The new US hypertension guidelines, released at the recent American Heart Association (AHA) 2017 Scientific Sessions, have been generally well received by the hypertension and cardiology communities, albeit with a few caveats from some.
The new guidelines, from the AHA and American College of Cardiology (ACC) in partnership with nine other professional societies, include several significant changes to previous recommendations, including lower thresholds for hypertension diagnosis and lower treatment targets, which will greatly increase the number of people classified as having hypertension and eligible for drug therapy.
Most experts appear to be in favor of the new targets and more aggressive approach, although some concerns have been expressed. These include the fact that half the population will now be designated as having a medical condition, with the associated anxiety that accompanies such a diagnosis and the feasibility of trying to identify and treat all these new patients, as well as concern over the same new aggressive targets being used for the elderly, which some experts believe are not appropriate.
The guidelines committee reviewed the latest clinical trial evidence with particular emphasis on the National Institutes of Health–sponsored SPRINT trial. This is the largest study of its kind to examine how maintaining systolic blood pressure at lower than previously recommended levels would affect outcomes in patients at high risk for heart disease, with results suggesting benefit of new lower targets for all.
But some of the key voices in Europe are cautious in their interpretation of the SPRINT results and, as a consequence, a little more hesitant about some of the new US recommendations.
Key Changes in the New Guidelines
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Most of the hypertension experts and preventive medicine specialists contacted by Medscape Medical News were positive about the new guidelines.
William Cushman, MD, University of Tennessee Health Science Center, Memphis, who was on the writing committee for the previous Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC) 6, 7, and 8 hypertension guidelines, said, “I think these are strong, evidence-based guidelines which will be generally well accepted. It is good to have a standard goal for everyone. I was not involved in these guidelines but I hope they will be given the same attention as prior JNCs.”
William B. White, MD, past president of the American Society of Hypertension and chief of the Division of Hypertension and Clinical Pharmacology at UConn Health, Farmington, Connecticut, was also upbeat. “In my opinion, the new hypertension guidelines will greatly improve the precision for diagnosing hypertension and will reduce the incidence of stroke, myocardial infarction, and congestive heart failure due to cardiovascular causes.”
Philip Greenland, MD, professor of preventative medicine, Feinberg School of Medicine, Chicago, Illinois, commented: “These are exciting, well-documented recommendations. Recent trials such as SPRINT have shown benefit of treating to lower targets, and I think SPRINT was highly representative of the hypertension population.”
Ethan J. Weiss, MD, associate professor, Cardiovascular Research Institute, University of California, San Francisco, added: “In general, I like the guidelines. They are aspirational. I think moving the thresholds back is the right move. My overall opinion is that is what the evidence supports — to get as close to normal as we can without causing harm.”
Anne Curtis, MD, professor of medicine at University at Buffalo in New York, said the new guidelines reflected latest understanding about the risk of mildly elevated pressures. “In some respects, we have acted in the past as if 140/90 is a ‘magic number,’ above which risk for adverse outcomes increases and below which patients are normotensive and thus not at risk from high blood pressure. What we are realizing now is that risk is graduated — above 120/80, the higher the blood pressure, the greater the risk.”
But some are worried about the focus shifting too much toward low-risk individuals.
Kenneth W. Lin, MD, associate professor of family medicine, Georgetown University School of Medicine, Washington, DC, raised the concern of possible overtreatment of some lower-risk patients. “I think there are pros and cons to the ACC/AHA’s new definition of hypertension,” he said. “Just like with blood sugar cut-offs for diabetes, shifting an arbitrary threshold downward will identify more persons who benefit from treatment, but it will also increase the likelihood that more persons who won’t benefit are treated unnecessarily.”
He believes a major omission from the guidelines is a discussion of the harms of a more intensive treatment strategy. “The guideline will lead to more patients being put on medications and more medication-related adverse effects, and it would have been helpful to provide physicians with a shared decision-making tool so that they can discuss the risks and benefits of more aggressive targets with patients.”
UK hypertension expert Bryan Williams, MD, chair of medicine, University College London, summed up concerns that the focus on low-risk patients may take away from the more important messages. “There is a lot that is good in the guidelines, but the danger is that the key message of getting high-risk patients treated to the lower goal will be lost in endless debates about what to do with the ‘worried well’ sipping on their soy chai latte, concerned about their systolic blood pressure of 130 mm Hg.”
Set Targets for All
Set Targets for All
One point that has generated discussion is the recommendation of the same target — less than 130/80 — for everyone, regardless of risk.
J. Michael Gaziano, MD, preventive cardiologist at Veterans Affairs Boston and Brigham and Women’s Hospitals in Massachusetts, explained. “The trials have shown clearly that the more aggressively we lower blood pressure, the more the risk of cardiovascular events falls. But they don’t tell us that 130/80 is the magic new number. I think better advice would be for any patient with raised blood pressure deemed worthy of treatment to lower blood pressure substantially without a particular target in mind.”
Dr Gaziano gave the example of two patients, both with heart disease. “One has a systolic of 180 and with treatment I manage to get him down to 139/90. I have done him an awful lot of good but my health system will be judging me on whether I have hit the magic 130/80 target and so I will have failed. The other patient has a starting systolic of 132 and I give him a tiny dose of a water pill and this falls to 129.
“The health system is happy, I get my bonus, but I haven’t helped this patient much at all,” he added. “I could have got him down to under 120 and served him much better but there’s nothing here to encourage me to do that. So with guidelines we will be undertreating some patients and overtreating others, and calling some patients failures when they are actually successes, and vice versa.”
Franz Messerli, MD, professor of medicine, University of Bern, Switzerland, and Mount Sinai Icahn School of Medicine, New York City, also objects to the universal target for all. “I think some of the new recommendations are thoughtful — I agree with the more aggressive target and that 130/80 is right for many but not all. The guidelines do not differentiate between low- and high-risk patients for target blood pressure and I think the one-size-fits-all is a big drawback.
“Our patients are genetically, physiologically, metabolically, pathologically, psychologically, and socially different,” he added. “Accordingly, there never will be just one way to diagnose and treat hypertension. Attempts to lower blood pressure of the US population uniformly to one target clearly has to be considered absurd. We can only hope that despite guidelines, physicians will continue to treat patients and not millimeters of Hg only.”
Steven E. Nissen, MD, chair, Department of Medicine, Cleveland Clinic Foundation, Ohio, voiced a similar opinion. “In general, I support more aggressive targets, but would have preferred a more nuanced approach. There are clearly harms associated with attempting to reach lower goals so that individualization of therapy is critically important. I have concerns about a ‘one-size-fits-all’ approach.”
George Bakris, MD, professor of medicine and director of the ASH Comprehensive Hypertension Center at the University of Chicago in Illinois, also concurs. “While I understand and support lowering the threshold for many who are at high risk, I’m not convinced it should be lowered for everyone. The American Diabetes Association BP Consensus Report, recently published, recommends less than 140/90 for everyone and less than 130/80 if high CV [cardiovascular] risk, that is in keeping with the AHA/ACC guidelines but a bit more discriminating.”
What to Do With the Elderly?
One group for whom there is particular controversy regarding the 130/80 target is the elderly because historically, older patients have always had higher blood pressure targets.
“The guidelines could have proposed modification of the targets for some older patients and those deemed more fragile or at higher risk for falls or renal compromise, et cetera,” Dr Nissen said.
Dr Messerli agreed. “I still believe the elderly need higher targets. Just a few months ago the ACP/AAFP [American College of Physicians/American Academy of Family Physicians] guidelines recommended a target systolic of less than 150 mm Hg for the elderly. An 85-year-old is not the same as a 25-year-old. The systolic target used to be 100 plus the patient’s age. That’s obviously not the right advice now but maybe it could be 100 and half the age. So 125 mm Hg for a 50-year-old and 140 for an 80-year-old. That is reasonably simple.”
But Michael A. Weber, MD, professor of medicine at State University of New York, editor-in-chief of The Journal of Clinical Hypertension, and a former president of the American Society of Hypertension, pointed out that the new treatment thresholds and targets in the guidelines are based largely on the SPRINT trial, “and the benefit of the lower target was especially strong in older patients. Admittedly, more side effects occur in older people treated to low blood pressure levels, but the reductions in fatal and nonfatal events clearly outweigh these concerns.”
Dr Gaziano agreed with Dr Weber. “The totality of the data show the elderly get just as much if not more benefit from lowering BP. Yes, you have to be careful, but it is very manageable.”
Dr Greenland also has this view. “In SPRINT, the elderly showed the same benefits in older patients as in everyone else. But clinical judgment does sometimes need to deviate from the guidelines. However, the guidelines take this into account. They say if the patient is frail, make a clinical judgment. They have it covered. We have to remember guidelines are just that — guidelines — they are not law. Clinicians are free to use their judgment.”
Half the Population Now Designated Hypertensive
One concern voiced by some was that the new classification of stage 1 hypertension would mean that half the population would now be classified as hypertensive.
Dr Messerli pointed out that within a few months, the number of US adults meeting the definition for hypertension has risen from 72 million to over 100 million people, which he describes as “alarming.”
“Many patients in the new stage 1 hypertension classification will be at low risk, but labeling a healthy person with a disease comes at a cost. The act of labeling someone as hypertensive not only triggers absenteeism, neuroticism, anxiety, perception of poor health, deterioration of marital and home life, and symptoms of depression, but also it may cause a subsequent increase in blood pressure, most probably mediated by increased sympathetic activity. Thus, becoming aware that one has hypertension may beget more hypertension.”
But Dr Greenland argued that it is appropriate for all these people to be labeled as hypertensive. “If your blood pressure is over 120/80, your risk of cardiovascular events is increased. It’s not the guidelines that are making people sick, it is their lifestyles. We have to accept that too many people have raised blood pressure. This is a population-wide epidemiologic fact. This is appropriate to recognize and it is appropriate to recommend lifestyle changes for everyone with raised blood pressure.”
Dr Weiss agreed. “I think people are paying far too much attention to the literal nature of the words. I am not as bothered by labeling anything above 120/80 as hypertension.”
Dr Curtis was also on board with the new definition: “If labeling almost half the population as hypertensive gets more people to pay attention to risk factor modification, that’s a good thing. It should lead to better CV outcomes with no extra risk/cost. The expected improvement in outcomes is worth the effort,” she said.
Dr Williams was more doubtful. “Labeling everybody as hypertensive when their systolic is above 130/80 mmHg has huge implications for the many millions of people who now become patients. This is a massive public health debate and is not something that should be adjudicated by a guideline committee in isolation, notwithstanding the fact that many would argue that it has little direct evidence to support it and is contradicted by some trials that were not discussed in the guidance. I am not suggesting the decision is necessarily wrong, just that it was not the way to do it. “
Recommendations for Lower-Risk Patients Not Clear-Cut
Others have pointed out that the new stage 1 hypertension classification will be useful in identifying and treating those patients at higher risk for CV disease but they are not sure about the benefit to the lower-risk patients.
“Certainly for the high-risk population there is very strong evidence that under 130 is an appropriate goal,” Dr Cushman said. “They will certainly derive a great deal of benefit from this. The argument will be for those at lower risk or younger age: Should we be defining them as hypertension with pressures slightly above 130? That debate will go on.”
Dr Lin points out that the average 10-year CV risk level in the SPRINT trial was much higher than the guideline threshold of 10%, “which means that the guideline authors extrapolated the trial’s benefits to a lower-risk population who may not experience the same benefit from lower targets.”
But Dr Cushman countered that epidemiologic studies show that young people with systolic pressures above 130 have a very high lifetime risk for complications. “We can’t afford to do 10-, 20-, 30-year randomized trials in this group, but I would expect that they would benefit from lowering their pressure below 130. But we should keep in mind that we can’t have the strength of evidence in the lower-risk groups, so we may not need to be so aggressive or worry so much if they’re not quite at the 130/80 goal.
“The trouble is if you have different goals for different groups, it makes it more difficult to implement,” he added. “That is what guidelines committees have to try and balance. How to make it as evidence based as possible while also making it feasible, bearing in mind we can’t afford to do studies in everyone.”
Although the guidelines recommend the same targets for high- and low-risk individuals, they have different treatment strategies for these different risk groups within the new stage 1 classification, with those at higher risk for CV disease recommended to receive antihypertensive medication and those at lower risk to be given lifestyle advice alone. This again has caused much discussion.
Dr Bakris said he is in “absolute agreement” with this advice. “Patients known to be at increased cardiovascular risk should be aggressively managed into a range that demonstrates reduced risk. Not all people have high cardiovascular risk, however, and thus do not need aggressive management.”
Dr Weiss also agreed. “Knowing that the risk of CV disease is higher would motivate me to be more aggressive with my treatment. This is where the guidelines are helpful.”
But Dr Nissen said that more work needs to be done on the risk calculator used and that it has not been tested for selection of goals for hypertension treatment. “Although the concept of risk-based treatment goals is reasonable, the approach needs to be tested and validated before its use in a national guideline.”
Dr Weber noted that this is the first time this approach has been used in US hypertension guidelines. “It is reasonable to use high cardiovascular risk as a justification for intensifying treatment of hypertension, but the calculations may not always be easily accessible and I suspect that over time most or all patients will somehow find themselves treated as though they are high risk. But given the well-tolerated nature of most modern medications, this should not be a problem.”
“People are saying everyone will end up on medication, but lifestyle advice has been given a 1A recommendation,” Dr Greenland responded. “I think the guidelines have struck the right balance in recommending medication for the higher-risk patients over 130 and lifestyle for all.”
But Dr Messerli pointed out that adherence to lifestyle modifications is notoriously poor. “Among the 11% of US adults who now meet the definition of hypertension as per ACC/AHA guideline but in whom drug therapy is not advised, most if not all will never reach the target less than 130/80 mmHg, and any attempt to postpone antihypertensive therapy will slowly but relentlessly give rise to target organ disease.”
He added: “I think lifestyle advice is just too difficult to implement. I have practiced for many years and treated thousands of patients and I treat first with a pill. I tell my patients, ‘If you lose weight, exercise, reduce salt intake, et cetera, you can stop the medication,’ but I’ve yet to see a patient where this has happened. Patients just don’t do it.”
“By advocating lifestyle first and waiting for the blood pressure to reach 140 until we start prescribing medication we are wasting time,” Dr Messerli asserted. “Okay, yes, we should be pushing lifestyle to everyone but not at the cost of withholding medication.”
Dr Gaziano disagreed: “I like the recommendation to offer lifestyle advice for those between 130 and 140,” he said. “Some doctors will grumble about this and say it doesn’t work but that’s because they don’t encourage the patient enough. There are ways to get better results by making the patient take ownership of it with behavioral change programs. I recommend one of these and I have patients who have lost 30 pounds. It can be done.
“But we don’t train our physicians in how to empower people to make lifestyle changes,” he pointed out. “We train them to prescribe medicines. The health system has to make investments in the lifestyle concept if this is to work. It doesn’t have to be the case that everyone ends up on medication, but this will probably be what happens.”
Paul D. Thompson, MD, chief of cardiology at Hartford Hospital in Connecticut, agreed that lifestyle changes need to be addressed at a public health level.
“Patients and doctors are terrible at lifestyle, so the guideline advice won’t work and doctors will use drugs in the low-risk groups, which will cause side effects,” Dr Thompson said. “We need a push for better lifestyles, but this has got to be engineered into the environment, forced no-car zones, walking paths embedded in communities, and safe streets so the people I ask to exercise actually can do it.”
Another point of discussion is the feasibility of identifying and treating all the extra patients now classified as having hypertension. How are family doctors going to cope with the extra workload?
“GPs [general practitioners] are certainly overwhelmed, and this will increase their workload still more,” Dr Greenland said of this issue. “But it is not the remit of the guidelines committee to take this into account. It is the remit of the medical care system. Yes, the medical care system is inadequately equipped to address the problem only in the clinic. We need system-wide changes, and that will involve a better partnership between medical care and the public health system.”
“The cost of implementing the new recommendations clearly will be high, but can be defended by the human value inherent in the reductions in death, heart disease, strokes, and other cardiovascular outcomes,” Dr Weber added. “As a society we must accept that this is money well spent and figure out ways to adjust our national spending priorities. There are no easy answers.”
“These more aggressive values for blood pressure targets will make the job of the primary care physicians, who already have a very difficult job thanks to insurance companies and policymakers, much more difficult,” Dr Bakris noted. “While it is the physicians’ job to educate patients, just like the student who may or may not do the homework, the patient may or may not heed the advice of the physician and take the medication, but the physician is blamed. We must reassign responsibility.”
Will the Europeans Follow Suit?
Giving a European perspective, Giuseppe Mancia, MD, University of Milan, Italy, and co-chair of the task force for the European Society of Hypertension /European Society of Cardiology hypertension guidelines, said he thought the new US guidelines addressed some important issues and “hopefully this new aggressive approach will help get more patients on therapies and reduce blood pressure more effectively than has been the case until now.”
He said he particularly liked the recommendation of starting treatment with two drugs. “This will make the world of difference. What often happens is patients are put on one drug and then a therapeutic inertia sets in and while most patients need an additional therapy this is never added.”
He said he wasn’t so sure about the classification of “elevated blood pressure” in those with a systolic pressure of 120 to 129. “I think this is disconcerting. If I have an 82-year-old guy with a systolic of 122, rather than congratulating him, I would have to tell him that he has elevated blood pressure. I understand the reason — they wanted to be provocative — there is a big problem of inertia. But labeling someone with a problem without doing anything about it just creates a lot of anxiety.”
He added: “I think the same could be said for the stage 1 hypertension classification for systolic between 130 and 139. If these people have a low to moderate risk of heart disease, which the majority will have, I’m not sure we need to worry them too much. The evidence isn’t really there for this group. I would prefer to keep the old classification of ‘high normal’ for these individuals.”
But Dr Mancia said he did agree with using medication for those in the 130 to 139 range who are at high risk for heart disease. “I agree we do have the evidence for that.”
Dr Mancia and colleague Sverre Erik Kjeldsen, MD, Oslo University Hospital Ullevaal, Norway, recently published a critique of the SPRINT trial, raising questions on several issues that Dr Mancia said causes them to be “cautious of the results and the strong influence the trial it will have had on the new US guidelines.”
He explained that because blood pressure was measured in an automated way without a healthcare professional in attendance in the trial, significantly lower values could have been recorded compared with other studies.
“At the end of the day I think there is evidence from other studies for a target of below 130, but maybe not for all patients. In particular, I think the evidence for this in the elderly is missing. Previous guidelines recommended a target of less than 150 mm Hg for the elderly. I think we could go a bit lower than this — maybe to 140 — but I think 130 may be too low. The evidence for less than 130 in the elderly has come from SPRINT and because of the way they measured blood pressure this could be more like less than 140 in the clinic.”
Dr Mancia and Dr Kjeldsen also take issue with the inclusion of incident heart failure in the SPRINT composite endpoint. “This can be quite a subjective endpoint and is difficult to quantify,” Dr Mancia commented. “Diuretics can also mask the symptoms of heart failure, and more patents in the aggressive treatment group in SPRINT would have been on a diuretic. So this also makes us a little cautious about the study results.”
But he added: “I do think the US guidelines have done a good job and I agree with most of it in that we need a more aggressive approach. I’m not completely convinced about the SPRINT trial, but medicine is not mathematics — everything is open to interpretation. And for most of the recommendations in the new guidelines there is evidence from other studies as well, but we still have a few caveats.”
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