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How Low To Go: The Continuing Controversy on BP Targets

by U.S. Medicine

March 10, 2017

VA Research Supports More Flexible Goals in Older Patients

By Brenda L. Mooney

PHILADELPHIA — After the release of the SPRINT research in 2015, the question about treating hypertension in older adults appeared to be, “How low can you go?”

Now, based on critical research from the Portland, OR, VA Healthcare System, two major physicians group have rejected that mentality in recent guidelines. Those documents suggested that systolic blood pressure below 150 mm Hg is sufficient for most patients older than 60 to reduce their risk of mortality, stroke and cardiac events.

The evidence-based clinical practice guideline on the appropriate systolic blood pressure target for adults 60 years old and older with hypertension was developed jointly by the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) and published in Annals of Internal Medicine.1

The new document has provoked controversy because many other guidelines recommend that all adults, at least to age 80, seek to lower systolic blood pressure to below 140 mm Hg. In addition, the high-profile 2015 SPRINT study urged that the target be even lower.

Background information in the guidelines article, authored by a team from the American College of Physicians and University of Pennsylvania Health System, noted that about 65% of those older than 60 have hypertension in the United States, compared to an overall adult rate of about 29%.

“The evidence showed that any additional benefit from aggressive blood pressure control is small, with a lower magnitude of benefit and inconsistent results across outcomes,” said ACP President Nitin S. Damle, MD, MS, MACP. “Most benefits of targeting of less than 150 mm Hg apply to individuals regardless of whether or not they have diabetes.”

 

In conducting the evidence review for the guidelines, the Portland VA’s Evidence-based Synthesis Program sought to answer the following key questions:

  • In adults aged 60 years or older, what are the health outcome effects of differing BP targets?
  • In patients who have suffered a TIA or stroke, does treatment of BP to specific targets affect health outcomes?
  • How does age modify the benefits of differing BP targets? How does the patient burden of comorbid conditions modify the benefits of differing BP targets?
  • What are the harms of targeting lower BP in older patients?
  • Do the harms vary with age?
  • Do the harms of targeting lower BP vary with patient burden of comorbid conditions?

 

To do that, reviewers searched EMBASE and the Cochrane Database of Systematic Reviews from database inception through January 2015, MEDLINE through September 2016 and ClinicalTrials.gov to identify studies that were in progress or unpublished. Observational studies were excluded from analysis of such health outcomes as mortality, stroke and cardiovascular events.

The focus was adults age 60 years or older with a diagnosis of hypertension, and researchers evaluated treatment to higher—greater than 150 mm Hg—vs. lower—defined as 140 mm Hg or lower—systolic blood pressure targets. Evaluated outcomes included all-cause mortality; cardiac events (myocardial infarction and sudden cardiac death); morbidity and mortality related to stroke; and harms, including cognitive impairment, quality of life, falls, fractures, syncope, functional status, hypotension, acute kidney injury (defined as the doubling of serum creatinine or need for renal replacement therapy), medication burden and withdrawal due to adverse events.

 

Tighter Control

In the supporting evidence review, Jessica Weiss, MD, MCR, from the Portland VAMC, and colleagues cautioned that the that the benefits of a lower threshold (i.e., less than 140/90) should be measured against risk. “Tighter control may prevent, on average, roughly 10 to 20 events for every 1,000 high-risk patients treated over five years across a population,” they wrote, adding that, at the same time, the risk for hypotension and syncope are likely to increase.2

“On the other hand, evidence that there is not an increased risk for cognitive impairment, falls and reduced quality of life may provide flexibility for providers in crafting an individualized antihypertensive treatment plan,” the VA team pointed out.

The reviewers also emphasized that most of the support for treatment targets below 140 mm Hg come from a single trial, the Systolic Blood Pressure Intervention Trial (SPRINT), which compared the benefit of a systolic target of less than 120 mm Hg to less than 140 mm Hg. SPRINT found meaningful reductions in cardiac events and deaths with lower targets.

On the other hand, the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, which focused on the same targets, did not show similar benefits, according to the reviewers. In addition, they pointed out, when SPRINT data is removed from the analysis, the effects on mortality were reduced and the effects on cardiovascular events were no longer significant.

The guidelines emphasized the importance of accurate systolic blood pressure readings.

“The most-accurate measurements come from multiple blood pressure measurements made over time,” said AAFP president John Meigs Jr., MD. “These may include multiple measurements in clinical settings or ambulatory or home-monitoring.”

 

The evidence review was conducted by the Portland VA Health Care System Evidence-based Synthesis Program to address the following key questions (KQs):

KQ 1: In adults aged 60 years or older, what are the health outcome effects of differing BP targets?

KQ 1b: In patients who have suffered a TIA or stroke, does treatment of BP to specific targets affect health outcomes?

KQ 2: How does age modify the benefits of differing BP targets?

KQ 3: How does the patient burden of comorbid conditions modify the benefits of differing BP targets?

KQ 4: What are the harms of targeting lower BP in older patients? Do the harms vary with age?

KQ 5: Do the harms of targeting lower BP vary with patient burden of comorbid conditions?

 

Search Strategy

The reviewers searched EMBASE and the Cochrane Database of Systematic Reviews from database inception through January 2015, MEDLINE through September 2016, and ClinicalTrials.gov to identify studies that were in progress or unpublished. Observational studies were excluded from analysis of such health outcomes as mortality, stroke, and cardiovascular events. For additional information, including inclusion and exclusion criteria, refer to the accompanying article (8) and full report (9).

Meta-analysis and Individual-Patient Data Meta-analysis

The reviewers conducted a meta-analysis on study-level data using the random-effects model. They also conducted individual-patient data meta-analysis to assess treatment according to age subgroups.

Quality Assessment

The quality of studies was assessed using the Cochrane risk-of-bias tool (49). The evidence reviewers graded the quality of evidence using the Agency for Healthcare Research and Quality system (50).

Population

Adults aged 60 years or older with a diagnosis of hypertension were studied.

Interventions Evaluated

The interventions evaluated included treatment to higher (<150 mm Hg) vs. lower (≤140 mm Hg) SBP targets.

 

Comparators

The comparator was less intensive BP treatment.

Outcomes

Evaluated outcomes included all-cause mortality; cardiac events (myocardial infarction and sudden cardiac death); morbidity and mortality related to stroke; and harms, including cognitive impairment, quality of life, falls, fractures, syncope, functional status, hypotension, acute kidney injury (defined as the doubling of serum creatinine or need for renal replacement therapy), medication burden and withdrawal due to adverse events.

Timing

Outcomes were assessed in the long-term (>6 months) for KQs 1, 2 and 3 and any time frame for KQs 4 and 5.

 

Study Design

Controlled study designs (randomized, controlled trials and nonrandomized, controlled trials) (KQs 1, 2, 3, 4 and 5) and cohort studies (KQs 4 and 5) were included. Case reports; case series; randomized, controlled trials with less than 6-month follow-up; and controlled before-after studies were excluded.

Peer Review

The VA evidence review was sent to invited peer reviewers and posted on the VA website for public comments, and the published review article was peer reviewed through the journal. The guideline had a peer-review process through the journal and was posted online for comments from ACP Regents and Governors, who represent physician members at the national level. It was also reviewed by members of AAFP’s Commission on Health of the Public and Science.

The guideline also cautioned about “white coat hypertension,” whereby patients might have falsely elevated readings in clinical settings which could lead to unnecessary initiation or increase in hypertension medications.

Effective nonpharmacologic options for reducing BP include such lifestyle modifications as weight loss, such dietary changes as the DASH (Dietary Approaches to Stop Hypertension) diet, and an increase in physical activity. Nonpharmacologic options are typically associated with fewer side effects than pharmacologic therapies and have other positive effects; ideally, they are included as the first therapy or used concurrently with drug therapy for most patients with hypertension. Effective pharmacologic options include antihypertensive medications, such as thiazide-type diuretics (adverse effects include electrolyte disturbances, gastrointestinal discomfort, rashes and other allergic reactions, sexual dysfunction in men, photosensitivity reactions, and orthostatic hypotension), ACEIs (adverse effects include cough and hyperkalemia), ARBs (adverse effects include dizziness, cough and hyperkalemia), calcium-channel blockers (adverse effects include dizziness, headache, edema and constipation), and β-blockers (adverse effects include fatigue and sexual dysfunction). Effective nonpharmacologic options for reducing BP include such lifestyle modifications as weight loss, such dietary changes as the DASH (Dietary Approaches to Stop Hypertension) diet, and an increase in physical activity. Nonpharmacologic options are typically associated with fewer side effects than pharmacologic therapies and have other positive effects; ideally, they are included as the first therapy or used concurrently with drug therapy for most patients with hypertension. Effective pharmacologic options include antihypertensive medications, such as thiazide-type diuretics (adverse effects include electrolyte disturbances, gastrointestinal discomfort, rashes and other allergic reactions, sexual dysfunction in men, photosensitivity reactions, and orthostatic hypotension), ACEIs (adverse effects include cough and hyperkalemia), ARBs (adverse effects include dizziness, cough, and hyperkalemia), calcium-channel blockers (adverse effects include dizziness, headache, edema, and constipation), and β-blockers (adverse effects include fatigue and sexual dysfunction).While the document advised that non-pharmacologic approaches, such as dietary changes, exercise and weight loss be attempted, it also detailed the range of medication therapies that can be used to treat hypertension and their common side-effects:

  • thiazide-type diuretics (adverse effects include electrolyte disturbances, gastrointestinal discomfort, rashes and other allergic reactions, sexual dysfunction in men, photosensitivity reactions, and orthostatic hypotension),
  • ACEIs (adverse effects include cough and hyperkalemia),
  • ARBs (adverse effects include dizziness, cough, and hyperkalemia), calcium-channel blockers (adverse effects include dizziness, headache, edema, and constipation), and
  • β-blockers (adverse effects include fatigue and sexual dysfunction).

Systolic blood pressure targets might be lower, less than140 mm Hg, in older with a history of stroke or transient ischemic attack, according to the guidelines. The authors also recommended that 140 mm Hg be the goal an individualized assessment indicates high cardiac risk.

The report pointed out that increased cardiovascular risk includes all patients with known vascular disease as well as most of those with diabetes, with chronic kidney disease with estimated glomerular filtration rate (eGFR) <45 mL/min/per 1.73 m2, with metabolic syndrome—abdominal obesity, hypertension, diabetes, and dyslipidemia—and, in some cases, who are older.

Because of similar efficacy, reduced cost, and therefore better adherence, the guidelines recommended that physicians prescribe generic formulations over brand name drugs.

Citing insufficient evidence, the ACP and AAFP did not make any recommendations about diastolic blood pressure targets.

  1. Qaseem A, Wilt TJ, Rich R, Humphrey LL, Frost J, Forciea MA; ClinicalGuidelines Committee of the American College of Physicians and the Commission on Health of the Public and Science of the American Academy of Family Physicians.Pharmacologic Treatment of Hypertension in Adults Aged 60 Years or Older toHigher Versus Lower Blood Pressure Targets: A Clinical Practice Guideline Fromthe American College of Physicians and the American Academy of Family Physicians.Ann Intern Med. 2017 Jan 17. doi: 10.7326/M16-1785. [Epub ahead of print] PubMed PMID: 28135725. 
  2. Weiss J, Freeman M, Low A, Fu R, Kerfoot A, Paynter R, Motu’apuaka M, Kondo K, Kansagara D. Benefits and Harms of Intensive Blood Pressure Treatment in Adults Aged 60 Years or Older: A Systematic Review and Meta-analysis. Ann Intern Med. 2017 Jan 17. doi: 10.7326/M16-1754. [Epub ahead of print] PubMed PMID: 28114673.

4 Comments

  • Mark McConnell, M.D. says:

    Will VA Performance Measures catch up with evidence and allow home BP readings to “count” when assessing control? I suspect there is a lot of potential over-treatment caused by chasing only “in office” readings.

  • William C. Cushman, MD says:

    I was one of the lead investigators for ACCORD and SPRINT and am the principal investigator overseeing the VA clinical center networks for those trials. I was also the VA Champion for the 2014 VA/DoD Hypertension guidelines and on the 2014 JNC 8 Hypertension Guideline panel – in both of those guidelines we also recommended the same /=50 years). The landmark VA Cooperative Hypertension Study of the 1960s proved the treatment of (diastolic) hypertension is beneficial, SHEP in 1991 proved treating isolated systolic hypertension (>/=160 mm Hg) is beneficial and both changed subsequent guidelines as single trials. I also believe the accompanying meta-analysis supports treating to lower levels despite including many trials with much higher BP goals. The 2016 Canadian and Australian hypertension guidelines have already recommended lower goals in certain high-risk groups and a guideline sponsored by ACC, AHA, ASH, and many other organizations is due out later this year. Hopefully, VA/DoD guidelines will also be updated subsequently as well. I would encourage clinicians to now consider treating patients at high risk for cardiovascular disease (at least those who are similar to SPRINT participants) to systolic BP levels well below 150 mm Hg.

  • William C. Cushman, MD says:

    I was one of the lead investigators for ACCORD and SPRINT and am the principal investigator overseeing the VA clinical center networks for those trials. I was also the VA Champion for the 2014 VA/DoD Hypertension guidelines and on the 2014 JNC 8 Hypertension Guideline panel – in both of those guidelines we also recommended the same /=50 years). The landmark VA Cooperative Hypertension Study of the 1960s proved the treatment of (diastolic) hypertension is beneficial, SHEP in 1991 proved treating isolated systolic hypertension (>/=160 mm Hg) is beneficial and both changed subsequent guidelines as single trials. I also believe the accompanying meta-analysis supports treating to lower levels despite including many trials with much higher BP goals. The 2016 Canadian and Australian hypertension guidelines have already recommended lower goals in certain high-risk groups and a guideline sponsored by ACC, AHA, ASH, and many other organizations is due out later this year. Hopefully, VA/DoD guidelines will also be updated subsequently as well. I would encourage clinicians to now consider treating patients at high risk for cardiovascular disease (at least those who are similar to SPRINT participants) to systolic BP levels well below 150 mm Hg.

  • Mark McConnell, M.D. says:

    Will VA Performance Measures catch up with evidence and allow home BP readings to “count” when assessing control? I suspect there is a lot of potential over-treatment caused by chasing only “in office” readings.


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