Amir Qaseem, MD, PhD, MHA; Timothy J. Wilt, MD, MPH; Robert Rich, MD; Linda L. Humphrey, MD, MPH; Jennifer Frost, MD; Mary Ann Forciea, MD; for the Clinical Guidelines Committee of the American College of Physicians and the Commission on Health of the Public and Science of the American Academy of Family Physicians (*)
Note: Clinical practice guidelines are “guides” only and may not apply to all patients and all clinical situations. Thus, they are not intended to override clinicians' judgment. All ACP clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.
Disclaimer: The authors of this article are responsible for its contents, including any clinical or treatment recommendations.
Financial Support: Financial support for the development of this guideline comes exclusively from the ACP operating budget.
Disclosures: Authors followed the policy regarding conflicts of interest described at www.annals.org/article.aspx?articleid=745942. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-1785. All financial and intellectual disclosures of interest were declared and potential conflicts were discussed and managed. Drs. Boyd, Kansagara, and Vijan participated in the discussion for this guideline, but they were recused from voting on the recommendations because of active indirect intellectual conflicts. Dr. Manaker participated in the discussion for this guideline but was recused from voting on the recommendations because of an active indirect financial conflict. A record of disclosures of interest and management of conflicts of is kept for each Clinical Guidelines Committee meeting and conference call and can be viewed at www.acponline.org/clinical_information/guidelines/guidelines/conflicts_cgc.htm.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Requests for Single Reprints: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106-1572; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Qaseem: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106-1572.
Dr. Wilt: Minneapolis Veterans Affairs Medical Center, One Veterans Drive (111-0), Minneapolis, MN, 55417.
Dr. Rich: Bladen Medical Associates, 300 A East McKay Street, PO Box 517, Elizabethtown, NC 28337.
Dr. Humphrey: Veterans Affairs Portland Health Care System, 3710 SW U.S. Veterans Hospital Road, Portland, OR 97201.
Dr. Frost: American Academy of Family Physicians, 11400 Tomahawk Creek Parkway, Leawood, KS 66211.
Dr. Forciea: University of Pennsylvania Health System, 3615 Chestnut Street, Philadelphia, PA 19104.
Author Contributions: Conception and design: A. Qaseem, L.L. Humphrey.
Analysis and interpretation of the data: A. Qaseem, T.J. Wilt, L.L. Humphrey, J. Frost, M.A. Forciea.
Drafting of the article: A. Qaseem, T.J. Wilt, R. Rich, L.L. Humphrey, J. Frost.
Critical revision of the article for important intellectual content: A. Qaseem, T.J. Wilt, R. Rich, L.L. Humphrey, J. Frost, M.A. Forciea.
Final approval of the article: A. Qaseem, T.J. Wilt, R. Rich, L.L. Humphrey, J. Frost, M.A. Forciea.
Statistical expertise: A. Qaseem, T.J. Wilt.
Administrative, technical, or logistic support: A. Qaseem.
The American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) jointly developed this guideline to present the evidence and provide clinical recommendations based on the benefits and harms of higher versus lower blood pressure targets for the treatment of hypertension in adults aged 60 years or older.
This guideline is based on a systematic review of published randomized, controlled trials for primary outcomes and observational studies for harms only (identified through EMBASE, the Cochrane Database of Systematic Reviews, MEDLINE, and ClinicalTrials.gov), from database inception through January 2015. The MEDLINE search was updated through September 2016. Evaluated outcomes included all-cause mortality, morbidity and mortality related to stroke, major cardiac events (fatal and nonfatal myocardial infarction and sudden cardiac death), and harms. This guideline grades the evidence and recommendations using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) method.
The target audience for this guideline includes all clinicians, and the target patient population includes all adults aged 60 years or older with hypertension.
ACP and AAFP recommend that clinicians initiate treatment in adults aged 60 years or older with systolic blood pressure persistently at or above 150 mm Hg to achieve a target systolic blood pressure of less than 150 mm Hg to reduce the risk for mortality, stroke, and cardiac events. (Grade: strong recommendation, high-quality evidence). ACP and AAFP recommend that clinicians select the treatment goals for adults aged 60 years or older based on a periodic discussion of the benefits and harms of specific blood pressure targets with the patient.
ACP and AAFP recommend that clinicians consider initiating or intensifying pharmacologic treatment in adults aged 60 years or older with a history of stroke or transient ischemic attack to achieve a target systolic blood pressure of less than 140 mm Hg to reduce the risk for recurrent stroke. (Grade: weak recommendation, moderate-quality evidence). ACP and AAFP recommend that clinicians select the treatment goals for adults aged 60 years or older based on a periodic discussion of the benefits and harms of specific blood pressure targets with the patient.
ACP and AAFP recommend that clinicians consider initiating or intensifying pharmacologic treatment in some adults aged 60 years or older at high cardiovascular risk, based on individualized assessment, to achieve a target systolic blood pressure of less than 140 mm Hg to reduce the risk for stroke or cardiac events. (Grade: weak recommendation, low-quality evidence). ACP and AAFP recommend that clinicians select the treatment goals for adults aged 60 years or older based on a periodic discussion of the benefits and harms of specific blood pressure targets with the patient.
Table. The American College of Physicians' Guideline Grading System*
Summary of the American College of Physicians and American Academy of Family Physicians joint guideline on pharmacologic treatment of hypertension in adults aged 60 years or older to higher versus lower blood pressure targets.
ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin-receptor blocker; BP = blood pressure; SBP = systolic blood pressure.
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Dr. Doreen M. Rabi, Dr. Stella S. Daskalopoulou, Dr Alexander A. Leung, Dr. George Dresser, Dr. Raj Padwal, Dr. Nadia Khan
January 24, 2017
Hypertension Canada's Response to ACP/AAFP Guidelines
As contributors to Hypertension Canada’s clinical practice guidelines, we have concerns about the American College of Physicians and the American Association of Family Physicians (ACP/AAFP) new recommendations on hypertension management in persons over 60-years (1). The ACP/AAFP recommendations were based on a systematic review by Weiss et al. evaluating the impact of more vs. less intensive SBP-lowering on cardiovascular outcomes in adults over 60-years (2). While the study was well done, there were notable limitations. Namely that data were pooled by strategy (i.e., intensive vs. less intensive) rather than specific targets, blood pressure measurement methods were inconsistent across included studies, and the analytic approach to important sub-populations was inconsistent (diabetes and non-diabetes trials were pooled while stroke trials were analyzed separately). Furthermore, the Action to Control Cardiovascular Disease in Diabetes (3) trial was pooled despite evidence of an interaction effect of SBP treatment and glycemic control. Notwithstanding these limitations, Weiss et al. demonstrated a significant reduction in stroke with more intensive SBP-lowering (relative risk=0.79, 95% confidence interval=0.59-0.99). The point estimates for all-cause mortality and cardiac events favored intensive SBP-lowering but the confidence intervals were wide. A larger review (n=42,000 individuals) demonstrated unambiguous benefit with intensive BP-lowering strategies on cardiovascular outcomes among older (≥62-years) individuals (4). Another meta-analysis of 123 hypertension trials noted a linear relationship between SBP-lowering and cardiovascular risk reduction, with every 10mmHg SBP reduction being associated with a decrease in cardiovascular events, stroke, and all-cause mortality by 20% 27%, and 13%, respectively (5). These meta-analyses suggest that lower SBP is associated with incrementally greater benefit, regardless of age. And among the elderly, the Systolic Blood Pressure Intervention Trial (SPRINT) indicates that intensive systolic blood pressure (SBP)-lowering (<120 mmHg, measured by automated method) leads to significant reductions in cardiovascular outcomes when compared to standard SBP-lowering (<140 mmHg), especially in the elderly (6), thus providing high-quality evidence for a specific target in older adults.Safety concerns in older patients are understandable. While institutionalized elderly and those with severe orthostasis were excluded, SPRINT supports lower SBP targets even in frail individuals (6). While serious adverse-events were overall higher in the elderly SPRINT sub-population, the adverse-event rate did not differ by treatment assignment (intensive: 48.4%; standard: 48.3%) (6). Importantly, no significant increase in falls, fractures or adverse renal outcomes with intensive vs. less intensive strategy was noted in the Weiss et al. review. Compelling evidence supports lower SBP targets in older patients. Intensive treatment guided by accurate blood pressure measurement will produce greater outcome reductions in older compared to younger patients. We commend the ACP/AAFP for encouraging meaningful communication with patients and the promotion of patient-centered treatment goals, but the best available evidence should also inform decisions.Sincerely,Dr. Doreen M. Rabi, Hypertension Canada Guidelines Task Force ChairDr. Stella S. Daskalopoulou, Hypertension Canada Central Review Committee ChairDr. Alexander A. Leung, Hypertension Canada Guidelines Task Force Dr. George Dresser, Hypertension Canada Guidelines Task ForceDr. Raj Padwal, Hypertension Canada Board MemberDr. Nadia Khan, Hypertension Canada PresidentReferences1) Qaseem A, Wilt TJ, Rich R, Humphrey LL, Frost J, Forciea MA; for the Clinical Guidelines 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 to Higher Versus Lower Blood Pressure Targets: A Clinical Practice Guideline From the American College of Physicians and the American Academy of Family Physicians. Annals of Internal Medicine, 2017 January 17.2) Weiss J, MD, Freeman M, Low A, Fu R, Kerfoot A, Paynter R, et al. Benefits and Harms of Intensive Blood Pressure Treatment in Adults Aged 60 Years or Older: A Systematic Review and Meta-analysis. Annals of Internal Medicine, 2017 Jan 17.3) ACCORD Study Group, Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010;362:1575-85.4) Xie X, Atkins E, Lv J, Bennett A, Neal B, Ninomiya T, et al. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. Lancet. 2016;387:435-43.5) Ettehad D, Emdin CA, Kiran A, Anderson SG, Callender T, Emberson J, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016;387:957-67.6) Williamson JD, Supiano MA, Applegate WB, Berlowitz DR, Campbell RC, Chertow GM, et al; SPRINT Research Group. Intensive vs. Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial. JAMA. 2016;315:2673-82..
William C. Cushman, MD, Karen C. Johnson, MD, MPH, William B. Applegate, MD, MPH, Jeffrey A. Cutler, MD, MPH
Memphis Veterans Affairs Medical Center, University of Tennessee Health Science Center, Wake Forest University, National Heart, Lung and Blood Institute, National Institutes of Health
February 15, 2017
Conflict of Interest:
All authors are investigators in the Systolic Blood Pressure Intervention Trial (SPRINT); Dr. Cushman is an uncompensated consultant for Takeda and has an institutional grant with Eli Lilly. The content is solely the responsibility of the authors and does not necessarily represent the official views of the SPRINT Research Group, NIH, the U.S. Department of Veterans Affairs, or the United States Government.
Systolic blood goals pressure in older adults with hypertension
We read with interest the ACP-AAFP hypertension guidelines.(1) While we agree there is very strong evidence to support a systolic blood pressure goal <150 mm Hg in older hypertensive adults, we believe the guideline committee underestimated the strength of evidence for <120 mm Hg, based on the Systolic Blood pressure Intervention Trial (SPRINT), which demonstrated a highly significant reduction in mortality (-27%) and cardiovascular events (-25%).(2) In the accompanying meta-analysis,(3) for the group of trials with baseline blood pressure <160 mm Hg, both mortality and cardiac events were significantly reduced. However, the inclusion of trials in this meta-analysis that were clearly underpowered for major cardiovascular or mortality outcomes is questionable. In the supplement of the meta-analysis, for those trials that achieved a systolic blood pressure <140 mm Hg, total mortality, stroke, and cardiovascular events are all significantly reduced. We believe a meta-analysis including adequately powered trials that tested a systolic blood pressure goal <120-130 mm Hg would also demonstrate significant benefit.
Therefore, the guidelines’ failure to recommend a systolic blood pressure goal <120-130 mm Hg was apparently because there was only one definitive trial (SPRINT). (2) We believe one high quality large trial should be sufficient to inform guideline recommendations. For example, when the Veterans Administration Cooperative Hypertension Study demonstrated benefit for treating diastolic blood pressure ≥90 mm Hg in 1970,(4) guideline committees recommended treatment of diastolic hypertension and clinical practice changed. Similarly, after the Systolic Hypertension in the Elderly Program (SHEP) trial was reported in 1991,(5) it was considered by most as definitive and guidelines then recommended treating systolic blood pressure. Although subsequent trials addressed similar questions, they were often considered by many as unethical to conduct, since benefit had already been proven for the control groups. Therefore, the desire for guideline committees to have multiple trials showing the same thing for a “strong” recommendation is questionable and does not follow previous hypertension guideline development procedures. One could also question the ethical stance of not treating populations similar to SPRINT to a systolic BP <120 mm Hg.
We would urge clinicians to consider treating older hypertensive patients at higher risk for cardiovascular disease, at least those similar to the SPRINT trial participants, to a lower level of systolic blood pressure than is recommended by the ACP-AAFP hypertension guidelines, and we would recommend guidelines now reflect the strength of evidence from SPRINT.
1. Qaseem A, Wilt TJ, Rich R, Humphrey LL, Frost J, Forciea MA; Clinical Guidelines 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 to Higher Versus Lower Blood Pressure Targets: A Clinical Practice Guideline From the 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]
2. Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, et al; SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med. 2015;373:2103-16. doi:10.1056/NEJMoa1511939
3. Weiss J, Freeman M, Low A, Fu R, Kerfoot A, Paynter R, et al. 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. [Epub ahead of print]. doi:10.7326/M16-1754
4. Veterans Administration Cooperative Study Group on Antihypertensive Agents. Effects of treatment on morbidity in hypertension. II. Results in patients with diastolic blood pressure averaging 90 through 114 mm Hg. JAMA. 1970;17;213:1143-52.
5. SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA. 1991;265:3255-64.
Devan Kansagara, MD, MCR, Timothy J. Wilt, MD, MPH, Jennifer Frost, MD, Amir Qaseem, MD, PhD
March 8, 2017
IN RESPONSE: We thank Drs. Rabi and colleagues for their comments and careful review of the guideline and accompanying systematic review. ACP and AAFP Clinical Guidelines are based on best available evidence (1) and meet the GIN/IOM Standards for Guidelines (2, 3). We wholeheartedly agree that there are important differences among the studies addressing hypertension treatment goals. Drs. Rabi and colleagues point out that blood pressure measurement techniques are one source of clinical heterogeneity amongst the studies, but there are many other dramatic differences among the studies which also need to be considered. We have read in detail the two meta-analyses mentioned (4, 5), both of which are acknowledged and discussed in our evidence review (1). There are important differences between these meta-analyses and our evidence review, and there are trade-offs in any meta-analytic approach. Very large meta-analyses have the power to reveal important findings, but can also obscure differences across studies and hamper application of the evidence to clinical practice. For example, the vast majority of studies suggesting benefit from antihypertensive treatment in patients with baseline blood pressure < 140 mmHg in the Ettehad review included patients with heart failure or acute myocardial infarction. The benefit of antihypertensive medications in these patients is not in dispute and is not necessarily derived from lowering blood pressure. Since the clinical questions addressed by the evidence review and the ACP/AAFP guideline (1, 6) centered on blood pressure treatment targets rather than clinical management of distinct clinical conditions (such as acute myocardial infarction or congestive heart failure), we excluded studies of these patient populations. We disagree with Drs. Rabi and colleagues that the data support a broad-based systolic treatment target of < 130 mmHg. We agree that a lower blood pressure target may be appropriate for older patients at high cardiovascular risk. The evidence in support of a lower treatment target largely comes from the SPRINT trial (7), though results have not been consistent across studies. As the review and guideline report, there are several potential reasons for the inconsistencies. A weak recommendation in support of a lower treatment target in specific patient populations is not a recommendation against more aggressive treatment in these populations. Rather, a weak recommendation emphasizes the need for individual decision making and accounting for the magnitude of benefits, harms, and treatment burden; it may still support more aggressive treatment in some patients. Devan Kansagara, MD, MCRPortland Evidence-based Synthesis Program and Portland VA Medical CenterTimothy J. Wilt, MD, MPHMinneapolis VA Center for Chronic Disease Outcomes Research and University of Minnesota School of MedicineJennifer Frost, MDAmerican Academy of Family Physicians; Leawood, KansasAmir Qaseem, MD, PhDAmerican College of Physicians; Philadelphia, PennsylvaniaReferences1. Weiss J, Freeman M, Low A, et al. Benefits and harms of intensive blood pressure treatment in adults aged 60 years or older: A systematic review and meta-analysis. Annals of Internal Medicine. 2017.2. Qaseem A, Forland F, Macbeth F, et al. Guidelines international network: Toward international standards for clinical practice guidelines. Annals of Internal Medicine. 2012;156(7):525-31.3. Institute of MedicineClinical Practice Guidelines We Can Trust.Washington, DC. National Academies Pr 2011.4. Ettehad D, Emdin CA, Kiran A, Anderson SG, Callender T, Emberson J, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. The Lancet;387(10022):957-67.5. Xie X, Atkins E, Lv J, Bennett A, Neal B, Ninomiya T, et al. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. The Lancet;387(10017):435-43.6. Qaseem A, Wilt TJ, Rich R, et al. Pharmacologic treatment of hypertension in adults aged 60 years or older to higher versus lower blood pressure targets: A clinical practice guideline from the american college of physicians and the american academy of family physicians. Annals of Internal Medicine. 2017.7. Williamson JD, Supiano MA, Applegate WB, et al. Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ≥75 years: A randomized clinical trial. JAMA. 2016.
Qaseem A, Wilt TJ, Rich R, Humphrey LL, Frost J, Forciea MA, et al. Pharmacologic Treatment of Hypertension in Adults Aged 60 Years or Older to Higher Versus Lower Blood Pressure Targets: A Clinical Practice Guideline From the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2017;166:430-437. doi: 10.7326/M16-1785
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Published: Ann Intern Med. 2017;166(6):430-437.
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