Choosing Drug Therapy for Patients with
Hyperlipidemia
TABLE 1Determining Patient-Specific LDL Goals Through Risk Factors
Risk-factor score*
LDL goal, by risk-factor score†
Age: men > 45 years; women >55 years or postmenopausal without ERTCurrent smokerHypertensionDiabetesCHD in first-degree relative (male relative <55>60 mg per dL
0 to 1 point: <160 color="#33cc00">more points: <130 color="#33cc00">Patients with history of CHD: <100>)
LDL = low-density lipoprotein; ERT = estrogen replacement therapy; CHD = coronary heart disease; HDL = high-density lipoprotein.*--Score 1 point for each positive factor
.
TABLE 2 Outcomes of Studies Involving Statins
Drug
Outcome
Simvastatin
Decreased cardiac morbidity and mortality in patients with CHD and elevated cholesterol levels
Pravastatin
Decreased coronary morbidity and mortality in hypercholesterolemic men with no clinical evidence of CHD
Pravastatin
Significantly reduced incidence of subsequent MI, death from CHD, stroke and need for revascularization procedure in patients with recent MI and normal cholesterol levels
Pravastatin
Reduced overall mortality and incidence of MI and stroke in patients with CHD and a broad range of cholesterol levels.
Fluvastatin
Slowed progression of artherosclerotic lesions in patients with CHD
Lovastatin
Significantly reduced incidence of first acute major coronary events in patients without CHD, but with normal to mildly elevated total and LDL cholesterol levels and low HDL cholesterol levels
CHD = coronary heart disease; MI = myocardial infarction; LDL = low-density lipoprotein; HDL= high-density lipoprotein.
..
TABLE 3 Niacin (Nicotinic Acid)
Drug
Dosage
Adverse effects
Patient information
Monitoring
Nonprescription niacin
50 to 100 mg twice daily for the first week. Double the dosage every week to 1,000 to 1,500 mg daily, in 2 or 3 divided doses.If response is inadequate after 4 to 8 weeks, increase dosage slowly to maximum of 3,000 mg daily.If patient switches brands, restart from low dosage and titrate up to minimize risk of hepatic necrosis.
Flushing, pruritus, abdominal pain, nausea, vomiting, elevated liver enzyme levels, glucose intolerance, rare reversible acanthosis nigricans
To decrease flushing, take in p.m.; take aspirin 30 minutes before, avoid concomitant ingestion of alcohol or hot beverage.To decrease gastrointestinal distress, take daily in 2 or 3 divided doses; take after a low-fat snack.
Check lipid levels before and 4 weeks after reaching desired dosage, and 4 weeks after every dosage increase.Perform LFTs, uric acid determination and fasting glucose test before initiating therapy and 6 weeks after target dose is reached. Repeat LFTs every 12 weeks thereafter for first year, then every 6 to 12 months.Discontinue drug if serum transaminase levels exceed 3 times normal level.
Extended-release niacin tablets (Niaspan)*
Take daily at bedtime: 500 mg--weeks 1 through 4 1,000 mg--weeks 5 through 8 1,500 mg--after week 8Maximum dosage: 2,000 mg
Flushing, pruritus, abdominal pain, nausea, vomiting, elevated liver enzymes, glucose intolerance
To decrease flushing, take in p.m.; take aspirin 30 minutes before; avoid concomitant ingestion of alcohol or hot beverage.To decrease gastrointestinal distress, take after a low-fat snack.
Check lipid levels 4 weeks after starting and 4 weeks after every dosage increase.Obtain uric acid level and fasting glucose levels before initiating therapy and 6 weeks after target dose is reached. Perform LFTs before initiating therapy and every 12 weeks thereafter for first year, then every 6 to 12 months.Discontinue if serum transaminase levels exceed 3 times normal level.
LFTs = liver function tests.
TABLE 2 Outcomes of Studies Involving Statins
Drug
Outcome
Simvastatin
Decreased cardiac morbidity and mortality in patients with CHD and elevated cholesterol levels
Pravastatin
Decreased coronary morbidity and mortality in hypercholesterolemic men with no clinical evidence of CHD
Pravastatin
Significantly reduced incidence of subsequent MI, death from CHD, stroke and need for revascularization procedure in patients with recent MI and normal cholesterol levels
Pravastatin
Reduced overall mortality and incidence of MI and stroke in patients with CHD and a broad range of cholesterol levels.
Fluvastatin
Slowed progression of artherosclerotic lesions in patients with CHD
Lovastatin
Significantly reduced incidence of first acute major coronary events in patients without CHD, but with normal to mildly elevated total and LDL cholesterol levels and low HDL cholesterol levels
CHD = coronary heart disease; MI = myocardial infarction; LDL = low-density lipoprotein; HDL= high-density lipoprotein.
..
TABLE 3 Niacin (Nicotinic Acid)
Drug
Dosage
Adverse effects
Patient information
Monitoring
Nonprescription niacin
50 to 100 mg twice daily for the first week. Double the dosage every week to 1,000 to 1,500 mg daily, in 2 or 3 divided doses.If response is inadequate after 4 to 8 weeks, increase dosage slowly to maximum of 3,000 mg daily.If patient switches brands, restart from low dosage and titrate up to minimize risk of hepatic necrosis.
Flushing, pruritus, abdominal pain, nausea, vomiting, elevated liver enzyme levels, glucose intolerance, rare reversible acanthosis nigricans
To decrease flushing, take in p.m.; take aspirin 30 minutes before, avoid concomitant ingestion of alcohol or hot beverage.To decrease gastrointestinal distress, take daily in 2 or 3 divided doses; take after a low-fat snack.
Check lipid levels before and 4 weeks after reaching desired dosage, and 4 weeks after every dosage increase.Perform LFTs, uric acid determination and fasting glucose test before initiating therapy and 6 weeks after target dose is reached. Repeat LFTs every 12 weeks thereafter for first year, then every 6 to 12 months.Discontinue drug if serum transaminase levels exceed 3 times normal level.
Extended-release niacin tablets (Niaspan)*
Take daily at bedtime: 500 mg--weeks 1 through 4 1,000 mg--weeks 5 through 8 1,500 mg--after week 8Maximum dosage: 2,000 mg
Flushing, pruritus, abdominal pain, nausea, vomiting, elevated liver enzymes, glucose intolerance
To decrease flushing, take in p.m.; take aspirin 30 minutes before; avoid concomitant ingestion of alcohol or hot beverage.To decrease gastrointestinal distress, take after a low-fat snack.
Check lipid levels 4 weeks after starting and 4 weeks after every dosage increase.Obtain uric acid level and fasting glucose levels before initiating therapy and 6 weeks after target dose is reached. Perform LFTs before initiating therapy and every 12 weeks thereafter for first year, then every 6 to 12 months.Discontinue if serum transaminase levels exceed 3 times normal level.
LFTs = liver function tests.
*--Pregnancy category C: adverse effects in animals, no human data.
TABLE 4 National Cholesterol Education Program (NCEP) Guidelines: Serum Triglyceride Action Limits
Triglyceride value
Intervention
< mg per dL (<2.25 mmol per L)
Normal value. Some recommend a lower normal value of 150 mg per dL (1.70 mmol per L).
to 400 mg per L (2.25 to 4.50 mmol per L)
Primary treatment is lifestyle modification: weight control, low-fat, low-cholesterol diet, regular exercise, smoking cessation and (in selected patients) alcohol restriction. Medication may be considered in patients with established CHD, family history of premature CHD, concomitant total cholesterol level of >=240 mg per dL (>=6.20 mmol per L) and HDL value of <35 mg per dL (<1.0 mmol per L), genetic form of hypertriglyceridemia (e.g., dysbetalipoproteinemia or familial combined hyperlipidemia) or multiple risk factors.
400 to 1,000 mg per dL (4.50 to 11.30 mmol per L)
Treatment as in previous category but with an emphasis on controlling causes of secondary hypertriglyceridemia. Medication is recommended by some authorities and certainly should be used if the patient has a history of acute pancreatitis.
>1,000 mg per dL (>11.30 mmol per L)
Vigorous triglyceride-lowering efforts are required because of increased risk for pancreatitis. Treat causes of secondary hypertriglyceridemia (e.g., diabetes mellitus). Institute very-low-fat diet, curtail alcohol; if triglyceride level of <1,000 mg per dL (<11.30 mmol per L) is not achieved, use medications.
CHD = coronary heart disease; HDL = high-density lipoprotein..
34
TABLE 5 Fibric Acid Derivatives (Fibrates)
Drug
Dosage
Adverse effects
Patient information
Monitoring
Gemfibrozil (Lopid)*
mg twice daily, 30 minutes before morning and evening meals.Maximum dosage: 600 mg twice daily
Dyspepsia, diarrhea, fatigue, nausea, vomiting, abdominal pain, eczema, rash, vertigo
Take with meals.Report any muscle pain, tenderness or weakness.
Perform LFTs before initiating therapy and repeat periodically during first year of therapy.
Micronized fenofibrate (Tricor)*
67 mg (1 tablet) daily, taken with main meal.Increase dosage at 4-week intervals as tolerated.Maximum dosage: 201 mg daily (may be taken at one time)
Dyspepsia, diarrhea, fatigue, headache, nausea, vomiting, muscle or joint pain, rash, vertigo
Take with meals.Report any muscle pain, tenderness or weakness.
Perform LFTs before initiating therapy and repeat periodically during first year of therapy.Drug contraindicated in patients with severe liver or renal disease.
LFTs = liver function tests.
TABLE 4 National Cholesterol Education Program (NCEP) Guidelines: Serum Triglyceride Action Limits
Triglyceride value
Intervention
< mg per dL (<2.25 mmol per L)
Normal value. Some recommend a lower normal value of 150 mg per dL (1.70 mmol per L).
to 400 mg per L (2.25 to 4.50 mmol per L)
Primary treatment is lifestyle modification: weight control, low-fat, low-cholesterol diet, regular exercise, smoking cessation and (in selected patients) alcohol restriction. Medication may be considered in patients with established CHD, family history of premature CHD, concomitant total cholesterol level of >=240 mg per dL (>=6.20 mmol per L) and HDL value of <35 mg per dL (<1.0 mmol per L), genetic form of hypertriglyceridemia (e.g., dysbetalipoproteinemia or familial combined hyperlipidemia) or multiple risk factors.
400 to 1,000 mg per dL (4.50 to 11.30 mmol per L)
Treatment as in previous category but with an emphasis on controlling causes of secondary hypertriglyceridemia. Medication is recommended by some authorities and certainly should be used if the patient has a history of acute pancreatitis.
>1,000 mg per dL (>11.30 mmol per L)
Vigorous triglyceride-lowering efforts are required because of increased risk for pancreatitis. Treat causes of secondary hypertriglyceridemia (e.g., diabetes mellitus). Institute very-low-fat diet, curtail alcohol; if triglyceride level of <1,000 mg per dL (<11.30 mmol per L) is not achieved, use medications.
CHD = coronary heart disease; HDL = high-density lipoprotein..
34
TABLE 5 Fibric Acid Derivatives (Fibrates)
Drug
Dosage
Adverse effects
Patient information
Monitoring
Gemfibrozil (Lopid)*
mg twice daily, 30 minutes before morning and evening meals.Maximum dosage: 600 mg twice daily
Dyspepsia, diarrhea, fatigue, nausea, vomiting, abdominal pain, eczema, rash, vertigo
Take with meals.Report any muscle pain, tenderness or weakness.
Perform LFTs before initiating therapy and repeat periodically during first year of therapy.
Micronized fenofibrate (Tricor)*
67 mg (1 tablet) daily, taken with main meal.Increase dosage at 4-week intervals as tolerated.Maximum dosage: 201 mg daily (may be taken at one time)
Dyspepsia, diarrhea, fatigue, headache, nausea, vomiting, muscle or joint pain, rash, vertigo
Take with meals.Report any muscle pain, tenderness or weakness.
Perform LFTs before initiating therapy and repeat periodically during first year of therapy.Drug contraindicated in patients with severe liver or renal disease.
LFTs = liver function tests.
- *--Pregnancy category C: adverse effects in animals, no human data.
TABLE 6 Bile Acid Sequestrants
Drug
Dosage
Adverse effects
Patient information
Monitoring
Cholestyramine (LoCholest) powder
Initially, 4 g daily in 2 or 3 divided dosesIncrease dosage at 4-week intervals as tolerated.Maximum dosage: 24 g daily
Constipation
Take 1 hour before or 4 hours after other medications.Take with meals.Mix with 3 to 6 oz of water, fruit juice or pulpy fruit (applesauce or crushed pineapple).Mixing a dose the night before and refrigerating it will improve palatability. Stir well.Increase fluid intake to avoid constipation.
Check lipid profile at 2 to 4 weeks and monitor for constipation.If constipation occurs, increase fluid and fiber intake, consider stool softener.Some patients require a laxative to prevent constipation.
Colestipol (Colestid) granules*
Initially, 5 g daily in 2 or 3 divided doses (granules) or 2 g daily (tablets)Increase dosage at 4-week intervals as tolerated.Maximum dosage: 30 g daily
ConstipationFlavored products contain aspartame.Avoid in phenyketonuric patients.
Same as above
Same as above
*--Pregnancy category B: no adverse effects in animals, no human data..
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