The purpose of this website is to present, to all who want the knowledge, a safe and dependable method through which individuals can lower their elevated blood triglyceride levels. However, it is heartening to realize you can achieve astonishing results - if you put your mind to it.
Failure to treat patients with elevated blood triglycerides, thereby increasing their risk of a cardiovascular event or of pancreatitis, is a potential medical pitfall. |
The NCEP recommendations ("consensus statements") are the products of independent, non-Federal panels of experts and are based on the panels' assessments of medical knowledge available at the time the statements were made.
Therefore, they provide "snapshots in time" of the state of knowledge of the topics (new knowledge, however, is inevitably accumulating through medical research).
It should be noted, however, that the usually quoted "normal" blood lipid levels do change as they depend upon the levels found in the majority of the population as well as upon what... health officials decide is normal.
Therefore, the declared "normal" triglyceride levels -- that your doctor will use to tell you whether your various serum/blood levels are "normal" -- do NOT necessarily mean "healthy" levels; rather these will include both healthy and many very unhealthy patients.
Here is the American Cholesterol Education Program Expert Panel’s current policy on fasting blood triglyceride levels in adults:
| less than 150 mg/dL (<1.7 mmol/L) | Normal |
| 150 - 199 mg/dL (1.7–2.3 mmol/L) | Borderline-high |
| 200 - 499 mg/dL (2.3–5.64 mmol/L) | High |
| higher than 500 mg/dL (>5.64 mmol/L) | Very high |
Here are the Canadian guidelines on fasting blood triglyceride levels in adults:
| less than 2.0 mmol/L (<177.2 mg/dL) | Optimal |
| 2.0 - 2.5 mmol/L (177.2 - 221.5 mg/dL) | Acceptable |
| higher than 2.5 mmol/L (>221.5 mg/dL) | Compromised |
According to some European guidelines, blood triglyceride levels in adults should be categorized as follows:
| less than 1.7 mmol/L (<150.1 mg/dL) | No risk |
| between 1.7 - 2.3 mmol/L (150.1 - 203.1 mg/dL) | Suspect |
| fasting 1.7 - 2.3 mmol/L (151.1 - 203.1 mg/dL) | Requiring attention and intervention |
|
2.3 - 4.6 mmol/L (203.1 - 407.1 mg/dL) with high LDL cholesterol (greater than 4.1 mmol/L, or 160 mg/dL) |
Requiring aggressive treatment |
The following "normal" blood triglyceride reference ranges are based on someone's age:
| Age | "Normal" Triglyceride Range |
| 10 - 29 years | 53 - 104 mg/dL, or 0.6 - 1.2 mmol/L |
| 30 - 39 years | 55 - 115 mg/dL, or 0.6 - 1.3 mmol/L |
| 40 - 49 years | 66 - 139 mg/dL, or 0.7 mmol/L - 1.6 mmol/L |
| 50 - 59 | 75 - 163 mg/dL, or 0.8 - 1.8 mmol/L |
| 60 - 69 | 78 - 158 mg/dL, or 0.9 - 1.8 mmol/L |
| > 70 years | 83 - 141 mg/dL, or 0.94 - 1.6 mmol/L |
Here's another example of the "normal range" of blood triglycerides based on gender and age. Many health professionals find it quite accurate:
| Adult Males | Upper level: 130 mg/dL + age; Maximum: 200 mg/dL, or 2.3 mmol/L |
| Adult Females | Lower level: 80 mg/dL + age; Maximum: 165 mg/dL, or 1.9 mmol/L |
| Adult Males and Females | Lower level: Your age |
| Adult Males and Females | Below 100 mg/dL, or 1.1 mmol/L: Ideal level |
PLEASE NOTE: Fasting values should be based on two serial measurements of serum (blood) triglycerides. Serial measurements are important because of intraindividual triglyceride variability which is 5 times that of cholesterol.
NCEP Expert Panel's Ties to Statin Drugmakers
Not surprisingly, the 2001 expert panel's guidelines may ultimately increase the number of patients on statin drugs to as many as 50 million users. (Cholesterol Guidelines A Gift For Merck, Pfizer. 07.12.04, 4:30 PM ET Forbes Magazine).
However, in an embarrassing oversight, the same government panel drafting the guidelines failed to mention that several of the panelists are linked to some of the pharmaceutical companies that manufacture statin drugs.
In fact, six of the nine panelists had either received grants or were paid consulting or speakers' fees by the companies that produce some of the most popular statin medications on the market (Panel's ties to drugmakers not cited in new cholesterol guidelines. Newsday.com), including:
High Blood Triglycerides: Standard Prescription Medications
A study recently published in the JAMA states that fewer than 10 percent of all patient decisions are well informed. |
Unfortunately, for many people lifestyle changes have not been sincere enough, and a lipid-lowering drug treatment is being prescribed.
From conventional doctors' point of view, being on medication doesn’t mean you failed – just that you need a little more help that diet and exercise can provide.
And that it is not correct to say that once you start on medicines, you get hooked to it. It all depends - your doctor says - whether your triglycerides levels remain within acceptable limits or not. (You need to take your medication for initially 3 months and then check your triglycerides level under medical supervision.)
And your doctor will tell you there is nothing to worry about side effects which are minor and in any event more acceptable than high triglycerides levels.
However, the fact is prescription drugs do have serious potential side effects and there are far safer ways to treat abnormal blood lipid levels and decrease cardiac deaths without taking medications.
Despite this, you would be astounded how many people would rather take a pill with multiple health risks than consider changing anything else.
I. Statins: HMG-CoA Reductase Inhibitors
Triglycerides are lowered modestly and only a small increase in HDL-”good” cholesterol can occur with statins. |
There several statins available on the market today in tablet or capsule form. Some commonly used brand names are:
- in the U.S. - Lescol, Lipitor, Mevacor, Pravachol, Zocor
- in Canada - Lescol, Mevacor, Pravachol, Zocor
- in the UK - Zocor, Lipostat, Lescol, Lipitor, and Crestor.
Statin therapy can achieve reductions in LDL-“bad” cholesterol of approximately 30-40 percent. However, reductions in excess of 50 percent are achievable only with high doses of some statins.
Statins work by blocking a key liver enzyme involved in this process, thereby slowing down the production of cholesterol in the liver.
This encourages the liver to take extra cholesterol, LDL-“bad” cholesterol in particular, out of the bloodstream, causing the LDL cholesterol level to decrease.
As cholesterol synthesis tends to be highest at night patients are generally advised to take their statin dose at night, with the exception of Lipitor, which can be taken at any time.
Statins are now recommended for all patients with established coronary disease.
They are also indicated for those at high risk of developing heart disease, particularly those with
- diabetes,
- high blood pressure
- a family history of premature death from heart disease
- total cholesterol level above 5 mmol/L, or 194 mg/dL, and
- LDL-“bad” cholesterol level above 3 mmol/L, or 116 mg/dL.
Statins are relatively free of adverse effects, however, some people may experience symptoms such as
- skin rash
- gastrointestinal upsets
- sleep disturbances and
- headaches.
PLEASE NOTE: Combination therapy of statins and fibrates should not be ruled out for all patients (Feher et al 1994). Certain high-risk individuals with dyslipidemia, for instance those with familial hypercholesterolaemia, diabetes, or coronary heart disease (CHD), may need to have combination therapy.
Statin Toxicity: The Grapefruit Juice-Statin Issue
Grapefruit juice should be off the menu for people taking statins. Not enough people know or take notice of the grapefruit/statin issue. The leaflets accompanying the tablets (but how many people take notice of these?) often state that you need to be wary of this citrus fruit.
If you are taking statins, particularly simvastatin (Zocor) and atorvastatin (Lipitor), you should avoid grapefruit juice; other fresh fruits, including limes and lemons, seem fine.
A chemical in grapefruit juice deactivates a liver enzyme that is important in breaking down statins; and this leads to excessively high levels of the drug in the bloodstream, causing statin toxicity symptoms such as
- extreme tiredness
- muscle aches, even
- potentially lethal effects on the heart muscle.
If you take statins of any sort, but particularly these two (Zocor and Lipitor), steer well clear of grapefruit juice.
Some doctors think a little is OK occasionally, but we’d err on the side of caution and give it a wide berth.
Also alcohol potentiates the toxicity of cholesterol-lowering medications much more than the drugs would do alone. Actually, this is the major problem with the statins.
By drinking alcohol daily, you may increase your chances of serious statin side effects, especially liver problems. Therefore, to protect your liver, you should go easy on alcohol or avoid it completely while taking a statin drug.
FDA News: Counterfeit "Lipitor" Sold in the U. K.
On July 29, 2005, the Food and Drug Administration (FDA) alerted U.S. residents to the recent recall of a batch of counterfeit "Lipitor" (atorvastatin) sold in the United Kingdom (U.K.).
The counterfeit Lipitor 20mg tablets were recalled in the U.K. on July 28, 2005. Health authorities in the U.K. stated that initial results of tests performed on the counterfeit drugs do not indicate that this product poses an immediate risk to patients, however, they are advising that patients stop taking the drug and return it to the pharmacy where they obtained it.
U.K. pharmacies are being advised to return all remaining stock of this batch to Pfizer Ltd., the manufacturer of Lipitor.
Consumers who purchased FDA-approved Lipitor products through legitimate U.S. pharmacies should not have received any of these counterfeit tablets and are not subject to this recall.
But some U.S. residents may have obtained prescription drugs from the U.K. through the operations that do not supply legitimate, FDA-approved products, or through state-run drug importation programs that facilitate the purchase of unapproved foreign drugs. Consumers who purchase drugs through these arrangements may have received these counterfeit products.
The affected product is 20 mg. "Lipitor" and is sold in packages of 28 tablets. The drug packages are marked with batch number 004405K1 and an expiration date of "11 2007." The batch number can be found on the end of the box next to the expiration date and on the foil backing of the drug's blister pack. Legitimate U.K. Lipitor also has this same batch number.
Because the recalled Lipitor is fake, there is no guarantee of its quality or effectiveness. U.S. patients who have the identified U.K. drugs should stop using them and should consult their physician or pharmacist if they have any questions or concerns.
Statins: Zocor®
This well-known and one of the world’s best selling cholesterol-lowering prescription drugs was cleared by the U.S. Food and Drug Administration (FDA) in 1997 to lower triglyceride levels in patients with combined or mixed dyslipidemia (both high cholesterol and high triglycerides).
Zocor (Simvastatin) is indicated in addition to diet - after diet alone has failed to achieve target levels.
However, this drug should not be used by:
- anyone who is allergic to any of its components,
- patients with liver disease or elevated liver enzymes (liver function tests need to be performed first),
- women who are pregnant, breast-feeding, or of childbearing age who could become pregnant.
According to the Zocor website, major side effects include:
- unexplained muscle and abdominal pain or
- weakness.
ZOCOR is a registered trademark of Merck & Co., Inc.
Statins: Lescol ®
In 2000, a new indication for Lescol (fluvastatin sodium) - a prescription cholesterol-lowering drug - was approved to additionally decrease triglycerides in patients with mixed dyslipidemia .
Mixed dyslipidemia - both elevated cholesterol and triglycerides - is a condition which affects approximately 40 percent of patients in the U.S.
Lescol XL is now currently indicated as an adjunct to diet and exercise for the treatment for patients with
- hyperlipidemia and
- coronary heart disease (CHD)
The most commonly reported adverse reactions to Lescol XL are:
- fatigue
- nausea
- diarrhea
- dyspepsia
- abdominal pain
- rash
- upper respiratory tract infection
- influenza-like symptoms
- back pain
- headache
Lescol XL is contraindicated in
- patients with active liver disease or persistent transaminase elevations
- pregnant or nursing women.
Treatment with Lescol XL should be discontinued if myopathy and rhabdomyolysis are diagnosed or suspected.
Lescol: Full Prescribing Information (Print Out PDF Document Requiring Adobe Reader)
Statins: Advicor®
Advicor was approved by the FDA as a cholesterol-lowering prescription drug in December 2001.
Advicor is a combination product containing both extended-release niacin and lovastatin (Mevacor). This drug has been approved for the treatment of primary hypercholesterolemia and mixed dyslipidemia.
It is indicated for patients who were previously treated with either component of Advicor, but who require additional lipid modification for LDL or HDL cholesterol and triglycerides.
The most frequently reported adverse effects include the following:
- flushing, often accompanied by dizziness, fainting, heartbeat irregularities, chills, shortness of breath, or swelling
- upset stomach (indigestion, diarrhea)
- rash
Other common side effects include:
- abdominal pain
- back pain
- flu-like symptoms
- headache
- high blood sugar
- itching
- muscle pain
- nausea
- vomiting
- weakness
Contraindications: Advicor should not be used if
- you are pregnant or nursing (breastfeeding), or
- you have liver problems, active peptic ulcer, or arterial bleeding, kidney disease, gout, or the chest pain of angina
- you are allergic to niacin or lovastatin
- you have diabetes, as Advicor may affect your blood sugar levels
- you are a child.
Taking Advicor my interact with the following drugs:
- Antifungal drugs such as Sporanox and Nizoral
- Blood pressure medications such as Inderal, Lopressor, and Tenormin
- Calcium channel blockers such as Norvasc, Plendil, and Procardia
- Cholesterol-lowering drugs called fibrates such as Lopid and Atromid
- Cimetidine (Tagamet)
- Clarithromycin (Biaxin)
- Cyclosporine (Sandimmune)
- Erythromycin (E.E.S., Erythrocin)
- HIV protease inhibitors such as Viracept and Norvir
- Nefazodone (Serzone)
- Nitroglycerin (Nitro-Bid, Nitro-Dur, Nitrostat)
- Nutritional supplements containing niacin or nicotinamide
- Spironolactone (Aldactone)
- Warfarin (Coumadin)
Advicor is a registered trademark of Kos Pharmaceuticals, Inc.
Statins: Crestor®
An article in the June 26 2004 issue of The Lancet, raises issue with the FDA for approving one of the newest statin drugs, Crestor, despite pre-approval evidence that the drug caused rhabdomyolysis.
According to the author, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, Crestor was approved despite an FDA claim that new cholesterol drugs would only be approved only if they presented a comparable or lower risk of rhabdomyolysis than drugs already on the market.
According to Wolfe, patients taking Crestor experienced severe muscle deterioration at higher rates than patients taking other cholesterol-lowering drugs. In fact, the rate of post-marketing reports of rhabdomyolysis for Crestor appears to exceed that of all other currently marketed statins.
From its approval in August 2003 to mid-April 2004, 18 patients, including 11 in the United States, suffered severe muscle deterioration. In addition, eight cases of acute kidney failure and four cases of kidney insufficiency related to the use of Crestor have been reported. (Dangers of rosuvastatin identified before and after FDA approval. The Lancet, Vol. 363, Issue 9427, 26 June 2004. pp. 2189-2190.)
In their enthusiasm to reduce premature deaths from heart attack and strokes the authors of the current Cholesterol Education Program (NCEP) guidelines are recommending that millions of Americans be put on statin drugs while ignoring warning signs of potentially serious side effects from the long-term use of these compounds.
Would informed health consumers willingly choose to lower their risk of cardiovascular disease if it meant substantially increasing their chances for developing cancer or ALS after a decade or two?
Dean Ornish, clinical professor of medicine at the University of California, San Francisco and president of the nonprofit Preventive Medicine Research Institute, pointed out that “As tens of millions of people begin taking these medications for decades, more long-term side effects are likely to become apparent.”
Dr. Ornish also questioned why the NCEP expert panel failed to recommend other options, such as diet and lifestyle changes that, for most people, “can be a safe and effective alternative to a lifetime of cholesterol-lowering drugs?” (Lower Cholesterol Without Drugs. The Washington Post. Sunday, August 8, 2004; Page B07).
II. Fibrates
Fibrates are primarily effective in lowering triglycerides; they can lower triglyceride levels by 20 to 50 percent. |
- bezafibrate,
- gemfibrozil and
- fenofibrate.
There many fibrates available on the market today in tablet or capsule form. The most widely used brand name in the United States is Lopid (Gemfibrozil). In Canada, it is also known as Apo-Gemfibrozil, Gen-Fibro, Novo-Gemfibrozil, and Nu-Gemfibrozil.
Gemfibrizol is available only with doctor's prescription in capsule or tablet form.
Candidates for drug therapy with fibrates include individuals with
- mixed or combined hyperlipidemia - in such cases, raised cholesterol levels are associated with raised levels of triglycerides.
- raised triglycerides alone (often associated with low levels of HDL cholesterol) who are at risk of pancreatitis and disturbances of blood clotting mechanisms.
The drug acts by several mechanisms, the principal effect being to reduce VLDL (very low density lipoproteins) in the blood. These structures are composed predominantly of triglycerides.
Treatment with fibrates tends to increase HDL-"good" cholesterol levels by 10-15 percent. It may also lower cholesterol by up to 25 percent using the more modern fibrates.
However, fibrates are not very effective for lowering LDL-"bad" cholesterol.
Although side effects of fibrates commonly prescribed are considered minimal and temporary, those more frequently cited include:
- gastrointestinal discomfort (the most common side effect),
- increased likelihood of developing cholesterol gallstones,
- nausea,
- headache,
- skin rash, or, very rarely,
- muscle aches or liver disturbances.
PLEASE NOTE: Some people with hyperlipidemia may be treated with a fibrate and a statin. In such cases, the risk of muscle and liver damage is increased.
Fibrates are usually recommended for the management of hyperlipidemia in diabetes, where the nature of the lipid abnormality is more often of a raised triglyceride and low HDL-"good" cholesterol.
Fibrates: Lopid ®
This popular antihyperlipidemic, non-statin prescription drug is used to lower both cholesterol and triglyceride blood levels.
Lopid (Gemfibrozil/Systemic) is usually recommended when treating:
- isolated hypertriglyceridemia (much less expensive)
- combined dyslipidemia requiring LDL-"bad" cholesterol reductions
- patients with coronary heart disease, 'normal' LDL cholesterol and HDL cholesterol< 40 (HDL Intervention Trial, NEJM 1999; 341:410-418).
However, results of a large study using Lopid seem to show that it may cause a higher rate of some cancers in humans.
As Lopid is similar to another prescription medicine, called clofibrate, it may also increase your risk of
- liver disease
- pancreatitis (inflammation of the pancreas)
- gallstones and problems from gallbladder surgery (although it may also decrease the risk of heart attacks).
More common side effects include:
- severe stomach pain
- gas
- heartburn
Less common side effects include:
- diarrhea
- nausea or vomiting
- skin rash
- cough or hoarseness
- fever or chills
- lower back or side pain
- painful or difficult urination.
- muscle pain
- unusual tiredness or weakness (rare).
For Lopid, the following should be considered, as it may
- increase the effect of the anticoagulants (blood thinners).
- cause muscle or kidney problems or make them worse when used with Lovastatin
- increase the risk of muscle damage and kidney failure when used with Lipitor
- make gallbaldder disease or gallstones conditions worse.
Lopid is also less effective if you are greatly overweight. In most cases, it does NOT reduce the LDL ("bad") cholesterol levels.
Lopid has not been studied in pregnant women. However, studies in animals have shown that high doses of Lopid may increase the number of fetal deaths, decrease birth weight, or cause some skeletal defects.
Lopid: Full U.S. Prescribing Information (Print Out PDF Document Requiring Adobe Reader)
Fibrates: TriCor ®
Available by prescription in the United States since 1998, TriCor (Fenofibrate) is indicated for the treatment of adults with hypertriglyceridemia - serum triglyceride elevations greater than 2,000 mg/dL, who are
However, TriCor may interfere with
- HMG-CoA reductase inhibitors (statin medications) and
- coumarin-type anticoagulants.
This drug is not recommended, if you have
- liver, gall bladder or severe kidney disease
- gallstones
- muscle pain, tenderness or weakness.
TriCor has also side effects, such as:
- allergic reactions
- breakdown of muscle tissue
- muscle pain.
III. Nicotinic Acid Derivatives: Niaspan®
Derivatives of nicotinic acid, commonly called niacin (vitamin B3), work in the liver to lower levels of both cholesterol and triglycerides.
There many nicotinic acid derivatives available on the market today in tablet, capsule or solution form. Some commonly used brand names are:
- in the U.S. - Niacor, Niaspan, Nicolar, Nicotinex Elixir, Slo-Niacin
- in Canada - Novo-Niacin.
Some strengths of niacin are available only with doctor's prescription. Others are available without a prescription, since niacin is also a vitamin.
Niaspan is one of only two products in the United States approved for increasing HDL-"good" cholesterol levels in patients with dyslipidemia. At doses of 1,000 to 2,000 mg per day, it can increase HDL levels by 14 to 32 percent.
Unfortunately, the most common side effect of Niaspan is the flushing sensation, which typically occurs on the face, neck, chest, and back, and is characterized by redness, tingling, or itching.
Fortunately, in most cases, flushing lasts for one hour, approximately two to four hours after taking the dose. To minimize flushing, you should avoid alcohol, hot drinks, and spicy foods.
The following adverse events - in general, more common in women than in to men - have also been reported with niacin products, either during clinical trials or in routine patient management:
- edema, asthenia, chills
- atrial fibrillation and other cardiac arrhythmias; tachycardia, palpitations, orthostasis, syncope
- hypotension
- toxic amblyopia, cystoid macular edema
- activation of peptic ulcers and peptic ulceration
- jaundice
- gout
- myalgia
- dizziness, insomnia
- hyper-pigmentation, acanthosis nigricans, maculopapular rash, urticara, dry skin
- sweating
- migraine.
Niaspan is not recommended for those who have:
- active liver disease
- peptic ulcer
- arterial bleeding.
Niaspan may cause decreased glucose tolerance, namely, an increase in blood sugar levels. If you have diabetes, you should carefully check your blood sugar levels and report any changes to your doctor.
Niaspan: Full Prescribing Information (Print Out PDF Document Requiring Adobe Reader)
IV. Omega-3-Acid Ethyl Esters: Lovaza™ (Formerly Omacor®)
Omega-3-Acid Ethyl Esters developed in 1999 by the Norsk Hydro subsidiary Pronova – the first therapeutic drug ever developed in Norway - has been approved for the treatment of post-infarct patients in several European countries. It has been marketed across Europe and Asia under the brand name Omacor and in the United States under the brand name Lovaza.
The active ingredients in Omacor are EPA/DHA ethyl esters, which have several beneficial effects on the cardio vascular system.
In November 2004, Omacor - manufactured by Pronova Biocare and Reliant Pharmaceuticals (aquired in 2007 by the UK drug giant GlaxoSmithKline) - was approved by the Food and Drug Administration as a drug available by a prescription only. According to the FDA’s Consumer Drug Information Sheet, it should be used in adult patients for
- post myocardial infarction and
- hypertriglyceridemia (very high triglyceride levels, over 500 mg/dL, or 5.7 mmo/L).
This drug is also meant to serve as an adjunctive therapy in addition to healthy eating habits, and the control of heart disease risk factors, such as high blood pressure, diabetes, and high cholesterol levels, and to be used in combination with other cholesterol-lowering medications.
The mechanism of action of this drug is completely known; however there are many theories surrounding how omega-3 fatty acids may work. These mechanisms may include:
- reducing the amount of triglycerides made in the liver
- inhibition of the esterification of other fatty acids, and
- the inhibition of diacylglycerol O-acyltransferase, which is an enzyme that catalyzes the final step of triglyceride synthesis.
Omacor is active on the plasma lipids by lowering triglyceride levels as a result of a fall in VLDL (very low density lipoprotein), and the substance is also active on hemeostasis and blood pressure.
Omacor reduces the synthesis of triglycerides in the liver because EPA and DHA are poor substrates for the enzymes responsible for triglyceride synthesis and they inhibit esterification of other fatty acids.
The increase in peroxisomes of ß-oxidation of fatty acids in the liver also contributes to the fall in triglycerides, by reducing the quantity of free fatty acids available for their synthesis. The inhibition of this synthesis lowers VLDL.
A rise in HDL-“good” cholesterol is only small, significantly smaller than seen after administration of fibrates, and not consistent.
The manufacturers of Omacor state that they use a highly modified purification process than differs from what can be obtained on the shelves at your local pharmacy.
Omacor should be taken with meals. The typical dosage is 4 grams a day, which may be taken as one 1-gram capsule four times a day or two 1-gram capsules twice daily, especially if adequate response is not been obtained.
An incomplete list of side effects associated with Omacor includes:
- rash pruritic, acne
- an increase in LDL-“bad” cholesterol levels in patients with hypertriglyceridemia
- belching, often called a “fish burp”
- upset stomach, dyspepsia, nausea
- an increase in the AST and ALT liver enzymes
- prolongation of bleeding time
- infection
- flu-like symptoms
- change in sense of taste
Omacor should not be taken by
- patients under 18 years of age
- patients who are pregnant or trying to become pregnant
- lactating, breast-feeding mothers
- patients with bleeding disorders or who are on anticoagulation therapy, and
- patients with liver disease (they should consult their health care practitioner before using this drug).
In the absence of efficacy and safety data, use of Omacor in children is not recommended. It also should be used with caution in patients allergic to fish.
If both Omacor and a blood thinner are taken, health care provider should check occasionally to see if an effect has occurred. Because of the moderate increase in bleeding time (with the high dosage, i.e. 4 capsules), patients receiving anticoagulant therapy must be monitored and the dosage of anticoagulant adjusted if necessary.
Regular monitoring of hepatic function (ASAT and ALAT) is required in patients with hepatic impairment (in particular with the high dosage, i.e. 4 capsules).
PLEASE NOTE: Omacor is not indicated in exogenous hypertriglyceridemia (type 1 hyperchylomicronemia). There is only limited experience in secondary endogenous hypertriglyceridemia, especially uncontrolled diabetes.
The long-term lipid-lowering effect of Omacor (after more than one year) is not known.
Omacor: Patient Information Leaflet PDF
![Adobe Acrobat [PDF] File](image_adobe_acrobat_reader.gif)
The Bowling Green Study
William E. Feeman Jr. MD, a family practitioner, Bowling Green, Ohio, United States, conducted the long-term, observational Bowling Green Study, which has followed 2,818 family-medicine patients since 1974.
The effort of this investigator-initiated and self-funded study was to determine what components of lipid profiles have the greatest impact on risk of atherosclerotic events.
In his scientific poster, Dr. Freeman presented data on 1,339 men and 1,479 women ages less than 29 to greater than age 80 who were seen in his practice between 1974 and 2001.
According to Dr. Freeman's findings, the earliest onset of atherosclerosis have people with abnormal values for
- HDL-"good" cholesterol (39 mg/dL or less)
- LDL-"bad" cholesterol (170 mg/dL or higher) and
- triglycerides (150 mg/dL or higher).
This group does require aggressive lipid therapy.
The most typical lipid disorder, however, represent people with
- normal HDL-"good" cholesterol (>39mg/dL) but
- abnormal LDL (>170 mg/dL) and triglycerides (>150 mg/dL)
The definition of metabolic syndrome X or insulin resistance represent people with
- normal LDL-"bad" cholesterol (<170 mg/dL) and
- abnormal HDL-"good" cholesterol (>39 mg/dL) and triglycerides (>150 mg/dL).
All these people require lipid therapy as - according to Dr. Freeman - dyslipidemia, after smoking, is the next most important risk factor for atherosclerosis.
However, lipid therapy is not required in people with
- normal HDL-"good" cholesterol (>39 mg/dL) and LDL-"bad" cholesterol (<170 mg/dL), but
- elevated triglycerides (>150 mg/dL).
-
Source: 17th World Conference of Family Doctors 2004, Orlando, Florida.
High Triglycerides: Standard Medical Treatment Options
The first, important step in choosing medical treatment for hypertriglyceridemia is to consider a patient's risk profile as - in general - triglycerides are associated with such cardiovascular risk factors as insulin resistance, diabetes, low HDL ("bad") cholesterol, obesity, smoking, and hypertension.
Here are standard treatment options offered at a typical doctor's office:
1. High Triglycerides and Low HDL-"Good" Cholesterol:
Your doctor will check first whether your HDL-"good" cholesterol is low (less than 35 mg/dl in men and 45 mg/dl in women). Research suggests that the combination of low HDL and high triglycerides indicates a generalized disorder of lipid (fat) metabolism, which may place you at high cardiovascular risk.
In this case, before prescribing any medication, your doctor will recommend basic lifestyle changes - suitable for all people with elevated triglycerides - such as exercising, losing excess weight, quitting smoking, reducing alcohol, and eating a diet low in carbohydrates and saturated fats.
-
1.1. Not Responding to Lifestyle Changes:
If despite the lifestyle changes, your triglycerides remain high and HDL ("good") cholesterol low, your doctor may consider adding a fibrate drug such as Lopid ® (gemfibrozil) to your regimen.
However, according to a Canadian study, fenofibrates should be the drugs of choice to increase HDL and reduce triglycerides, especially the newly available microcoated fenofibrate with better pharmacokinetics (Canadian Cardiovascular Congress 2000 Vancouver, B.C. / October 29-November 1, 2000).
From doctors' point of view, being on medication doesn’t mean you failed – just that you need a little more help that diet and exercise can provide. However, you would be astounded how many people would rather take a pill than consider changing anything else.
You need to take your medication for initially 3 months and then check your triglycerides level under medical supervision.
2. Familial Hyperlipidemia:If you have a family history of lipid disorders your doctor may choose niacin.
-
2.1. Not Responding to Niacin:
If that doesn’t work, he will probably add to your regimen a fibrate (e.g., gemfibrozil, fenofibrate) - especially, if you suffer from familial hypertriglyceridemia - or a statin (e.g., simvastatin, lovastatin).
Without treatment you may eventually develop atherosclerosis leading to a heart attack. (Familial combined hyperlipidemia manifests as high cholesterol, high triglycerides, or both).
3. Triglycerides Over 500 mg/dL:
If your triglycerides are greater than 500 mg/dL your doctor may prescribe fibrate therapy, either alone or in combination with niacin, a statin, or fish oil (taken in supplement form or as 30 per cent of dietary calories).
If left untreated, triglycerides over 500 mg/dL can cause pancreatitis (the inflammation of pancreas).
4. Borderline-High Triglycerides and Normal LDL:
If your triglycerides are borderline-high with normal LDL ("bad") cholesterol (less than 130 mg/dl) your doctor my consider using niacin or a fibrate.
However, not all doctors would agree you should be treated medically, unless you have history of vascular disease. However, this line of treatment may be considered, if you have not responded to lifestyle chagnes and have other cardiovascular risk factors, such as smoking or a family history of heart disease.
5. High Triglycerides and High LDL Cholesterol:
If you have elevated triglycerides in combination with high LDL ("bad") cholesterol, the LDL abnormality will be treated first - with lifestyle changes, medication (usually statins), or both.
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5.1. Not Responding to Statin Therapy:
If, however, your triglycerides remain high despite statin therapy, your doctor may consider adding niacin to bring them into the normal range.
6. High Triglycerides Due to an Underlying Disorder:
High triglycerides may be caused by other disorders, such as type 2 diabetes, alcoholism, hypothyroidism, Cushing’s syndrome, liver disease, uremia, dysglobulinemia, or nephrotic syndrome.
Once the underlying disorder is identified and treated, triglyceride levels often decrease. Because heavy drinking can cause hypertriglyceridemia, you will be asked by your doctor about your drinking paterns, and suggested - if needed - to cut back or eliminate alcohol before exploring other treatment options.
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Suggested Medications for Treating Hypertriglyceridemia* |
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| Over 500 |
Fibrate
If unsuccessful, add niacin, fish oil, or statin |
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| 200-500 and patient has familial combined hyperlipidemia |
Niacin If unsuccessful, add statin or fibrate |
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| 200-500 and patient has familial hypertriglyceridemia | Fibrate | |
| 200-500 with normal LDL |
Niacin or fibrate If unsuccessful, add fish oil |
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| 150-200 with normal LDL |
If at low cardiovascular risk:
no drug therapy If at high risk: niacin or fibrate |
|
| 150-500 with elevated LDL |
Statin
If unsuccessful, add niacin. If still unsuccessful, refer to a specialist |
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| 150-500 with low HDL | Fibrate or niacin | |
* Courtesy of Michael Schloss, MD, Associate Professor of Medicine, New York University Medical School
Health Problems Associated With Statins
There are numerous health conditions related to therapy with statin drugs.
Congestive Heart Failure
The decrease in CoQ 10 blood levels caused by statin therapy diminishes the energy output of heart muscle cells leading to congestive heart failure. A mysterious rise in the incidence of heart failure has been noted in the U.S. in recent years which may well relate to the continually increasing use of statin drugs.
Increased Muscle Weakness
Weakness of muscles when taking statin drugs probably relates to decreased muscle cell energy production caused by diminished levels of CoO Q 10.
When severe this muscle weakness may progress to a state where muscle soreness and pain appears. In this state the muscle cells break up releasing muscle protein and enzymes into the blood. If the muscle damage is extensive kidney failure (myoglobulinuria) and severe acidosis due to lactic acid production may occur (often a fatal problem).
Hyperinsulinemia
Rise in fasting insulin values by 13 percent is seen after statin therapy is started. This is undesirable because high levels of insulin increase the construction of arteriosclerotic plaques over time.
Also high insulin values accelerate the rate of development of both diabetes and aging.
Decreased Levels of Antioxidants
Antioxidant blood levels decrease Alpha Tocopherol and Beta Carotene levels in the blood fall by up to 22 percent in patients taking statin drugs.
Decreasing one's anti-oxidant stores in the blood is obviously undesirable as this means that our ability to remove free radicals will be impaired.
Greater Incidence of Peripheral Neuritis
The cause for peripheral neuritis is often obscure. The incidence of peripheral neuritis is 15 times greater in persons taking statin drugs than in control subjects. This could also relate to deficiency of CoQ 10.
Transient Global Amnesia (TGA)
This neurologic disorder causes patients to have a total loss of memory for several hours. During these episodes the person does not know who he or she is, does not know what they are doing and often has a complete loss of memory about their past history.
Recently it has been discovered that many persons taking statin drugs have experienced TGA and that there are thousands of persons with memory dysfunction, extreme forgetfulness, incapacitating confusion and profound disorientation for every person who has an episode of TGA.
The relationship of these memory problems to usage of statin drugs is nearly completely unknown in the medical community. Stopping the statin drug leads to recovery which may take several months.
Abnormal Liver Function
Abnormal results of liver function tests are common in persons taking statin drugs. Severe abnormalities are uncommon and the abnormal liver function disappears when statin therapy is stopped.
Increased Risk of Gallstones
Cholesterol-lowering drugs actually increase the amount of cholesterol secreted in bile. This in turn can increase the risk of gallstones.
Increased Risk of Stroke
Stroke risk goes up when cholesterol values are lowered below 140 mg. Dr. Gilbert Gordon suggests keeping cholesterol values near 220 mg. to preserve the natural antioxidant benefits of cholesterol for the body (Dr. Garry Gordon Chelation Discussion Group Feb 11, 2004 How low for cholesterol?).
Increase in Depths from Suicide and Cancer
A large population study of cholesterol levels in patients taking statin drugs revealed a decrease in deaths from heart disease but this occurred at the expense of an equivalent increase in deaths from suicide and cancer. Lowering cholesterol decreases the number of receptors for serotonin on brain cell membranes. Serotonin acts to suppress aggressive behavior so lowered serotonin levels could lead to increased violence and suicide.
Increase Risk of Cancer and Lymphoma
Possibly of greater importance several early studies of the results of statin therapy suggested that there might be an increased risk of developing cancers and lymphomas in persons taking statin drugs.
These studies were ignored and aggressive marketing of statins began. Such adverse results could easily take more than 10 years of statin usage to become manifest and the rapidly increasing rates of cancer might tend to obscure cancers being caused by statin therapy.
Certainly some of this increase in cancer incidence could be due to the rapidly increasing statin drug usage. Knowing that CoQ 10 is a fine therapy for cancer suggests that lowering the levels of CoQ 10 with statin drugs might increase the risk of cancer.
Lopid and Liver Impairment
As an antihyperlipoproteinemic drug that lowers triglycerides (and cholesterol) by decreasing VLDL, LDL, and increasing HDL, Lopid also:
There is no question that it does some very good things.
However, Lopid is also known to
- tax the liver and
- increase the liver enzyme production.
Our liver is our major detoxifying organ. People that live long are good detoxifiers while people that die early are poor ones.
This is directly related to our genetic ability to detoxify through standard liver enzyme pathways.
Unfortunately, Lopid, in its regular and ordinary pharmacologic course, causes an overproduction of liver enzymes. (There are 50 to 100 delicate liver enzyme systems involved in the cytochrome P450 liver phase I and phase II glutathione-S-Transferase).
As Ronald B. Keys, JD, PhD put it, by choosing liver-toxic Lopid, you overtax and burden these systems compromising the long-range liver capacity and function – and, consequently, shorten your life.
It is not just whether the liver enzymes are elevated from the toxic aspects of Lopid, but whether its long-term use is destroying the functional reserve of the liver at the same time.
In other words, you could have normal liver enzymes - yet have impaired hepatic function reserve from the long-term use of this toxic medication.
Lopid then is an ideal medication for those who want to live in physician’s office everyday instead of going to work and/or managing family.
Like numerous other toxic drugs, it creates a co-dependency relationship on your doctor.
Statins vs. Fibrates
Although less well studied than statins, fibrates have demonstrated similar cardiovascular benefits especially in people with high triglycerides and low HDL-"good" cholesterol values.
However, there are not any large-scale, randomized, controlled trials comparing both drugs alone or in combination.
But a combination therapy - with either statin-fibrate or statin-niacin - can be considered in people with:
- insulin resistance
- diabetes
- progressive atherosclerosis and
- a mixed hyperlipidemia.
When undergoing a combination therapy, these patients should be monitored closely (Parkhurst Exchange # 34:2003-04).
Statins vs. Other Drugs
In fairness, compared to many drugs, most of the statin drugs are some of the safer drugs you might take and actually have the beneficial effects of being powerful antioxidant and anti-inflammatory agents.
These beneficial features are likely the reason studies show decreased cardiac deaths when they are used.
Nevertheless, the statin drugs' potential side effects are significant. In some they deplete coenzyme Q 10 within the liver enough to cause liver enzyme elevations and within the muscles to cause myopathy (see below).
Also, in many physicians' experiences, statins cause depression or loss of motivation in the majority of patients, probably due to alteration of cholesterol metabolism in the brain.
As a result, many of these patients are also on SSRI (selective serotonin reuptake inhibitor) drugs, such as Zoloft, Paxil, or Prosac.
Statins and Coenzyme Q10 (CoQ10)
A study in the Archives of Neurology published unsettling new information: "Atorvastatin decreases the Coenzyme Q10 level in the blood of patients at risk for cardiovascular disease and stroke" (Arch Neurol, Jun 2004; 61: 889 - 89).
Atorvastatin is the chemical name for Lipitor ®, the world’s best selling cholesterol-lowering prescription drug.
This new study, however, is simply confirmation of what scientists have known for some time: “miracle” but potentially harmful statin drugs may lower levels of Coenzyme Q10 (CoQ10) - a superior antioxidant, essential for the production of energy in every cell of the body.
Isn’t it a little ironic? Millions of heart patients are taking a drug that depletes CoQ10 which - through many years of research - has been shown to be effective in protecting the cardiovascular system and helping to prevent heart disease.
Meanwhile, the United Kingdom has decided to reclassify Zocor (another best selling statin drug) as over-the-counter (OTC), in spite of the fact that Zocor may cause muscle pain or weakness, as well as liver problems (according to the Zocor website).
PLEASE NOTE: If you are on statins, taking 100 mg of CoQ10 daily will help you replenish depleted CoQ10 stores as you work with your doctor in weaning yourself off these drugs.
Coenzyme Q10 is one of the most valuable investments you can make for your heart - and one of the most important nutrients you can take for your health. In fact, if you can only take one or two supplements a day - CoQ10 should absolutely be one of them!
Nuclear Magnetic Resonance (NMR)
Lipid measurement may show normal total cholesterol, with a low HDL-“good” cholesterol and a moderately elevated triglyceride level; for example, total cholesterol of 197 mg/dL, an LDL-“bad” of 120 mg/dL, an HDL of 35 mg/dL, and a triglyceride of 210 mg/dL. That pattern is not unusual; in fact, it is seen in about 20 percent to 30 percent of people who have had a myocardial infarction (heart attack).
However, an important issue is how to best manage these people.
In those cases, doctors may now use a new commercially available test. This procedure uses nuclear magnetic resonance (NMR) spectroscopy to fractionate VLDL, LDL, and HDL concentrations into 15 different subfractions. It is completely automated and takes only about one minute to perform, since it measures all subfractions simultaneously.
For example, two people may have similar lipid levels, but if NMR spectroscopy shows that one has a much higher proportion of small, dense lipoprotein particles, that might tip the balance toward treatment, especially if there is a family history of cardiovascular artery disease (CAD) or other risk factors.
"TriCor Produced Side Effects So Badly...
Our customers write to us:
-
Wednesday, April 26, 2003:
Thanks! I have been trying to reduce my triglycerides for several years now. I was placed on (...) Tricor which produced side effects so badly that I could not take it.
I started taking your Triglyceride Reduction Formula and following the Diet just under two months ago.
My doctor just called and gave me my lab results. My triglycerides fell from 432 to 170, my HDL went from 30 to 48 and all the other results were normal which hasn't happened in years.
Needless to say, I just ordered another 2 months' supply of your Triglyceride Reduction Formula.
It really works!
-
Thanks again,
Gene
* The testimonial above has been presented as a true story. However, it has not been reviewed and is the sole opinion of the listed individual.
Hypertriglyceridemia: Drugs That Cause High Triglycerides
Among many, common and uncommon causes of high blood triglycerides there are also doctor prescribed medications for patients undergoing medical therapies, such as:
The Drug-Treatment Vicious Cycle
Physicians that have only been trained in pharmaceutical medicine keep prescribing toxic medications and neglect, fail, and often refuse to consider non-pharmaceutical methods to lower blood lipids through other, non-pharmaceutical means.
Prescribing drugs like Lopid is legal and within standard clinical practice guidelines. However, it is a horrible abomination to treat one problem and create a dozen other problems. The patient ends up in a vicious cycle of taking one drug to chase after the effects of another drug. Doctors call this problem an “adverse drug reaction” and the condition, “polypharmacy.”
Therefore, starting with lipid-lowering medications puts you - as Ronald B. Keys, JD, PhD put it - on the drug-treatment-merry-go-round nightmare.
In fairness, many physicians, legally, may be under a gag rule and be unable to tell you about non-pharmaceutical options and alternative treatments to lower triglycerides because of "managed care requirements" such as Health Maintenance Organization (HMO) - a health plan involved in delivery of health care.
These requirements have made the whole managed care set up controversial and destructive of the time-honored physician-patient relationship, detrimental to the short-term and long-term interests of the patient. Oftentimes, it is the system rather than the physician that is the problem.
Nevertheless, there are dozens of ways to lower triglycerides and other lipids without using drugs - potential poisons. These safer and much more beneficial methods applying a risk/benefit analysis include such simple things like
- diet
- nutritional supplementation, and
- biobehavioral modification, interconnected with the psychosocial, behavioral, and biological processes.
These non-drugs methods, however, usually require the person to be intimately involved with his or her own treatment and life. Unfortunately, most people choose to take their body to the doctor and say, "Here's my broken body. You fix it. Give me a magic pill."
This is ideal - but only for those who wish to have - besides a likely shorter life span - a co-dependency relationship and live in their physician’s office everyday.
Nutrition Vs. Medical Establishments
Compared to the standard medical treatment, the nutritional supplementation for high blood triglycerides and other lipids is clearly a superior option. |
Anecdotal and empirical experience regarding the nutritional approach to blood lipids has existed for almost 20 years. While reasonable people do not expect 100 per cent success for any therapy, hundreds of them can say that they have experienced a remarkable improvement with this approach.
Isn't that why we have science, to investigate methods such as nutritional control of high triglycerides? It is beyond comprehension that scientific medical studies neither refute nor support the nutritional approach.
There are no established medical research processes or procedures to evaluate "non-drug" remedies, and for a reason. There is still little medical evidence that vital substances (nutrients) required for life in small amounts can have great healing effects in larger amounts.
To understand why the nutritional approach to blood fats has not been investigated, you need to realize that there is no special interest or economic incentive to provide proof, only a large counter-incentive not to do so by those with the means to run such a study.
In other words, the only incentive is a general, rather than a special interest. So, if governments won't conduct a study on behalf of their people to verify inexpensive methods already available, who will, especially if it would cost a company millions? And why bother?
Should nutritional triglyceride reduction not work, it has been shown to be harmless. Furthermore, a large study isn't going to do the average person much good.
The only way to find out whether nutritional triglyceride reduction can work for you is for you to try it. Then you can find out what others learned years ago: Triglyceride Reduction Formula can control the level of blood fats, such as triglycerides, and reduce risk for heart attack or stroke safely.
Unfortunately, no effort what-so-ever has been made by the medical scientific establishment to investigate, much less verify, this approach.
It's time for medical establishments to place the patient foremost and to understand that doing "no harm" should be the only treatment. |
It's time then for true studies to be done on outcomes of the patient. The medical gold standard of research - the double blind, placebo controlled, crossover study - was great -- but only for infectious diseases. As it is impossible to hold all variables the same, this standard has become outmoded for today's outcome studies; it should go the way of the monetary gold standard.
Observational Evidence Vs. Formal Evidence
We recommend nutritional measures aimed at controlling elevated blood triglycerides. And we do so on the basis of evidence gained from observations in hundreds of users of our Triglyceride Reduction Formula supported by basic dietary and lifestyle modifications.
But not everybody agrees that this kind of evidence is enough to act upon. Until formal proof is established, this matter remains a legitimate question of judgment, which varies from one person to another.
However, the only way to obtain scientifically acceptable proof of the association between nutritional means and blood triglycerides would be to
- take a large number of persons from the same population,
- put half of them on a triglyceride reduction formula and a diet, and
- see if that half has lower triglyceride levels than the rest.
Such critical test should be performed in a three-to-five-year, $75-million study conducted, for example, by the American Heart Association. The conclusive evidence would be published as a formal proof of the role played by optimum nutrition in the process of controlling blood triglycerides.
Unfortunately, such a multi-million study has not been run yet.
Should we wait then for "conclusive" evidence, which may be years away and - too late for some of us? Can we accept probable evidence?
We need to realize that not taking a stand, insisting on waiting until all the evidence is in, is itself - a position and a recommendation! Not taking a stand is not really the neutral position it is made out to be.
On the other hand, physicians like to pretend, and many have kidded themselves into believing, that whatever they espouse has been "scientifically proved."
Nonsense!
A great deal of what established medicine recommends today with good conscience is not formally "proved"! In other words, in medicine it is not uncommon to recommend measures for which only substantial evidence exists.
Example No. 1:
Many doctors have for years been recommending the lowering of blood cholesterol because this would probably help prevent coronary heart disease, but this was not "proved" until 1984, and then for only a selected category of patient.
And only in early 1985 did a panel of 13 experts convened as part of a National Institutes of Health "consensus conference" conclude "beyond a reasonable doubt" that lowering elevated blood cholesterol levels would reduce the risk of heart attacks.
In fact, "beyond a reasonable doubt" means "with a high order of probability." Surely this is not formal proof. It's a consensus decision.
Example No. 2:
The formal proof on the health benefits of exercise is not yet in, yet practically all physicians recommend it. And they are right to do so, because the probable evidence is excellent.
The key question for much good nutritional advice is not whether proof is at hand, but what is the order of probability that the advice is correct.
Existing evidence indicates, with a very high order of probability, that elevated levels of triglycerides in the blood can be reduced by the nutritional measures - without multiple prescription drugs.
Are You Stressed, Depressed?
Prolonged stress is one of the main causes of elevated blood triglycerides. A new study has found the evidence that psychological, mental stress causes triglycerides to stay in the bloodstream longer contributing to cardiovascular health problems (Psychophysiology, 2002: 39; 80-85).
The stress factor, however, has been repeatedly underestimated with regards to elevated blood lipids (fats) both by doctors and their patients.
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Read more... |
"Doctors Aren't Doctors Anymore..."
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"Friday, April 25, 2003
I have high triglycerides and all the doctors told me was to lose weight or change my diet, not giving me a bit of information like you have on your website.
Doctors aren't doctors anymore, they don't explain or even give us pamphlets. That is very irritating. It's my life they are playing with!
Thank you for your time and consideration.
Martha M., Covington, KY"
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© 2001-2010 Reduce Triglycerides.com: Lowering High Triglycerides Naturally. Triglyceride Reduction TGs Formula - A Drug-Free Approach to Elevated Blood Triglycerides. All rights reserved worldwide. This document may not be copied in part or full without express written permission from the publisher. The information on high triglycerides and nutrition provided herein is a general overview on this topic and may not apply to everyone, therefore, it should not be used for diagnosis or treatment of any medical condition. While reasonable effort has been made to ensure the accuracy of the information on reducing elevated triglycerides, Full of Health, Inc. assumes no responsibility for errors or omissions, or for damages resulting from use of the high triglyceride information herein.