May 27, 2016
By Larry Hand
NEW YORK - In ambulatory adults above age 75, bringing systolic blood pressure to less than 120 mmHg led to significantly lower rates of fatal and nonfatal cardiovascular events and deaths from any cause in the Systolic Blood Pressure Intervention Trial (SPRINT).
"We can reassure patients, especially from this study, that lowering blood pressure is safe. There were no more serious adverse events or falls among people on intensive blood pressure control versus those on standard control," Dr. Jeff D. Williamson, of the Sticht Center on Aging at Wake Forest School of Medicine, Winston-Salem, North Carolina, told Reuters Health in a phone interview.
"This is really important news because there's been a lot of news (about studies) using administrative databases and self report that has indicated to older people that it's dangerous to treat blood pressure; you might fall more. This is the most rigorous scientific study to ever look at that and it shows that that's really not true. That's actually been found the case in other blood pressure studies but not to this level of detail," Dr. Williamson said.
Dr. Williamson and colleagues analyzed data on 2,636 participants in SPRINT who were 75 or older (mean age 79.9, 37.9% women) and hypertensive. They excluded patients with type 2 diabetes or a recent history of cardiovascular events, dementia, unintentional weight loss, or systolic blood pressure (SBP)
Overall, 1,317 patients had been treated to a target SBP of 120 mmHg and 1,319 to a target of 140 mmHg.
As reported online May 19 in JAMA, 95.2% completed follow-up.
The primary outcome was a composite of nonfatal cardiovascular infarction, acute coronary syndrome not resulting in myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes.
During a mean follow-up of 3.14 years, the intensive treatment group experienced significantly fewer composite outcomes than the standard treatment group (102 events versus 148, hazard ratio 0.66) and fewer deaths (73 versus 107, HR 0.67). The rate of serious adverse events did not differ between treatment groups (48.4% versus 48.3%).
The mean SBP in the intensive treatment group was 123.4 mmHg, compared with 134.8 mmHg in the standard treatment group, for a between-group difference of 11.4 mmHg. Mean diastolic blood pressures during the trial were 62.0 and 67.2 mmHg, respectively.
The researchers found no significant between-group differences for frailty as assessed with a 37-item frailty index or in gait speed as measured through a four-minute walk test.
The study had a fairly representative sample of older people who would typically come to their doctor's office, not living in a nursing home or assisted living, Dr. Williamson said. The results apply "to a broad spectrum of people, and it only required one additional medication on average to achieve this result. It's relatively practical, 90% of the medications used were generic," he said.
"There's so much hypertension in older people we almost begin to see it as normal. It can lull us to think this is not practical," he added. "The study shows that a lot of people are eligible to have better blood pressure."
"This study very carefully measured blood pressure and did it three times in the office without the doctor present to avoid white coat hypertension, but also to avoid what often happens in a doctor's office: the patient runs in from the parking lot flustered to take the blood pressure and it might be high," Dr. Williamson explained.
"Health systems will need to make more accommodation for more accurate assessment of patients, especially in the area of blood pressure. It's very important now to begin to look at how electronic medical records and value-based care models can incentivize the health care system to implement this," he concluded.
In an editorial, Dr. Aram V. Chobanian of Boston University School of Medicine wrote, "Achieving the SBP goal of less than 130 mmHg may be challenging for clinicians, because doing so could require use of additional medications, more careful monitoring, and more frequent clinic visits."
"Nevertheless," he concluded, "the important results reported by Williamson et al in this issue of JAMA 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."
SPRINT was funded by the National Institutes of Health.
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