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CHOLESTEROL DRUGS: THE RISKS VARY AS WIDELY AS THE CHOICES Part 2 - The Non-Statins

Dec 1, 2004 PART 2: The Non-Statins

In last month's Newsletter, we provided our readers with a thorough discussion of cholesterol, trans fatty acids, and the class of cholesterol-lowering drugs known as statins. This month, as promised, we will cover the remaining prescription medications which are used on their own or in combination with other drugs (including statins) for the same purpose.

Three other categories of cholesterol-lowering medications are fibrates, resins, and niacin (nicatonic acid). The fibrate group includes the drugs Bezalip, Atromid-S, Tricor, and Lopid. The resins are Cholybar, Questran, and Prevalite. Niacin based medications include Advicor, Niacor, Niaspan, Nicobid, and Nicolar. In addition to these three categories of drugs, there are two new cholesterol medications on the market. These drugs are Zetia and Vytorin.

All cholesterol-lowering drugs are intended to supplement a healthy lifestyle of proper diet and exercise. They should never be seen as a means by which to continue (or start) poor eating habits or other problematic behavior.

FIBRATES

The cholesterol drugs known as fibrates lower LDL ("bad") cholesterol and triglycerides while raising HDL ("good") cholesterol. They achieve this result by inhibiting: (a) the liver's production of proteins containing fat and cholesterol; and (b) the release of triglycerides from fat stores in the body. Generally, all of the fibrates act in a similar manner. It is important to know, however, that the severity of the side effects varies widely from one firate to another.

Lopid (gemfibrozil)

Lopid is used to help people who have had little success in lowering their cholesterol through diet and exercise alone as well as to reduce the risk of heart disease. Common side effects associated with Lopid include abdominal pain, acute appendicitis, constipation, diarrhea, eczema, fatigue, headache, indigestion, nausea/vomiting, rash, and vertigo. Rare side effects have included anemia, blood disorders, blurred vision, confusion, convulsions, decreased male fertility, decreased sex drive, depression, dizziness, fainting, hives, impotence, inflammation of the colon, irregular heartbeat, itching, joint pain, laryngeal swelling, muscle disease, muscle pain, muscle weakness, painful extremities, sleepiness, tingling sensation, weight loss, and yellow eyes and skin. Before taking Lopid, you should speak with your physician about the possibility that the drug may cause malignancy, gallbladder disease, abdominal pain leading to appendectomy, or other potentially fatal abdominal disorders.

Lopid should never be combined with any of the statin drugs as the combination can possibly cause serious muscle-wasting side effects. Blood-thinning drugs such as Coumadin should also be avoided while taking Lopid, and anyone beginning treatment for high cholesterol with Lopid should consult their physician to find out about any other potentially harmful drug interactions.

The recommended dosage of Lopid is 2 doses of 600mg taken 30 minutes before breakfast and dinner. Lopid is not approved for use in children and should be used carefully by older adults. If you are experiencing sudden abdominal cramps, diarrhea, joint and muscle pain, nausea or vomiting, you may be having symptoms of an overdose and should seek medical help immediately.

Tricor (fenofibrate)

Tricor, or Lofibra, is used to lower triglyceride levels. Common side effects of Tricor include abdominal pain, headache, and various respiratory disorders. Less common side effects include constipation, diarrhea, flu-like symptoms, nausea, runny nose, and general weakness. Perhaps the most serious side effect is the rare, but possible, development of rhabdomyolysis, the muscle-wasting disease also associated with statins. Tricor also has the potential to cause gallstones and may affect liver function negatively.

Sometimes Tricor will be prescribed with other cholesterol lowering drugs, specifically in the resin group. If this is the case, always take Tricor at least 1 hour before or 4 to 6 hours after taking the other drug. Tricor should always be taken with meals and is not recommended for use by children or nursing mothers.

The dosage for Tricor depends on the level of cholesterol and triglycerides but usually, the initial dosage is 160mg per day which is also the maximum dosage. The initial dosage for Lofibra, however, is usually only 67mg per day with a maximum daily dosage of about 200mg.

Bezalip (bezafibrate)

Before beginning treatment with Bezalip, make sure to tell your doctor if you currently have or have ever had kidney or liver problems, or gallbladder disease (with or without gallstones). Women who are pregnant or breastfeeding should not take Bezalip.

Side effects associated with Bezalip include anemia, loss of appetite, unexplained bleeding, tendency to bruise more easily, cholestasis, dizziness, feelings of fullness, fever, gallstones, being more prone to infection, hair loss, headache, hypersensitivity reaction including angiodema, itchy skin, muscle weakness (potentially leading to rhabdo), myopathy, nausea, photosensitivity, sexual dysfunction, and sore throat.

Bezalip may interact negatively with hypoglycemics, insulin and sulphonylureas, MAOI inhibitors, warfarin (Coumadin) and other blood thinners, oral contraceptives, and, most notably, statins and resins.

Atromid-S (clofibrate)

The lipid-lowering agent Atromid-S works just like other fibrates yet it has been linked to more serious side effects. Although the most common side effect is nausea, there is a remarkably lengthy list of less common side effects including vomiting, loose stools, dyspepsia, flatulence, abdominal distress, headache, dizziness, fatigue, muscle pain, skin rash, dry brittle hair, alopecia, increased or decreased angina, cardiac arrhythmias, allergic reactions including urticaria, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, gallstones, hepatomegaly, gastritis, anemia, impotence and decreased libido, renal dysfunction, myalgia, rhabdo, and weight gain.

Pregnant and nursing women should not take Atromid-S. It is also not recommended for patients who have had clinically significant hepatic or renal dysfunction.

The extensive list of side effects relating to Atromid-S (as opposed to the other fibrates) is particularly problematic as it poses some sort of hazard to almost every part of, or system in, the body. As a result, both the doctor and the patient should be convinced that Atromid-S is, indeed, the right choice before a treatment regimen is commenced.

RESINS

Resins, otherwise called bile acid sequestrants, help to reduce high levels of bad cholesterol by binding with cholesterol-containing bile acids found in the intestines. By doing this, resins prevent the bile from being reabsorbed before it is eliminated by the body. The liver, which normally makes bile out of cholesterol, can then produce a replacement supply of bile acids and take the extra cholesterol out of the bloodstream. These medications lower LDL-cholesterol levels by about 10 to 20 percent but do not specifically lower triglyceride levels. Thus, resins are often used in combination with other cholesterol-lowering drugs.

Questran (cholestyramine)

Questran is prescribed to lower LDL levels in the blood as well as to relieve itching associated with gallbladder obstruction. It is also available in a less-potent form known as Questran Light. Questran prescribed in powder form, should never be taken dry. It should always be mixed with water or another liquid, applesauce, or crushed fruits.

The most common side effect associated with Questran is constipation. People with a history of constipation are often discouraged from using Questran. Less common or rare side effects include; abdominal discomfort, anemia, anxiety, arthritis, asthma, backache, belching, black stools, bleeding gums, blood in the urine, brittle bones, dental cavities, diarrhea, difficulty swallowing, dizziness, drowsiness, fainting, fatigue, fluid retention, gas, headache, heartburn, hiccups, hives, increased sex drive, increased tendency to bleed, inflammation of eye or pancreas, irritation around anal area or skin and tongue, joint pain, lack or loss of appetite, muscle pain, nausea, night blindness, painful or difficult urination, rash, rectal bleeding and/or pain, ringing in the ears, shortness of breath, sour taste, swollen glands, tingling sensations, ulcer attack, vertigo, vomiting, weight gain or loss, wheezing and vitamins A, D, E and K deficiencies.

People with phenylketonuria (an inherited disease characterized by inability to oxidize a metabolic product of phenylalanine and by severe mental deficiency -- abbreviation PK) should be sure to check with their physician before taking Questran Light as it contains phenylalanine. Anyone taking drugs that may raise cholesterol levels or being treated for any disease contributing to increased blood cholesterol such as hypothyroidism, diabetes, nephritic syndrome, dysproteinemia, obstructive liver disease, or alcoholism should be especially careful when taking Questran.

Questran should not be taken in conjunction with hormones, oral diabetes drugs, Phenobarbital, thyroid medication such as Synthroid, and warfarin (Coumadin) amongst others. Consult your physician if you are taking any other medication prior to beginning treatment with Questran.

Welchol (colesevelam)

Welchol can be prescribed alone or in conjunction with statin drugs such as Lipitor or Zocor to help lower cholesterol. It should always be taken at mealtime with some kind of liquid unless your physician instructs you otherwise.

Side effects associated with Welchol include constipation, indigestion, muscle aches, sore throat, and weakness. If you have a bowel obstruction, have difficulty swallowing, or suffer from severe digestive problems you should not take Welchol. There are no significant food or drug interactions pertaining to Welchol.

Colestid (colestipol)

Colestid can be prescribed in granule or tablet form. The granules must be mixed with liquids such as flavored drinks, milk, orange juice, pineapple juice, tomato juice, or water. Although carbonated beverages may also be used, they may sometimes cause stomach or intestinal discomfort. If Colestid granules are accidentally inhaled they may cause serious effects and thus should never be taken in their dry form.

The most common side effects associated with Colestid are constipation and worsening of hemorrhoids. Less common side effects include abdominal bloating or distention/cramping/pain, aches and pains in arms and legs, angina (crushing chest pain), anxiety, arthritis, backache, belching, bleeding hemorrhoids, blood in stool, bone pain, chest pain, diarrhea, dizziness, drowsiness, fatigue, gas, headache, heartburn, hives, indigestion, insomnia, joint pain, light-headedness, loose stools, loss of appetite, migraine, muscle pain, nausea, rapid heartbeat, rash, shortness of breath, sinus headache, skin inflammation, swelling of hands or feet, vertigo, vomiting, and weakness.

People with diseases that may cause increased blood cholesterol such as underactive thyroid gland, diabetes, nephritic syndrome, dysproteinemia, obstructive liver disease and alcoholism should not take Colestid before consulting a physician. Colestid may cause or worsen constipation and therefore anyone who should avoid aggravated constipation, such as those with coronary artery disease or severe hemorrhoids, should talk to their physician before taking the drug. When Colestid is taken with other drugs including folic acid, certain vitamins, Hydrocortizone, Penicillin G, and the fibrate Lopid, it may have negative interactions.

NIACIN (Nicatonic Acid)

The cholesterol drugs in the niacin group are Niacor, Niaspan, Nicobid, Nicolar, Slonacin, and Advicor which is a combination of nicatonic acid and Lovostatin. While the aforementioned drugs have virtually the same effect, they fall into three different categories: immediate release, timed release, and extended release. Niacin, otherwise known as the vitamin B3, has been proven to help lower cholesterol levels when taken in high dosages. It works by inhibiting the liver's production of fat and cholesterol containing proteins.

General side effects for nicatonic acid include flushing or hot flashes, nausea, indigestion, gas, vomiting, diarrhea and activation of peptic ulcers. Flushing can be accompanied by dizziness, fainting, heartbeat irregularities, chills, hives, itchiness, shortness of breath, or swelling. Taking aspirin or a nonsteroidal anti-inflammatory medication (NSAID) such as Motrin or Aleve 30 minutes before taking Niaspan can help minimize flushing.

If you are taking a form of niacin, you must follow the instructions very carefully since many unpleasant side effects will result from not doing so. You must take the drug with food and avoid taking it with any warm or hot liquid. It must be taken in high dosages to be effective so most physicians recommend a gradual increase in the dosage until the maximum is reached. A sudden jolt of large doses of niacin may trigger some very unpleasant and even dangerous reactions.

Although things like hot flashes and hives sound relatively harmless, many people are unable to take massive doses of niacin because they are made so uncomfortable. Imagine being at work, at an important meeting, or in a movie theater when you suddenly break out in hives, feel as if you are burning up, and become so itchy that you begin scratching yourself until you bleed. You might also feel so lightheaded or dizzy that you become disoriented and unable to stand. While none of this is life-threatening, it can be so unpleasant that repeating it on a daily basis is simply unacceptable. Sometimes, a patient will develop a tolerance for niacin after several days or weeks. Most people who suffer these side effects, however, never reach that point and simply give up on the therapy.

Advicor

Advicor is a combination of extended-release niacin and lovostatin, or Mevacor. Common side effects include; abdominal pain, back pain, diarrhea, flu-like symptoms, flushing, headache, high blood sugar, indigestion, infection, itching, muscle pain, nausea, pain, rash, vomiting, and weakness.

There is, however, an even longer list of less-common side effects including various allergic reactions, anxiety, chest pain, chills, constipation, darkening of skin color, decreased sex drive, difficulty sleeping, dizziness, dry mouth, dry skin, enlarged breasts in men, eye irritation, fainting, gas, general feeling of unwellness, gout, hair loss, heartbeat irregularities, hives, inflammation of pancreas, impotence, joint pain, liver disorders, loss of appetite, low blood pressure, memory loss, mental changes, migraine, muscle cramps, muscle disorders, nerve disorders, runny nose, shortness of breath, skin and nail changes, sweating, swelling, tingling, tremor, ulcers, vertigo, vision disorders, and yellowing of skin and eyes.

You should not take Advicor if you have liver disease, an ulcer, or arterial bleeding. It should be taken at bedtime with food, specifically a low-fat snack unless you are instructed otherwise by your physician.

Drugs that may interact negatively with Advicor are: antifungal drugs such as Sporanox and Nizoral, blood pressure medications, cholesterol-lowering fibrates such as Lopid and Atromid, Erythromycin (E.E.S., Erythrocin), HIV protease inhibitors such as Viracept and Norvir, Nefazodone (Serzone), Nitroglycerin, Nutritional supplements containing niacin or nicotinamide, and warfarin (Coumadin).

Niacor is the extended-release version of Advicor.

Niaspan

Niaspan can be taken in conjunction with drugs from the resin group as well as the statin group to achieve lower LDL-cholesterol levels when diet and exercise have failed. Side effects associated with Niaspan include abdominal pain, hot flashes, chills, diarrhea, dizziness, fainting, flushing, headache, indigestion, hives and itching, nasal inflammation, nausea, pain, rapid heartbeat, rash, shortness of breath, sweating, swelling due to fluid retention, and vomiting.

As is the case with other niacin-based drugs, Niaspan can be hazardous for people with diabetes, heart conditions, or problems with gout. If you experience a change in blood-sugar levels while on Niaspan, tell your physician immediately. Pre-existing kidney and liver problems or weaknesses can lead to complications with Niacin as well.

Since niacin therapy is essentially taking a vitamin in large doses, overdosing with drugs such as Niaspan has occurred. An excessive amount of Niacin is more than 2,000 milligrams a day. This can cause liver damage and stomach ulcers. Other signs of long-term overdose could be nausea, vomiting, abdominal cramps, faintness, and yellowish skin and eyes.

Slo-Niacin is the extended release form of the drug.

A NEW CATEGORY

Since drugs designed to lower LDL-cholesterol levels and triglycerides have become increasingly popular, pharmaceutical companies are always seeking to cash in on the trend by developing new alternatives. One of the problems with the existing cholesterol remedies is that, more often than not, the bad outweighs the good. The possibility of trading high cholesterol for kidney or liver disease is an unpleasant choice that is made every day by people taking many of the drugs we have been discussing.

In the past year, however, two new cholesterol medications have been approved which might prove to be better options once all the results are in. Of course, in the unpredictable world of prescription drugs, they might also turn out to be more dangerous.

Zetia (ezetimibe)

Schering-Plough Pharmaceuticals developed the non-statin drug Zetia in hopes of competing with the current cholesterol drug leader, Lipitor. Zetia works slightly differently from statins by reducing the absorption of bad cholesterol in the digestive tract. While Zetia can be prescribed on its own, it is often prescribed in conjunction with a statin for optimal results.

Common side effects for Zetia are abdominal or back pain, diarrhea, joint pain, and sinusitis. Rare side effects include coughing, fatigue, sore throat, sexual dysfunction and viral infection. These minor side effects are similar to those associated with the other cholesterol lowering agents. More severe problems such as liver damage and serious muscle pain are also under investigation.

The recommended dose for Zetia is 10mg per day. Zetia should never be combined with any of the fibrates such as Lopid and Tricor, but it can be taken with resins such as Colestid, Questran, or WelChol.

Vytorin

Following Zetia's approval, Merck and Schering-Plough launched Vytorin, a combination of exetimibe, the active ingredient in Zetia, and simvastatin, the chemical found in Zocor. Vytorin was approved on July 23, 2004. Vytorin's approval coincided with the guidelines issued by The National Cholesterol Education Program which indicated that now more Americans need cholesterol-lowering medications than previously thought.

The starting dose of Vytorin is 10mg of Zetia and 10mf of Zocor. Side effects include allergic reactions including rash, inflammation of the pancreas, nausea, headache, dizziness, gallstones, inflammation of the gallbladder, and swelling of the face, lips, tongue, and or throat that may cause difficulty in breathing. The risk of muscle breakdown, a precursor to rhabdo, does exist with Vytorin and is categorized by muscle pain, tenderness or weakness. If you are experiencing any unexplained muscle pain while taking Vytorin, consult your physician immediately.

Those with liver problems or liver disease as well as any women who are pregnant or may become pregnant should not take Vytorin.

At present, Vytorin seems to be the safest existing solution for management of cholesterol and triglyceride levels. It is the first drug to reduce LDL-cholesterol by inhibiting cholesterol production in the liver as well as cholesterol absorption in the intestine. (This process is known as Dual Inhibition.) Dr. Bassem El-Masri, a cardiologist and cholesterol researcher at Cornell Weill Medical School, believes that Vytorin will allow doctors to treat heart disease forcefully without worrying as much about safety.

CONCLUSION

Currently, no cholesterol drug is without potentially serious side effects which may ultimately do more damage than the condition they are intended to treat. Ideally, these drugs should have beneficial side effects such as raising "good" cholesterol levels or preventing heart attacks. Unfortunately, that is not yet the case.

Thus, before beginning any type of drug regimen for high cholesterol, make sure to get all of the facts from your physician to be sure that you are selecting the medication that is best (or least risky) for you. The wide range of existing options provides some flexibility to those in need of such treatment. However, most medical experts continue to stress the fact that lifestyle modifications with respect to diet and exercise are the single most important "regimen" for the reduction of cholesterol levels.

If you believe that you or a loved one has suffered an injury associated with the use of any of the medications discussed in this Newsletter (or last month's Newsletter), please seek immediate medical attention and then contact Parker & Waichman for a free consultation and case evaluation. If you are taking the statin, Crestor, we urge you to be extremely careful and to have yourself monitored frequently for any signs of liver damage.
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