This post has been updated with additional expert commentary on the SPRINT trial and the NIH’s announcement regarding the results (scroll to the bottom).
The National Institutes of Health (NIH) today made an announcement about the SPRINT (Systolic Blood Pressure Intervention Trial) study that is making big waves across the world of health care.
And after reading the NIH release, you just might be convinced that the SPRINT study does indeed deserve a big red-carpet roll out.
Because the claims it makes are pretty bold:
More intensive management of high blood pressure, below a commonly recommended blood pressure target, significantly reduces rates of cardiovascular disease, and lowers risk of death in a group of adults 50 years and older with high blood pressure.
Coming from a big government-funded trial, such a finding certainly seems to qualify as a news-making, and potentially practice-changing, event.
There’s just one problem with all of this: The big announcement about these “landmark” results doesn’t actually include any “results” from the SPRINT study.
You can search the news release high and low but you’ll find nary a single statistic from the study or a number related to what the researchers found.
But there’s plenty about how pleased the researchers are to have “achieved this important milestone.”
The study apparently “provides potentially lifesaving information that will be useful to health care providers as they consider the best treatment options for some of their patients, particularly those over the age of 50,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI).
But what exactly is that information? Apparently we’ll need to wait a few more months for those pesky specifics.
At a news conference about the study, Director Gibbons said that the lower blood pressure target reduced events by 30% and cardiovascular deaths by 25%, according to journalist Larry Husten, who these statistics.
But Gibbons apparently gave no indication of either the absolute reduction in events or the Number Needed Treat — statistics that we think are vital to understanding the magnitude of the benefit.
And there was nothing in the news release (or apparently in the news conference) about the potential harms of treating to a lower target.
Harlan Krumholz, a Yale University cardiologist, immediately took to Twitter to voice his concern.
To alert public to imp finding, study must be ready to release to publi; not good enough to say need to wait months.
— Harlan Krumholz (@hmkyale)
Jeremy Sussman, described on Twitter as a primary care physician, was also a prominent early voice weighing in with criticism about how the results were communicated.
It’s also a shame to see the SPRINT trial benefits being promoted without any numbers or without harms even being assessed yet. — Jeremy Sussman (@JeremySussman)
Let me be clear about one thing: It may well turn out that the study is just as important and influential as the NIH communications suggest it will be. And I certainly hope that it is. My point and my concern is that we shouldn’t have to guess at what the results will eventually show. The horse is already out of the barn, with the New York Times headlining the study and calling for blood pressure targets that are “way lower than the current guidelines.” But the Times’ incomplete report, like the incomplete news release that it’s based on, has very few specifics about the study results as of this writing. Let’s all slow down, take a deep breath, and wait until there’s some real news to report here.
The study may be called SPRINT, but good health care is more like a marathon.
Update 9/14/15: Michael Wilkes, MD, PhD, Professor of Medicine at the University of California, Davis and a recent addition to the ubiquinol-coq10.info team, pointed us to his audio commentary about SPRINT, for NPR affiliate KCRW.
Update 9/12/15: A longtime contributor to ubiquinol-coq10.info, Michael Pignone, MD, MPH, Professor of Medicine and Chief of the Division of General Internal Medicine at University of North Carolina – Chapel Hill, said: “I agree with Harlan [Krumholz] (and others) that they should have released more data simultaneously. A larger, more general issue is whether to look at this trial in isolation, or whether to consider it in the context of other trials that have asked similar questions. Most such trials have been done in higher risk populations (particularly patients with diabetes); the HOT trial is an exception. Of course, we will need more data and details in order to do the systematic review work and meta-analyses that are the foundation for such (Bayesian) consideration. One technical, epidemiological point: I actually care less about the ARR (absolute risk reduction)/NNT (number needed to treat) for this trial alone because it is mainly a representation of the population studied in this trial, and because it is difficult to synthesize ARR or NNT across trials. Instead, I want to know whether the relative risk reduction is similar for patients across different risk and blood pressure levels (this is controversial). If it is, then I want to develop a summary estimate of the RRR (relative risk reduction) and then be able to apply it to patients at different levels of risk, as we can do with statins. Once we have a stable RRR, say 20%, then we can say:
The key is to determine whether the RRR (relative risk reduction) is stable at different BP and risk levels- this new trial suggests that it is . . . but I would need to see more data to be confident in that conclusion.”