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LE Magazine March 2003

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Medications side effects

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Dosage problems with other antidepressants
Doctors follow the guidelines in the drug company-written PDR. The PDR still advises 75 mg initially for Elavil® (amitriptyline), yet 10 mg or 25 mg is frequently enough for mild depressions or pain syndromes. Effexor® is recommended at 75 mg, but 37.5 mg or 50 mg often is enough initially. Zoloft® is recommended at 50 mg, but 25 mg works well for many mild depressions. Serzone is recommended at 100 mg twice-daily, but 50 mg once or twice daily is usually plenty initially.

Similar strategies apply to Paxil®, Wellbutrin®, Celexa®, Norpramin®, Pamelor®, imipramine, doxepin and just about every other antidepressant. "The sales representatives for most antidepressants are now giving out sample packs starting with half-strength doses," Dr. Anthony Weisenberger, a top psychopharmacologist, recently told me. "They lose so many sales because patients get side effects and quit treatment, the drug companies have finally caught on that the dose makes a big difference."

Why is this happening with drug after drug? One reason is that the standard doses of antidepressants are based on studies of major depression-a severe disorder that requires strong treatment. In contrast, the great majority of office patients with depression have mild disorders. Yet, no distinction is made about treating mild and severe disorders in the dosage guidelines of most antidepressants, so doctors prescribe the same doses to everyone.

Drugs for elevated cholesterol and C-reactive protein

The statins-Lipitor®, Zocor®, Pravachol®, Mevacor®, Lescol®-were the best-selling group of drugs in America in 2001. There's no doubt that statins help millions by reducing heart attacks, strokes and overall cardiac mortality. But statins harm thousands, perhaps millions more, often unnecessarily.

Duane Graveline's first dose of Lipitor® caused amnesia "so severe that I landed in the emergency room of a hospital near my Vermont home. I didn't remember any of it." Dr. Graveline, a retired family doctor, flight surgeon and astronaut (www.spacedoc.net), was perplexed. After all, he wasn't usually sensitive to medications, and he'd taken only 10 mg, the lowest dose recommended and marketed by the manufacturer.

Yet, 10 mg of Lipitor® is very strong, much stronger than many people need. It was much stronger than Dr. Graveline needed, because he needed only 2.5 mg of Lipitor®-75% less medication than he got. How do I know? Experts advise doctors to select statin doses based on the reduction in LDL-C (the bad, low density lipoprotein-cholesterol) that each person needs.8 10 mg of Lipitor® reduces LDL-C 39%, a strong response needed by cardiac patients and people with severely elevated cholesterol.

But most people with high cholesterol have mild-to-moderate elevations and no cardiac history, and they require only 20% to 30% reductions in LDL-C. This can be attained with only 2.5 mg or 5 mg of Lipitor®.9-12 Dr. Graveline required a 25% reduction in LDL-C and should have been started at 2.5 mg mg. Yet, there's no information about 2.5 or 5 mg of Lipitor® in the package insert or PDR and no pills in these doses, so doctors start everyone at 10 mg, or even 20 mg or 40 mg.

Excessive statin doses, unnecessary side effects

TABLE 3: THE POTENCY OF DIFFERENT STATIN DRUGS

The initial dose is generally based on the amount of LDL reduction required. However, these numbers are averages, and you may get a larger or smaller response than listed. Statin therapy should always be combined with a heart healthy diet.

Medication
Average LDL Reduction
Lescol® (fluvastatin)
20 mg 22%
40 mg 25%
80 mg 36%

Lipitor® (atorvastatin)
2.5 mg 20-25%
5 mg 27-29%
10 mg 39%
20 mg 43%
40 mg 50%
80 mg 60%

Mevacor® (lovastatin)
10 mg 21%
20 mg 27%
40 mg 32%
80 mg 40%

Pravachol® (pravastatin)
10 mg 22%
20 mg 32%
40 mg 34%

Zocor® (simvastatin)
5 mg 26%
10 mg 30%
20 mg 38%
40 mg 41%
80 mg 47%

Adapted from: Over Dose: The Case Against The Drug Companies. Prescription Drugs, Side Effects, and Your Health. Tarcher/Putnam, New York: October 2001.

Dr. Graveline received 400% more medication than he needed and got a major dose-related side effect because of it. This is a common story. Cognitive and memory problems, sometimes severe and long lasting, occur far more often with statins than doctors recognize. Muscle pain and abdominal discomfort occur frequently. All of these are dose-related.

Liver disorders occur in 1% of patients taking statins. With statins now recommended for 35 million Americans, that's 350,000 people with liver problems, which include liver toxicity and, rarely, death. Dr. W.C. Roberts, the Editor-in-Chief of the American Journal of Cardiology, states, "With each doubling of the dose, the frequency of liver enzyme elevations also doubles."13 Liver enzyme elevations signify liver injury. So if you get 10 mg of Lipitor® when you only need 2.5 mg, your risk of liver injury is also quadrupled.

Lipitor® is the best-selling drug In America. In 2001, patients filled more than 57 million prescriptions for Lipitor®, and sales are skyrocketing. Zocor®, the third best-selling drug, presents the same dose problems as Lipitor®. Zocor's® standard starting dose, 20 mg, reduces LDL-C 38%. Many people need only 10 mg or even 5 mg, which reduce LDL-C 30% and 26%, respectively.7 If the standard doses of such widely advertised, top-selling drugs, are so strong, how can we rely on the standard doses of any drug?

More is not always better with medications. Some people do need strong statins. Often, however, a milder drug that works is preferable to a potent one. "Pravachol® is the statin drug I prescribe most often because it is the weakest of the bunch," Dr. Stephen Sinatra writes. "We don't need to prescribe large doses of these statins to get results."14 People with mild cholesterol elevations usually don't need high potency doses of Lipitor® and Zocor®, but doctors prescribe them anyway even when milder statins-Pravachol®, Mevacor®, Lescol®-would do (Table 3).

Even with the latter drugs, lower doses work for millions of people. A study conducted by the manufacturer of Pravachol® showed that just 10 mg was sufficient for 83% of people with moderate cholesterol elevations.15 Four studies by Mevacor's® manufacturer showed that just 10 mg, with diet counseling, reduced cholesterol satisfactorily in 69% to 75% of subjects. Indeed, the LDL-C of 17% to 26% of subjects dropped below 100 mg/dl, the level sought for people with cardiac disease.16 This isn't surprising; some people get much better LDL-C reductions than the averages in the PDR.

Treating elevated C-reactive protein

Half of all cardiac deaths occur in people with normal cholesterol levels. Something else is going on. New studies suggest that elevated C-reactive protein (CRP), a test for internal inflammation, may be as important an indicator of cardiovascular risk as cholesterol levels, because inflammation in artery walls plays an important role in the development of atherosclerosis.17

Mainstream doctors are already prescribing statins to people with elevated C-reactive protein (CRP) levels, often at doses that are unnecessarily high. Meanwhile, other, safer methods such as omega-3 oils, which are known to reduce inflammation and cardiac risk,18,19 are being overlooked.

Drugs for high blood pressure

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Fifty million Americans have high blood pressure (hypertension), and 90% of us will ultimately develop this potentially deadly disease as we age. Hypertension is a particularly vicious disease, a silent destroyer of blood vessels that causes heart attacks, strokes, kidney disease, peripheral vascular diseases and erectile dysfunctions in men. Much of this is preventable with treatment. Yet half of the people starting treatment for hypertension quit within a year. Most do not last 90 days. Why? Medication side effects.

Wendy reacted to one antihypertensive drug after another. Her side effects were dose-related, usually occurring with the first doses, a sure sign of excessive dosing. Wendy knew her hypertension posed a serious threat because relatives had died prematurely from hypertension-related strokes. Wendy was motivated, but side effects made treatment impossible. "I don't know what I'm going to do," she told me.

Experts acknowledge the problem: "Often, the cure is perceived as being worse than the disease, and when this is the case, the patient is unlikely to remain [in] treatment."20

People get worn down by side effects such as dizziness, weakness, drowsiness, fatigue, diarrhea, muscle cramps and sexual impairments, and give up. Doctors often dismiss so-called "minor" side effects, but minor reactions drive millions from needed treatment-with dire consequences. There's a better solution.

Continued on Page 3 of 6

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