Two editorialists in Annals of Internal Medicine urge caution in interpreting and adopting the findings of the SPRINT (Systolic Blood Pressure Intervention Trial), which last year showed a benefit for a more aggressive approach to blood pressure therapy. The trial found improved outcomes in high risk patients treated to a target of of 120 mm Hg instead of 140 mm Hg.
Although the 25% reduction in relative risk in the primary composite outcome “sounds impressive,” write Eduardo Ortiz and Paul James, they note that this “corresponds to a decrease in event rates from 6.8% to 5.2% over 3.2 years, or an absolute risk reduction of 1.6%.”
They estimate that treating 1,000 people for 3.2 years with more aggressive treatment would result, on average, in a beneficial effect in 16 persons, serious harm in 22, and no benefit or harm in 962. They write:
“Patients may believe that it is worthwhile to aim for lower BPs if they hear that receiving 3 drugs every day for more than 3 years might reduce their risk for cardiovascular events by 25%. However, after learning that their likelihood of absolute benefit is only 1.6%, with a greater likelihood of serious harm, their enthusiasm for more medications may diminish.”
Given the low overall rate of events in SPRINT, “statistically significant differences may not necessarily correspond to differences that patients or their physicians consider clinically significant.”
Ortiz and James also criticize the way the NIH promoted the study, emphasizing the benefits of aggressive therapy while ignoring its harms. This, they say, raises the specter of overtreatment.
SPRINT, of course, should be incorporated into clinical practice, but the “process should carefully consider the overall body of evidence; potential harms, burdens, and costs of more aggressive treatment; and patient preferences.”
They recommend a nuanced response to SPRINT as opposed to a “one-size-fits-all” approach. A more aggressive approach may be warranted in a 55-year-old high risk patient without other conditions. More caution is warranted for a 79-year old patients with multiple comorbid conditions who is already taking 2 or 3 antihypertensive drugs.
SPRINT, they conclude, does not provide “convincing evidence that large segments of the population should be treated with additional drugs to a systolic BP goal less than 120 mm Hg, especially when the adverse events, costs, and burden of such treatment are considered.”
Additional Commentary
Christie Ballantyne (Baylor College of Medicine) offered stronger support for SPRINT than other physicians asked to comment. He said that although he agrees that “‘one size does not fit all’ and that one must look at both risks and benefits” he thinks the editorial did not provide a “fair and even” view of the trial. “For example, if you are an older individual, one of the major concerns would be an increase in injurious falls. Although the authors of the commentary state that this is increased, in regards to serious adverse events, there were actually fewer injurious falls” and a similar number of emergency room visits.
“Why not let the individual who is 79 years old make the decision with real information, show the events that are avoided such as death and heart failure and show the increase in side effects which most patients would not consider as serious?” he asks.
Further, he pointed out, the absolute reduction in risk is actually greater in older patients. “I do not understand why the authors of this paper suggest that we selectively ignore the much greater absolute benefit in the elderly and the greater relative risk reduction. How can the results of this study be used to say we should be aggressive in the young when they had the least benefit?”
Lee Green (University of Alberta) said that he largely agrees with the editorialists and that he shares “their concern about the hype exceeding the reality.” Lee is slightly more encouraged by the risk-benefit analysis of the trial, as the serious harms in the trial had “less impact on patients than the benefits (stroke, MI).” He thinks that “for a very limited subset of properly chosen patients,” aggressive therapy as in SPRINT “is a reasonable, though by no means compelling, option for a small benefit at the risk of a lot of side effects.”
Marc Itskowitz (Temple University) said it was an “important editorial.” “Many people do not understand the difference between relative and absolute risk reduction. I remain concerned about the potential risks of over treating hypertension,” he said. “We need to apply the results of SPRINT very selectively.”
Albert Levy, a primary care physician in New York City, said that he “started to be more aggressive with my patients” when SPRINT first came out.” But, he said, the Annals editorial is “timely and welcome.” I have found many of my elderly patients do feel better on a little elevated blood pressure rather than with hypotensive symptoms.”
Franz Messerli (Mt. Sinai) and Sripal Bangalore (New York University) said that there was no reason to rush to embrace SPRINT: “A simple but inescapable truth of medicine is that all patients are physiologically, psychologically, pathologically, culturally, and genetically different. Accordingly there never will be one best way to diagnose and treat many medical disorders, including hypertension. To lower systolic pressure of all hypertensive patients uniformly to 120 mm Hg or below clearly has to be considered absurd, regardless of the SPRINT results. As Ortiz and James eloquently state: ‘Some patients and their physicians may believe that the benefit (of going to 120 mmHg) is worth the additional effort, risks, and costs of taking more medications, whereas others may not’. We can only hope that despite (or even because of) SPRINT physicians will continue to treat patients and not blood pressure numbers only.
Previous Coverage of SPRINT:
- SPRINT Will Change But Not Revolutionize Blood Pressure Treatment
- You Don’t Know It But The Debate About SPRINT Is Already Over
- Heart Failure Experts SPRINT To An Early Finish
- A Premature SPRINT To The Finish Line
- NIH Trial, Stopped Early, Supports More Intensive Blood Pressure Targets
I think the editorial is a big snore. No one advocated “one size fits all.” No one is advocating rushing to treat to 120 mmHg as a target. The conclusions of the paper were honest and straightforward and the authors acknowledged all of the issues raised by the editorialists. The paper and presentations have been sober. It’s like a big straw man manufactured argument. Christie Ballantyne is right that the largest potential for benefit was in older patients (not those with multiple co-morbidities, as they were excluded). The patients we all fear treating were excluding (old, frail, non-compliant, already on a million drugs). And Messerli and Banglore are right, too – treating everyone to 120 mmHg is not medically reasonable or advisable. The take home messages are that we can do better with BP control if we are careful and are good doctors.
I would agree completely if I were on Mars and I had only read the NEJM paper. But in the real world the paper was preceded by an NIH press conference and press release that touted a huge benefit in relative risk without any mention of side effects or the small absolute benefit. Then when the paper was finally published months later it was accompanied by multiple papers in other journals, nearly all of which echoed the investigators’ perspective. So this was a pretty good example of hype and spin. I think it’s important to push back on the spin cycle. Editorials like this may help.
I did not read it that way. The media may have hyped it that way but I thought it was exciting and sober. They promoted the high level findings and why it was stopped. The paper was fair. Doctors don’t treat based on old press releases. And BTW, I don’t live on Mars. I treat real patients in a real hypertension and cardiology clinic. I don’t need a press release, blog, or sound bite to tell me that not every patient needs to be treated to 120 mmHg, that we need to look at ARR rather then RRR, or that the study cohort was selected. This study was an incredible accomplishment and the kind of work the government should fund. It also will save countless CVD deaths and strokes among people over 60 years old when the last set of guidelines get modified.
I agree the trial itself is useful, though I remain concerned about the early halt. I don’t think it’s been demonstrated that it was absolutely necessary. And I continue to be disturbed by the press release and news conference. We would not be having this discussion if those had been handled better. There is NEVER a valid reason to release relative risk findings without the context of the overall absolute risk and without any discussion of the counterbalance of harm and side effects.
Though that is a different message than the article here implied. It was one relatively small point. Recall the media and medical community would have had a kniption fit if it was stopped without any information. The time from press release to full presentation and publication was pretty darn short.
I can’t help but be reminded of the back and forth spin and arguments during the 2016 US presidential primary election debates going on at this time. I am not sure whom I should trust and whose side I should be in as regards this SPRINT study. Is this science or politics, one should wonder? It is no surprise that I am not a critic or a skeptic any more, but have become a cynic!
After 40 years of practice, I continue to believe that medicine is the art of knowing the science and treating the patients and not just their diseases and provide customize and common sense care. But science doesn’t have to be made so complex and confusing to be scientific!
Climate variability causing dehydration augmented peripheral vasodilation and then orthostatic hypotension in the summer months and inter current illness which occur often as age progresses are not in the data base .
The trial demands a lot of time and skilled measurement of blood pressure levels as well as intensive monitoring of patients taking their medication which the primary health care system even in the developed economies cannot meet .