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Quality Outpatient Care of Older Persons Department of Family Medicine and Program on Aging – University of North Carolina at Chapel Hill Evidence-Based Geriatric Module: Hypertension Rationale Hypertension is one of the most common medical diagnoses in persons over the age of 65. At least two-thirds of people in the US aged 70+ have hypertension (defined as a systolic BP ≥ 140 mm Hg and/or a diastolic BP ≥ 90 mmHg), and the prevalence of hypertension increases further with advancing age. (1-3) Among elderly hypertensives, 60-87% have isolated systolic hypertension (ISH), and ISH has been found to be associated with mortality, cardiovascular disease, and stroke. (4-9) Unfortunately, ISH is the least likely form of hypertension to be treated. (4, 10,11) Diastolic hypertension is also a risk factor for cardiovascular disease in the elderly, but between ages 50 and 60, systolic hypertension assumes a superior role over diastolic blood pressure as a predictor of adverse cardiovascular outcomes. (5, 12-16) A widened pulse pressure (>50 mm Hg) is often seen in the setting of ISH, and thus may be a marker of increased cardiovascular risk and the need for hypertension treatment. (1) (See “III. Treatment: …J-Curve Hypothesis” for information regarding management of another cause of a widened pulse pressure: a low diastolic blood pressure.) In the US, the elderly account for the group with the largest relative risk of uncontrolled hypertension, despite having the most frequent contact with the medical system. (1) One study suggests this may be because of lack of awareness of the issue and lack of adequate control with current treatment strategies. (17). Aside from the burden of morbidity and mortality, the financial costs of untreated hypertension can be staggering. In 1999 alone the estimated direct and indirect cost of hypertensive disease was above $33.3 billion. (1) Numerous large-scale placebo-controlled trials of hypertension treatment in elderly patients have shown that successful reductions in blood pressure are associated with significant reductions in cardiovascular events and mortality. (18-23) The evidence is most compelling for patients aged 65-79, since this population figured prominently in the trials. It is more difficult to extrapolate benefit to patients aged 80+, since not as many people in this age group were featured in each trial. In fact, no large scale trials of hypertension treatment in octo- or nonagenarians have been completed as yet, although the Hypertension in the Very Elderly Trial (HYVET) is ongoing. (24) Therefore, for now, we must rely on secondary analyses of data from existing trials: one meta-analysis of 1670 octogenarians involved in several large-scale placebo-controlled trials of antihypertensive treatment showed a relative risk reduction in stroke, cardiovascular events, and heart failure of 34%, 22%, and 39% respectively. However, there was a non-significant 6% increase in all-cause mortality. (25) It is hoped that the results of the HYVET trial will more directly address benefits vs. risks of hypertension treatment in the very elderly. For now, however, given the cardiovascular risks associated with age and with hypertension, and given the evidence of cardiovascular event reduction with hypertension treatment, limits on attempts at treatment should not be based upon age alone. Conversely, it is acceptable to individualize treatment decisions for very elderly hypertensives based upon the assessment of risk vs. benefit of treatment in the person. Any decision to treat an asymptomatic condition must consider the impact of treatment on quality of life. In most cases quality of life is enhanced by measures that maintain activities of daily living and cognitive function – i.e. by measures which prevent strokes and heart attacks. Hence, hypertensive therapy in older persons is usually worthwhile. However, for some individuals, particularly the very frail or the very old, the adverse effects of medication may outweigh the benefits. Setting a goal blood pressure of <140/90 may be inappropriate and dangerous for a frail older person with risks for orthostasis and other adverse treatment effects. In these situations, decisions regarding treatment must be left to the discretion of physician and patient. (26,27, 28) Recommended Quality of Care Indicators I. Screening Recommendation All older persons should be screened for hypertension using a sphygmomanometer at each health examination. Rationale Screening is low-cost. Identification and treatment of hypertension can lead to reductions in morbidity and mortality from cardiovascular events. Hypertension in older persons is defined as a systolic pressure ≥ 140 mmHg or a diastolic pressure ≥ 90 mmHg on three or more separate occasions. Conversely, not following criteria for diagnosis can lead to a mistake in diagnosis, resulting in unnecessary use of medications, increase in risk of adverse effects, and increased cost.The burden of false labeling can include negative psychological, social, and economic effects. References 1, 29, 30 II. Initial Assessment Recommendation Rationale References A baseline electrocardiogram (ECG) should be considered when a new diagnosis of hypertension is made in the older patient. No studies exist that assess the relationship between the performance of an ECG and either prognosis or treatment outcome. However, there is indirect evidence linking the performance of an ECG with better outcomes from hypertensive treatment. This may be due to risk stratification and subsequent aggressiveness of treatment if ventricular hypertrophy is identified. 1, 31-36 Blood urea nitrogen (BUN), creatinine, basic electrolytes, fasting lipid panel, glucose, and microalbuminuria or proteinuria should be measured. Measurement of renal function (including proteinuria/microalbuminuria), lipids, and glucose allows for risk stratification. Measurement of renal function and electrolytes also provide information necessary for making safe and effective treatment choices. Older patients with a new diagnosis of hypertension should be assessed for evidence of target organ damage and for cardiovascular risk factors (smoking, dyslipidemia, diabetes, male gender, and family history of cardiovascular disease). Older patients have a higher prevalence of target organ damage and higher rates of additional risk factors for cardiovascular disease. Although there is no direct evidence that documentation of target organ damage and cardiovascular risk factors will result in improved patient outcomes, awareness of these factors may lead to more aggressive hypertension control, thus reducing the risk of future adverse events. Targeting additional risk factors may further decrease the risk of cardiovascular events. 1, 31-34 III. Treatment: Threshold for Initiation of Treatment Recommendation In most elderly patients, treatment (nonpharmacologic and/or pharmacologic) for hypertension should be initiated if SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg. However, treatment decisions need to be individualized to the patient: advanced age and/or frailty may create a situation in which the risk of treatment outweighs the benefit. The strongest benefit in treatment is seen if the initial SBP > 160 mmHg, or if there are multiple cardiac risk factors or evidence of target organ damage. Rationale For persons aged 40-70 years, starting at a BP of 115/75 mmHg, there is a doubling in the risk of cardiovascular disease for each rise in SBP of 20 mmHg or DBP of 10 mmHg. The Framingham Study has shown a significantly higher age-adjusted risk ratio for cardio- and cerebrovascular events and sudden death among hypertensive elders. A treatment threshold of BP ≥140/90 allows blood pressure lowering to be started before further vascular damage occurs. See “Treatment: Age-based Recommendations and Rationale” (next page) for evidence regarding treatment of hypertension in ages 80+. A review of 36 studies of hypertension treatment in the elderly found that the strongest evidence for treatment effect occurred with an initial SBP > 160 mmHg, with weaker data to guide therapy if the SBP was lower than this. References 1, 7, 37, 38 (see next page) 39 III. Treatment: Goal Blood Pressure Reduction Recommendation Non-diabetic and non-proteinuric elders: < 140/90 mmHg and no orthostasis or significant side-effects. diabetics: < 130/80 mm Hg. proteinuric patients: < 125/75 mmHg (and no orthostasis or significant sideeffects for either group) If these goals cannot be achieved, a sustained reduction in systolic blood pressure should still be made, especially if initial systolic blood pressure is > 160 mmHg. Rationale Numerous large-scale placebo-controlled trials of hypertension treatment in elderly patients have shown that successful reductions in blood pressure are associated with significant reductions in cardiovascular events and mortality. More aggressive blood pressure reduction in diabetics and in those with renal disease is associated with more favorable outcomes. References 1, 18-23, 32, 33 Expert opinion has not established a less aggressive treatment goal in older patients, but orthostasis and other harmful side-effects of treatment should be minimized. Therefore, it is mandatory to check for orthostasis and to alter treatment means/goals if this is occurring. A meta-analysis of 15, 693 older patients with ISH showed that just a 10 point reduction in systolic blood pressure, even if SBP remained greater than 140 mmHg, was associated with a 30% reduction in strokes, 26% reduction in cardiovascular event-related deaths, 23% reduction in myocardial infarctions, and a 13% reduction in all-cause deaths. 8 III. Treatment: Age-based Recommendations and Rationale Type of Hypertension Age 65-79 Age ≥ 80 Isolated Diastolic (DBP ≥ 90 mm Hg) RCT’s suggest that treatment lowers risk of stroke, cardiac events, and death. (1, 19, 21,23) Insufficient evidence, due to lack of large numbers of octogenarians in each RCT.(19,21,23) Expert opinion suggests treatment.(1) Decision must be individualized to the patient, assessing expected life span, comorbidities, and risks vs. benefits of treatment. RCT’s show that treatment significantly lowers risk of stroke, cardiac events, congestive heart failure, and cardiovascular mortality. (1, 18-23) Benefit is more conclusive in patients with SBP >160 mmHg. (39) RCT's involving broad age ranges (6th-9th decades) support treatment, but extrapolation should be done carefully as there are fewer numbers of patients aged 80+ in these trials. (18-23) Expert opinion and secondary analyses of trials suggests treatment. (1, 41,42) Benefit of treatment is more conclusive in patients with SBP >160 mmHg. (39) Isolated Systolic ( SBP ≥ 140 mm Hg) A dedicated double-blinded RCT is needed to conclusively address mortality effect of treatment. Therefore, decision to treat must be individualized to the patient, assessing expected life span, comorbidities, and risks vs. benefits of treatment. Notes: Range of event reduction in 3 large trials: (18-20) 36-47% in stroke, 13-30% in MI's, 29-51%, in CHF. Meta-analysis of 8 ISH trials: (40) 30% in stroke, 26% in cardiac events, 13% in total mortality Notes: One meta-analysis of 7 RCT’s suggested caution with treatment: (25) Subjects: 1,670 patients, age 80+, most with ISH Results: Among treated group, 33% in strokes (NNT = 30), 23% in cardiovascular events (NNT = 21), and a 40% in CHF (NNT = 48). No reduction in all-cause or cardiovascular mortality. However, restricting analysis to double-blind trials would have produced a nonsignificant 6% increase in all-cause mortality. Hypertension in the Very Elderly Trial (HYVET): (24) RCT specifically designed to evaluate the benefit of HTN treatment in age 80+. Primary endpoint: stroke incidence. Secondary endpoints: cardiovascular events and mortality. Results not available yet. Systolic/Diastolic (BP ≥ 140/90 mmHg) RCT's: treatment significantly lowers risk of stroke, cardiac events, and cardiovascular mortality. (19,21,23) Insufficient evidence, but expert opinion suggests treatment.(1) Decision must be individualized to the patient, assessing expected life span, comorbidities, and risks vs. benefits of treatment. III. Treatment: Considerations Regarding Blood Pressure Reduction: J-Curve Hypothesis Recommendation The presence of a “J curve phenomenon” (higher cardiovascular morbidity and mortality associated with lower DBP’s) is not well-established: it is not clear that there is a cause and effect relationship between low DBP’s and mortality. Rationale Some clinical trials have shown a J-shaped relationship between DBP and risk of coronary events. It is hypothesized that lowering DBP excessively may affect coronary perfusion, thus leading to an increased risk of myocardial events and death. However, a J-shaped relationship between DBP and morbidity/mortality is not wellestablished, as some studies have failed to demonstrate this phenomenon. References Therefore, a low DBP is not a contraindication to trying to treat isolated systolic hypertension. However, during treatment, it is advisable to monitor the degree of DBP reduction in patients with existing cardiovascular disease. Other studies have suggested that the increased risk of coronary events seen in people with lower DBP’s may be due to the presence of underlying existing cardiac disease or chronic disease (i.e. the low DBP is a proxy measure for higher risk). 49, 50 One meta-analysis of seven RCT’s involving hypertension treatment of 40, 233 patients found a J-shaped relationship between diastolic blood pressure and risk for total and cardiovascular deaths for both treated and untreated patients, suggesting that the increased death risk was not related to hypertension treatment, but perhaps was related to underlying health conditions causing a low DBP. 51 21, 43-47 18, 48 III. Treatment: Nonpharmacologic Interventions Intervention Reduction in Sodium Intake Recommendation Limit sodium to less than 2.4 gm/day. Rationale RCT's and well-designed clinical studies support effect of sodium intake limitations on clinically significant BP reductions. Although individuals vary in their sodium sensitivity, older patients tend to be more salt-sensitive than younger hypertensives. Limitations should be modified per patient’s overall nutritional status or quality of life issues. References 1, 40, 52, 53 Increased Intake of Calcium/Potassium Diet should be rich in grains, fruits and vegetables, and low-fat dairy products. Trials involving the use of the DASH diet in treating hypertension showed moderate reductions in BP in older hypertensives. 54-56 If overweight (BMI > 25), reduce weight to at least within 10% of ideal body weight. For starters, encourage at least 10 kg of weight loss. Individualize recommendations to patient’s other health concerns, as well. Excess weight is correlated with elevated BP's, and a weight loss of only 10 kg can lower systolic BP by 520 mmHg. 1, 52, 57 (“Dietary Approaches to Stopping Hypertension” Diet: DASH Diet) Weight Loss III. Treatment: Guidelines on Selection of Therapeutic Agents, per Compelling Indication Compelling Indication Obesity Recommendation All older obese persons should be educated about the benefits of weight loss and decreasing sodium intake Rationale Trial of Antihypertensive Interventions and Management (TAIM) suggests that effective weight loss of 4.5 kg or more lowers blood pressure similarly to low-dose drug therapy and potentiates drug effects. References 1, 52, 57 Trial of Nonpharmacologic Interventions in the Elderly (TONE) suggests that weight loss and reduced sodium intake was a feasible, effective, and safe nonpharmacologic therapy of hypertension in older persons. Note: Neither of these trials demonstrated a reduction in cardiovascular morbidity/mortality. Isolated Systolic Hypertension Consider using a thiazide diuretic as first line agent. Predominance of ISH RCT’s showing treatment benefit used thiazide diuretics (usually chlorthalidone). A meta-analysis of 42 trials involving 192,478 adults with all forms of hypertension showed that low-dose diuretics, compared to multiple other classes of anti-hypertensives, were the most effective first-line agents for preventing the occurrence of cardiovascular disease morbidity and mortality. 1, 18-20, 23, 58 Diabetes mellitus ACE Inhibitors or angiotensin receptor blockers (ARB’s) should be considered as first line agents. Watch serum glucose if using thiazide diuretics. Due to renoprotective effects and neutral effects on glucose and lipids, ACE Inhibitors and ARB’s are preferred agents. Cost must be considered when choosing which agent to use among these categories. 1, 26, 28, 59, 60 First line treatment with chlorthalidone is not associated with any adverse effects on quality of life, including cognitive performance. However, one may see mild elevations in serum glucose with thiazide diuretics, so glucose monitoring is encouraged. III. Treatment: Guidelines on Selection of Therapeutic Agents, per Compelling indication Compelling Indication Recommendation Rationale References Congestive Heart Failure Use ACE Inhibitors or ARB’s as first-line agents. B-blockers are also beneficial. ACE Inhibitors and ARB’s have been found to have benefits on left ventricular remodeling and systolic function in patients with CHF. These agents and Bblockers have a positive effect on reducing mortality in patients with CHF. 1, 32 , 61-64 Myocardial Infarction Beta-blockers and/or ACE inhibitors (or ARB’s) should be considered as first-line agents. If an anti-anginal is necessary, the use of calcium channel blockers can be considered. B-blockers and ACE Inhibitor’s are associated with decreased mortality after myocardial infarctions. 1, 32, 65-67 Nephropathy Use ACE inhibitors ( or ARB’s) when the serum creatinine is greater than 1.5 mg/dL or the 24-hour urine protein is greater than 1 gram. Meta-analyses have shown that in “non-vulnerable elders,” ACE inhibitors slow the progression toward end stage renal disease and dialysis in the setting of hypertensive nephropathy. Gout Avoid thiazide diuretics in patients with gout. Patients predisposed to acute attacks of gout may be susceptible to the increased resorption or decreased secretion of serum uric acid when taking thiazide diuretics. 1, 60 Hyperlipidemia Use calcium channel blockers or ACE inhibitors Effects of calcium channel blockers or ACE inhibitors tend to be neutral on blood glucose and lipids; therefore, there may be an advantage over the use of thiazide diuretics or B-blockers. 59, 69 Erectile dysfunction Use chlorthalidone with caution. Chlorthalidone is associated with erectile dysfunction in 10-15% of middle aged men. 26, 28 1, 68 IV. Treatment: Therapies Not Recommended Recommendation Short-acting calcium channel blockers should be avoided. Rationale Short-acting calcium channel blockers (sublingual nifedipine) have been associated with rapid and excessive drops in blood pressure. Expert opinion does not advocate use of these agents, as observational studies and meta-analyses have shown higher mortality in groups receiving these agents. References 32, 70-72 IV. Treatment: Additional Information Regarding Treatment Strategies See Teaching Card and Slide Shows which accompany this module. (Evidence-Based Geriatric Module: Hypertension) V. Quality of Care Indicators for Continuous Quality Improvement Activities - See Quicksheet and Audit form which accompany this module. (Evidence-Based Geriatric Module: Hypertension) References 1. Chobanian A, Bakris G, Black H, et al. The seventh report of the Joint National Committee on prevention, detection, evaluation and treatment of high blood pressure, JAMA 289:2560-2572, 2003. 2. Wolz M, Cutler J, Roccella E, et al. 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Authorship These guidelines were developed by the Geriatric Education Guidelines development group of the Department of Family Medicine, University of North Carolina at Chapel Hill. Members of the guidelines group include: Amrit Singh, MD (chair), John Harrington MD. Julie Price, MD; Bron Skinner, PhD; Philip Sloane, MD, MPH, and Sam Weir, MD, MPH. Primary author of this guideline was Dr. Singh. This work was supported by funding from HRSA grant #5 D22 HP 00167-02 and from the Donald W. Reynolds Foundation. © 2006 The University of North Carolina at Chapel Hill Program on Aging