The Journals of Gerontology Series A: Biological Sciences and Medical Sciences 56:M138-M145 (2001)
© 2001 The Gerontological Society of America
Treatment of Older Persons With Hypercholesterolemia With and Without Cardiovascular Disease
Wilbert S. Aronowa,b
a Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York
b Department of Medicine, Hebrew Hospital Home, Bronx and Valhalla, New York
Wilbert S. Aronow, Corporate Medical Director, Hebrew Hospital Home, 801 Co-op City Blvd., Bronx, NY 10475. Telephone: (718) 239-6488 fax: (718) 239-6492 E-mail: WSAronow{at}aol.com.
Decision Editor: John E. Morley, MB, BCh
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Abstract
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Hypercholesterolemia is a risk factor for new coronary events in older men and women. Secondary prevention trials have demonstrated in persons with coronary artery disease (CAD) and hypercholesterolemia that statin drugs reduced in older persons all-cause mortality, cardiovascular mortality, coronary events, coronary revascularization, stroke, and intermittent claudication. Statins have also been shown to slow progression of coronary atherosclerotic plaques in persons with CAD, to reduce restenosis after coronary stent implantation, and to decrease myocardial ischemia in persons with CAD. Older men and women with CAD, prior atherothrombotic brain infarction, peripheral arterial disease, or extracranial carotid arterial disease and a serum low-density lipoprotein (LDL) cholesterol level higher than 125 mg/dl despite diet should be treated with statin drug therapy to lower the serum LDL cholesterol level below 100 mg/dl. Primary prevention trials have shown that statins were also effective in reducing cardiovascular events in older persons with hypercholesterolemia. On the basis of data from the Air Force/Texas Coronary Atherosclerosis Prevention Study, the physician should consider using statins in persons aged 65–80 years without cardiovascular disease with a serum LDL cholesterol level above 130 mg/dl and serum high-density lipoprotein cholesterol level below 50 mg/dl.
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Serum Lipids and Coronary Artery Disease
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Numerous studies have demonstrated that hypercholesterolemia is a risk factor for new coronary events in older men and women (1)(2)(3)(4)(5)(6). Among persons aged 65 years and older with prior myocardial infarction in the Framingham Study, serum total cholesterol was most strongly related to death from coronary artery disease (CAD) and to all-cause mortality (2). At a 40-month follow-up of 664 older men and at a 4-year follow-up of 1488 older women, an increase of 10 mg/dl of serum total cholesterol significantly increased the relative risk of new coronary events by 1.12 times in men and by 1.12 times in women after other prognostic variables were controlled for, as shown in Table 1 (5). In 1793 older men and women, mean age 81 years, there was a 1.28 times significantly greater probability of having CAD for an increment of 10 mg/dl of serum low-density lipoprotein (LDL) cholesterol after other prognostic variables were controlled for (6).
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Table 1. Association of Serum Lipids With New Coronary Events at 40-Month Follow-Up of 664 Men and at 4-Year Follow-Up of 1488 Women
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A low serum, high-density lipoprotein (HDL) cholesterol is also a risk factor for new coronary events in older men and women (1)(5)(6)(7)(8)(9). In the Framingham Study (1), in the Established Population for Epidemiologic Studies of the Elderly Study (7), and in 2152 older men and women (5), a low serum HDL cholesterol was a more powerful predictor of new coronary events than was serum total cholesterol. At a 40-month follow-up of 664 older men and at a 4-year follow-up of 1448 older women, a decrease of 10 mg/dl of serum HDL cholesterol significantly increased the relative risk of new coronary events by 1.7 times in men and by 1.95 times in women after other prognostic variables were controlled for, as shown in Table 1 (5). In 1793 older men and women, there was a 2.56 times significantly greater probability of having CAD for a decrease of 10 mg/dl of serum HDL cholesterol after other prognostic variables were controlled for (6).
Hypertriglyceridemia has been shown to be a risk factor for new coronary events in older women but not in older men (1)(5). At a 40-month follow-up of 664 older men and at a 4-year follow-up of 1488 older women, the multivariate Cox regression model showed that the presence of serum triglycerides was not an independent risk factor for new coronary events in older men and was a very weak independent risk factor for new coronary events in older women, as shown in Table 1 (5).
In addition to hypercholesterolemia's being a risk factor for increased mortality from CAD in older persons, a low serum total cholesterol in older persons may be a risk factor for mortality secondary to comorbidity and frailty (10)(11). Low serum total cholesterol may result from malnutrition and chronic diseases with an inflammatory component. Proinflammatory cytokines such as interleukin-6 have been shown to decrease serum total cholesterol levels by reducing the hepatic production of lipoproteins, by reducing the cholesterol content of lipoprotein particles, and by increasing the catabolism of lipoproteins (12).
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Dietary Treatment of Hypercholesterolemia
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An older person with hypercholesterolemia and CAD should be treated with a Step II American Heart Association diet. The person should achieve and maintain a desirable weight. Cholesterol intake should be less than 200 mg daily. Less than 30% of total caloric intake should be fatty acids. Saturated fatty acids should comprise less than 7% of total calories, polyunsaturated fatty acids up to 10% of total calories, and monunsaturated fatty acids 10–15% of total calories. Protein intake should account for 10% to 20% of total calories. Carbohydrates should comprise 50–60% of total calories. In addition to loss of weight in obese persons, long-term aerobic exercise, and dietary treatment of hypercholesterolemia, cigarette smoking should be stopped, hypertension treated, and diabetes mellitus well controlled.
There are no data showing that diet alone improves the end points of cardiovascular events in older persons as observed with the use of statin drugs. One should also be cautious that dietary restrictions do not lead to malnutrition in older persons (13)(14).
Lignans inhibit oxidation of LDL and small dense LDL particles. Healthy middle-aged Finnish men with high serum concentrations of the lignan enterolactone had a lower rate of acute coronary events than Finnish men with lower concentrations of enterolactone (15). These data support the hypothesis that plant-dominated fiber-rich food reduces the risk of CAD. However, these findings must be confirmed by further studies.
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Effect of Exercise on Serum Lipids
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Short-term aerobic exercise (8 weeks) in older persons has not been associated with any significant changes in serum lipids (16). However, long-term aerobic exercise (2 years) in conjunction with weight loss and improvement in body fat distribution has been associated with a significant increase in serum HDL cholesterol levels (4–9%), less predictable effects on reduction of serum triglycerides (0–9%), and no effect on serum LDL or total cholesterol (16).
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Drug Therapy of Hypercholesterolemia
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Lipid-lowering drugs include the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors or statin drugs, the bile acid sequestrants such as cholestyramine and colestipol, nicotinic acid, and gemfibrozil. The statin drugs include simvastatin, pravastatin, lovastatin, atorvastatin, fluvastatin, and cerivastatin. Statin drugs suppress cholesterol biosynthesis by competitively inhibiting HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a precursor of sterols including cholesterol. This action induces upregulation of LDL receptors in the liver and increased clearance of LDL from the plasma, thereby decreasing plasma cholesterol levels.
Scandinavian Simvastatin Survival Study
The Scandinavian Simvastatin Survival Study was a secondary prevention study that randomized 4444 men and women 35–70 years of age (1021 of whom were 65–70 years of age) with CAD and hypercholesterolemia (serum total cholesterol of 213–310 mg/dl) to treatment with double-blind placebo or simvastatin 20–40 mg daily (17)(18)(19). Median follow-up was 5.4 years (up to 6.3 years). Simvastatin significantly reduced serum total cholesterol by 25% to 196 mg/dl, serum LDL cholesterol by 35% to 122 mg/dl, and serum triglycerides by 10% to 120 mg/dl, and it significantly increased serum HDL cholesterol by 8% to 52 mg/dl (17).
Compared with placebo, simvastatin significantly reduced all-cause mortality by 30%, death from CAD by 42%, death from CAD or nonfatal myocardial infarction by 34%, stroke by 30%, new or worsening angina pectoris by 26%, new intermittent claudication by 38%, one or more new bruits by 30%, new carotid bruits by 48%, and hospital days by 34%, and it insignificantly decreased femoral bruits by 11% (17)(19). The reduction in major coronary events by simvastatin was similar in men and women and was similar in persons older and younger than 65 years (18). Table 2 shows the reduction in all-cause mortality and in cardiovascular events by simvastatin in 1021 persons aged 65–70 years at study entry and in 3423 persons younger than 65 years (18).
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Table 2. Effect of Simvastatin on All-Cause Mortality and Cardiovascular Events at 5.4-Year Median Follow-Up in 1021 Persons Aged 65–70 Years at Study Entry and in 3423 Persons Younger Than Age 65 Years With CAD and Hypercholesterolemia
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Compared with placebo, a reduction in coronary events occurred at 6 months after treatment with simvastatin (17). Compared with placebo, a decrease in all-cause mortality occurred at 18 months after treatment with simvastatin (17).
Cholesterol and Recurrent Events Trial
The Cholesterol and Recurrent Events Trial randomized 4159 men and women 21–75 years of age (1283 of whom were 65–75 years of age) with myocardial infarction, serum total cholesterol levels less than 240 mg/dl, and serum LDL cholesterol levels of 115 mg/dl or higher (mean serum LDL cholesterol level of 139 mg/dl) to pravastatin 40 mg daily or double-blind placebo (20)(21)(22)(23)(24). Median follow-up was 5 years (up to 6.2 years). Pravastatin significantly reduced serum total cholesterol by 20% to 167 mg/dl, serum LDL cholesterol by 32% to 98 mg/dl, and serum triglycerides by 14% to 135 mg/dl, and it significantly increased serum HDL cholesterol by 5% to 41 mg/dl (20).
Pravastatin significantly reduced major coronary events by 35% in persons with serum LDL cholesterol levels above 150 mg/dl and by 26% in persons with serum LDL cholesterol levels of 125–150 mg/dl, and it insignificantly reduced major coronary events by 3% in persons with serum LDL cholesterol levels of 115–124 mg/dl (20). The reduction of major coronary events was 46% in women and 20% in men (20). In persons with a low serum HDL cholesterol, pravastatin significantly reduced major coronary events by 21% (20). In persons with high serum triglycerides, pravastatin caused a 15% borderline (p = .07) significant reduction in major coronary events (20). Table 3 shows the reduction in cardiovascular events by pravastatin in 1283 persons aged 65–75 years at study entry (23).
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Table 3. Effect of Pravastatin on Cardiovascular Events at 5-Year Median Follow-Up in 1283 Persons Aged 65–75 Years at Study Entry With Myocardial Infarction and a Mean Serum Lipoprotein Cholesterol Level of 139 mg/dl
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Compared with placebo, a reduction in cardiovascular events occurred at 6 months after treatment with pravastatin in women and at 2 years after treatment with pravastatin in men (20). The need for coronary revascularization was reduced within 1–2 years of initiating pravastatin therapy (20).
The Long-Term Intervention With Pravastatin in Ischaemic Disease Study
The Long-Term Intervention With Pravastatin in Ischaemic Disease Study randomized 9014 men and women 31–75 years of age (3514 of whom were aged 65–75 years) with myocardial infarction (64%) or unstable angina pectoris (36%) and serum total cholesterol levels of 155–271 mg/dl to pravastatin 40 mg daily or double-blind placebo (25). Mean follow-up was 6.1 years. Pravastatin significantly decreased serum total cholesterol from 218 mg/dl by 18%, serum LDL cholesterol from 150 mg/dl by 25%, and serum triglycerides from 142 mg/dl by 11%, and it significantly increased serum HDL cholesterol from 36 mg/dl by 5% (25).
Pravastatin significantly reduced all-cause mortality by 22%, deaths from CAD by 24%, fatal and nonfatal myocardial infarction by 29%, death from cardiovascular disease by 25%, need for coronary artery bypass surgery by 22%, need for coronary angioplasty by 19%, hospitalization for unstable angina pectoris by 12%, and stroke by 19% (25). Pravastatin reduced death from CAD and nonfatal myocardial infarction by 28% in persons aged 65–69 years and by 15% in persons aged 70–75 years at study entry (25). Pravastatin significantly decreased death from CAD and nonfatal myocardial infarction by 30% in persons with serum LDL cholesterol levels of 174 mg/dl or higher and by 26% in persons with serum LDL cholesterols of 135–173 mg/dl, and it insignificantly reduced death from CAD and nonfatal myocardial infarction by 16% in persons with serum LDL cholesterol levels below 135 mg/dl (25).
Treatment of 1000 persons for 6 years with pravastatin prevented 30 deaths, 28 nonfatal myocardial infarctions, 9 nonfatal strokes, 23 episodes of coronary artery bypass surgery, 20 episodes of coronary angioplasty, and 82 hospital admissions for unstable angina pectoris (25). The absolute benefits of treatment with pravastatin were greater in groups of persons at higher absolute risk for a major coronary event, such as older persons, those with a higher serum LDL cholesterol level, those with a lower serum HDL cholesterol level, and those with a history of diabetes mellitus or smoking (25).
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Revascularized Postinfarction Patients
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In postinfarction patients who underwent coronary revascularization (1154 by coronary angioplasty and 1091 by coronary artery bypass surgery) and a serum total cholesterol level below 240 mg/dl (mean serum total cholesterol of 209 mg/dl) in the Cholesterol and Recurrent Events Trial, compared with placebo, pravastatin significantly reduced coronary death or nonfatal myocardial infarction by 36%, fatal or nonfatal myocardial infarction by 39%, repeat coronary revascularization by 18%, and stroke by 39% (26).
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Coronary Angiographic Atherosclerosis
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Pravastatin slowed progression of coronary atherosclerotic plaques in persons, mean age 57 years, with CAD and serum LDL cholesterol levels between 130 and 189 mg/dl assessed by quantitative coronary angiography at 3-year follow-up (27) and in persons, mean age 64 years, with CAD and serum total cholesterol levels of 160–220 mg/dl assessed by quantitative coronary angiography at 2-year follow-up (28). The Post Coronary Artery Bypass Graft Trial investigated 1351 persons, 21–74 years of age, who had undergone coronary artery bypass surgery and who had serum LDL cholesterol levels between 130 and 175 mg/dl randomized to lovastatin and, if needed, cholestyramine to achieve LDL cholesterol levels of 93–97 mg/dl versus 132–136 mg/dl (29). At a 4.3-year follow-up (29), the mean percentage of grafts with progression of atherosclerosis was significantly reduced by aggressive treatment (27%) versus moderate treatment (39%). At a 7.5-year follow-up (30), compared to moderate lipid-lowering treatment, the reduction of serum LDL cholesterol levels to between 93–97 mg/dl significantly reduced the composite end point of death from cardiovascular or unknown causes or nonfatal myocardial infarction, stroke, coronary artery bypass surgery, or coronary angioplasty by 24%. Statin drug therapy was also associated with a significant reduction in restenosis after coronary stent implantation in persons, mean age 63 years, during a 6-month follow-up (31).
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Myocardial Ischemia
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After 4–6 months of randomized treatment with lovastatin 20–40 mg daily versus placebo in 40 persons older than 60 years of age with CAD, myocardial ischemia, and serum total cholesterol levels between 191 and 327 mg/dl, follow-up 48-hour ambulatory electrocardiograms showed no evidence of myocardial ischemia in 13 of 20 persons (55%) treated with lovastatin versus 2 of 20 persons (10%) treated with placebo (32). In a 2-year randomized, placebo-controlled study of 768 men, mean age 63 years, with CAD, stable angina pectoris, serum total cholesterol levels between 155–310 mg/dl, and optimal antianginal therapy, pravastatin significantly reduced transient myocardial ischemia assessed by 48-hour ambulatory electrocardiograms by 55% (33).
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Mechanisms of Reducing Coronary Events by Statins
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By reducing high serum LDL cholesterol levels and increasing low serum HDL cholesterol levels, statins can slow the rate of progression of coronary atherosclerosis, can occasionally cause regression of coronary atherosclerosis, and can cause stabilization of atherosclerotic plaques that are prone to rupture (27)(28)(29)(34). Statins improve endothelial dysfunction in persons with CAD (34)(35)(36). Statins decrease platelet aggregation and deposition and maintain a favorable balance between prothrombotic and fibrinolytic mechanisms (34)(37). Statins reduce myocardial ischemia (32)(33). In addition, statins may decrease the inflammatory component of atherosclerosis progression, in which oxidized LDL cholesterol exerts an adverse effect on endothelial cells, smooth muscle cells, and macrophages (34)(38).
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Indications for Treatment With Statins
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On the basis of the available data, older men and women with CAD who have a serum LDL cholesterol higher than 125 mg/dl despite the American Heart Association Step II diet should be treated with lipid-lowering drug therapy, preferably statin drug therapy, to reduce the serum LDL cholesterol level to less than 100 mg/dl (39)(40). The statin drug trials demonstrated a reduction in all-cause mortality, coronary events, stroke, and intermittent claudication in older persons with CAD up to 81 years of age at follow-up (18)(23)(25). Statin drug therapy should also be given to persons older than 81 years of age with CAD and serum LDL cholesterol levels higher than 125 mg/dl in the absence of other competing illnesses that will limit survival. Despite the evidence that lowering of elevated serum LDL cholesterol in older persons with CAD improves survival and reduces the incidence of new coronary events, stroke, and intermittent claudication, lipid-lowering drug therapy is underutilized in these persons (41)(42)(43).
Older men and women with prior atherothrombotic brain infarction (44)(45)(46), peripheral arterial disease (47)(48)(49), and extracranial carotid arterial disease (ECAD) (50)(51) are at high risk for developing new coronary events and also should be treated with statin drug therapy if their serum LDL cholesterol levels are higher than 125 mg/dl despite the use of the American Heart Association Step II diet.
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Stroke
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There are conflicting data about the association of abnormal serum lipids with atherothrombotic brain infarction in older men and women (44)(52)(53)(54). Despite these conflicting data, simvastatin and pravastatin have been shown to cause a significant reduction in stroke in older men and women with CAD in the Scandinavian Simvastatin Survival Study (18), in the Cholesterol and Recurrent Events Trial (24), and in the Long-Term Intervention With Pravastatin in Ischaemic Disease Study (25).
A meta-analysis of 11 secondary and three primary prevention randomized trials reported the incidences of total mortality and new stroke in 28,701 persons treated with simvastatin, pravastatin, lovastatin, or double-blind placebo (55). Mean follow-up was 3.3 years. Compared with the placebo, simvastatin, pravastatin, and lovastatin significantly reduced total mortality by 22% and the incidence of new stroke by 29% (55).
Another meta-analysis of eight secondary prevention studies in persons with CAD and four primary prevention studies showed that statin drugs significantly reduced the incidence of new stroke by 27% in these 12 studies, significantly decreased the incidence of new stroke by 32% in the eight secondary prevention studies, and insignificantly reduced the incidence of new stroke by 15% in the four primary prevention studies (56).
Reduction in elevated serum LDL cholesterol levels and increase in low serum HDL cholesterol levels by statins may reduce stroke by decreasing the rate of progression of extracranial carotid atherosclerosis, by stabilizing extracranial carotid atherosclerotic plaques, and by reducing stroke through its decrease of coronary events (56). On the basis of the available data, older persons with prior atherothrombotic brain infarction and serum LDL cholesterol levels above 125 mg/dl despite dietary therapy should be treated with statins to reduce the incidence of new stroke as well as new coronary events.
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Extracranial Carotid Arterial Disease
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Numerous studies have shown that a high serum total cholesterol and a low serum HDL cholesterol are risk factors for ECAD (57)(58)(59). Many studies have also demonstrated the beneficial effect of statins in reducing progression of ECAD (19)(60)(61). On the basis of the available data, older men and women with 40–100% ECAD and a serum LDL cholesterol level above 125 mg/dl despite dietary therapy should be treated with statins to reduce the progression of ECAD and to decrease the incidence of new stroke and coronary events.
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Primary Prevention
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West of Scotland Coronary Prevention Study
In the West of Scotland Coronary Prevention Study, 6595 middle-aged men 45–64 years of age with no heart disease and hypercholesterolemia were randomized to pravastatin 40 mg daily or double-blind placebo (62). Mean follow-up was 4.9 years (up to 6.2 years). Pravastatin significantly reduced serum total cholesterol by 20% to 218 mg/dl, serum LDL cholesterol by 26% to 142 mg/dl, and serum triglycerides by 12% to 142 mg/dl, and it significantly increased HDL cholesterol by 5% to 46 mg/dl (62).
Compared with placebo, pravastatin reduced all-cause mortality by 22% (p = .051), significantly decreased death from all cardiovascular causes by 32% and death from CAD or nonfatal myocardial infarction by 31%, and insignificantly reduced stroke by 10% (62). Treatment of 1000 middle-aged men with hypercholesterolemia and no CAD for 5 years caused seven fewer deaths from cardiovascular causes, two fewer deaths from other causes, 20 fewer nonfatal myocardial infarctions, eight fewer coronary revascularization procedures, and 14 fewer coronary angiograms (62).
Air Force/Texas Coronary Atherosclerosis Prevention Study
In the Air Force/Texas Coronary Atherosclerosis Prevention Study, 6605 men and women 45–73 years of age (22% aged 65–73 years) without cardiovascular disease, a mean serum total cholesterol level of 221 mg/dl, a mean serum LDL cholesterol level of 150 mg/dl, and a mean serum HDL cholesterol level of 36 mg/dl in men and 40 mg/dl in women were randomized to lovastatin 20–40 mg daily or double-blind placebo (63). Mean follow-up was 5.2 years (up to 7.2 years). Lovastatin significantly reduced serum total cholesterol by 18%, serum LDL cholesterol by 25%, and serum triglycerides by 15%, and it significantly increased serum HDL cholesterol by 6%.
Compared with placebo, lovastatin significantly reduced the primary end point acute major coronary events defined as fatal or nonfatal myocardial infarction, unstable angina pectoris, or sudden cardiac death by 37% and by 30% in older persons (63). Compared with placebo, lovastatin significantly decreased the secondary end points of coronary revascularization by 33%, of unstable angina pectoris by 32%, of fatal and nonfatal myocardial infarction by 40%, of fatal and nonfatal cardiovascular events by 25%, and of fatal and nonfatal coronary events by 25% (63). The reduction in major coronary events appeared as early as 1 year, with 40 coronary events occurring in the placebo group versus 23 coronary events occurring in the lovastatin-treated group (63). Five years of treating 1000 persons with lovastatin prevented 12 myocardial infarctions, seven presentations of unstable angina pectoris, and 17 coronary revascularizations (63).
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Primary Prevention Treatment
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The position paper from the Society of Geriatric Cardiology recommended that persons aged 65–80 years without CAD with a serum total cholesterol level of 240 mg/dl or higher or a serum LDL cholesterol level of 160 mg/dl or higher and one other major risk factor such as hypertension, diabetes mellitus, smoking, or a serum HDL cholesterol level less than 35 mg/dl despite diet should be treated with lipid-lowering drug therapy to reduce the serum total cholesterol to less than 200 mg/dl and the serum LDL cholesterol to less than 130 mg/dl (64). It is reasonable to treat high-risk persons older than 80 years with hypercholesterolemia without CAD with diet and lipid-lowering drug therapy if they are otherwise healthy (64). On the basis of data from the Air Force/Texas Coronary Atherosclerosis Prevention Study, the physician should consider using statin drug therapy in persons aged 65–80 years without atherosclerotic cardiovascular disease with serum LDL cholesterol levels above 130 mg/dl and serum HDL cholesterol levels below 50 mg/dl (63).
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Adverse Effects of Statins
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Elevation of serum hepatic transaminases more than three times the upper limit of normal occurs in approximately 1% of persons taking statins. These alterations are generally reversible and rarely of clinical significance. Skeletal muscle myopathy occurs in less than 0.2% of persons taking statins. The risk of skeletal muscle myopathy is higher if statins are used in combination with gemfibrozil, nicotinic acid, erythromycin, or cyclosporin A. Statin drugs should not be used in persons with active liver disease or unexplained persistent elevated serum hepatic transaminases. Statin drugs should be used cautiously in persons with a history of liver disease or in persons who drink alcohol excessively.
Liver function tests should be obtained before initiation of statin drug therapy, at 6 weeks and 12 weeks after initiating statin drug therapy, after increasing the dose of drug, and at 6-month intervals. Treatment should be initiated with a low dose of statin drug and the dose increased if necessary according to follow-up serum lipids obtained at intervals of 4 weeks or longer. Persons taking statins should be advised to report promptly to their physicians unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever.
Results from the Cholesterol Reduction in Seniors Program Pilot Study, which included 431 older men and women, showed that compared with placebo, lovastatin 40 mg daily was well tolerated with regard to symptoms and to health-related quality of life with no change in cognitive function (65).
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Use of Statins
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Although treatment with any of the statin drugs will probably reduce all-cause mortality, coronary events, stroke, and intermittent claudication in older persons with CAD and serum LDL cholesterol levels higher than 125 mg/dl, the author prefers to use simvastatin, pravastatin, or lovastatin because these drugs have been demonstrated to reduce cardiovascular events in older persons with CAD (18)(23)(25) and those without CAD (62)(63). The initial dose of simvastatin should be 10 mg once daily in the evening, and the maximum dose 80 mg once daily in the evening. The initial dose of pravastatin should be 10 mg once daily at bedtime, and the maximum dose is 40 mg once daily at bedtime. The initial dose of lovastatin should be 10 mg once daily, taken with the evening meal, and the maximum dose is 80 mg once daily, taken with the evening meal.
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Combination Lipid-Lowering Drug Therapy
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Atorvastatin causes the greatest reduction in serum LDL cholesterol levels. The initial dose of atorvastatin is 10 mg daily, and the maximum dose is 80 mg daily. However, simvastatin causes a greater increase in serum HDL cholesterol levels than does atorvastatin (66). If statin drug therapy does not lower the serum LDL cholesterol level to less than 100 mg/dl in older persons with CAD, a bile acid binding resin such as cholestyramine should be added, because this drug does not increase the incidence of myositis in persons taking statins. The initial dose of cholestyramine is 4 g taken one to two times daily, and the maximum dose is 24 g daily taken in two doses (67). The initial dose of nicotinic acid is 750 mg twice daily, and the maximum dose is 3 g daily taken in three doses (60). The initial dose of gemfibrozil is 300 mg twice daily, and the maximum dose is 600 mg twice daily (67).
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Metabolic Syndrome
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The clustering of high serum triglycerides, small dense LDL particles, low serum HDL cholesterol levels, hypertension, insulin resistance (with or without glucose intolerance), and a prothrombotic state is called the metabolic syndrome (68). Statin drug therapy alone, or in combination with gemfibrozil, can be used to treat atherogenic dyslipidemia (68).
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Cost of Statins to Save 1 Year of Life
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Data from the Scandinavian Simvastatin Survival Study showed that the use of simvastatin for secondary prevention of CAD would cost $12,000 in U.S. dollars to save 1 year of life (69). Data from the West of Scotland Coronary Prevention Study showed that the use of pravastatin for primary prevention of CAD would cost $16,000 to $32,000 in U.S. dollars to save 1 year of life, but less money if higher-risk persons such as smokers and hypertensives were treated (70). It has been estimated that the use of statins in persons 75–84 years of age with prior myocardial infarction would cost $18,000 in 1998 U.S. dollars to save 1 year of life (71). However, this analysis did not use in its model benefits from statins such as reduction in coronary revascularization and decrease in CAD death other than fatal myocardial infarction (71).
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Heart and Estrogen/Progestin Replacement Study
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In the Heart and Estrogen/Progestin Replacement Study, 2763 postmenopausal women, mean age 67 years, with CAD were randomized to 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate in one tablet daily or to double-blind placebo (72). Mean follow-up was 4.1 years (up to 5 years). At the end of the first year of treatment, the hormone-treated group had a 14% significant reduction in serum LDL cholesterol, an 8% significant increase in serum HDL cholesterol, and a 10% significant increase in serum triglycerides. At the end of the study, there was no significant difference in the primary outcome, which was CAD death or nonfatal myocardial infarction in persons treated with hormone therapy or placebo. However, there was a 52% significant increase in new coronary events during the first year in women treated with hormone therapy, with a reduced risk for coronary events in women treated with hormone therapy during years 3, 4, and 5 of the study (72).
The significant increase in new coronary events during the first year of treatment may have possibly been caused by a prothrombotic effect of estrogen. The reduction in coronary events during years 3, 4, and 5 of the study may have been caused by hormone therapy's causing a reduction in serum LDL cholesterol and an increase in serum HDL cholesterol. On the basis of the data from this study, the American College of Cardiology/American Heart Association guidelines recommend not starting hormone therapy in postmenopausal women with CAD (72).
Received August 1, 2000
Accepted August 4, 2000
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Abstract
Serum Lipids and Coronary...