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Table 9A. ATP III: LDL-C Treatment Cutpoints for Therapy

Risk Category Initiate TLC* Consider Drug Therapy
 High risk:

 CHD or CHD risk equivalents  
 (10-year risk >20%)


 >100 mg/dL** 


 >100 mg/dL
 (<100 mg/dL: consider drug options)
 Moderately high risk:

 >2 risk factors
 (10-year risk 10–20%)


 >130 mg/dL**


 >130 mg/dL
 (100–129 mg/dL: consider drug options)††
 Moderate risk:

 >2 risk factors
 (10-year risk <10%)


  >130 mg/dL  


 >160 mg/dL 
 Lower risk:

 0–1 risk factor


 >160 mg/dL


 >190 mg/dL
(160–189 mg/dL: LDL-C–lowering drug optional)

* Therapeutic lifestyle changes.
** Any person at high risk or moderately high risk who has lifestyle-related risk factors (obesity, physical inactivity, elevated triglycerides, low HDL-C, or metabolic syndrome) is a candidate for TLC to modify these risk factors regardless of LDL-C level.
If baseline LDL-C is <100 mg/dL, institution of an LDL-lowering drug is a therapeutic option on the basis of available clinical trial results. If a high-risk person has high triglycerides and low HDL-C, combining a fibrate or nicotinic acid with an LDL-C lowering drug can be considered.
†† For moderately high-risk persons, when LDL-C level is 100-129 mg/dL, at baseline or on lifestyle therapy, initiation of an LDL-C lowering drug to achieve an LDL-C level <100 mg/dL is a therapeutic option on the basis of available clinical trial results.

Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda, Md: National Institutes of Health, National Heart, Lung, and Blood Institute; 2001. NIH Publication 01-3095.
Updated with: Grundy SM, Cleeman JI, Merz CNB, et al. Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004;110:227-239.






Table 9B. ATP III: Risk Categories, LDL-C Goals

Risk Category   LDL-C Goal (mg/dL)      

 High risk:

CHD* and CHD risk equivalents  
(10-year risk >20%)



<100
(optional goal: <70)

 Moderately high risk:

 >2 risk factors††
 (10-year risk 10%–20%)



<130
(optional goal: <100)

 Moderate risk:

 >2 risk factors††
 (10-year risk <10%)
 

 

<130 

 Lower risk:

 0–1 risk factor#



<160

* CHD includes history of myocardial infarction, unstable angina, stable angina, coronary artery procedures (angioplasty or bypass surgery), or evidence of clinically significant myocardial ischemia.
CHD risk equivalents include clinical manifestations of noncoronary forms of atherosclerosis (PVD, AAA, and carotid disease; diabetes, and >2 risk factors with 10-year risk for CHD >20%.
†† Risk factors include cigarette smoking HTN (BP >140/90 or on medication), low HDL-C (<40 mg/dL), family history of premature CHD (<55 yrs of first-degree male relative and <65 yrs female), age (men >45 yrs; women >55 yrs).
# Almost all persons with zero or 1 risk factor have a 10-yr risk <10% and thus a 10-yr risk assessment is not necessary.

Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda, Md: National Institutes of Health, National Heart, Lung, and Blood Institute; 2001. NIH publication 01-3095.
Updated with: Grundy SM, Cleeman JI, Merz CNB, et al. Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004;110:227-239.






Table 9C. ATP III: Nutritional Components of the TLC Diet

  Nutrient Recommended Intake
  Saturated fat* <7% of total calories
  Polyunsaturated fat Up to 10% of total calories
  Monounsaturated fat Up to 20% of total calories
  Total fat 25%–35% of total calories
  Carbohydrate (esp. complex carbs)           50%–60% of total calories    
  Fiber 20–30 g/d
  Protein ~15% of total calories
  Cholesterol <200 mg/d

*Trans fatty acids also raise LDL-C and should be kept at a low intake. Note: Regarding total calories, balance energy intake, and expenditure to maintain desirable body weight.

Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda, Md: National Institutes of Health, National Heart, Lung, and Blood Institute; 2001. NIH Publication 01-3095.






Table 9D. Drugs Affecting Lipoprotein Metabolism

 Drug Class, Agents  
 and Daily Doses
Lipid/Lipoprotein
Effects
Side Effects Contraindications Clinical Trial
Results
 HMG CoA
 reductase
 inhibitors (statins)*  
 LDL   ↓ 18–55%
 HDL ↑  5–15%
 TG ↓  7–30%
 
Myopathy
Increased liver enzymes  
 Absolute:
 •   Active or chronic liver disease
 Relative:
 •   Concomitant use of certain drugs
  
Reduced major coronary events, CHD deaths, need for coronary procedures, stroke, and total mortality  
 Bile acid  sequestrants
 LDL   ↓ 15–30%
 HDL ↑  3–5%
 TG No change or increase
 
Gastrointestinal distress
Constipation
Decreased absorption of other drugs
 Absolute:
 •   Dysbeta-lipoproteinemia
 •   TG >400 mg/dL

 Relative:
 •   TG >200 mg/dL
Reduced major coronary events and CHD deaths
 Nicotinic acid§  
 LDL   ↓  5–25%
 HDL ↑  15–35%
 TG ↓  20–50%
Flushing Hyperglycemia Hyperuricemia (or gout)
Upper GI distress Hepatotoxicity  
 Absolute:
 •   Chronic liver disease
 •   Severe gout
 Relative:
 •   Diabetes
 •   Hyperuricemia
 •   Peptic ulcer disease  
Reduced major coronary events and possibly total mortality  
 Fibric acidsII
 LDL   ↓  5–20%
(may be
increased in
patients with
high TG)

 HDL   ↑  10–20%
 TG ↓  20–50%
Dyspepsia
Gallstones
Myopathy
 Absolute:
 •   Severe renal disease
 •   Severe hepatic disease
Reduced major coronary events
 Intestinal
 cholesterol
 inhibitor  
 LDL   ↓ 18%
 HDL ↓  8%
 Apo B   ↓  16%
Well tolerated with few adverse reactions similar to placebo in clinical trials    Absolute:
 •   Active or chronic liver disease
 •   Do not use in combination with resins, fibrates, or cyclosporin
  
No long-term clinical trial data  
 Omega-3-acid
 ethyl esters#
 LDL   ↑  44.5%
(Patients should be
monitored to ensure
LDL levels do not
increase excessively)

 HDL   ↑  9.1%
 TG ↓  44.9%
Eructation
Infection
Flu symptoms
Dyspepsia
Rash
Change in sense of taste
 Absolute:
 •   Hypersensitivity to any component of this medication
Decreased triglyceride concentrations in patients with severe hypertriglyceridemia

* Lovastatin (20–80 mg), pravastatin (20–40 mg), simvastatin (20–80 mg), fluvastatin (20–80 mg), atorvastatin (10–80 mg), rosuvastatin (10–40 mg).
Cyclosporine, macrolide antibiotics, various antifungal agents and cytochrome P-450 inhibitors (fibrates and niacin should be used with appropriate caution).
Cholestyramine (4–16 g), colestipol (5–20 g), colesevelam (2.6–3.8 g).
§ Immediate-release (crystalline) nicotinic acid (1.5–3 g), extended-release nicotinic acid (Niaspan®) (1–2 g), sustained-release nicotinic acid (1–2 g).
II Gemfibrozil (600 mg BID), fenofibrate (54 mg + 160 mg), clofibrate (1000 mg BID).
Ezetimibe (10 mg).
# Omega-3-acid ethyl esters (4 g/d).

Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda, Md: National Institutues of Health, National Heart, Lung, and Blood Institute; 2001. NIH Publication 01-3095.

US Food and Drug Information, Omacor® Consumer Drug Information Sheet.
Omacor® prescription information.






Figure 9A. Procedure for Implementing Therapeutic Lifestyle Changes (TLC)


Visit 1:
Begin TLC Diet

6 wk

Visit 2:
Evaluate LDL response. If LDL goal not achieved, intensify LDL-lowering therapy

6 wk

Visit 3:
Evaluate LDL response. If LDL goal not achieved, consider drug therapy

Q 4–6 wk

Monitor
adherence
to TLC
       
 •   Emphasize reduction in saturated fat & cholesterol
 •   Moderate physical activity
 •   Consider referral to a dietitian
 
 •   Reinforce TLC
 •   Consider adding plant stanols/sterols
 •   Increase fiber intake
 •   Consider dietitian for control
  If LDL-C goal achieved:
 •   Initiate therapy for metabolic syndrome
 •   Intensify weight management & exercise
 •   Consider dietitian for control of weight, TGs, LDL-C
   

Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda, Md: National Institutes of Health, National Heart, Lung, and Blood Institute; 2001. NIH Publication 01-3095.






Figure 9B. Procedure for Implementing Drug Therapy to Treat Lipid Abnormalities


Initiate LDL-C lowering drug therapy

6 wk

If LDL-C goal not achieved, intensify LDL-C lowering therapy

6 wk

If LDL-C goal not achieved, intensify drug therapy or refer to a lipid specialist

If LDL-C goal achieved, treat other lipid risk factors (HDL-C <40 mg/dL, TG >150 mg/dL)

Q 4–6 wk

Monitor response and adherence to therapy
       
Start statin, bile acid sequestrant, or niacin
 
Consider higher dose of statin or add bile acid sequestrant or niacin
 
1.  Treat elevated triglycerides (>150 mg/dL) levels to non–HDL goals by adding niacin or fibrate to further lower VLDL, or intensify therapy with LDL-lowering drug
2.  Consider treating low HDL with niacin or fibrate after achieving non–HDL goal in high-risk patients.
   

Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda, Md: National Institutes of Health, National Heart, Lung, and Blood Institute; 2001. NIH Publication 01-3095.


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