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The report of this week's International Conference of Alzheimer's Association (AAIC) was relentlessly optimistic and positive about the findings of the NIH SPRINT The message: Aggressive control of blood pressure can help protect the brain, but unless you look very carefully at newsletters and "expert" statements, you will not know that SPRINT MIND was a negative trial missed its main evaluation criterion or the results have not yet been peer-reviewed
Preliminary results of the SPRINT MIND trial were presented Wednesday in Chicago at the congress of AAIC, SPRINT MIND is a SPRINT study study. Blood pressure control (systolic target of 120 mm Hg or less) reduced the rate of major cardiovascular events and mortality by rap less intensive blood pressure control (systolic blood pressure of 140 mm Hg or less). The title of the AAIC press release sets the tone for this coverage: "One study shows that controlling blood pressure reduces the risk of mild cognitive impairment and the combined risk of MCI and dementia.
The scientific lead of AAIC leaves no doubt that the results have immediate and important relevance for clinical practice: "To reduce new cases of MCI and dementia globally, we must do everything in our power to reduce blood pressure to the levels indicated in this study. what we know is beneficial for cardiovascular risk. "
The NIH press release is a little more cautious, noting that the results are" preliminary "and have not yet been peer-reviewed (although Francis Collins, the director of NIH , tweeted that the trial was "a big news").] The reports have been consistently optimistic.The headlines tell the story:
- Time: " It may finally be something you can do to reduce your risk of dementia "
- Washington Post:" A Healthier Heart Can Mean a Better Health Mind, a New Study Shows "
- Medscape:" Lowering Aggressive Blood Pressure Cup MCI risk "
- Forbes: " Blood pressure medications can prevent memory problems "
- Tight control of blood pressure reduces the risk of Alzheimer's dementia, according to the etu from
- USA Today: "The aggressive lowering of blood pressure could reduce the risk of dementia, according to a study
the avalanche of exaggeration was the most important fact that everyone needs to know about SPRINT MIND: the test missed its primary endpoint, namely the incidence of all-cause dementia. Even the summary pbades above the primary endpoint that failed, signaling first the secondary (but significant) criterion of mild cognitive impairment (MCI):
There was a significantly higher rate MCI incident (HR = 0.81, 95% CI: 0.70 to 0.95, p = 0.01) and a nonsignificant reduction in likely dementia (HR = 0.83, 95% CI: 0.67 to 1.04, p = 0.10). The combined result of MCI most likely all-cause dementia was significantly lower (HR = 0.85, 95% CI: 0.74 to 0.97, p = 0.02) in the intensive treatment group compared with at the standard treatment
MCI, of course, wants to get, but it's not the same as dementia, and it's unclear whether the difference found in the test, even if it is true , would have a clinically significant impact on dementia.
Sanjay Kaul (Cedars Sinai) the effort to pbad over the primary end point missed. "How does one interpret the results of an essay that fails to gain on the primary endpoint (probable dementia incident), but that produces a significant therapeutic effect on a secondary endpoint (mild cognitive impairment)? a lot of circumspection Why? the positive effect on the secondary result represents a false positive conclusion (false) has not been ruled out. "
Kaul pointed to another important missing element in the abstract and in the media coverage of the trial. The researchers report a 19% reduction in the relative risk of the secondary endpoint (MCI). This seems impressive, but lost in coverage is the much lower absolute reduction in risk. Kaul calculates that absolute risk reduction was only 0.6% for the primary endpoint and only 1.34% for the MCI secondary endpoint. Here are Kaul's calculations for the primary endpoint (PEP) and the secondary endpoint (SEP):
- PEP (probable incident of dementia): 147/4678 (3.14% ) vs 175/4683 (3.74%); ARD = 0.6%; RR 0.84, 95% CI 0.68-1.04, p = 0.11
- MS (MCI): 285/4678 (6.09%) vs 348/4683 (7.43%); ARD = 1.34%; RR 0.82, 95% CI 0.70-0.95, p = 0.009
- Combined MCI or dementia criterion: 398/4678 (8.51%) vs 463/4683 (9.89%); ARD = 1.38%; RR 0.86, 95% CI 0.76-0.98, p = 0.02
Kaul stated that these results do not "represent a robust effect, but this must be interpreted in the context of 39, no effect of treatment on this result with currently available So, promising data, but not all enchilada, as do the investigators. "
As Kaul suggests, the results certainly do not mean that aggressive blood pressure t helps protect the brain, but for now the evidence is not conclusive And almost no one commented on the study pointing out that there were potentially damaging effects of a more aggressive blood pressure reduction including, most importantly, an increased risk of falling.
Now, it is important to remember that dementia is a huge and rapidly growing public health problem.The desperate need for real progress is undoubtedly feeding some of the hype. that we have seen, but it is precisely because of its desperate nature that we must be very careful not to grasp the first straw we find.
It is also important to remember that this is not the only thing we have. is not the first rodeo of SPRINT The results of the main trial were announced for the first time in 2015. As I reported at the time, SPRINT investigators sought to interpret the meaning of SPRINT. test before actual results and details are made public. Since then, the trial has sparked a huge controversy. Although it is widely acknowledged that this is an important trial, it is fair to say that it has not gotten the acclaim and acceptance that its investigators have had. 39 first claimed. It may be time for the NIH to stop prematurely proclaiming victory. Instead, the NIH should present its test data and let the scientific and medical community decide for themselves how the data should be interpreted.
Previous SPRINT Cover:
- Slow Down. SPRINT will change but not revolutionize the treatment of blood pressure
- Experts in heart failure SPRINT at an early start
- A premature SPRINT at the finish line
- NIH Trial, Stopped Early SPRINT: More controversy and confusion about the "Landmark" test
- New questions raised about SPRINT
- Can SPRINT be used to inform the treatment of hypertension?
- The Principal Investigator Defends SPRINT Against Critics
- The Survey Says: The Measurement of Blood Pressure in SPRINT WAS ALWAYS
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This is once again a" breakthrough This week's International Conference (AAIC) was relentlessly optimistic and positive about the results of the NIH SPRINT MIND study The message: aggressive control of blood pressure can help protect the brain. you look closely at the news reports and statements of "experts", you will not know that SPRINT MIND was a negative test that missed its primary evaluation criterion or that the results have not yet been peer reviewed.] The preliminary results of the SPRINT MIND trial were presented Wednesday in Chicago at the AAIC.SPRINT MIND is a sub-study of the main SPRINT trial that showed that Control intensive blood pressure (systolic blood pressure less than or equal to 120 mm Hg) reduced the rate of major cardiovascular events and deaths compared to a blood pressure control minus 140 mm Hg or less)
The title of the release AAIC press release set the tone: "One study shows that controlling blood pressure reduces the risk of mild cognitive impairment (MCI) and the combined risk of MCI and dementia.
The scientific director of AAIC leaves no doubt that the results have immediate and immediate relevance for clinical practice: "To reduce new cases of MCI and dementia on the scale world, we must do everything in our power. Blood pressure at the levels shown in this study, which we know is beneficial to cardiovascular risk. "
The NIH press release is a little more cautious, noting that the results are" preliminary "and have not yet been peer reviewed (although Francis Collins, director of the NIH, tweeted that the trial was "a big news").
The reports were uniformly optimistic. Titles tell the story:
- Time: " It may finally be something you can do to reduce your risk of dementia"
- Washington Post: " A Healthier Heart may mean better health mind, a new study shows "
- Medscape:" Lowering Aggressive Blood Pressure Cut the Risk MCI "
- Forbes: " Blood Pressure Medications Can Prevent Memory Problems "
- Tight Control of Blood Pressure Reduces the Risk of Alzheimer's Dementia, According to a Study
- USA Today: " The Aggressive Lowering of Tension arterial could reduce the risk of dementia, according to a study
