not anything to worry about.”
He predicted that the findings would change practice.
“If [patients] are having side effects, we’re not going to push through them. But we will push a little harder on blood pressure,” he said. “We do a lot of other heroic things for elderly people, but this is a standard therapy that can have a big effect. We can’t ignore that data.”
Izzo agreed: “Remember that you’re going to be more likely to prevent an event by treating somebody who is 80 than you are by treating somebody who is 40, because the event rate is so much higher in people 80 years old — Age being the number one cardiovascular risk factor.”
There are important caveats to keep in mind in applying SPRINT to practice, such as the exclusion of patients with prior stroke, diabetes, or serious frailty, or those who are institutionalized, trial investigator Suzanne Oparil, MD, of the University of Alabama at Birmingham, had cautioned earlier in the week regarding another subanalysis on frailty.
Izzo, though, noted that a study on people in long-term care facilities is unlikely to be finished and suggested that the findings of a good risk-to-benefit ratio would likely generalize to those elderly people as well. It would take “a leap of faith, but how big a leap is it? Not much, not to me,” he said.
Also, there were measures taken to ensure the safety of the approach, Oparil toldMedPage Today. “When the drugs were titrated to get to the goal, people were seen every month. Within the first 6 months, some people were seen every month — and that’s more than some doctors would want to do.”
She urged clinicians to:
- Be patient with titrating drugs.
- Monitor blood pressure, electrolytes, serum potassium, kidney function, and standing blood pressures.
- Measure blood pressure in the same way that SPRINT did, “with a device that’s programmed to take the blood pressure after a lag time of 5 minutes.”
Chobanian concluded that even if it is challenging for clinicians, “the important results reported … cannot be discounted, and unless unexpected adverse effects are observed on further examination of the trial data, then major changes in treatment goals for patients 75 years or older with hypertension will be warranted.”