Adult Hypertension Clinical Practice Guidelines

Transcription

1 NATIONAL CLINICAL PRACTICE GUIDELINES Adult Hypertension Clinical Practice Guidelines Reviewed/Approved by the National Guideline Directors: March 2016 Next Review/Approval: March 2018 Developed by the National Hypertension Guideline Development Team Disclaimer This guideline is informational only. It is not intended or designed as a substitute for the reasonable exercise of independent clinical judgment by practitioners, considering each patient s needs on an individual basis. Guideline recommendations apply to populations of patients. Clinical judgment is necessary to design treatment plans for individual patients. 1

2 Table of Contents Table of Contents... 2 Adult Hypertension Clinical Practice Guidelines... 3 Topic: Treatment Initiation and Blood Pressure Targets... 3 Appendix A: National Hypertension Guideline Development Team... 6 Appendix B1: Crosswalk of KP Recommendations... 7 Appendix B2: Crosswalk of Recommendation Ratings Appendix C: Rationale for KP-Modified Recommendation Topic: Diastolic Blood Pressure Targets Topic: Systolic Blood Pressure Targets Topic: Hypertension Treatment in patients with CKD Topic: Blood Pressure Targets in the Diabetic Population 60 years Appendix D: Systematic Review AGREE II Summary Key Questions Inclusion/Exclusion Criteria References

3 Adult Hypertension Clinical Practice Guidelines Purpose This guideline was developed by the KP National Hypertension Guideline Development Team (GDT) (Appendix A) to assist primary care physicians and other health care professionals in the outpatient treatment of hypertension in non-pregnant adults aged 18 and older. Background This guideline is an update of the 2014 KP National Clinical Practice Guideline for Hypertension. It is based on the 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults Report from the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) 1. Major changes in this update are: There are no significant clinical content changes to the Hypertension Guideline. The previous 2014 guideline has been updated to include rationale tables for several recommendations to provide greater transparency and explanation regarding recommendation strength. The recommendations crosswalk (Appendix B1) compares the current recommendations with previous ones in detail. Methods KP National Guideline Program follows a methodology 2 that incorporates well-established scientific frameworks to critically appraise evidence and evaluate external guidelines. Recommendations consider the balance between desirable and undesirable effects, quality of evidence, patient values and preferences, and resource use 2. The guidelines in this report have evolved from multiple rating systems. Recommendations are accompanied by language that clinicians can use to weigh the strength of the recommendation against the individual patient situation (i.e., strong/weak recommendation, consensus and expert opinion-based, and evidence grades). The KP National Guideline methodology, updated most recently in 2016, streamlines ratings to strong, weak, or no recommendation (i.e., when evidence is reviewed but is inadequate to drive a recommendation for or against an intervention). Appendix B2 provides a crosswalk to interpret the recommendation language used in this guideline; the Report from the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) uses a different grading system than the KP methodology. Recommendations that were adapted with some modifications are discussed in Appendix C. Additional discussion of the evidence review in the Report from the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) is available in Appendix D. Recommendations Topic: Treatment Initiation and Blood Pressure Targets In the general population aged 60 years, initiate pharmacologic treatment to lower blood pressure (BP) at systolic blood pressure (SBP) 150mm Hg or diastolic blood pressure (DBP) 90 mm Hg and treat to a goal SBP < 150 mm Hg and goal DBP < 90 mm Hg. (Strong Recommendation) In the general population aged 60 years, consider not adjusting treatment if pharmacologic treatment for high BP results in lower achieved SBP (e.g.,< 140mmHg) and treatment is well tolerated and without adverse effects on health or quality of life. 3

4 In the general population < 60 years, initiate pharmacologic treatment to lower BP at DBP 90mmHg and treat to a goal DBP < 90mmHg. (Strong Recommendation) This is an adapted recommendation. In the general population < 60 years, initiate pharmacologic treatment to lower BP at SBP 140mmHg and treat to a goal SBP < 140mmHg. (Strong recommendation) This is an adapted recommendation. In the population aged 60 years with chronic kidney disease (CKD), consider initiating pharmacologic treatment at SBP 140mmHg or DBP 90 mmhg and treat to goal SBP < 140mmHg and goal DBP < 90mmHg. ** This is an adapted recommendation. **When weighing the risks and benefits of a lower BP goal for people aged 70 years with estimated GFR < 60 ml/min/ 1.73m2, antihypertensive treatment should be individualized, taking into consideration factors such as frailty, comorbidities, albuminuria, and estimation of non-age related egfr decline (for example egfr + (age/2) < 85). In the population aged 60 years with diabetes, initiate pharmacologic treatment to lower BP at SBP 140mmHg or DBP 90mmHg and treat to a goal SBP < 140mmHg and goal DBP < 90mmHg. (Strong Recommendation) This is an adapted recommendation. In the general non-african American population, including those with diabetes, consider initiating antihypertensive treatment to include a thiazide-type diuretic, calcium channel blocker (CCB), angiotensin-converting enzyme inhibitor (ACEI), or angiotensin receptor blocker (ARB). In the general African American population, including those with diabetes, consider initiating initial antihypertensive treatment to include a thiazide-type diuretic or CCB. In the population aged 18 years with CKD, consider initial (or add-on) antihypertensive treatment that includes an ACEI or ARB to improve kidney outcomes. This applies to all CKD patients with hypertension regardless of race or diabetes status. The main objective of hypertension treatment is to attain and maintain goal BP. If goal BP is not reached within a month of treatment, consider increasing the dose of the initial drug or add a second drug from one of the thiazide-type diuretic, CCB, ACEI, or ARB classes. The clinician should consider continued assessment of BP and adjust the treatment regimen until goal BP is reached. If goal BP cannot be reached with 2 drugs, consider adding and titrating a third drug from the indicated classes. Consider avoiding combined use of an ACEI and an ARB. If goal BP cannot be reached using only the drugs in these classes because of contraindications or the need for more than 3 drugs to reach goal BP, antihypertensive drugs from other classes can be considered. Consider referral to a hypertension specialist for 4

5 patients in whom goal BP cannot be attained using the above strategy or for the management of complicated patients for whom additional clinical consultation is needed. The complete guideline and supplemental document from the report from the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) can be accessed below: The report from the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) James PA, Oparil S, Carter BL, et al Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014; 311(5): Supplemental Document for the report from the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) Appendix to the JNC 8 Guideline 5

6 Appendix A: National Hypertension Guideline Development Team Lead Team: Joseph Young, MD, Clinical Lead, Internal Medicine, KP Northern California Marc Jaffe, MD, ICVH Clinical Lead, Endocrinology, KP Northern California Richard A. Mularski, MD, MSHS, MCR, FCCP, Methodologist, Pulmonary and Critical Care, KP Northwest Qiana R. Amos, MPH, Sr. Consultant, CMI Evidence Services Guideline Development Team Debbi Baker, Sr. Mgr., Clinical Pharmacy Services, KP Georgia Gary Besinque, PharmD, Pharmacy, Southern California (Distribution List) Jeffrey Brettler, MD, Internal Medicine, KP Southern California Anna Cosyleon, MD, Internal Medicine, KP Colorado Jim Dudl, MD, Endocrinology, Program Office Syed Elham, MD, Internal Medicine, KP Georgia John Golden MD, Cardiology, KP MAS Joel Handler, MD, Internal Medicine, KP Southern California Steven Hong, MD, Cardiology, KP Hawaii Ali Rahimi, MD, Cardiology, KP Georgia Stephanie Schneider, Prevention Specialist, KP Colorado Sheila Stadler, PharmD, Pharmacy, KP Colorado Ross Takara, Sr. Director, Pharmacy, KP Hawaii Christopher Thomas, MD, Nephrology, KP Northwest Kory Vanderschaaf, PharmD, Pharmacy, KP Colorado Joel Whittaker, MPH, Sr. Consultant, Southern California Evidence-Based Medicine Services Click here for more information on the Kaiser Permanente National Guideline Program Process and Methodology for Systematic Development of Clinical Practice Recommendations 6

7 Appendix B1: Crosswalk of KP Recommendations 2016 KP Recommendation Source Recommendation(s) * KP GDT Decision Justification Treatment Initiation and Blood Pressure Targets In the general population aged 60 years, initiate pharmacologic treatment to lower blood pressure (BP) at systolic blood pressure (SBP) 150mm Hg or diastolic blood pressure (DBP) 90 mm Hg and treat to a goal SBP < 150 mm Hg and goal DBP < 90 mm Hg. (Strong Recommendation) The KP 2014 guideline recommends: In the general population aged 60 years, initiate pharmacologic treatment to lower blood pressure (BP) at systolic blood pressure (SBP) 150mm Hg or diastolic blood pressure (DBP) 90 mm Hg and treat to a goal SBP < 150 mm Hg and goal DBP < 90 mm Hg. (Strong Recommendation) No changes from 2014 KP guideline Approved by GDT with no additional changes needed. In the general population aged 60 years, consider not adjusting treatment if pharmacologic treatment for high BP results in lower achieved SBP (e.g.,<140 mm Hg) and treatment is well tolerated and without adverse effects on health or quality of life. The KP 2014 guideline recommends: In the general population aged 60 years, if pharmacologic treatment for high BP results in lower achieved SBP (e.g., <140 mm Hg) and treatment is well tolerated and without adverse effects on health or quality of life, treatment does not need to be adjusted. (Expert Opinion Grade E) No changes from 2014 KP guideline Approved by GDT with no additional changes needed. In the general population < 60 years, initiate pharmacologic treatment to lower BP at DBP 90mmHg and treat to a goal DBP < 90mmHg. (Strong Recommendation) The KP 2014 guideline recommends: In the general population < 60 years, initiate pharmacologic treatment to lower BP at DBP 90mmHg and treat to a goal DBP < 90mmHg. Adapted with minor changes See rationale for KP-modified recommendations (App. D) * Various recommendation rating and evidence grading systems are used; see Appendix B2 for a crosswalk with KP recommendation ratings. 7

8 2016 KP Recommendation Source Recommendation(s) * (For ages years, Strong Recommendation Grade A; For ages years, Expert Opinion Grade E) KP GDT Decision Justification In the general population < 60 years, initiate pharmacologic treatment to lower BP at SBP 140mmHg and treat to a goal SBP < 140mmHg. (Strong recommendation) The KP 2014 guideline recommends: In the general population <60 years, initiate pharmacologic treatment to lower BP at SBP 140 mm Hg and treat to a goal SBP <140 mm Hg. (Expert Opinion Grade E) Adapted with minor changes See rationale for KP-modified recommendations (App. D) In the population aged 60 years with chronic kidney disease (CKD), consider initiating pharmacologic treatment at SBP 140mmHg or DBP 90 mmhg and treat to goal SBP <140mmHg and goal DBP <90mmHg. **. **When weighing the risks and benefits of a lower BP goal for people aged 70 years with estimated GFR < 60 ml/min/ 1.73m 2, antihypertensive treatment should be individualized, taking into consideration factors such as frailty, comorbidities, albuminuria, and estimation of non-age related egfr decline (for example egfr + (age/2) < 85). The KP 2014 guideline recommends: In the population aged 18 years with chronic kidney disease (CKD), initiate pharmacologic treatment to lower BP at SBP 140mmHg or DBP 90mmHg and treat to goal SBP < 140mmHg and goal DBP < 90mmHg. (Expert Opinion Grade E) Adapted with minor changes See rationale for KP-modified recommendations (App. D) 8

9 2016 KP Recommendation Source Recommendation(s) * KP GDT Decision Justification In the population aged 60 years with diabetes, initiate pharmacologic treatment to lower BP at SBP 140mmHg or DBP 90mmHg and treat to a goal SBP <140mmHg and goal DBP <90mmHg. (Strong Recommendation) The KP 2014 guideline recommends: In the population aged 18 years with diabetes, initiate pharmacologic treatment to lower BP at SBP 140mmHg or DBP 90mmHg and treat to a goal SBP <140 mm Hg and goal DBP <90 mm Hg. (Expert Opinion Grade E) Adapted with minor changes See rationale for KP-modified recommendations (App. D) In the general non-african American population, including those with diabetes, consider initiating antihypertensive treatment to include a thiazide-type diuretic, calcium channel blocker (CCB), angiotensin-converting enzyme inhibitor (ACEI), or angiotensin receptor blocker (ARB). The KP 2014 guideline recommends: In the general nonblack population, including those with diabetes, initial antihypertensive treatment should include a thiazide-type diuretic, calcium channel blocker (CCB), angiotensin-converting enzyme inhibitor (ACEI), or angiotensin receptor blocker (ARB). (Moderate Recommendation Grade B) No changes from 2014 KP guideline Approved by GDT with no additional changes needed. In the general African American population, including those with diabetes, consider initiating initial antihypertensive treatment to include a thiazide-type diuretic or CCB. The KP 2014 guideline recommends: In the general black population, including those with diabetes, initial antihypertensive treatment should include a thiazidetype diuretic or CCB. (For general black population: Moderate Recommendation Grade B; for black patients with diabetes: Weak Recommendation Grade C) No changes from 2014 KP guideline Approved by GDT with no additional changes needed. In the population aged 18 years with CKD, consider initial (or add-on) antihypertensive treatment that includes an ACEI or ARB to improve kidney outcomes. This applies to all CKD patients The KP 2014 guideline recommends: In the population aged 18 years with CKD, initial (or add-on) antihypertensive treatment should include an ACEI or ARB to improve kidney outcomes. This applies to all No changes from 2014 KP guideline Approved by GDT with no additional changes needed. 9

10 2016 KP Recommendation Source Recommendation(s) * KP GDT Decision Justification with hypertension regardless of race or diabetes status. CKD patients with hypertension regardless of race or diabetes status. (Moderate Recommendation Grade B) The main objective of hypertension treatment is to attain and maintain goal BP. If goal BP is not reached within a month of treatment, consider increasing the dose of the initial drug or add a second drug from one of the thiazide-type diuretic, CCB, ACEI, or ARB classes. The clinician should consider continued assessment of BP and adjust the treatment regimen until goal BP is reached. If goal BP cannot be reached with 2 drugs, consider adding and titrating a third drug from the indicated classes. Consider avoiding combined use of an ACEI and an ARB. If goal BP cannot be reached using only the drugs in these classes because of contraindications or the need for more than 3 drugs to reach goal BP, antihypertensive drugs from other classes can be considered. Consider referral to a hypertension specialist for patients in whom goal BP cannot be attained using the above strategy or for the management of complicated patients for whom additional clinical consultation is needed. The KP 2014 guideline recommends: The main objective of hypertension treatment is to attain and maintain goal BP. If goal BP is not reached within a month of treatment, increase the dose of the initial drug or add a second drug from one of the classes in recommendation6 (thiazide-type diuretic, CCB, ACEI, or ARB). The clinician should continue to assess BP and adjust the treatment regimen until goal BP is reached. If goal BP cannot be reached with 2 drugs, add and titrate a third drug from the list provided. Do not use an ACEI and an ARB together in the same patient. If goal BP cannot be reached using only the drugs in recommendation 6 because of a contraindication or the need to use more than 3 drugs to reach goal BP, antihypertensive drugs from other classes can be used. Referral to a hypertension specialist may be indicated for patients in whom goal BP cannot be attained using the above strategy or for the management of complicated patients for whom additional clinical consultation is needed. (Expert Opinion Grade E) No changes from 2014 KP guideline Approved by GDT with no additional changes needed. 10

11 Appendix B2: Crosswalk of Recommendation Ratings JNC 8 1 Grading System Kaiser Permanente 2 Grading System Grade Strong Recommendation (Grade A) Strength of recommendation There is high certainty based on evidence that the net benefit is substantial Grade Strong Intended action Strong affirmative Provide the intervention. Most individuals should receive the intervention; only a small proportion will not want the intervention. Recommendation language: start, initiate, prescribe, treat, provide, offer, evaluate Recommendation against (Grade D) Expert Opinion (Grade E) There is at least moderate certainty based on evidence that it has no net benefit or that risks/harms outweigh benefits. ( There is insufficient evidence or evidence is unclear or conflicting, but this is what the committee recommends. ) Strong negative Do not provide the intervention. Most individuals should not receive the intervention; only a small proportion will want the intervention. Recommendation language: do not start, initiate, prescribe treat, provide, offer, evaluate Moderate Recommendation (Grade B) Net benefit is unclear. Balance of benefits and harms cannot be determined because of no evidence, insufficient evidence, unclear evidence, or conflicting evidence, but the committee thought it was important to provide clinical guidance and make a recommendation. Further research is recommended in this area. There is moderate certainty based on evidence that the net benefit is moderate to substantial or there is high certainty that the net benefit is moderate. Weak Weak affirmative Assist each patient in making a management decision consistent with personal values and preferences. The majority of individuals in this situation will want the intervention, but many will not. Different choices will be appropriate for different patients. Recommendation language: consider starting, initiating, prescribing, treating, providing, offering, evaluating Weak Recommendation (Grade C) There is at least moderate certainty based on evidence that there is a small net benefit. Weak negative Assist each patient in making a management decision consistent with personal values and preferences. The majority of individuals in this situation will not want the intervention, but many will. The evidence quality rating system used in this guideline was developed by the National Heart, Lung, and Blood Institute s (NHLBI s) Evidence-Based Methodology Lead (with input from NHLBI staff, external methodology team, and guideline panels and work groups) for use by all the NHLBI CVD guideline panels and work groups during this project. As a result, it includes the evidence quality rating for many types of studies, including studies that were not used in this guideline. Additional details regarding the evidence quality rating system are available in the online Supplement. 11

12 JNC 8 1 Grading System Kaiser Permanente 2 Grading System Grade No recommendation for or against (Grade N) Strength of recommendation ( There is insufficient evidence or evidence is unclear or conflicting. ) Net benefit is unclear. Balance of benefits and harms cannot be determined because of no evidence, insufficient evidence, unclear evidence, or conflicting evidence, and the committee thought no recommendation should be made. Further research is recommended in this area. Grade No recommendation for or against Intended action Different choices will be appropriate for different patients. Recommendation language: consider stopping, consider not starting, initiating, prescribing, treating, providing, offering, evaluating Given that the balance between desirable and undesirable effects, the evidence quality, the values & preferences, and the resource allocation implications of an intervention do not drive a recommendation in one particular direction, recommendations will be made at the discretion of the individual clinician. Recommendation language: No recommendation for or against 12

13 Appendix C: Rationale for KP-Modified Recommendation Topic: Diastolic Blood Pressure Targets Recommendation In the general population <60 years, initiate pharmacologic treatment to lower BP at DBP 90mmHg and treat to a goal DBP <90mmHg. (Strong Recommendation) Basis of Recommendation There is strong evidence for this recommendation for ages 30 to 59. There is insufficient evidence to determine an optimal DBP goal in people ages 18 to 29. No high quality outcome trials assessing optimal diastolic blood pressure targets included large numbers of adults ages 18 to 29. The balance between benefit and harm from a DBP goal lower than <90 for ages 18 to 29 cannot be determined, however expert opinion favors the use of this goal, and risk of harm is expected to be low. Despite the low quality of evidence, and the unknown balance of desirable and undesirable effects, a strong recommendation is warranted based on the discourse of the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) and its implications for health care delivery implementation. GRADE criteria Balance of desirable and undesirable effects Quality of Evidence Values and Preferences Resource Implications GRADE assessment Outcome evidence for patients aged 30 to 59 demonstrates that lower DBP is associated with lower rates of CVD. However for patients 18 to 29 the optimal goal DBP has not been determined in well conducted randomized controlled trials. The balance between risks of overtreatment of younger individuals versus the potential benefits of a lower DBP target is unknown, but expected to be significant. Strong for ages 30 to 59. For ages 18 to 29- Expert opinionwhile there is insufficient/unclear evidence we agree with the discourse of the JNC 8 committee and its recommendations 1. This recommendation places a low value on preventing undertreatment of younger people and a higher value on the potential high expected reduction of CV events with DBP targets. Values and preferences were derived by polling the GDT. Uncertainty around and variability of values and preferences are estimated to be high, regarding hypertension therapy among patients. Low to moderate as agents are of low to moderate cost and therapy of hypertension has been shown in some populations to be cost effective with reduced morbidity and mortality. Uncertainty: Moderate as net benefits are unknown and outcome studies of comparative effectiveness are lacking. 13

14 Topic: Systolic Blood Pressure Targets Recommendation Basis of Recommendation GRADE criteria Balance of desirable and undesirable effects Quality of Evidence Values and Preferences Resource Implications In the general population <60 years, initiate pharmacologic treatment to lower BP at SBP <140mmHg and treat to a goal SBP <140mmHg. (Strong recommendation) There is insufficient evidence to determine an optimal SBP goal in people aged 60 and younger. No high quality outcome trials assessing optimal systolic blood pressure targets included large numbers of adults younger than 60 years. The balance between benefit and harm from a BP goal <140 cannot be determined, however expert opinion favors the use of this goal, and risk of harm is expected to be low. Despite the low quality of evidence, and the unknown balance of desirable and undesirable effects, a strong recommendation is warranted based on the discourse of the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) and its implications for health care delivery implementation. GRADE assessment Pathophysiological evidence in younger people suggests that lower SBP is associated with lower rates of CVD. However the optimal goal SBP has not been determined in well conducted randomized controlled trials. The balance between risks of overtreatment of younger individuals versus the potential benefits of a lower SBP target is unknown, but expected to be significant. Expert opinion-while there is insufficient/unclear evidence we agree with the discourse of the JNC 8 committee and its recommendations 1. This recommendation places a low value on preventing undertreatment of younger people and a higher value on the potential high expected reduction of CV events with SBP targets. Values and preferences were derived by polling the GDT. Uncertainty around and variability of values and preferences are estimated to be high, regarding hypertension therapy among patients. Low to moderate as agents are of low to moderate cost and therapy of hypertension has been shown in some populations to be cost effective with reduced morbidity and mortality. Uncertainty: Moderate as net benefits are unknown and outcome studies of comparative effectiveness are lacking. 14

15 Topic: Hypertension Treatment in patients with CKD Recommendation In the population aged 60 years with chronic kidney disease (CKD), consider initiating pharmacologic treatment to lower BP at SBP 140mmHg or DBP 90 mmhg and treat to goal SBP <140mmHg and goal DBP <90mmHg. ** Basis of Recommendation **When weighing the risks and benefits of a lower BP goal for people aged 70 years or older with estimated GFR less than 60 ml/min/ 1.73m2, antihypertensive treatment should be individualized, taking into consideration factors such as frailty, comorbidities, albuminuria, and estimation of non-age related egfr decline (for example egfr + 1/2 age < 85). For individuals < age 60, regardless of comorbidity of CKD, the prior strong recommendations apply. There is insufficient evidence to determine an optimal BP goal in people aged 70 and older with CKD, nor on the diagnostic criteria for CKD that would identify people who would benefit from a BP goal lower than <150/90. No outcome trials included large numbers of adults older than 70 years with CKD. The balance between benefit and harm from a BP goal lower than <150/90 cannot be determined, however some expert opinions favor more aggressive treatment of people aged 70 and over with CKD. GRADE criteria Balance of desirable and undesirable effects Thus, when weighing the risks and benefits of a lower BP goal for people aged 70 years or older with estimated GFR less than 60 ml/min/ 1.73m2, antihypertensive treatment should be individualized. Given the low quality of evidence, and the unknown balance of desirable and undesirable effects, a weak recommendation is warranted. GRADE assessment Pathophysiological evidence in younger people suggests that lower BP is associated with less progression of renal disease. However the optimal goal BP goal has not been determined in good randomized controlled trials. Those trials excluded people >=70 years old, so the effect of a more aggressive BP goal is unknown in elderly people with CKD. There is also no evidence on the definition of CKD that would identify elderly people who might benefit from BP goal lower than the strong recommendation of <150/90 for the general population age 60 and over. The commonly used estimating equations for GFR were not developed in populations with significant numbers of people older than 70 years and have not been validated in older adults. Observation data suggest that a modified definition of CKD (for example for example egfr + 1/2 age < 85) may indicate individuals more likely to progress to ESRD, and may be candidates for a lower BP goal. The balance between risk of overtreatment of older individuals with CKD versus the potential benefits of a lower SBP target is unknown. Quality of Evidence Very low quality (Indirect evidence) 1,3,4 Values and Preferences Resource Implications This recommendation places a high value on preventing overtreatment of elderly people and a lower value on the small risk of harms of increased CV and renal risk potentially associated with slightly higher SBP targets. Values and preferences were derived by polling the GDT. Uncertainty around and variability of values and preferences are estimated to be high, regarding hypertension therapy among patients in whom a treatment decision for lower SBP target is unclear. Low to moderate as agents are of low to moderate cost and therapy of hypertension has been shown in some populations to be cost effective with reduced morbidity and mortality. Uncertainty: Moderate as net benefits are unknown and outcome studies of comparative effectiveness are lacking. 15

16 Topic: Blood Pressure Targets in the Diabetic Population 60 years Recommendation Basis of Recommendation GRADE criteria Balance of desirable and undesirable effects Quality of Evidence Values and Preferences Resource Implications In the population aged 60 years with diabetes, initiate pharmacologic treatment to lower BP at SBP 140mmHg or DBP 90mmHg and treat to a goal SBP <140mmHg and goal DBP <90mmHg. (Strong Recommendation) For individuals < age 60, regardless of comorbidity of DM, the prior strong recommendations apply. There is insufficient evidence to determine an optimal BP goal in adults with diabetes mellitus over age 60. No high quality outcome trials comparing systolic blood pressure targets 140 vs150 included large numbers of adults with diabetes mellitus. The balance between benefit and harm from a SBP goal <140 cannot be determined, however expert opinion favors the use of this goal, and risk of harm is expected to be low. Despite the low quality of evidence, and the unknown balance of desirable and undesirable effects, a strong recommendation is warranted as based on the discourse summarized by the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) and its implications for health care delivery implementation. GRADE assessment Pathophysiological evidence suggests that lower BP is associated with lower rates of CVD. However the optimal goal BP has not been determined in well conducted randomized controlled trials including individuals with diabetes. The balance between risks of overtreatment versus the potential benefits of a lower BP target is unknown, but expected to be significant. Expert opinion-while there is insufficient/unclear evidence we agree with the discourse of the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) and their recommendations 1. This recommendation places a low value on preventing undertreatment of adults with diabetes and a higher value on the potential high expected reduction of CV events with lower SBP targets. Values and preferences were derived by polling the GDT. Uncertainty around and variability of values and preferences are estimated to be high, regarding hypertension therapy among patients. Low to moderate as agents are of low to moderate cost and therapy of hypertension has been shown in some populations to be cost effective with reduced morbidity and mortality. Uncertainty: Moderate as net benefits are unknown and outcome studies of comparative effectiveness are lacking. 16

17 Appendix D: Systematic Review The NGP methodology calls for the KP guideline development process to first seek high-quality external guidelines for adoption or adaption, and to conduct additional evidence review only as needed 2. The Hypertension National Guideline Lead Team conducted a review of existing KP regional guidelines and potential high-quality existing guidelines on hypertension available for adaptation or adoption. The Lead Team determined that the JNC 8 1 guideline best addressed the needs of the NGP and proceeded to analyze the quality and content of this guideline for comprehensiveness and adoption to the KP NGP. The final product of the KP guideline is based primarily on the JNC 8 guideline. AGREE II Summary The AGREE (Appraisal of Guidelines Research and Evaluation) 5 II tool is used to assess the methodological quality of existing clinical practice guidelines being considered for adoption into the NGP portfolio. An AGREE assessment was completed on the JNC 8 guideline in 2014 and it was considered to be of good quality and rigor; no additional evidence review was conducted by KP. Following are the key questions addressed by the JNC 8 guideline: Key Questions 1. In adults with hypertension, does initiating antihypertensive pharmacologic therapy at specific blood pressure thresholds improve health outcomes? 2. In adults with hypertension, does treatment with antihypertensive pharmacologic therapy to a specified BP goal lead to improvements in health outcomes? 3. In adults with hypertension, do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes? Inclusion/Exclusion Criteria The Panel Members Appointed to the Eighth Joint National Committee (JNC 8) 1 conducted an evidence review that focused on adults aged 18 years or older with hypertension and included studies with the following pre-specified subgroups: diabetes, coronary artery disease, peripheral artery disease, heart failure, previous stroke, chronic kidney disease (CKD), proteinuria, older adults, men and women, racial and ethnic groups, and smokers. Studies with sample sizes smaller than 100 were excluded, as were studies with a follow-up period of less than one year, because small studies of brief duration are unlikely to yield enough health-related outcome information to permit interpretation of treatment effects. Studies were included in the evidence review only if they reported the effects of the studied interventions on any of these important health outcomes: Overall mortality, cardiovascular disease (CVD) related mortality, CKD-related mortality Myocardial infarction, heart failure, hospitalization for heart failure, stroke Coronary revascularization (includes coronary artery bypass surgery, coronary angioplasty and coronary stent placement), other revascularization (includes carotid, renal, and lower extremity revascularization) End-stage renal disease (ESRD) (i.e., kidney failure resulting in dialysis or transplantation), doubling of creatinine level, halving of glomerular filtration rate (GFR). 17

18 References 1. James PA, Oparil S, Carter BL, et al evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5): Kaiser Permanente National Guideline Program. Kaiser Permanente National Guideline Program Process and Methodology for Systematic Development of Clinical Practice Recommendations. Kaiser Permanente; 2016: Rutkowski M, Mann W, Derose S, et al. Implementing KDOQI CKD definition and staging guidelines in Southern California Kaiser Permanente. Am. J. Kidney Dis. 2009;53(3 Suppl 3):S Kidney Disease; Improving Global Outcomes (KDIGO) Blood PressureWork Group. KDIGO clinical practice guideline for the management of blood pressure in chronic kidney disease. Kidney Int Suppl,. 2012;2(5): Brouwers MC, Kho ME, Browman GP, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. Can. Med. Assoc. J. 2010;182(18):E