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High Blood Cholesterol
 National Cholesterol Education Program


 ATP III Guidelines At-A-Glance
 Quick Desk Reference
       1
  Step 1      Determine lipoprotein levels–obtain complete lipoprotein profile after
              9- to 12-hour fast.

              ATP III Classification of LDL, Total, and HDL Cholesterol (mg/dL)

              LDL Cholesterol – Primary Target of Therapy
                 <100                           Optimal
                 100-129                        Near optimal/above optimal
                 130-159                        Borderline high
                 160-189                        High
                 >190                           Very high

              Total Cholesterol
                 <200                                   Desirable
                 200-239                                Borderline high
                  >240                                  High

              HDL Cholesterol
                <40                                     Low
                >60                                     High



       2
  Step 2      Identify presence of clinical atherosclerotic disease that confers high risk
              for coronary heart disease (CHD) events (CHD risk equivalent):

                  s   Clinical CHD
                  s   Symptomatic carotid artery disease
                  s   Peripheral arterial disease
                      Abdominal aortic aneurysm.

       3
                  s




  Step 3      Determine presence of major risk factors (other than LDL):

              Major Risk Factors (Exclusive of LDL Cholesterol) That Modify LDL Goals
              Cigarette smoking
              Hypertension (BP >140/90 mmHg or on antihypertensive medication)
              Low HDL cholesterol (<40 mg/dL)*
              Family history of premature CHD (CHD in male first degree relative <55 years;
              CHD in female first degree relative <65 years)
              Age (men >45 years; women >55 years)
              * HDL cholesterol >60 mg/dL counts as a “negative” risk factor; its presence removes one
                risk factor from the total count.



              s   Note: in ATP III, diabetes is regarded as a CHD risk equivalent.


N A T I O N A L              I N S T I T U T E S                      O F         H E A L T H
N A T I O N A L   H E A R T ,        L U N G ,       A N D       B L O O D        I N S T I T U T E
4
Step 4   If 2+ risk factors (other than LDL) are present without CHD or CHD risk equivalent, assess
         10-year (short-term) CHD risk (see Framingham tables).
         Three levels of 10-year risk:

             s   >20% — CHD risk equivalent
             s   10-20%
             s   <10%


  5
Step 5   Determine risk category:

             s   Establish LDL goal of therapy
             s   Determine need for therapeutic lifestyle changes (TLC)
             s   Determine level for drug consideration

         LDL Cholesterol Goals and Cutpoints for Therapeutic Lifestyle Changes (TLC) and Drug Therapy in Different
         Risk Categories.

                                                                               LDL Level at Which
                                                                               to Initiate Therapeutic          LDL Level at Which to
         Risk Category                           LDL Goal                      Lifestyle Changes (TLC)          Consider Drug Therapy

         CHD or CHD Risk Equivalents             <100 mg/dL                    >100 mg/dL                        >130 mg/dL
         (10-year risk >20%)                                                                                    (100-129 mg/dL: drug optional)*

                                                                                                                10-year risk 10-20%:
         2+ Risk Factors                         <130 mg/dL                    >130 mg/dL                       >130 mg/dL
         (10-year risk <20%)                                                                                    10-year risk <10%:
                                                                                                                >160 mg/dL

         0-1 Risk Factor†                        <160 mg/dL                    >160 mg/dL                       >190 mg/dL
                                                                                                                (160-189 mg/dL: LDL-lowering
                                                                                                                drug optional)

         * Some authorities recommend use of LDL-lowering drugs in this category if an LDL cholesterol <100 mg/dL cannot be achieved by
           therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL, e.g., nicotinic acid or fibrate.
           Clinical judgment also may call for deferring drug therapy in this subcategory.
         † Almost all people with 0-1 risk factor have a 10-year risk <10%, thus 10-year risk assessment in people with 0-1 risk factor is
           not necessary.




  6
Step 6
         Initiate therapeutic lifestyle changes (TLC) if LDL is above goal.

         TLC Features

         s   TLC Diet:
              — Saturated fat <7% of calories, cholesterol <200 mg/day

              — Consider increased viscous (soluble) fiber (10-25 g/day) and plant stanols/sterols
                 (2g/day) as therapeutic options to enhance LDL lowering
         s   Weight management
         s   Increased physical activity.
7
Step 7   Consider adding drug therapy if LDL exceeds levels shown in Step 5 table:

             s   Consider drug simultaneously with TLC for CHD and CHD equivalents
             s   Consider adding drug to TLC after 3 months for other risk categories.

         Drugs Affecting Lipoprotein Metabolism

         Drug Class                   Agents and                     Lipid/Lipoprotein             Side Effects              Contraindications
                                      Daily Doses                    Effects

         HMG CoA reductase            Lovastatin (20-80 mg)          LDL       ↓18-55%             Myopathy                 Absolute:
         inhibitors (statins)         Pravastatin (20-40 mg)         HDL       ↑5-15%              Increased liver          • Active or chronic
                                      Simvastatin (20-80 mg)         TG        ↓7-30%              enzymes                    liver disease
                                      Fluvastatin (20-80 mg)                                                                Relative:
                                                                                                                            • Concomitant use of
                                      Atorvastatin (10-80 mg)
                                                                                                                              certain drugs*
                                      Cerivastatin (0.4-0.8 mg)



         Bile acid sequestrants       Cholestyramine (4-16 g)        LDL       ↓15-30%             Gastrointestinal         Absolute:
                                      Colestipol (5-20 g)            HDL       ↑3-5%               distress                 • dysbeta-
                                                                                                   Constipation               lipoproteinemia
                                      Colesevelam (2.6-3.8 g)        TG        No change
                                                                               or increase         Decreased absorp-        • TG >400 mg/dL
                                                                                                   tion of other drugs      Relative:
                                                                                                                            • TG >200 mg/dL



         Nicotinic acid               Immediate release              LDL       ↓5-25%              Flushing                 Absolute:
                                      (crystalline) nicotinic acid   HDL       ↑15-35%             Hyperglycemia            • Chronic liver disease
                                      (1.5-3 gm), extended           TG        ↓20-50%             Hyperuricemia            • Severe gout
                                      release nicotinic acid                                       (or gout)                Relative:
                                      (Niaspan®) (1-2 g),                                          Upper GI distress        • Diabetes
                                      sustained release                                            Hepatotoxicity           • Hyperuricemia
                                      nicotinic acid (1-2 g)                                                                • Peptic ulcer disease


         Fibric acids                 Gemfibrozil                    LDL       ↓5-20%              Dyspepsia                Absolute:
                                      (600 mg BID)                   (may be increased in          Gallstones               • Severe renal disease
                                      Fenofibrate (200 mg)           patients with high TG)        Myopathy                 • Severe hepatic
                                      Clofibrate                     HDL       ↑10-20%                                        disease
                                      (1000 mg BID)                  TG        ↓20-50%


         * Cyclosporine, macrolide antibiotics, various anti-fungal agents, and cytochrome P-450 inhibitors (fibrates and niacin should be used with
           appropriate caution).
8
Step 8   Identify metabolic syndrome and treat, if present, after 3 months of TLC.

         Clinical Identification of the Metabolic Syndrome – Any 3 of the Following:
         Risk Factor                                       Defining Level
         Abdominal obesity*                                Waist circumference†
           Men                                              >102 cm (>40 in)
           Women                                            >88 cm (>35 in)

         Triglycerides                                        >150 mg/dL

         HDL cholesterol
           Men                                                <40 mg/dL
           Women                                              <50 mg/dL

         Blood pressure                                       >130/>85 mmHg

         Fasting glucose                                      >110 mg/dL

         * Overweight and obesity are associated with insulin resistance and the metabolic syndrome.
           However, the presence of abdominal obesity is more highly correlated with the metabolic risk
           factors than is an elevated body mass index (BMI). Therefore, the simple measure of waist cir-
           cumference is recommended to identify the body weight component of the metabolic syndrome.
         † Some male patients can develop multiple metabolic risk factors when the waist circumference is
           only marginally increased, e.g., 94-102 cm (37-39 in). Such patients may have a strong genetic
           contribution to insulin resistance. They should benefit from changes in life habits, similarly to
           men with categorical increases in waist circumference.


         Treatment of the metabolic syndrome

            s   Treat underlying causes (overweight/obesity and physical inactivity):
                  – Intensify weight management
                  – Increase physical activity.

            s   Treat lipid and non-lipid risk factors if they persist despite these lifestyle therapies:
                  – Treat hypertension
                  – Use aspirin for CHD patients to reduce prothrombotic state
                  – Treat elevated triglycerides and/or low HDL (as shown in Step 9).
9
Step 9   Treat elevated triglycerides.

         ATP III Classification of Serum Triglycerides (mg/dL)

         <150              Normal
         150-199           Borderline high
         200-499           High
         ≥500              Very high

         Treatment of elevated triglycerides (≥150 mg/dL)

         s   Primary aim of therapy is to reach LDL goal
         s   Intensify weight management
         s   Increase physical activity
         s   If triglycerides are >200 mg/dL after LDL goal is reached, set
             secondary goal for non-HDL cholesterol (total – HDL)
             30 mg/dL higher than LDL goal.
         Comparison of LDL Cholesterol and Non-HDL Cholesterol Goals for Three Risk Categories

         Risk Category                       LDL Goal (mg/dL)           Non-HDL Goal (mg/dL)

         CHD and CHD Risk Equivalent              <100                         <130
         (10-year risk for CHD >20%)
         Multiple (2+) Risk Factors and           <130                         <160
         10-year risk <20%
         0-1 Risk Factor                          <160                         <190



         If triglycerides 200-499 mg/dL after LDL goal is reached, consider adding drug if needed to
         reach non-HDL goal:
             •   intensify therapy with LDL-lowering drug, or
             •   add nicotinic acid or fibrate to further lower VLDL.

         If triglycerides >500 mg/dL, first lower triglycerides to prevent pancreatitis:
             •   very low-fat diet (<15% of calories from fat)
             •   weight management and physical activity
             •   fibrate or nicotinic acid
             •   when triglycerides <500 mg/dL, turn to LDL-lowering therapy.


         Treatment of low HDL cholesterol (<40 mg/dL)

         s   First reach LDL goal, then:
         s   Intensify weight management and increase physical activity
         s   If triglycerides 200-499 mg/dL, achieve non-HDL goal
         s   If triglycerides <200 mg/dL (isolated low HDL) in CHD or CHD equivalent
             consider nicotinic acid or fibrate.
Men
Estimate of 10-Year Risk for Men
                                                                                          Women
                                                                                         Estimate of 10-Year Risk for Women
(Framingham Point Scores)                                                                (Framingham Point Scores)

Age                       Points                                                         Age                       Points

20-34                        -9                                                          20-34                         -7
35-39                        -4                                                          35-39                         -3
40-44                         0                                                          40-44                          0
45-49                         3                                                          45-49                          3
50-54                         6                                                          50-54                          6
55-59                         8                                                          55-59                          8
60-64                        10                                                          60-64                         10
65-69                        11                                                          65-69                         12
70-74                        12                                                          70-74                         14
75-79                        13                                                          75-79                         16


                                            Points                                       Total                                        Points
Total
Cholesterol                                                                              Cholesterol
              Age 20-39    Age 40-49     Age 50-59      Age 60-69   Age 70-79                          Age 20-39    Age 40-49       Age 50-59       Age 60-69   Age 70-79

 <160             0           0               0              0           0                <160            0            0               0                0          0
160-199           4           3               2              1           0               160-199          4            3               2                1          1
200-239           7           5               3              1           0               200-239          8            6               4                2          1
240-279           9           6               4              2           1               240-279         11            8               5                3          2
 ≥280            11           8               5              3           1                ≥280           13           10               7                4          2

                                            Points                                                                                    Points

              Age 20-39   Age 40-49      Age 50-59     Age 60-69    Age 70-79                          Age 20-39    Age 40-49       Age 50-59       Age 60-69   Age 70-79

Nonsmoker          0           0               0              0           0              Nonsmoker        0             0               0                0          0
Smoker             8           5               3              1           1              Smoker           9             7               4                2          1


HDL (mg/dL)                 Points                                                       HDL (mg/dL)                 Points

  ≥60                        -1                                                            ≥60                        -1
 50-59                        0                                                           50-59                        0
 40-49                        1                                                           40-49                        1
  <40                         2                                                            <40                         2

Systolic BP (mmHg)        If Untreated               If Treated                          Systolic BP (mmHg)        If Untreated                 If Treated

 <120                          0                         0                                <120                          0                           0
120-129                        0                         1                               120-129                        1                           3
130-139                        1                         2                               130-139                        2                           4
140-159                        1                         2                               140-159                        3                           5
 ≥160                          2                         3                                ≥160                          4                           6


Point Total               10-Year Risk %                                                 Point Total               10-Year Risk %
  <0                        <1                                                              <9                       <1
   0                          1                                                               9                        1
   1                          1                                                              10                        1
   2                          1                                                              11                        1
   3                          1                                                              12                        1
   4                          1                                                              13                        2
   5                          2                                                              14                        2
   6                          2                                                              15                        3
   7                          3                                                              16                        4
   8                          4
                                                                                             17                        5
   9                          5
  10                          6                                                              18                        6
  11                          8                                                              19                        8
  12                         10                                                              20                       11
  13                         12                                                              21                       14
  14                         16                                                              22                       17
  15                         20                                                              23                       22
  16                         25                       10-Year risk ______%                   24                       27                            10-Year risk ______%
 ≥17                       ≥ 30                                                             ≥25                     ≥ 30


U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES                        NIH Publication No. 01-3305
Public Health Service                                               May 2001
National Institutes of Health
National Heart, Lung, and Blood Institute

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Atglance

  • 1. High Blood Cholesterol National Cholesterol Education Program ATP III Guidelines At-A-Glance Quick Desk Reference 1 Step 1 Determine lipoprotein levels–obtain complete lipoprotein profile after 9- to 12-hour fast. ATP III Classification of LDL, Total, and HDL Cholesterol (mg/dL) LDL Cholesterol – Primary Target of Therapy <100 Optimal 100-129 Near optimal/above optimal 130-159 Borderline high 160-189 High >190 Very high Total Cholesterol <200 Desirable 200-239 Borderline high >240 High HDL Cholesterol <40 Low >60 High 2 Step 2 Identify presence of clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (CHD risk equivalent): s Clinical CHD s Symptomatic carotid artery disease s Peripheral arterial disease Abdominal aortic aneurysm. 3 s Step 3 Determine presence of major risk factors (other than LDL): Major Risk Factors (Exclusive of LDL Cholesterol) That Modify LDL Goals Cigarette smoking Hypertension (BP >140/90 mmHg or on antihypertensive medication) Low HDL cholesterol (<40 mg/dL)* Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years) Age (men >45 years; women >55 years) * HDL cholesterol >60 mg/dL counts as a “negative” risk factor; its presence removes one risk factor from the total count. s Note: in ATP III, diabetes is regarded as a CHD risk equivalent. N A T I O N A L I N S T I T U T E S O F H E A L T H N A T I O N A L H E A R T , L U N G , A N D B L O O D I N S T I T U T E
  • 2. 4 Step 4 If 2+ risk factors (other than LDL) are present without CHD or CHD risk equivalent, assess 10-year (short-term) CHD risk (see Framingham tables). Three levels of 10-year risk: s >20% — CHD risk equivalent s 10-20% s <10% 5 Step 5 Determine risk category: s Establish LDL goal of therapy s Determine need for therapeutic lifestyle changes (TLC) s Determine level for drug consideration LDL Cholesterol Goals and Cutpoints for Therapeutic Lifestyle Changes (TLC) and Drug Therapy in Different Risk Categories. LDL Level at Which to Initiate Therapeutic LDL Level at Which to Risk Category LDL Goal Lifestyle Changes (TLC) Consider Drug Therapy CHD or CHD Risk Equivalents <100 mg/dL >100 mg/dL >130 mg/dL (10-year risk >20%) (100-129 mg/dL: drug optional)* 10-year risk 10-20%: 2+ Risk Factors <130 mg/dL >130 mg/dL >130 mg/dL (10-year risk <20%) 10-year risk <10%: >160 mg/dL 0-1 Risk Factor† <160 mg/dL >160 mg/dL >190 mg/dL (160-189 mg/dL: LDL-lowering drug optional) * Some authorities recommend use of LDL-lowering drugs in this category if an LDL cholesterol <100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. † Almost all people with 0-1 risk factor have a 10-year risk <10%, thus 10-year risk assessment in people with 0-1 risk factor is not necessary. 6 Step 6 Initiate therapeutic lifestyle changes (TLC) if LDL is above goal. TLC Features s TLC Diet: — Saturated fat <7% of calories, cholesterol <200 mg/day — Consider increased viscous (soluble) fiber (10-25 g/day) and plant stanols/sterols (2g/day) as therapeutic options to enhance LDL lowering s Weight management s Increased physical activity.
  • 3. 7 Step 7 Consider adding drug therapy if LDL exceeds levels shown in Step 5 table: s Consider drug simultaneously with TLC for CHD and CHD equivalents s Consider adding drug to TLC after 3 months for other risk categories. Drugs Affecting Lipoprotein Metabolism Drug Class Agents and Lipid/Lipoprotein Side Effects Contraindications Daily Doses Effects HMG CoA reductase Lovastatin (20-80 mg) LDL ↓18-55% Myopathy Absolute: inhibitors (statins) Pravastatin (20-40 mg) HDL ↑5-15% Increased liver • Active or chronic Simvastatin (20-80 mg) TG ↓7-30% enzymes liver disease Fluvastatin (20-80 mg) Relative: • Concomitant use of Atorvastatin (10-80 mg) certain drugs* Cerivastatin (0.4-0.8 mg) Bile acid sequestrants Cholestyramine (4-16 g) LDL ↓15-30% Gastrointestinal Absolute: Colestipol (5-20 g) HDL ↑3-5% distress • dysbeta- Constipation lipoproteinemia Colesevelam (2.6-3.8 g) TG No change or increase Decreased absorp- • TG >400 mg/dL tion of other drugs Relative: • TG >200 mg/dL Nicotinic acid Immediate release LDL ↓5-25% Flushing Absolute: (crystalline) nicotinic acid HDL ↑15-35% Hyperglycemia • Chronic liver disease (1.5-3 gm), extended TG ↓20-50% Hyperuricemia • Severe gout release nicotinic acid (or gout) Relative: (Niaspan®) (1-2 g), Upper GI distress • Diabetes sustained release Hepatotoxicity • Hyperuricemia nicotinic acid (1-2 g) • Peptic ulcer disease Fibric acids Gemfibrozil LDL ↓5-20% Dyspepsia Absolute: (600 mg BID) (may be increased in Gallstones • Severe renal disease Fenofibrate (200 mg) patients with high TG) Myopathy • Severe hepatic Clofibrate HDL ↑10-20% disease (1000 mg BID) TG ↓20-50% * Cyclosporine, macrolide antibiotics, various anti-fungal agents, and cytochrome P-450 inhibitors (fibrates and niacin should be used with appropriate caution).
  • 4. 8 Step 8 Identify metabolic syndrome and treat, if present, after 3 months of TLC. Clinical Identification of the Metabolic Syndrome – Any 3 of the Following: Risk Factor Defining Level Abdominal obesity* Waist circumference† Men >102 cm (>40 in) Women >88 cm (>35 in) Triglycerides >150 mg/dL HDL cholesterol Men <40 mg/dL Women <50 mg/dL Blood pressure >130/>85 mmHg Fasting glucose >110 mg/dL * Overweight and obesity are associated with insulin resistance and the metabolic syndrome. However, the presence of abdominal obesity is more highly correlated with the metabolic risk factors than is an elevated body mass index (BMI). Therefore, the simple measure of waist cir- cumference is recommended to identify the body weight component of the metabolic syndrome. † Some male patients can develop multiple metabolic risk factors when the waist circumference is only marginally increased, e.g., 94-102 cm (37-39 in). Such patients may have a strong genetic contribution to insulin resistance. They should benefit from changes in life habits, similarly to men with categorical increases in waist circumference. Treatment of the metabolic syndrome s Treat underlying causes (overweight/obesity and physical inactivity): – Intensify weight management – Increase physical activity. s Treat lipid and non-lipid risk factors if they persist despite these lifestyle therapies: – Treat hypertension – Use aspirin for CHD patients to reduce prothrombotic state – Treat elevated triglycerides and/or low HDL (as shown in Step 9).
  • 5. 9 Step 9 Treat elevated triglycerides. ATP III Classification of Serum Triglycerides (mg/dL) <150 Normal 150-199 Borderline high 200-499 High ≥500 Very high Treatment of elevated triglycerides (≥150 mg/dL) s Primary aim of therapy is to reach LDL goal s Intensify weight management s Increase physical activity s If triglycerides are >200 mg/dL after LDL goal is reached, set secondary goal for non-HDL cholesterol (total – HDL) 30 mg/dL higher than LDL goal. Comparison of LDL Cholesterol and Non-HDL Cholesterol Goals for Three Risk Categories Risk Category LDL Goal (mg/dL) Non-HDL Goal (mg/dL) CHD and CHD Risk Equivalent <100 <130 (10-year risk for CHD >20%) Multiple (2+) Risk Factors and <130 <160 10-year risk <20% 0-1 Risk Factor <160 <190 If triglycerides 200-499 mg/dL after LDL goal is reached, consider adding drug if needed to reach non-HDL goal: • intensify therapy with LDL-lowering drug, or • add nicotinic acid or fibrate to further lower VLDL. If triglycerides >500 mg/dL, first lower triglycerides to prevent pancreatitis: • very low-fat diet (<15% of calories from fat) • weight management and physical activity • fibrate or nicotinic acid • when triglycerides <500 mg/dL, turn to LDL-lowering therapy. Treatment of low HDL cholesterol (<40 mg/dL) s First reach LDL goal, then: s Intensify weight management and increase physical activity s If triglycerides 200-499 mg/dL, achieve non-HDL goal s If triglycerides <200 mg/dL (isolated low HDL) in CHD or CHD equivalent consider nicotinic acid or fibrate.
  • 6. Men Estimate of 10-Year Risk for Men Women Estimate of 10-Year Risk for Women (Framingham Point Scores) (Framingham Point Scores) Age Points Age Points 20-34 -9 20-34 -7 35-39 -4 35-39 -3 40-44 0 40-44 0 45-49 3 45-49 3 50-54 6 50-54 6 55-59 8 55-59 8 60-64 10 60-64 10 65-69 11 65-69 12 70-74 12 70-74 14 75-79 13 75-79 16 Points Total Points Total Cholesterol Cholesterol Age 20-39 Age 40-49 Age 50-59 Age 60-69 Age 70-79 Age 20-39 Age 40-49 Age 50-59 Age 60-69 Age 70-79 <160 0 0 0 0 0 <160 0 0 0 0 0 160-199 4 3 2 1 0 160-199 4 3 2 1 1 200-239 7 5 3 1 0 200-239 8 6 4 2 1 240-279 9 6 4 2 1 240-279 11 8 5 3 2 ≥280 11 8 5 3 1 ≥280 13 10 7 4 2 Points Points Age 20-39 Age 40-49 Age 50-59 Age 60-69 Age 70-79 Age 20-39 Age 40-49 Age 50-59 Age 60-69 Age 70-79 Nonsmoker 0 0 0 0 0 Nonsmoker 0 0 0 0 0 Smoker 8 5 3 1 1 Smoker 9 7 4 2 1 HDL (mg/dL) Points HDL (mg/dL) Points ≥60 -1 ≥60 -1 50-59 0 50-59 0 40-49 1 40-49 1 <40 2 <40 2 Systolic BP (mmHg) If Untreated If Treated Systolic BP (mmHg) If Untreated If Treated <120 0 0 <120 0 0 120-129 0 1 120-129 1 3 130-139 1 2 130-139 2 4 140-159 1 2 140-159 3 5 ≥160 2 3 ≥160 4 6 Point Total 10-Year Risk % Point Total 10-Year Risk % <0 <1 <9 <1 0 1 9 1 1 1 10 1 2 1 11 1 3 1 12 1 4 1 13 2 5 2 14 2 6 2 15 3 7 3 16 4 8 4 17 5 9 5 10 6 18 6 11 8 19 8 12 10 20 11 13 12 21 14 14 16 22 17 15 20 23 22 16 25 10-Year risk ______% 24 27 10-Year risk ______% ≥17 ≥ 30 ≥25 ≥ 30 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NIH Publication No. 01-3305 Public Health Service May 2001 National Institutes of Health National Heart, Lung, and Blood Institute