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LE Magazine August 2007

Do Your Really Need Maximum-Dose Lipitor®?

By Jay S. Cohen, MD (Introduction by William Faloon)

Questions and Answers: What should I do if I am taking Lipitor®?

If you are doing well on Lipitor®, you don’t have to change anything. If Lipitor® has helped you reach your cholesterol goals, and it is not causing any side effects, you are getting a good result.

Table 3. Current Medical Guidelines for Low-Density Lipoprotein (LDL) Levels

Just how low you should seek to decrease your LDL level depends on your state of health and your current cardiovascular risk factors. Those at higher risk should strive to achieve lower LDL levels than those who have no risk factors for cardiovascular disease.

HIGH RISK

People with a history of heart attack, coronary artery disease, angina,
abdominal aortic aneurysm, stroke, or diabetes.

LDL Goal: below 100 mg/dL for high risk patients, and at or below 70 mg/dL for very high risk situations, such as immediately after a heart attack or a procedure for unstable angina.

WHEN TO CONSIDER DRUG THERAPY: If your LDL is 130 mg/dL or above (or for people with very high risk, 100 mg/dL or above; nutritional interventions should be employed, too.)

MODERATE RISK

People who do not have heart disease or diabetes, but have multiple other risk factors (e.g., low HDL; male over 44 or female over 54; high blood pressure; cigarette smoking; premature coronary artery disease, heart attack, or stroke in a parent or sibling).

LDL Goal: 130 mg/dL or lower

WHEN TO CONSIDER DRUG THERAPY: LDL 160 mg/dL or above (nutrition and lifestyle
interventions should be tried first)

LOW RISK

People with 0 or 1 risk factors.

LDL Goal: 160 mg/dL or lower

WHEN TO CONSIDER DRUG THERAPY: LDL 190 mg/dL or above (nutrition and lifestyle
interventions should be tried first)

LIFE EXTENSION GUIDELINES: ALL RISK CATEGORIES

LDL Goal: below 100 mg/dL

WHEN TO CONSIDER DRUG THERAPY: LDL of 100 mg/dL or above. Nutritional and lifestyle interventions should be tried first, then natural cholesterol-lowering agents. Statins may sometimes be necessary; lower, safer doses should be considered to start.

Lipitor® and other statins are important drugs that help millions of people. I support the use of statin drugs when they are used appropriately. Even maximum-dose Lipitor® has its uses, but it should be reserved for people who have a very high risk of cardiovascular disease or who do not obtain adequate LDL reduction with lower statin doses.

What should I do if I am experiencing side effects with Lipitor®?

Tell your doctor and ask about reducing the dose. This often solves the problem. If your side effects involve serious muscle or abdominal pain, call your doctor right away.

It is very important for doctors to handle statin side effects quickly and effectively. Side effects are a main reason that so millions of people discontinue statin treatment. The fact that this occurs is a failure of the medical system. When statins are used carefully, starting with lower, safer doses, fewer side effects occur and more people stay in treatment. If a lower dose is not strong enough, it can then be increased.

My doctor wants to switch me to another statin. Is that okay?

When side effects occur, the choice is either to reduce the dose of the current statin or to switch to another. Either approach is fine, but if you are switched, make sure your doctor prescribes a lower, milder dose of the new statin. For example, if your doctor is switching you from maximum-dose 80-mg Lipitor® to Zocor®, make sure that he drops the Zocor® dose down, perhaps to 40 or 20 mg. Or he can switch you to another statin such as Pravachol® or Mevacor®. High-potency statins such as Lipitor® and Zocor® are not needed by everyone with elevated cholesterol. Many people get good results with milder statins, which have a lower risk of side effects.

I am doing well on Lipitor®, but it is very expensive. What do you think of switching to a generic?

Cost is an important consideration in choosing a statin medication. Today, three statin drugs are available as generics: lovastatin, pravastatin, and simvastatin. Simvastatin is the closest of the three to Lipitor® in its cholesterol-lowering potency.

Be sure to shop around, because prices of generic statins vary widely from pharmacy to pharmacy. Significant savings can be achieved using generic pharmaceuticals, particularly when purchased from the Life Extension Pharmacy (see Table 2).

My total cholesterol is 160 mg/dL and my LDL is 110 mg/dL. Because I have coronary artery disease, my doctor says I should be on a statin. Do you agree?

The current guidelines for LDL goals are most stringent for people at high risk. These include people with a history of heart attack, angina, coronary artery disease, or diabetes. The current goal for high-risk people is a LDL below 100 mg/dL, and in some cases below 70 mg/dL. Because your LDL is only 110, you may be able to accomplish this with a low-dose statin. Indeed, you may not need a statin at all if you adopt a heart-healthy nutritional program as well soluble fiber, fish oil, CoQ10, plant phytosterols/ stanols, small amounts of red wine (1-2 glasses daily), regular exercise, and stopping smoking.

My total cholesterol is 180 mg/dL and my LDL is 120 mg/dL. I am completely healthy and have no family history of heart disease or stroke. My doctor says I need to take a statin to lower my LDL. Do you agree?

Current guidelines state that for people at low risk, cholesterol below 200 mg/dL and LDL lower than 160 mg/dL is fine. A LDL of 160 mg/dL or above should be lowered, but treatment should start with nutritional and lifestyle changes rather than with prescription drugs. Natural therapies can also be very helpful in reducing a moderately elevated LDL.

Life Extension believes that most people should seek to keep LDL below 100 mg/dL. In the case presented above, however, the total cholesterol is already low, so attempts to reduce the LDL lower could also reduce the total cholesterol too much (below 150 mg/dL). A LDL of 120 mg/dL may be acceptable, yet anyone with a LDL reading near 160 mg/dL or above should seek to reduce it with natural approaches, and if necessary, a standard-dose statin.

Life Extension recommends obtaining a VAP® (vertical auto profile) cholesterol analysis to assess LDL particle size, lipoprotein(a) levels, and other factors that indicate atherogenic potential. It is also critical to address other cardiovascular risk factors besides cholesterol, such as triglycerides, homocysteine, fibrinogen, CRP, elevated fasting plasma glucose, obesity, and hypertension—ALL of which are important risk factors for heart attack and stroke.

My doctor seems to want to reduce every patient’s LDL to 70 mg/dL. Is this a good idea?

Although there is evidence that aggressive LDL reduction is helpful for people with heart disease, current guidelines do not support the aggressive treatment of healthy people. The push for stronger and stronger statins for everyone stems from intensive marketing campaigns, as seen with the maximum-dose Lipitor® onslaught.

This has led to a great deal of confusion among doctors and patients. Many people are put on statins although they do not really need them. Others receive far stronger statins than they need and become overmedicated. To avoid these problems, you should ask your doctor some questions if he or she recommends a statin for you. Why do you think I need a statin? What is my LDL goal? I would prefer to start with a milder statin dose in order to avoid side effects—what do you think? What about trying nutritional approaches for reducing LDL first? Is my HDL okay?

My cholesterol numbers are good, except that I have a low HDL. Should I be concerned?

Some experts believe that the most important cholesterol test is neither your total cholesterol nor your LDL, but instead your level of HDL, the beneficial blood lipid. Studies suggest that in women, a low HDL is a more worrisome risk factor than a high LDL.

Dr. Davis states, “High cholesterol is among the risk factors for heart disease, but is not the leading risk factor. The most prevalent risk factor is low HDL, along with small LDL particles, which commonly occur together. In fact, of every 100 people with coronary heart disease, 60-70 will have low HDL and small LDL particles, but fewer than 30 will have high LDL. Why do we not hear more about low HDL and small LDL particles? Because treating these is not as profitable for drug companies.”9

My doctor says that LDL is only one of several risk factors that should be considered before prescribing anything. Do you agree?

Your doctor is one of many who now recognize that LDL is only one of several important risk factors for heart disease. In recent years, an elevated C-reactive protein level has been identified as a sign of arterial inflammation. Elevated fibrinogen can lead to sticky platelets and an increased risk of heart attacks, especially in women. Triglycerides are waxy substances that increase your risk; if elevated, control of carbohydrate intake is required. As mentioned previously, the VAP® test can identify your level of small particle LDL, which defines whether your LDL is dangerous or not. The VAP® will also determine your level of lipoprotein(a), which some experts consider as important a cardiovascular risk factor as elevated LDL.

Table 4. High-Density Lipoprotein (HDL) Levels
HDL carries cholesterol away from the arteries and to the liver for elimination. This helps keep cholesterol from building up in walls of arteries. Higher levels of HDL confer greater cardiovascular protection.
HDL LEVEL Less than 40 mg/dL 40 to 59 mg/dL 60 mg/dL and above	EFFECT Increased risk of heart disease Some benefit Protective against heart disease
A low HDL is defined as a level below 40 mg/dL in men and below 45 mg/dL in women, but levels above 50 mg/dL are preferred. A HDL of 60 mg/dL or higher reduces the risk of cardiovascular disease. Statins are not particularly effective at raising HDL. In contrast, niacin not only reduces LDL, but also can raise HDL substantially. Mainstream doctors usually recommend prescription Niaspan®, which is expensive and can cause side effects. Instead, you might first try plain niacin. Taking niacin with food and a baby aspirin (81 mg) seem to reduce the unpleasant “niacin flush”. Best results are usually obtained by working with an experienced integrative practitioner. The goal is to raise the HDL level to 60 mg/dL or higher. Olive oil, raw nuts, omega-3 fatty acids, a daily glass of red wine, and exercise can all help boost artery-protecting HDL.

Tests for these factors should be performed on people with cardiovascular disease or at high risk of developing it. Testing should also be done on anyone interested in knowing about possible risks for cardiovascular disease.

I often encounter side effects with medications. How can I avoid side effects with a statin?

Most statin side effects are dose-related. The higher the dose, the greater the risk. This was seen in both the TNT heart study and the stroke study, in which maximum-dose Lipitor® caused more side effects, more liver injuries, and more deaths from non-cardiovascular causes. Maximum-dose Lipitor® also caused more people to discontinue treatment. This is a huge problem in medical care today: side effects are one of the reasons that millions of people quit statin treatment each year.

If you want to avoid side effects, ask your doctor about starting with a low dose. You should also ask about starting with a moderate-potency statin, such as pravastatin, instead of a high-potency statin.

Studies show that some people obtain excellent responses to small doses of statins and do not need a higher dose. For example, in a study using just 2.5 mg of Zocor®, 18 people obtained LDL reductions of 40% or greater.15 This was an unexpected yet excellent result.

If a low statin dose does not reduce your LDL adequately, your doctor can gradually increase the dose until you reach your LDL goal. This “start low, go slow” method is recommended by the FDA, especially for older people starting a statin.16 A “start low” approach works anyone who wants to emphasize safety with statin drugs.

Cardiologists have reported that their patients who concomitantly use coenzyme Q10 with statin drugs seem to suffer fewer drug side effects such as muscle aches and pains. This observation is supported by a recent study that found that 30 days of treatment with coenzyme Q10 decreased muscle pain related to statin medications by a dramatic 40%.17

I do not like taking medications. Are there natural alternatives that reduce LDL?

Start with nutrition. A heart-healthy diet (reduced saturated fat and simple sugar intake) can lower cholesterol levels as much as a moderate-strength statin.

Supplements for reducing LDL include red yeast rice (do not use with a statin), niacin (which lowers LDL and raises beneficial HDL), and plant sterols (which block cholesterol absorption from the intestine).

Other supplements to consider for heart health are magnesium and coenzyme Q10. Regular consumption of wild salmon or sardines, or daily fish oil capsules, can reduce the risk of death from a heart attack as much as a statin drug.18

If you are interested in using non-drug therapies, work with a health care professional who is knowledgeable about natural approaches and products.

I have heart disease, and my doctor wants to prescribe maximum-dose Lipitor®. What alternatives do I have?

As Dr. Pitt suggested in his editorial against maximum-dose Lipitor®, substantial LDL reduction can be accomplished with a moderate dose of a statin combined with other therapies. These include Zetia® (ezetimibe) and Welchol® (colesevelam), which block cholesterol absorption in the intestine, and a similar effect can be obtained with natural plant sterols. Or ask your doctor about combining modest doses of a statin and a niacin product.

Many people think statins provide 100% protection against heart attacks, but the effect is about 30%. In other words, if 100 people likely to have a heart attack are placed on statins, about thirty will avoid the heart attack. Seventy will not. No treatment, natural or prescription, provides full protection against heart disease. This is why people need to use all of the therapies—nutritional, natural and, if necessary, medications—to reduce their risk as much as possible. Your treatment should be individualized. Treatment may differ from person to person because different people have different risks and goals, and thus need different therapies. Shotgun, one-size-fits-all therapies should be avoided. If your doctor insists that maximum-dose Lipitor® is the only solution, get a second opinion.

Jay S. Cohen, MD, is an associate professor of family and preventive medicine and psychiatry at the University of California, San Diego. Dr. Cohen is a nationally recognized expert on medications and their side effects. He has published books and medical journal articles and has spoken at major conferences and at the US Food and Drug Administration regarding the need for improved drug safety. Dr. Cohen also provides expert analyses and opinions in cases involving medication-induced injuries. His most recent book, What You Must Know About Statin Drugs and Their Natural Alternatives (Square One Publishers, 2006) explains who needs to reduce cholesterol or other risk factors for heart disease, and how they can do so safely. For more information, visit Dr. Cohen’s website at www.MedicationSense.com.

Coenzyme Q10 and Statin Drugs

In an effort to prevent the progression of dangerous atherosclerosis, millions of Americans now take cholesterol-lowering statin drugs daily. These drugs dramatically lower harmful cholesterol and LDL, and some even raise levels of beneficial high-density lipoprotein (HDL). But these drugs are not without risk. Potentially serious side effects, including liver damage, chronic muscle pain, muscle wasting, and even death have been associated with their use.7,8

In 2001, Bayer announced the withdrawal from the market of its statin drug, Baycol®. This withdrawal of a potential blockbuster drug, which was conducted with the FDA’s support, was prompted by the deaths of 31 people due to rhabdomyolysis, a severe form of muscle damage. The deaths were attributed to Baycol® use. Although Baycol® is no longer available, rhabdomyolysis is a potential side effect, albeit rare, of statin drugs.19

While statin medications effectively lower cholesterol and LDL levels, they also can induce a coenzyme Q10 deficiency. Although the conventional medical establishment has been painfully slow to embrace this association, the scientific literature supports this conclusion.20-24 For many years, Life Extension has alerted the public to the need for supplementation with coenzyme Q10 when taking statins, to prevent depletion of this important antioxidant/mitochondrial cofactor. CoQ10 is involved in the production of ATP, the basic unit of energy used to power cellular functions throughout the body. For years, manufacturers have remained inexplicably silent on this issue, despite the fact that the first manufacturer of a statin drug filed a patent for a co-formulation of their statin with CoQ10.

“The depletion of the essential nutrient CoQ10 by the increasingly popular cholesterol lowering drugs…(statins), has grown from a level of concern to one of alarm,” wrote scientists in the British medical journal, Biofactors. “With ever higher statin potencies and dosages, and with a steadily shrinking target [LDL], the prevalence and severity of CoQ10 deficiency is increasing noticeably.”25 More recently, the same team wrote: “We conclude that statin-related side effects, including statin cardiomyopathy, are far more common than previously published.”26

—Dale Kiefer

References

1. LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005 Apr 4;352(14):1425‑35.

2. Pitt B. Low‑density lipoprotein cholesterol in patients with stable coronary heart disease—is it time to shift our goals? N Engl J Med. 2005 Apr 7;352(14):1483‑4.

3. Amarenco P, Bogousslavasky J, Callahan A, et al. High‑dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006 Aug 10;355(6):549‑59.

4. American Heart Association. Heart disease and stroke statistics—2005 update. Dallas, Texas: American Heart Association 2005.

5. Available at: www.escardio.org/bodies/associations/EACPR/slides/EuroPrevent0. Accessed March 14, 2007.

6. Kent DM. Stroke—an equal opportunity for the initiation of statin therapy. N Engl J Med. 2006 Aug 10;355(6):613-5.

7. Anfossi G, Massucco P, Bonomo K, Trovati M. Prescription of statins to dyslipidemic patients affected by liver diseases: a subtle balance between risks and benefits. Nutr Metab Cardiovasc Dis. 2004 Aug;14(4):215-24.

8. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol. 2006 Apr 17;97(8A):52C-60C.

9. Davis W. Cholesterol and Statin Drugs: separating hype from reality. Life Extension. 2005 Mar;11(3):114-24.

10. Cohen JS. Risks of troglitazone apparent before approval in USA. Diabetologia. 2006 Jun;49(6):1454-5.

11. Physicians’ Desk Reference, 52nd and 54th Editions. Montvale, N.J.: Medical Economics Company, 1998 and 2000.

12. Cohen JS. Statin therapy after stroke or transient ischemic attack. N Engl J Med. 2006 Nov 30;355(22):2368.

13. Available at: www.bloomberg.com/apps/news?pid=20601086&sid=aU0FKY3RaHIM&refer=news. Accessed August 26, 2006.

14. Available at: www.boston.com. Accessed March 8, 2007.

15. Tuomilehto J, Guimaraes AC, Kettner H, et al. Dose‑response of simvastatin in primary hypercholesterolemia. J Cardiovasc Pharmacol. 1994 Dec;24(6):941‑9.

16. Williams RD. Medications and older adults. FDA Consumer magazine. Sept.-Oct. 1997.

17. Caso G, Kelly P, McNurlan MA, Lawson WE. Effect of coenzyme Q10 on myopathic symptoms in patients treated with statins. Am J Cardiol. 2007 May15;99(101):1409-12.

18. Studer M, Briel M, Leimenstoll B, Glass TR, Bucher HC. Effect of different antilipidemic agents and diet on mortality, a systematic review. Arch Intern Med. 2005 Apr;165(7):725-30.

19. Available at: www.medicinenet.com/script/main/art.asp?articlekey=18196.Accessed May 30, 2007.

20. Farswan M, Rathod SP, Upaganlawar AB, Semwal A. Protective effect of coenzyme Q10 in simvastatin and gemfibrozil induced rhabdomyolysis in rats. Indian J Exp Biol. 2005 Oct;43(10):845-8.

21. Lamperti C, Naini AB, Lucchini V, et al. Muscle coenzyme Q10 level in statin-related myopathy. Arch Neurol. 2005 Nov;62(11):1709-12.

22. Paiva H, Thelen KM, Van CR, et al. High-dose statins and skeletal muscle metabolism in humans: a randomized, controlled trial. Clin Pharmacol Ther. 2005 Jul;78(1):60-8.

23. Mabuchi H, Higashikata T, Kawashiri M, et al. Reduction of serum ubiquinol-10 and ubiquinone-10 levels by atorvastatin in hypercholesterolemic patients. J Atheroscler Thromb. 2005;12(2):111-9.

24. Thomas JE, Lee N, Thompson PD. Statins Provoking MELAS Syndrome. A Case Report. Eur Neurol. 2007 Mar 26;57(4):232-5.

25. Langsjoen PH, Langsjoen AM. The clinical use of HMG CoA-reductase inhibitors and the associated depletion of coenzyme Q10. A review of animal and human publications. Biofactors. 2003;18(1-4):101-11.

26. Langsjoen PH, Langsjoen JO, Langsjoen AM, Lucas LA. Treatment of statin adverse effects with supplemental Coenzyme Q10 and statin drug discontinuation. Biofactors. 2005;25(1-4):147-52.

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The information provided on this site is for informational purposes only and is not intended as a substitute for advice from your physician or other health care professional or any information contained on or in any product label or packaging. You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment. You should consult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem. You should not stop taking any medication without first consulting your physician.