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The Case Against Statins

A pharmaceutical expert argues the cholesterol-fighting drugs are overprescribed, with potentially dangerous side effects

By Dr. Armon B. Neel, Jr.

An estimated 30 million Americans take statins, the most popular class of drugs in the nation. Prescribed primarily to lower LDL ("bad") cholesterol, they include atorvastatin (Lipitor), the bestselling prescription drug in history; pravastatin (Pravachol); rosuvastatin (Crestor); and simvastatin (Zocor). According to the National Center for Health Statistics, 50 percent of all American men age 65 to 74 take statins.

In my view, however, statins are among the most ineffective and dangerous drugs on the market, largely because the doctors who prescribe them haven't done their homework.

(MORE: Get Your Pharmacist on Your Health Team)

Statins lower your LDL levels by interfering with the liver's ability to produce it. (The liver produces about 75 percent of the cholesterol that circulates in our blood; the rest comes from our diet.) If you're taking a statin, your doctor probably placed you in one of two treatment categories — primary prevention or secondary prevention. In the first case, you likely have high cholesterol but no known coronary artery disease; your doctor's assumption is that the statin will help prevent your from developing heart disease or having a heart attack. In the second classification, you've probably received a diagnosis of coronary artery disease and may have even had one or more heart attacks. Your doctor believes the statin will help stave off another cardiac event.

But there are some things your doctor may not have told you about statins:

Statins may not reduce your risk of death. If you've been prescribed a statin because you're in the primary prevention category, like 75 percent of all people who take the drugs, you'd do well to question whether you really need to be taking it, and whether it might be doing more harm than good.

A comprehensive review of previous studies published in 2011 by the Cochrane Collaboration, a well-respected nonprofit research organization, found no "strong evidence" that statins reduce deaths from coronary heart disease among patients of any age who have not suffered a heart attack or other cardiovascular event.

A similar review of studies published in the Archives of Internal Medicine in 2010 found "little evidence that statins reduce the risk of dying from any cause in individuals without heart disease."

Statins can destroy your muscles. When I see an older patient who complains of muscle pain, fatigue and weakness, I know from experience that a statin drug is the most likely culprit. In my judgment, muscle-related adverse effects are much more common than most research suggests because they often go undiagnosed or misdiagnosed.

When you consider that nearly everyone 60 and older has sarcopenia — the gradual, natural loss of muscle mass and strength that comes with aging — it's wise to question the use of any drug that could accelerate the effect.

Statins inhibit cell growth in muscles, so from the time you start taking a statin, your muscle health is compromised — and statin-induced muscle conditions often don't go away when the drug is discontinued. A study of statin-induced myopathies (muscle diseases) published in the journal Muscle & Nerve in 2006 found that "variable persistent symptoms occurred in 68 percent of patients despite cessation of [statin] therapy."

(MORE: What Your Mystery Pains Are Trying to Tell You)

Statins can cause serious cognitive problems. In a study published in 2004 in the American Journal of Medicine, University of Pittsburgh School of Medicine researchers examined 283 patients with high cholesterol treated over a six-month period with statin drugs or a placebo, giving them test of cognitive function before and after the trial. As a group, the patients on statins showed major declines in performance on test measuring attention, memory and overall mental efficiency.

Statins increase your risk of developing Type 2 diabetes. An analysis of statin studies published in the Journal of the American Medical Association in 2011 found that people treated with higher doses of statins were more likely to develop diabetes than those treated with moderate doses. Other studies have reached similar conclusions, and the federal Food and Drug Administration recently ordered manufacturers of statin drugs to add a new safety warning about the increased risks of diabetes to their product information.

If you've had a hemorrhagic stroke, taking a statin drug may increase your risk of having another one. Many patients at risk of hemorrhagic stroke — the type that occurs when a blood vessel in the brain bursts or breaks — are prescribed statins. But a team of researchers from Massachusetts General Hospital and Harvard Medical School reported in the Archives of Neurology in 2011 that the use of statins in such patients actually increased their risk of a second hemorrhagic stroke by up to 22 percent, offsetting any cardiovascular benefits.

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Statins can interfere with your ability to metabolize other drugs. Some of the most widely prescribed statins are metabolized by a liver enzyme known as CYP3A4. So are about half of all prescription drugs. Drugs that interfere with the CYP3A4 pathway — or merely compete within it, as a regular statin dose would — can lead to a wide variety of adverse drug reactions, the buildup of drugs within the liver to toxic levels and the lessening of intended pharmacological effects.

What Doctors Don't Recognize

Doctors often fail to recognize the side effects of statin drugs and prescribe additional drugs to treat those problems, which could be resolved more simply by withdrawing the statins. When I see a patient who has been prescribed ropinirole (Requip) or another drug to treat restless legs syndrome (RLS), for example, I've learned to immediately check to see if there's a statin on board. Nearly always there is.

Other potentially telltale side effects of statins, particularly in older patients, include muscle and joint pain; stomach pain (which I tend to believe results from the degradation of muscles in the stomach and diaphragm); trouble swallowing (also a muscle problem); balance problems; and elevated liver enzymes.

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Doctors too often dismiss the possibility that the statin drugs they've prescribed as a preventive measure could be causing these complaints. A study published in the journal Drug Safety in 2007 looked at 650 cases of adults who had muscle pain, cognitive impairment or other recognized symptoms of statin toxicity. Researchers reported that 87 percent of patients talked with their doctors about whether these symptoms could be related to their statin regimen — with the vast majority of the discussions initiated by the patients, not the doctors. But more often than not, the doctors rejected the notion that statins might be responsible for the symptoms.

A Simpler Solution

When considering if a statin is right for you or a loved one, it's important to keep in mind that older people tend to have higher levels of the essential amino acid homocysteine in their blood, which in itself can elevate one's LDL levels. Instead of trying to address that problem with statins, I recommend using the body's own chemistry to lower homocysteine levels through a combination of nondrug approaches, including changes in diet, like avoiding foods high in saturated fat and consuming more fiber.

Exercise is probably the best way to boost protective HDL ("good") cholesterol levels. Inactive people who take up some form of regular physical activity can expect to see their HDL levels rise by as much as 20 percent.

Vitamin B complex therapy can also be helpful. If you're already taking a statin for slightly elevated cholesterol, talk with your doctor about treating it instead with a combination of sublingual (under-the-tongue) vitamin B12 (1000 micrograms daily), folic acid (800 micrograms daily) and vitamin B6 (200 mg daily). This approach should raise your HDL level and benefit your overall health — without all the baggage that statins bring on board.

These approaches can be so effective that we should view statins as drugs of last resort.

Dr. Armon B. Neel, Jr. is a geriatric pharmacist who has counseled older patients and their caregivers on the safe, effective use of medications for more than 40 years. He maintains the website, MedicationXpert.com, is AARP.org's "Ask the Pharmacist" columnist, and is co-author, with Bill Hogan, of Are Your Prescriptions Killing You?: How to Prevent Dangerous Interactions, Avoid Deadly Side Effects, and Be Healthier with Fewer Drugs (Atria, 2012). Read More
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