Category: cholesterol

What foods are high in bad cholesterol? Learn about the worst foods to avoid if you have high cholesterol

If you have high cholesterol, you need to be especially careful about what you include in your diet. In general, the worst foods for high cholesterol are those with tons of:

• Sugar
• Salt
• Bad fats (trans-fats, hydrogenated fat, or partially hydrogenated fat)
• Simple carbohydrates (these get broken down into sugar, resulting in a spike of blood sugar levels and bad cholesterol)

Examples of foods to avoid with high cholesterol include:

• Fried foods: Chicken nuggets, French fries
• Frozen foods: Frozen hot dogs, sausages, pizza, waffles
• Hydrogenated oils: Potato chips, cookies, donuts, crackers, margarine, vegetable shortening
• Saturated fats: Coconut cream, deep-fried foods, cakes, biscuits, pies, pastries, egg yolk, whole milk, butter, and cheese
• High-fat proteins: Duck, goose, steak
• Organ meat: Kidney, heart, liver 
• Shellfish: Oysters, mussels, crab, and lobster
• Refined carbs: White bread, pasta, rice
• Sugar: Soda, fruit juices, cakes, donuts, pastries
• Alcohol: Reduce alcohol intake to no more than 1-2 drinks per day or don't drink at all. Even one drink can increase triglycerides for some people.

What is cholesterol?

Cholesterol is a waxy substance that your body needs to build healthy cells. But there are several different types:

• Total cholesterol: Total amount of cholesterol in the blood, which includes low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, and high-density lipoprotein (HDL) cholesterol.
• LDL (bad) cholesterol: Transports cholesterol particles throughout the body and can build up in the walls of the arteries, making them hard and narrow.
• HDL (good) cholesterol: Picks up excess cholesterol in your blood and takes it back to your liver.
• Non-HDL: Total cholesterol minus HDL. Non-HDL includes LDL and other types of cholesterol such as VLDL.
• Triglycerides: Another form of fat in the blood that can increase your risk of heart disease, especially in women.

Too much of bad (LDL) cholesterol or not enough of good (HDL) cholesterol increases the risk of cholesterol buildup o in the inner walls of the arteries that feed the heart and brain.

What causes high cholesterol?

Apart from an unhealthy diet, causes of high cholesterol may include:

• Heredity: Cholesterol or heart disease may run in the family.
• Comorbid diseases: Conditions such as diabetes, liver disease, kidney disease, and thyroid disease can increase your risk of having high cholesterol.
• Smoking: Cigarette smoking damages the walls of your blood vessels, making them more prone to accumulating fatty deposits. Smoking can also lower your level of HDL or good cholesterol.
• Age: Liver function may reduce with age and become less able to remove LDL or bad cholesterol.
• Obesity: Having a body mass index (BMI) of 30 or higher puts you at a risk of high cholesterol. 
• Lack of exercise: Lack of physical activity and exercise can increase bad cholesterol deposits in the arteries.

What foods can lower cholesterol levels?

To lower your cholesterol, try building meals and snacks around whole, unprocessed foods as much as possible. Here are examples of what to include in your diet:

• Whole grains: Oats, barley, whole wheat bread, whole wheat pasta, brown rice, quinoa, amaranth, farro
• High-fiber, nutrient-dense vegetables: Leafy greens, brussels sprouts, broccoli, cauliflower, peppers, zucchini, carrots, cucumbers, green beans, tomatoes
• High-fiber, antioxidant-rich fruits: Berries, citrus fruits, bananas, apples, pears, peaches, melon
• Fatty fish: Salmon, tuna, herring, mackerel, anchovies
• Lean protein: Chicken, turkey, beans, nuts, lentils, tofu, edamame
• Dairy: Yogurt, kefir, milk, (occasionally) cheese
• Anti-inflammatory spices: Ginger, garlic, turmeric, basil

What are statins? Find out how these cholesterol-lowering medications work, as well as what side effects they may cause

Statins are a class of drugs that lower blood cholesterol, mainly low-density lipoprotein (LDL), also known as “bad” cholesterol.

Statins work mainly by lowering the activity of the key enzyme involved in cholesterol synthesis in the body (hydroxymethylglutaryl [HMG]-CoA reductase). They help stabilize plaque and prevent these fatty deposits from building up in the walls of the arteries and causing blockages that can lead to heart attack or stroke.

In the U.S., statins available in the market include: 

• Atorvastatin
• Rosuvastatin
• Simvastatin
• Fluvastatin

Who should take statins?

Whether you need to take statins depends on your cholesterol levels and overall heart health. Cholesterol is the waxy substance found in the blood, and high levels of LDL or “bad” cholesterol can put you at risk of plaque buildup.

In the initial stages, a high LDL cholesterol level can be managed by lifestyle changes such as a healthy diet, exercise, and quitting smoking. However, if these measures fail or are not enough, your doctor may prescribe statins to lower your risk of developing cardiovascular disorders.

Pregnant or breastfeeding women should not take statins, and women trying to conceive must discontinue use. Generally, statins should be discontinued at least 6 weeks and preferably 12 weeks before planned conception.

What are the side effects of statins?

Side effects of statins include:

• Muscle damage or weakness: The most common side effect of statins is the development of statin-associated muscle symptoms (SAMS). SAMS may be felt as muscle soreness, weakness, or fatigue. Very rarely, statins may cause life-threatening muscle damage called rhabdomyolysis.
• Liver damage: Damage to the liver may cause loss of appetite, weakness, fatigue, pain in the abdomen, or yellowish discoloration of the skin and eyes.
• Kidney dysfunction: This is an uncommon side effect that may occur secondary to rhabdomyolysis (muscle damage). Kidney damage may present as altered urine output, swelling over the face or feet, pale skin, and weakness.
• Diabetes mellitus: Research suggests that statins affect the way glucose is used by the body, which may increase the risk of diabetes, particularly with intensive therapy. However, this shouldn’t discourage you from taking your statin if you have coexisting diabetes. Discuss with your doctor so they can adjust your dose accordingly.
• Neurological and behavioral issues: Research suggests that statins may be associated with mood changes such as irritability and aggression, depression, and memory impairment, although scientific evidence is insufficient to support this claim.
• Neuropathy: Some studies have suggested that statin use may cause neuropathy (nerve damage), although research is still inconclusive.
• Lupus: Statins have been associated with an autoimmune condition called lupus (drug-induced lupus) in some people.

If you develop side effects while you are on statins, contact your doctor. Your doctor will evaluate your condition and may prescribe you a different statin, modify the dose of the same statin, or prescribe another medication altogether.

Can your cholesterol be too low? While less common, low cholesterol can affect your health

Most of us associate cholesterol problems with high cholesterol, which we know can cause high blood pressure, heart disease, and stroke.

But is it possible for your cholesterol to be too low? Yes. While less common, low cholesterol can affect your health as well.

Cholesterol levels that are considered too low:

• Low-density lipoprotein (LDL) cholesterol: lower than 40 mg/dL
• High-density lipoprotein (HDL) cholesterol: lower than 40 mg/dL

Why is cholesterol important for your body?

What is cholesterol?

Cholesterol is a waxy type of fat that can be found in your blood, and is necessary for your body to maintain the structure and fluidity of cell membranes. It’s also responsible for synthesizing sex hormones, vitamin D, and bile, which your body needs for digestion.

Types of cholesterol

Cholesterol is divided into different types based on the relative proportions of fats and protein in lipoproteins.

• Low-density lipoprotein (LDL) cholesterol
• High-density lipoprotein (HDL) cholesterol
• Total cholesterol
• Non-HDL cholesterol (total cholesterol minus HDL cholesterol)
• Very-low-density lipoprotein (VLDL) cholesterol

Good vs. bad cholesterol

• HDL cholesterol is called “good” cholesterol because it absorbs cholesterol and carries it back to the liver, thereby reducing your risk of heart diseases and stroke.
• LDL cholesterol is considered “bad” because increased levels can narrow your arteries and cause blockages, increasing the risk of heart diseases and stroke.

What are the dangers of low cholesterol?

Although the emphasis is generally on reducing cholesterol levels, cholesterol levels that are too low may also be problematic, although research is still inconclusive.

• When LDL cholesterol levels are too low, it can lead to increased risk of health issues such as cancer, depression, anxiety, and cardiovascular diseases. Too low levels of LDL cholesterol during pregnancy may increase the risk of having a baby with low birth weight or a preterm baby.
• When HDL cholesterol levels are too low, it can increase the risk of atherosclerosis, which is when your arteries harden, as well as cardiovascular diseases like heart attack and stroke.

What causes low LDL cholesterol levels?

Low LDL cholesterol levels may be caused by genetic factors (inherited diseases) or acquired factors (diseases, medications):

Genetic

• Abetalipoproteinemia
• Hypobetalipoproteinemia
• Familial combined hypolipidemia
• Anderson’s disease (chylomicron retention disease)

Acquired

• Certain types of cancer such as leukemia, colorectal cancer, prostate cancer, and myeloma
• Certain types of anemia such as thalassemia and pernicious anemia
• Chronic infections such as tuberculosis
• Chronic infestations such as schistosomiasis
• Malabsorption (defective absorption of nutrients in the gut) as seen in celiac disease, giardiasis, and pancreatic diseases

What causes low HDL cholesterol levels?

Low HDL cholesterol levels may be caused by:

• Genetic factors (such as hypoalphalipoproteinemia)
• Obesity or being overweight
• Sedentary lifestyle or lack of physical activity
• Cigarette smoking
• Diet low in fruits and vegetables and high in processed, sugary, and fatty foods

What are statins, and how do they work?

“Statins” is a class of drugs that lowers the level of cholesterol in the blood by reducing the production of cholesterol by the liver.
(The other source of cholesterol in the blood is dietary cholesterol.) Statins block the enzyme in the liver that is responsible for making cholesterol. This enzyme is called hydroxy-methylglutaryl-coenzyme A reductase (HMG-CoA reductase). Scientifically, statins are referred to as HMG-CoA reductase inhibitors.

Cholesterol is critical to the normal function of every cell in the body. However, it also contributes to the development of atherosclerosis, a condition in which cholesterol-containing plaques form within arteries. These plaques block the arteries and reduce the flow of blood to the tissues the arteries supply. When plaques rupture, a blood clot forms on the plaque, thereby further blocking the artery and reducing the flow of blood. When blood flow is reduced sufficiently in the arteries that supply blood to the heart, the result is angina (chest pain) or a heart attack. If
reduced flow is caused by plaques in the arteries of the brain, the result is a stroke. If
reduced flow is caused by plaques in the arteries of the leg, they cause intermittent claudication (pain in the legs while walking). By reducing the production of cholesterol, statins are able to slow the formation of new plaques and occasionally can reduce the size of plaques that already exist. In addition, through mechanisms that are not well understood, statins may also stabilize plaques and make them less prone to rupturing and develop clots.

The important role of cholesterol in atherosclerosis is widely accepted by scientists. Research from the last few years shows that aggressive cholesterol reduction is more beneficial than modest reductions.
Nevertheless, atherosclerosis is a complex process that involves more than just cholesterol. For example, scientists have discovered that inflammation in the walls of the arteries may be an important factor in
in the development of atherosclerosis. In addition to lowering cholesterol levels, statins also reduce inflammation, which could be another mechanism by which statins beneficially affect atherosclerosis. This reduction of inflammation does not depend on statins’ ability to reduce cholesterol. Furthermore, these anti-inflammatory effects can be seen as early as two weeks after starting statins.

What are some examples of statins?

Statins that are approved for use in the U.S. include:

• atorvastatin (Lipitor),
• fluvastatin (Lescol, Lescol XL),
• lovastatin (Mevacor, Altoprev),
• pravastatin (Pravachol),
• rosuvastatin (Crestor),
• simvastatin (Zocor), and
• pitavastatin (Livalo).

For what conditions are statins used?

Statins are used for preventing and treating atherosclerosis that causes chest pain, heart attacks, strokes, and intermittent claudication in individuals who have or are at risk for atherosclerosis.

Risk factors for atherosclerosis include:

• Abnormally elevated cholesterol levels
• A family history of heart attacks (particularly at a young age)
• Increasing age

• Diabetes

• High blood pressure
• Obesity

Most individuals are placed on statins because of high levels of cholesterol. Though reduction of cholesterol is important, heart disease is complex and, as discussed previously, other factors such as inflammation may play a role. Thirty-five percent of individuals who develop heart attacks do not have high blood cholesterol levels, yet most of them have atherosclerosis. This means that high levels of cholesterol are not always necessary for atherosclerotic plaques to form.

Because it is not clear which effect of statins is responsible for their benefits, the goal of treatment with statins should not be only the reduction of cholesterol to normal levels, but rather the prevention of the complications of atherosclerosis (angina, heart attacks, stroke, intermittent claudication, and death). This concept is important because it allows for individuals who have or are at risk for atherosclerosis, but do not have high levels of cholesterol to be considered for treatment with statins. Statins, like angiotensin converting enzyme
inhibitors (ACE inhibitors), are an important class of drugs because they have been shown to reduce the incidence of heart attacks, strokes, and death.

What are the side effects of statins?

The most common side effects are:

• headache,
• nausea,
• vomiting,
• constipation,
• diarrhea,
• rash,
• weakness, and
• muscle pain.

The most serious side effects are liver failure and rhabdomyolysis
(injury or death of muscle tissue). Serious liver damage caused by statins is rare. More often, statins cause abnormalities of
liver tests. Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test value is greater than three times the upper limit of normal, the statin usually is stopped. Liver tests should be measured before statins are started and if there is a medical concern about liver damage thereafter.

Rhabdomyolysis is a rare serious side effect which involves damage to muscles. Rhabdomyolysis often begins as muscle pain and can progress to loss of muscle cells,
kidney failure, and death. It occurs more often when statins are used in combination with other drugs that themselves cause rhabdomyolysis or with drugs that prevent the elimination of statins and raise the levels of statins in the blood. Since rhabdomyolysis may be fatal, unexplained joint or muscle pain that occurs while taking statins should be brought to the attention of a health care
professional for evaluation. Statins must not be used
during pregnancy because of the risk of serious adverse effects to the developing fetus.

Statins have been associated with increases in
HbA1c and fasting serum glucose levels that are seen in diabetes.

There are also post-marketing reports of memory loss, forgetfulness, amnesia, confusion, and memory impairment. Symptoms may start
one day to years after starting treatment and resolve within a median of three weeks after stopping the statin.

Which drugs interact with statins?

Statins have some important drug interactions. The first type of interaction involves the enzymes responsible for the elimination of statins by the liver. Liver enzymes (specifically, the cytochrome P-450 liver enzymes) are responsible for eliminating all statins from the body with the exception of pravastatin and rosuvastatin. Therefore, drugs that block the action of these liver enzymes increase the levels of simvastatin, lovastatin, fluvastatin, and atorvastatin (but not pravastatin or rosuvastatin) in the blood and can lead to the development of rhabdomyolysis. Drugs or agents that block these enzymes include:

• protease inhibitors, for example, indinavir (Crixivan), ritonavir (Norvir) used in treating AIDS)
• erythromycin (E-Mycin)
• itraconazole, (Sporanox)
• clarithromycin, (Biaxin)
• telithromycin (Ketek)
• cyclosporine (Sandimmune)
• boceprevir (Victrelis)
• telaprevir (Incivek)
• voriconazole (Vfend)
• diltiazem, (Cardizem, Dilacor, Tiazac)
• verapamil (Calan, Verelan, Verelan PM, Isoptin, Isoptin SR, Covera-HS)
• ombitasvir/paritaprevir/ritonavir and dasabuvir (Viekira Pak)
• grapefruit juice (> one quart daily)

Lovastatin and simvastatin should not be combined with the following drugs:

• erythromycin
• ketoconazole (Nizoral, Extina, Xolegel, Kuric)
• itraconazole
• clarithromycin
• telithromycin
• cyclosporine
• boceprevir
• telaprevir
• voriconazole
• danazol (Danocrine)
• protease inhibitors
• amiodarone (Cordarone)
• amlodipine (Norvasc)
• ranolazine (Ranexa)

Another important drug interaction occurs between statins and niacin and fibric acids, for example, gemfibrozil (Lopid), clofibrate (Atromid-S), and fenofibrate (Tricor). Niacin and the fibric acid drugs (lipid-lowering agents) can cause rhabdomyolysis or liver failure when used alone, and combining them with statins increases the likelihood of rhabdomyolysis or liver failure. Gemfibrozil should not be combined with statins. Other fibric acids and niacin are used, with caution, in combination with statins.

Cholestyramine (Questran) as well as colestipol (Colestid) bind statins in the intestine and reduce their absorption into the body. To prevent this binding within the intestine, statins should be taken one hour before or four hours after cholestyramine or colestipol.

Stains increase the effect of warfarin (Coumadin). Patients taking statins and warfarin should have their blood clotting ability monitored carefully.

Statins should not be combined with red yeast rice because red yeast rice contains a chemical that is similar to statins. Combining red yeast rice with statins can lead to serious side effects such as muscle breakdown (myopathy).

Are there differences among statins?

Statins differ in several ways. The most obvious difference is in their ability to reduce cholesterol. Currently, atorvastatin (Lipitor) and rosuvastatin (Crestor) are the most potent, and fluvastatin (Lescol) is the least potent.

The statins also differ in how strongly they interact with other drugs. Specifically, pravastatin (Pravachol) and rosuvastatin (Crestor) levels in the body are less likely to be elevated by other drugs that may be taken at the same time as the statins. This is so because the enzymes in the liver that eliminate pravastatin and rosuvastatin are not blocked by many of the drugs that block the enzymes that eliminate other statins. This prevents the levels of pravastatin and rosuvastatin from rising and leading to increased toxicity such as myopathy (inflammation of the muscles). For example, in scientific studies, patients who took both verapamil (Calan, Verelan, Verelan PM, Isoptin, Isoptin SR, Covera-HS) and simvastatin (Zocor) experienced myopathy 10 times more often than patients who received simvastatin alone because verapamil increased the blood levels of simvastatin.

Statins differ in the frequency with which they cause a severe type of myopathy called rhabdomyolysis, in which muscles are severely damaged. Cerivastatin (Baycol) was withdrawn from pharmacies worldwide because it caused rhabdomyolysis 10 to 100 times more often than other statins. Rhabdomyolysis may occur more often in patients taking statins with drugs that also cause rhabdomyolysis or drugs that increase the blood concentration of the statin.

What is Pravachol, and how does it work?

Pravachol is a prescription medicine used to treat the symptoms of high cholesterol, to lower blood levels of “bad” cholesterol (low-density lipoprotein or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL) and to lower triglycerides. Pravachol may be used alone or with other medications.

Pravachol belongs to a class of drugs called Lipid-Lowering Agents, Statins, HMG-CoA Reductase Inhibitors.

It is not known if Pravachol is safe and effective in children younger than 8 years of age.

Therapy with lipid-altering
agents should be only one component of multiple risk factor intervention in
individuals at significantly increased risk for atherosclerotic vascular
disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to
diet when the response to a diet restricted in saturated fat and cholesterol
and other nonpharmacologic measures alone has been inadequate.

Prevention Of Cardiovascular Disease

In hypercholesterolemic patients without clinically
evident coronary heart disease (CHD),
Pravachol (pravastatin sodium) is
indicated to:

• reduce the risk of myocardial infarction (MI).
• reduce the risk of undergoing myocardial
  revascularization procedures.
• reduce the risk of cardiovascular mortality with no
  increase in death from non-cardiovascular causes.

In patients with clinically evident CHD, Pravachol is
indicated to:

• reduce the risk of total mortality by reducing coronary
  death.
• reduce the risk of MI.
• reduce the risk of undergoing myocardial
  revascularization procedures.
• reduce the risk of stroke and stroke/transient ischemic
  attack (TIA).
• slow the progression of coronary atherosclerosis.

Hyperlipidemia

Pravachol is indicated:

• as an adjunct to diet to reduce elevated total
  cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C),
  apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase
  high-density lipoprotein cholesterol (HDL-C) in patients with primary
  hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and
  IIb).¹
• as an adjunct to diet for the treatment of patients with
  elevated serum TG levels (Fredrickson Type IV).  
• for the treatment of patients with primary
  dysbetalipoproteinemia (Fredrickson Type III) who do not respond
  adequately to diet.
• as an adjunct to diet and lifestyle modification for
  treatment of heterozygous familial hypercholesterolemia (HeFH) in children and
  adolescent patients ages 8 years and older if after an adequate trial of diet
  the following findings are present:
  1. LDL-C remains ≥ 190 mg/dL or
  2. LDL-C remains ≥ 160 mg/dL and:
• there is a positive family history of premature
  cardiovascular disease (CVD) or
• two or more other CVD risk factors are present in the
  patient.

Limitations Of Use

Pravachol has not been studied in conditions where the
major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types
I and V).

What are the side effects of Pravachol?

Pravachol may cause serious side effects including:

• unexplained muscle pain, tenderness or weakness,
• fever,
• unusual tiredness,
• dark colored urine,
• chest pain,
• upper stomach pain,
• loss of appetite, and
• yellowing of the skin or eyes (jaundice)

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Pravachol include:

• muscle or joint pain,
• nausea,
• vomiting,
• diarrhea,
• headache, and
• cold symptoms (stuffy nose, sneezing or sore throat)

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Pravachol. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Pravachol?

General Dosing Information

• The patient should be placed on a standard cholesterol-lowering diet before
  receiving Pravachol and should continue on this diet during treatment with
  Pravachol.

Adult Patients

• The recommended starting dose is 40 mg once daily. If a
  daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once
  daily is recommended.
• Pravachol can be administered orally as a single dose at
  any time of the day, with or without food.
• Since the maximal effect of a given
  dose is seen within 4 weeks, periodic lipid determinations should be performed
  at this time and dosage adjusted according to the patient’s response to therapy
  and established treatment guidelines.

Patients With Renal Impairment

• In patients with severe renal impairment, a starting dose
  of 10 mg pravastatin daily is recommended.
• Although the Pravachol 10 mg tablets
  are no longer available, pravastatin 10 mg tablets are available.

Pediatric Patients

Children (Ages 8 to 13 Years, Inclusive)

• The recommended dose is 20 mg once daily in children 8 to
  13 years of age.
• Doses greater than 20 mg have not been studied in this patient
  population.

Adolescents (Ages 14 to 18 Years)

• The recommended starting dose is 40 mg once daily in
  adolescents 14 to 18 years of age.
• Doses greater than 40 mg have not been
  studied in this patient population.
• Children and adolescents treated with pravastatin should be reevaluated
  in adulthood and appropriate changes made to their cholesterol-lowering
  regimen to achieve adult goals for LDL-C.

Concomitant Lipid-Altering Therapy

• Pravachol may be used with
  bile acid resins.
• When
  administering a
  bile-acid-binding
  resin (e.g., cholestyramine, colestipol) and pravastatin, Pravachol should be
  given either 1 hour or more before or at least 4 hours following the resin.

Dosage In Patients Taking Cyclosporine

• In patients taking
  immunosuppressive
  drugs such as cyclosporine concomitantly with pravastatin, therapy should begin
  with 10 mg of pravastatin sodium once-a-day at bedtime and titration to higher
  doses should be done with caution.
• Most patients treated with this combination
  received a maximum pravastatin sodium dose of 20 mg/day.
• In patients taking
  cyclosporine, therapy should be limited to 20 mg of pravastatin sodium once
  daily.
• Although the Pravachol 10 mg
  tablets are no longer available, pravastatin 10 mg tablets are available.

Dosage In Patients Taking Clarithromycin

• In patients taking clarithromycin, therapy should be limited to 40 mg of
  pravastatin sodium once daily.

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What drugs interact with Pravachol?

For the concurrent therapy of either cyclosporine, fibrates, niacin
(nicotinic acid), or erythromycin, the risk of myopathy increases.

Cyclosporine

• The risk of myopathy/rhabdomyolysis is increased with concomitant
  administration of cyclosporine. Limit pravastatin to 20 mg once daily for
  concomitant use with cyclosporine.

Clarithromycin And Other Macrolide Antibiotics

• The risk of myopathy/rhabdomyolysis is increased with concomitant
  administration of clarithromycin. Limit pravastatin to 40 mg once daily for
  concomitant use with clarithromycin.
• Other macrolides (e.g.,
  erythromycin and azithromycin)
  have the potential to increase statin exposures while used in combination.
• Pravastatin should be used cautiously with
  macrolide antibiotics due to a
  potential increased risk of myopathies.

Colchicine

• The risk of myopathy/rhabdomyolysis is increased with
  concomitant administration of
  colchicine.

Gemfibrozil

• Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase
  inhibitors are coadministered with gemfibrozil, concomitant administration of
  Pravachol with gemfibrozil should be avoided.

Other Fibrates

• Because it is known that the risk of myopathy during treatment with HMG-CoA
  reductase inhibitors is increased with concurrent administration of other
  fibrates, Pravachol should be administered with caution when used concomitantly
  with other fibrates.

Niacin

• The risk of
  skeletal muscle effects may be enhanced when
  pravastatin is used in combination with
  niacin;
  a reduction in Pravachol dosage should be considered in this setting.

Is Pravachol safe to use while pregnant or breastfeeding?

• Pravachol is contraindicated for use in pregnant woman because of the potential for fetal harm. As safety in pregnant women has not been established and there is no apparent benefit to therapy with
  Pravachol during pregnancy, Pravachol should be immediately discontinued as soon as pregnancy is recognized.
• Limited published data on the use of Pravachol in pregnant women are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage.
• Pravastatin use is contraindicated during breastfeeding.
• Based on one lactation study in published literature, pravastatin is present in human milk. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production.
• Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with
  Pravachol.

What is Repatha, and what is it used for?

Repatha (evolocumab) Injection, an antibody cholesterol medication, is a human monoclonal immunoglobulin G2 (IgG2) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C). Repatha is also indicated as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.

The safety and effectiveness of REPATHA have not been established in pediatric patients with HoFH who are younger than 13 years old.

What are the side effects of Repatha?

Common side effects of Repatha include:

• runny or stuffy nose,
• upper respiratory tract infection,
• influenza,
• back pain,
• injection site reactions (redness, pain, and bruising),
• allergic reactions (rash and hives),
• cough,
• urinary tract infection,
• sinus infection,
• headache,
• muscle pain,
• dizziness,
• high blood pressure,
• diarrhea, and
• stomach upset.

What is the dosage of Repatha?

The recommended subcutaneous dosage of Repatha in adults with established cardiovascular disease or in adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) is either 140 mg every 2 weeks OR 420 mg once monthly, based on patient preference for dosing frequency and injection volume. When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen.

The recommended subcutaneous dosage of Repatha in patients with HoFH is 420 mg once monthly. In patients with HoFH, measure LDL-C levels 4 to 8 weeks after starting Repatha, since response to therapy will depend on the degree of LDL-receptor function.

When monitoring LDL-C for patients receiving Repatha 420 mg once monthly, note that LDL-C can vary considerably during the dosing interval in some patients.

• If a dose is missed, instruct the patient to administer Repatha within 7 days from the missed dose and resume the patient's original schedule.
• If an every-2-week dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.
• If a once-monthly dose is not administered within 7 days, instruct the patient to administer the dose and start a new schedule based on this date.

What drugs interact with Repatha?

No information provided

Is Repatha safe to use while pregnant or breastfeeding?

There are no data available on use of Repatha in pregnant women to inform a drug-associated risk.

In animal reproduction studies, there were no effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dose of 420 mg every month.

In a similar study with another drug in the PCSK9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses. The exposures where immune suppression occurred in infant monkeys were greater than those expected clinically.

No assessment for immune suppression was conducted with evolocumab in infant monkeys. Measurable evolocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that evolocumab, like other IgG antibodies, crosses the placental barrier.

FDA’s experience with monoclonal antibodies in humans indicates that they are unlikely to cross the placenta in the first trimester; however, they are likely to cross the placenta in increasing amounts in the second and third trimester. Consider the benefits and risks of Repatha and possible risks to the fetus before prescribing Repatha to pregnant women.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Repatha during pregnancy.

Please contact 1-877-311-8972 or https://mothertobaby.org/ongoing-study/repatha/ to enroll in or to obtain information about the registry.

There is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Repatha and any potential adverse effects on the breastfed infant from Repatha or from the underlying maternal condition. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts.

Generic drug: lomitapide

Brand name: Juxtapid

What is Juxtapid (lomitapide), and how does it work?

Juxtapid (lomitapide) is a prescription medicine used along with diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, in people with homozygous familial hypercholesterolemia (HoFH) to reduce:

• LDL ("bad") cholesterol
• total cholesterol
• a protein that carries "bad" cholesterol in the blood (apolipoprotein B)
• non-high-density lipoprotein cholesterol (non-HDL-C)

It is not known if Juxtapid can decrease problems from high cholesterol, such as heart attack, stroke, death or other health problems.

It is not known if Juxtapid is safe and effective in people with high cholesterol who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).

What are the side effects of Juxtapid?

WARNING

RISK OF HEPATOTOXICITY

Juxtapid can cause elevations in transaminases. In the Juxtapid clinical
trial, 10 (34%) of the 29 patients treated with Juxtapid had at least one
elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
=3x upper limit of normal (ULN). There were no concomitant clinically meaningful
elevations of total bilirubin, international normalized ratio (INR), or alkaline
phosphatase.

Juxtapid also increases hepatic fat, with or without concomitant increases in
transaminases. The median absolute increase in hepatic fat was 6% after both 26
and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance
spectroscopy. Hepatic steatosis associated with Juxtapid treatment may be a risk
factor for progressive liver disease, including steatohepatitis and cirrhosis.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating
treatment and then ALT and AST regularly as recommended. During treatment,
adjust the dose of Juxtapid if the ALT or AST are =3x ULN. Discontinue Juxtapid
for clinically significant liver toxicity.

Because of the risk of hepatotoxicity, Juxtapid is available only through a
restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called
the Juxtapid REMS Program. Prescribe Juxtapid only to patients with a clinical
or laboratory diagnosis consistent with HoFH. The safety and effectiveness of
Juxtapid have not been established in patients with hypercholesterolemia who do
not have HoFH.

Juxtapid can cause serious side effects, including:

• problems absorbing certain nutrients. Juxtapid may decrease your
  ability to absorb fat-soluble nutrients such as Vitamin E and fatty acids.
  You should take supplements each day that contain fat-soluble vitamins.
  People with bowel or pancreas problems may have an increased chance of not
  being able to absorb these nutrients.
• gastrointestinal symptoms. Diarrhea, nausea, vomiting, and stomach pain or discomfort are very common when taking
  Juxtapid. Strictly following a low-fat diet may help lower the chance of having these symptoms. Stop taking Juxtapid and tell your doctor if you have severe diarrhea, especially if you also have lightheadedness, decreased urine output, or tiredness.
• increased levels of certain blood thinners. Juxtapid can increase the level of the blood thinner, warfarin. If you take warfarin, your doctor should check your blood clotting times frequently, especially after your dose of
  Juxtapid changes.
• liver problems caused by certain drugs. Certain medicines can cause liver problems, including isotretinoin, acetaminophen, methotrexate, tetracyclines, and tamoxifen. If you take these medicines with
  Juxtapid your doctor may do blood tests more often to check your liver.

The most common side effects of Juxtapid include:

• diarrhea
• nausea
• vomiting
• indigestion
• stomach cramping/pain

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Juxtapid. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Juxtapid?

Initiation And Maintenance Of Therapy

Before beginning treatment with Juxtapid:

• Measure transaminases (ALT, AST), alkaline phosphatase, and total bilirubin;
• Obtain a negative pregnancy test in females of reproductive potential prior to initiating treatment with Juxtapid;
• Initiate a low-fat diet supplying <20% of energy from fat.

The recommended starting dosage of Juxtapid is 5 mg once daily, and the dose should be escalated gradually based on acceptable safety and tolerability. Transaminases should be measured prior to any increase in dose.

The maintenance dosage of Juxtapid should be individualized, taking into account patient characteristics such as goal of therapy and response to treatment, to a maximum of 60 mg daily as described in Table 1. Modify dosing for patients taking concomitant weak CYP3A4 inhibitors and for those with renal impairment or baseline hepatic impairment.

Monitor transaminases during treatment with Juxtapid as described in the prescribing information, and reduce or withhold dosing for patients who develop transaminase values =3x the upper limit of normal (ULN).

Table 1: Recommended Regimen for Titrating Dosage

DOSAGE
DURATION OF ADMINISTRATION BEFORE CONSIDERING INCREASE TO NEXT DOSAGE

5 mg daily
At least 2 weeks

10 mg daily
At least 4 weeks

20 mg daily
At least 4 weeks

40 mg daily
At least 4 weeks

60 mg daily
Maximum recommended dosage

• To reduce the risk of developing a fat-soluble nutrient deficiency due to Juxtapid's mechanism of action in the small intestine, patients treated with Juxtapid should take daily supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linolenic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA).

Administration

• Juxtapid should be taken once daily with a glass of water, without food, at least 2 hours after the evening meal because administration with food may increase the risk of gastrointestinal adverse reactions. Patients should swallow Juxtapid capsules whole. Capsules should not be opened, crushed, dissolved, or chewed.

Dosing With Cytochrome P450 3A4 Inhibitors

• Juxtapid is contraindicated with concomitant use of moderate and strong cytochrome P450 3A4 (CYP3A4) inhibitors.
• The recommended maximum dosage of Juxtapid is 30 mg daily with concomitant use of weak CYP3A4 inhibitors (such as alprazolam, amiodarone, amlodipine, atorvastatin, bicalutamide, cilostazol, cimetidine, cyclosporine, fluoxetine, fluvoxamine, ginkgo, goldenseal, isoniazid, lapatinib, nilotinib, pazopanib, ranitidine, ranolazine, ticagrelor, zileuton). However, the recommended maximum dosage of Juxtapid is 40 mg daily with concomitant use of oral contraceptives.
• When initiating a weak CYP3A4 inhibitor in a patient already taking Juxtapid 10 mg daily or more, decrease the dose of Juxtapid by half; patients taking Juxtapid 5 mg daily may continue with the same dosage.
• Careful titration of Juxtapid may then be considered according to LDL-C response and safety/tolerability to a maximum recommended dosage of 30 mg daily except when coadministered with oral contraceptives, in which case the maximum recommended lomitapide dosage is 40 mg daily.

Dose Modification Based On Elevated Transaminases

Table 2 summarizes recommendations for dose adjustment and monitoring for patients who develop elevated transaminases during therapy with Juxtapid.

Table 2: Dose Adjustment and Monitoring for Patients with Elevated Transaminases

ALT OR AST
TREATMENT AND MONITORING RECOMMENDATIONS*

≥3 and <5 ULN

• Confirm elevation with a repeat measurement within one week.
• If confirmed, reduce the dose and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR).
• Repeat tests weekly and withhold dosing if there are signs of abnormal liver function (increase in bilirubin or INR), if transaminase levels rise above 5 ULN, or if transaminase levels do not fall below 3 ULN within approximately 4 weeks. In these cases of persistent or worsening abnormalities, also investigate to identify the probable cause.
• If resuming Juxtapid after transaminases resolve to <3 ULN, consider reducing the dose and monitor liver-related tests more frequently.

≥5 ULN

• Withhold dosing, obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR), and investigate to identify the probable cause.
• If resuming Juxtapid after transaminases resolve to <3 ULN, reduce the dose and monitor liver-related tests more frequently.

*Recommendations based on an ULN of approximately 30-40 international units/L.

• If transaminase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin =2x ULN, or active liver disease, discontinue treatment with Juxtapid and investigate to identify the probable cause.

Dosing In Patients With Renal Impairment

• Patients with end-stage renal disease receiving dialysis should not exceed 40 mg daily. There are no data available to guide dosing in other patients with renal impairment.

Dosing In Patients With Baseline Hepatic Impairment

• Patients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily.

What drugs interact with Juxtapid?

Moderate And Strong CYP3A4 Inhibitors

• A strong CYP3A4 inhibitor has been shown to increase lomitapide exposure
  approximately 27-fold.
• Concomitant use of strong CYP3A4 inhibitors (such as boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, tipranavir/ritonavir, voriconazole) with lomitapide is contraindicated.
• Concomitant use of moderate CYP3A4 inhibitors (such as amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil) has not been studied, but concomitant use with lomitapide is contraindicated since lomitapide exposure will likely increase significantly in the presence of these inhibitors.
• Patients must avoid grapefruit juice while taking Juxtapid.

Weak CYP3A4 Inhibitors

• Weak CYP3A4 inhibitors (such as alprazolam, amiodarone, amlodipine,
  atorvastatin, bicalutamide, cilostazol, cimetidine, cyclosporine,
  fluoxetine, fluvoxamine, ginkgo, goldenseal, isoniazid, lapatinib,
  nilotinib, pazopanib, ranitidine, ranolazine, ticagrelor, zileuton) can
  increase lomitapide exposure approximately 2-fold.
• When administered with weak CYP3A4 inhibitors, the dose of Juxtapid
  should be decreased by half.
• Careful titration of Juxtapid may then be considered based on LDL-C
  response and safety/tolerability to a maximum recommended dosage of 30 mg
  daily except when coadministered with oral contraceptives, in which case the
  maximum recommended lomitapide dosage is 40 mg daily.

Warfarin

• Lomitapide increases plasma concentrations of both R(+)-warfarin and
  S(-)-warfarin by approximately 30% and increased the INR 22%. Patients
  taking warfarin should undergo regular monitoring of INR, particularly after
  any changes in lomitapide dosage. The dose of warfarin should be adjusted as
  clinically indicated.

Simvastatin And Lovastatin

• The risk of myopathy, including rhabdomyolysis, with simvastatin and
  lovastatin monotherapy is dose related. Lomitapide approximately doubles the
  exposure of simvastatin; therefore, the recommended dose of simvastatin
  should be reduced by 50% when initiating Juxtapid.
• While taking Juxtapid, limit simvastatin dosage to 20 mg daily (or 40 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity).
• Refer to the simvastatin prescribing information for simvastatin dosing recommendations.
• Interaction between lovastatin and lomitapide has not been studied.
• However, the metabolizing enzymes and transporters responsible for the disposition of lovastatin and simvastatin are similar, suggesting that
  Juxtapid may increase the exposure of lovastatin; therefore, reducing the dose of lovastatin should be considered when initiating
  Juxtapid.

P-glycoprotein Substrates

• Lomitapide is an inhibitor of P-glycoprotein (P-gp). Coadministration of lomitapide with P-gp substrates (such as aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, imatinib, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, saxagliptin, sirolimus, sitagliptin, talinolol, tolvaptan, topotecan) may increase the absorption of P-gp substrates.
• Dose reduction of the P-gp substrate should be considered when used concomitantly with lomitapide.

Bile Acid Sequestrants

• Juxtapid has not been tested for interaction with bile acid sequestrants.
• Administration of Juxtapid and bile acid sequestrants should be separated by at least 4 hours since bile acid sequestrants can interfere with the absorption of oral medications.

Is Juxtapid safe to use while pregnant or breastfeeding?

• Based on findings from animal studies, Juxtapid use is contraindicated in pregnancy since it may cause fetal harm.
• There are no data on the presence of lomitapide in human or animal milk, effects on the breastfed infant or on milk production.
• Because of the potential for serious adverse reactions, including hepatotoxicity, advise patients that breastfeeding is not recommended during treatment with
  Juxtapid.

What is Livalo, and how does it work?

Livalo (pitavastatin) is a statin drug used to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Livalo is indicated as an adjunctive therapy to diet in:

• Adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C).
• Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.

Limitations Of Use

• The effect of
  Livalo on cardiovascular morbidity and mortality has not been determined.

What are the side effects of Livalo?

Common side effects of Livalo include:

• muscle pain,
• back pain,
• joint pain,
• pain in your arms and legs,
• diarrhea,
• constipation,
• skin rash,
• headache,
• sore throat,
• stuffy or runny nose, and
• flu symptoms.

What is the dosage for Livalo?

General Dosage And Administration Information

• Take Livalo orally once daily with or without food at the same time each day.
• Individualize the dose of
  Livalo according to patient characteristics, goal of therapy, and response.
• After initiation or upon titration of
  Livalo, analyze lipid levels after 4 weeks and adjust the dosage accordingly.

Recommended Dosage For Adults And Pediatric Patients Aged 8 Years And Older

• The recommended starting
  Livalo dosage is 2 mg once daily.
• The maximum recommended dosage is Livalo 4 mg once daily.

Recommended Dosage In Patients With Renal Impairment

• The recommended starting dose for patients with moderate and severe renal impairment (estimated glomerular filtration rate 30 – 59 mL/minute/1.73 m² and 15 – 29 mL/minute/1.73 m², respectively) and patients with end-stage renal disease receiving hemodialysis is
  Livalo 1 mg once daily.
• The maximum recommended dose for these patients is Livalo 2 mg once daily.

Livalo Dosage Adjustments Due To Drug Interactions

• In patients taking erythromycin, do not exceed Livalo 1 mg once daily.
• In patients taking rifampin, do not exceed Livalo 2 mg once daily.

What drugs interact with Livalo?

Drug Interactions That Increase The Risk Of Myopathy And Rhabdomyolysis With
Livalo

Table 2 includes a list of drugs that increase the risk of myopathy and
rhabdomyolysis when administered concomitantly with Livalo and instructions for
preventing or managing drug interactions.

Table 2: Drug
Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Livalo

CyclosporineClinical Impact:Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis.Intervention:
Concomitant use of cyclosporine with Livalo is contraindicated.GemfibrozilClinical Impact:Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including
Livalo.Intervention:Avoid concomitant use of gemfibrozil with
Livalo.ErythromycinClinical Impact:Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis.Intervention:In patients taking erythromycin, do not exceed
Livalo 1 mg once daily.RifampinClinical Impact:Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis.Intervention:In patients taking rifampin, do not exceed
Livalo 2 mg once daily.FibratesClinical Impact:Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins, including
Livalo.Intervention:Consider if the benefit of using fibrates concomitantly with
Livalo outweighs the increased risk of myopathy and rhabdomyolysis.NiacinClinical Impact:The risk of myopathy and rhabdomyolysis may be increased with concomitant use of lipid-modifying doses (≥1 g/day) of niacin with
Livalo.Intervention:Consider if the benefit of using lipid-modifying doses (>1 g/day) of niacin concomitantly with
Livalo outweighs the increased risk of myopathy and rhabdomyolysis.ColchicineClinical Impact:Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including
Livalo.Intervention:Consider the risk/benefit of concomitant use of colchicine with
Livalo.

Is Livalo safe to use while pregnant or breastfeeding?

• Livalo is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with
  Livalo during pregnancy.
• Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol,
  Livalo may cause fetal harm when administered to pregnant women. Livalo should be discontinued as soon as pregnancy is recognized.
• Livalo is contraindicated during breastfeeding. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production.
• However, it has been shown that another drug in this class passes into human milk. Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with
  Livalo.

Lipitor vs. Zetia: What’s the difference?

• Lipitor (atorvastatin) and Zetia (ezetimibe) are used to lower cholesterol levels in the blood.
• Lipitor and Zetia belong to different drug classes. Lipitor is an HMG-CoA reductase inhibitor (a “statin” drug) and Zetia is a cholesterol-lowering drug.
• Side effects of Lipitor and Zetia that are similar include diarrhea and joint pain.
• Side effects of Lipitor that are different from Zetia include constipation, fatigue, gas, heartburn, headache, common cold, pain in the extremities, and urinary tract infection (UTI).
• Side effects of Zetia that are different from Lipitor include abdominal pain, back pain, muscle aches, and sinusitis.

What is Lipitor? What is Zetia?

Lipitor (atorvastatin) is a “statin” drug (an HMG-CoA reductase inhibitor) used to lower cholesterol levels in the blood. Lipitor reduces total cholesterol along with LDL (“bad”) cholesterol, which is chiefly responsible for coronary artery disease development. Reducing LDL cholesterol slows the progression and can reverse coronary artery disease. Lipitor also raises HDL ("good") cholesterol that protects against coronary artery disease and reduces the concentration of triglycerides in the blood, which are also associated with coronary artery disease. Lipitor prevents angina, stroke, heart attack, hospitalization for congestive heart failure, and revascularization procedures in individuals with coronary artery disease.

Zetia (ezetimibe) is used to treat elevated blood cholesterol. The most commonly used class of drugs for lowering cholesterol levels, statins, acts by preventing the production of cholesterol by the liver. Zetia has a different mechanism of action and lowers blood cholesterol by reducing the absorption of cholesterol from the intestine. It does not affect the absorption of triglycerides or fat-soluble vitamins.

What are the side effects of Lipitor and Zetia?

Lipitor

Lipitor is generally well tolerated. Minor side effects include:

• Constipation
• Diarrhea
• Fatigue
• Gas
• Heartburn
• Headache

Other commonly reported side effects include:

• Common cold (nasopharyngitis)
• Joint pain (arthralgia)
• Pain in the extremities
• Urinary tract infection

Lipitor may cause liver and muscle damage. Serious liver damage caused by statins is rare. Liver tests should be performed at the beginning of treatment then as needed thereafter.

Inflammation of the muscles caused by statins can lead to serious breakdown of muscle cells called rhabdomyolysis. Rhabdomyolysis causes the release of muscle protein (myoglobin) into the blood, and myoglobin can cause kidney failure and even death. When used alone, statins cause rhabdomyolysis in less than one percent of patients. To prevent the development of serious rhabdomyolysis, patients taking atorvastatin should contact their health-care professional immediately if they develop unexplained muscle pain, weakness, or muscle tenderness.

Statins have been associated with increases in HbA1c and fasting serum glucose levels as seen in diabetes.

Post-marketing reports for atorvastatin of adverse events include:

• Memory loss
• Forgetfulness
• Amnesia
• Confusion
• Memory impairment

Symptoms may start one day to years after starting treatment and resolve within a median of three weeks after stopping the statin.

Zetia

The most common side effects of ezetimibe are:

• diarrhea,
• abdominal pain,
• back pain,
• joint pain,
• muscle aches, and
• sinusitis.

Hypersensitivity reactions, including angioedema (swelling of the skin and underlying tissues of the head and neck that can be life-threatening) and skin rash rarely occur.

Other important side effects include:

• Nausea,
• pancreatitis,
• muscle damage (myopathy or rhabdomyolysis) and
• hepatitis

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What is the dosage of Lipitor vs. Zetia?

Lipitor

• Lipitor is prescribed once daily.
• The usual starting dose for adults is 10-20 mg per day, and the maximum dose is 80 mg per day. Adults who need more than a 45% reduction in LDL cholesterol may be started at 40 mg daily.
• Pediatric patients should receive 10 mg once daily up to a maximum dose of 20 mg daily.
• Lipitor may be taken with or without food and at any time of day.

Zetia

• The recommended dose of ezetimibe is 10 mg daily. Ezetimibe can be taken with or without food and at the same time as statin drugs.

QUESTION

What is cholesterol?
See Answer

What drugs interact with Lipitor and Zetia?

Lipitor

Decreased elimination of Lipitor could increase levels of Lipitor in the body and increase the risk of muscle toxicity from Lipitor. Therefore, Lipitor should not be combined with drugs that decrease its elimination. Examples of such drugs includes:

• erythromycin (E-Mycin),
• ketoconazole (Nizoral),
• itraconazole (Sporanox),
• clarithromycin (Biaxin),
• telithromycin (Ketek),
• cyclosporine (Sandimmune),
• nefazodone (Serzone), and
• HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir).

Large quantities of grape fruit juice (>1.2 liters daily) also will increase blood levels of Lipitor and should not be taken.

The following drugs also may increase the risk of muscle toxicity when combined with Lipitor.

• amiodarone (Cordarone)
• verapamil (Calan Verelan, Isoptin)
• cyclosporine (Sandimmune)
• niacin (Niacor, Niaspan, Slo-Niacin)
• gemfibrozil (Lopid)
• fenofibrate (Tricor)

Lipitor increases the effect of warfarin (Coumadin) and the concentration in blood of digoxin (Lanoxin). Patients taking Lipitor and warfarin or digoxin should be monitored carefully. Cholestyramine (Questran) decreases the absorption of Lipitor. Lipitor should be given at least two hours before and at least four hours after cholestyramine.
Rifampin increases breakdown of Lipitor. To reduce the likelihood of this interaction both drugs should be given at the same time. Lipitor should not be given after rifampin.

Zetia

Cholestyramine (Questran), colestipol (Colestid) and colesevelam (WelChol), bile acid-binding drugs that may be used to treat elevated levels of cholesterol, bind to ezetimibe and reduce its absorption from the intestine by about 50%. Therefore, ezetimibe should be taken at least two hours before or 4 hours after administration of these drugs. Cyclosporine (Gengraf, Neoral) increases the levels of ezetimibe while ezetimibe increases levels of cyclosporine. Combining both drugs may increase side effects of either drug.

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Are Lipitor and Zetia safe to take while pregnant or breastfeeding?

Lipitor

• Lipitor should not be taken during pregnancy because the developing fetus requires cholesterol for development, and Lipitor reduces the production of cholesterol. Lipitor should only be administered to women of childbearing age if they are not likely to become pregnant.
• It is not known if Lipitor is secreted in breast milk. Because of the potential risk of adverse events, breastfeeding mothers should not use Lipitor.

Zetia

• There are no adequate studies of ezetimibe in pregnant women. Therefore, physicians must weight the benefit of prescribing ezetimibe during pregnancy against potential but unknown risks.
• There are no adequate studies of ezetimibe in women who are breastfeeding. Therefore, physicians must weight the benefit of prescribing ezetimibe to nursing women against potential but unknown risks.