2002 CLINICAL PRACTICE GUIDELINES MANAGEMENT OF LIPID ABNORMALITIES

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1 OVERVIEW The Management of Lipid Abnormalities guideline is based on the recommendations outlined in the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III). The purpose of the guideline is to improve management strategies for primary prevention of coronary heart (CHD) and LDL cholesterol (LDL-C) control in people with CHD. Additionally, the guideline seeks to foster and improve adherence to evidence-based medicine and practice in lipid and cholesterol management. THE PHYSICIAN S CLINICAL JUDGMENT MUST ULTIMATELY DETERMINE THE APPROPRIATE TREATMENT FOR EACH INDIVIDUAL CLASSIFICATION OF LDL, TOTAL, AND HDL CHOLESTEROL (MG/DL) A complete nine- to 12-hour fasting lipoprotein analysis measuring total cholesterol, LDL-C, highdensity lipoprotein (HDL) cholesterol, and triglyceride should be performed every five years. Level Primary Target of Therapy LDL-Cholesterol <100 Optimal Near optimal/above optimal Borderline High >190 Very high Total Cholesterol <200 Desirable Borderline high >240 High HDL Cholesterol <40 Low >0 High DETERMINE RISK FACTORS AND CATEGORY Risk Factors: Cigarette smoking Hypertension (BP >140/90 mmhg or on anti-hypertensive medication) Low HDL cholesterol (<40 mm/dl) Family history of premature CHD (First-degree relative of a male <55 years with CHD; First degree relative of female <5 years) Age (Men >45 years; Women >55 years) CHD and CHD risk equivalents: Symptomatic carotid artery Peripheral arterial Abdominal aortic aneurysm Diabetes Multiple risk factors that confer a 10-year risk for CHD >20%* *See 10-year risk assessment tool on page. Three levels of 10-year risk: >20% - CHD risk equivalent 10-20% <10%

2 DIABETES AS A CHD RISK EQUIVALENT EVIDENCE STATEMENTS: Persons with type 2 diabetes have a 10-year risk for major coronary events (MI and CHD death) that approximates the risk in CHD patients without diabetes. This high risk can be explained by the combination of hyperglycemia plus lipid and nonlipid risk factors of the metabolic syndrome. In addition, persons with type 2 diabetes have a high incidence of death at time of acute myocardial infarction, as well as a relatively poor prognosis for long-term survival after MI. RECOMMENDATIONS: Persons with type 2 diabetes should be managed as a CHD risk equivalent. Treatment for LDL cholesterol should follow ATP III recommendations for persons with established CHD (see below). For younger persons with type 2 diabetes, who otherwise are at lower risk, clinical judgment is required to determine the intensity of LDL-lowering therapy. However, consideration should be given to using LDL-lowering drugs when LDL-cholesterol levels are >130mg/dL. EVIDENCE STATEMENTS: Persons with type 1 diabetes have increased risk for coronary heart. However, some persons with type 1 diabetes have a 10-year risk for CHD less than percent (i.e., young persons without other risk factors). Nevertheless, such persons will have a high long-term risk for CHD. Moreover, there is no reason to believe that the benefits of LDL reduction are different in persons with type 1 and type 2 diabetes. RECOMMENDATIONS: The intensity of LDL-lowering therapy in persons with type 1 diabetes should depend on clinical judgment. Recent on-set type 1 diabetes need not be designated a CHD risk equivalent; hence reduction of LDL-cholesterol to <130 mg/dl is sufficient. With increasing duration of, a lower goal (<100 mg/dl) should be considered. Regardless of duration, LDL-lowering drugs should be considered in combination with lifestyle therapies when LDL-cholesterol levels are >130 mg/dl. DETERMINE RISK CATEGORY Risk Category LDL-C Goal LDL Level at which to Initiate Therapeutic Lifestyle Changes CHD or CHD Risk Equivalents <100 mg/dl >100 mg/dl 2+ Risk Factors <130 mg/dl >130 mg/dl LDL Level at which to Consider Drug Therapy >130 mg/dl ( mg/dl: drug therapy is optional) 10-year risk 10-20%: >130 mg/dl 10-year risk <10%: >10 mg/dl 0-1 Risk Factor <10mg/dL >10 mg/dl >190 mg/dl ( mg/dl: LDL-lowering drug is optional)

3 LIPID LOWERING THERAPY: THERAPEUTIC LIFESTYLE COUNSELING (TLC) Lipid lowering therapy can be approached through therapeutic lifestyle changes or drug therapy. The TLC approach focuses on reduction of saturated fat (<7% of total calories) and cholesterol (<200 mg/day), weight reduction, and increased physical activity. STEPS IN THERAPEUTIC LIFESTYLE CHANGES (TLC) VISIT 1 Begin lifestyle therapies VISIT 2 Evaluate LDL response If LDL goal is not achieved, intensify LDLlowering Rx VISIT 3 Evaluate LDL response If LDL goal not achieved, consider adding drug Rx 4- mos Visit 4 Monitor adherence to TLC Emphasize reduction in saturated fat & cholesterol Encourage moderate physical activity Consider referral to a dietitian Reinforce reduction in saturated fat and cholesterol Consider adding plant stanols/sterols Increase fiber intake Consider referral to a dietitian Initiate Rx for metabolic syndrome Intensify weight management & physical activity Consider referral to a dietitian

4 2002 CLINICAL PRACTICE G UIDELINES LIPID LOWERING THERAPY: DRUG/MEDICATION THERAPY Consider drug therapy simultaneously with TLC for CHD and CHD equivalents Consider adding drug to TLC after three months for other risk categories Drug Class Agents and Daily Doses Lipid Type and Side Effects Lipoprotein Effects HMG CoA Lovastatin (Mevacor ) mg LDL â18-55% Myopathy reductase Pravastatin (Pravachol ) mg HDL á5-15% inhibitors Simvastatin (Zocor ) mg TG Increased liver â7-30% (statins) Fluvastatin (Lescol ) mg enzymes Atorvastin (Lipitor ) mg mg Bile acid Cholestyramine sequestrants Colestipol Colesevelam 4 1 g 5 10 g g LDL HDL TG â15-30% á3-5% No change or increase Gastrointestinal distress Constipation Decreased absorption of other drugs Nicotinic acid Immediate release (crystalline) nicotinic acid Extended release nicotinic acid (Niaspan ) Sustained release nicotinic acid g LDL HDL TG â5-25% á15-35% â20-50% 1 2g Gemfibrozil Fenofibrate Clofibrate 00 mg BID 200 mg 1000 mg BID Hyperglycemia Hyperuricemia (or gout) Upper GI distress 1 2g Fibric acids Flushing LDL HDL TG â5-20% (may be increased in patients with high TG) á10-20% â20-50% Hepatotoxicity Dyspepsia Gallstones Myopathy Contraindications Absolute: Active or chronic liver Relative: Concomitant use of certain drugs* Absolute: Dysbetalipoproteinemia TC >400 mg/dl Relative: TG >200 mg/dl Absolute: Chronic liver Severe gout Relative: Diabetes Hyperuricemia Peptic ulcer Absolute: Severe renal Severe hepatic *Cyclosporine, macrolide antibiotics, various anti-fungal agents, and cytochrome P-450 inhibitors (fibrates and niacin should be used with appropriate caution).

5 DRUG THERAPY IN PRIMARY PREVENTION Initiate LDLlowering drug therapy s If LDL goal is not achieved, intensify LDLlowering therapy If LDL goal is not achieved, intensify drug therapy or refer to a lipid specialist Monitor response and adherence to therapy Start statin or bile acid sequestrant or nicotinic acid Consider higher dose of statin or add a bile acid sequestrant or nicotinic acid If LDL goal achieved, treat other lipid risk factors STRATEGIES TO IMPROVE PATIENT ADHERENCE TO DRUG THERAPY Simplify medication regimens Provide explicit patient instruction and use good counseling techniques to teach the patient how to follow the prescribed treatment Encourage the use of prompts to help persons remember regimens Use systems to reinforce adherence and maintain contact with the patient Encourage the support of family and friends Reinforce and reward adherence Increase patient visits for persons unable to achieve treatment goal Increase the convenience and access to care Involve patients in their care through self-monitoring

6 10-YEAR RISK CALCULATOR (Framingham Point Scores) MEN WOMEN Age Points Age Points Total Points (by Age) Total Points (by Age) Cholesterol Cholesterol < < > > Points (by Age) Points (by Age) Nonsmoker Nonsmoker Smoker Smoker HDL (mg/dl) Points HDL (mg/dl) Points >0-1 > <40 2 <40 2 Systolic BP (mmhg) If Untreated If Treated Systolic BP (mmhg) If Untreated If Treated < < > >10 4 Point Total 10-Year Risk % Point Total 10-Year Risk % Point Total 10-Year Risk % Point Total 10-Year Risk % <0 <1 9 5 <9 < >25 > >17 >

7 RESOURCES Agency for Healthcare Quality and Research (formerly the Agency for Health Care Policy and Research) American Heart Association 800-AHA-USA1 American Diabetes Association American College of Cardiology Center for Disease Control Cardiovascular Health Branch National Heart, Lung, and Blood Institute Oxford Health Plans Clinical Practice Guidelines Source: 2001 Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) We value your input on our guidelines. If you have any questions or comments, please or write to: Attn: Belinda O. Minta, MPH Quality Management Oxford Health Plans 44 South Broadway White Plains, NY 1001

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