New Statin Recommendations Put Millions ‘at risk’

Journal of the American College of Cardiology.

 

Thirty two million people take statins and an additional thirty three million may be added to that under the new guidelines.

The American College of Cardiologists and American Heart Association (ACC/AHA) are facing increasing questions about who—other  than pharmaceutical companies—will benefit from their new cardiovascular disease prevention guidelines. Earlier guidelines in the US and UK had recommended statin use for anyone with a 20% or greater risk of cardiovascular disease (CVD) over the next 10 years.

These new guidelines slash that threshold to anyone with a 7.5% or greater risk of CVD—affecting more than 30 million Americans who may now be advised to begin taking a prescription statin for the rest of their lives. However, two heart disease experts from Brigham and Women’s Hospital in Boston, Drs Paul Ridker and Nancy Cook, are concerned that as many as half of these people will be given the drug based on an incorrect assessment of their actual risk.

According to their research, the new “risk calculator” included in the updated guidelines is seriously flawed and has “systematically overestimated” cardiovascular risks. In other words, while they do not find fault with treating people with 7.5% risk of CVD, they believe that many people who will be classified as falling into that category are actually at much lower risk of having a heart attack or stroke. They tested the risk calculator using data from three large studies that involved over 100,000 people and ran for over a decade, and they found that the risk calculator overestimated these peoples’ risk of developing CDV over 10 years by a massive 75–150%.

The calculator also appeared to underestimate the risk in a much smaller segment of the population. In a commentary criticizing the new guidelines published this week in the Lancet, Ridker and Cook write, “It is possible that as many as 40 to 50 percent of the 33 million middle-aged Americans targeted by the new guidelines for statin therapy do not actually have risk thresholds exceeding the 7.5 percent level suggested for treatment.” In spite of this evidence, the ACC/AHA stand by their original recommendations. While the “experts” debate in medical conferences and editorials, patients are left to weight the possible benefits and risks of statins on their own.

2013

(Sources: Journal of the American College of Cardiology, 2013; doi:10.1016/j.jacc.2013.11.002. The Lancet, 2013; doi:10.1016/S0140-6736(13)62388-0.)

 


Controversy Over Statins for Older Patients – By JUDITH GRAHAM, The New York Times.

 

Should older adults take statins if they have elevated cholesterol but no evidence of heart disease? It’s a surprisingly controversial question, given the number of seniors taking statins.

Dr. Hosam Kamel, an Arkansas geriatrician who is vice chair of AMDA’s clinical practice committee, said that there is scarce scientific evidence supporting the use of statins by 70- or 80-year-olds without pre-existing cardiovascular disease. Only a handful of studies have focused on outcomes (heart attacks, strokes, premature death) in this older population.

There is evidence of harm linked to statin use in seniors, he added, including muscle aches, liver toxicity and gastrointestinal distress; growing evidence of impaired memory and a heightened risk of diabetes; and some evidence of an increased risk of cancer.

“Our recommendation is that physicians weigh the potential risks and benefits and not automatically prescribe these medications,” Dr. Kamel said. That advice applies only to seniors who haven’t been diagnosed with cardiovascular disease. A significant body of evidence does support the benefits of statins in older adults who have already had a heart attack or stroke.

Seniors who took the medications had fewer heart attack than those who did not, but they didn’t live longer. Yet the absolute risk of these events was small. In the control group, 3.9 percent of seniors suffered heart attacks over the course of three-and-a-half years; that declined to 2.7 percent in the group taking statins. Similarly, 2.8 percent of seniors in the control group suffered strokes, compared with 2.1 percent of statin users.

“I see elderly patients every week who tell me they couldn’t get out of bed, they had terrible diarrhea, they were walking around in a fog after they started taking statins, and when they stopped the medications those feelings went away,” Dr. Redberg said.

According to her summary of the evidence for using statins to prevent heart disease, heart attacks will be prevented in only one or two of every 100 healthy people with high cholesterol who take the medications for up to five years, while one person will develop diabetes. Meanwhile, it is worth noting that “older people are much more vulnerable to the side effects of medications,” she said, and there’s some evidence that “low cholesterol seems to be associated with higher mortality at an older age.”

Experts agree that more high quality evidence is needed about statin use in seniors without existing heart disease.

October 22, 2013 


“Statins for Everyone, and Forget Supplements!” – Alliance for Natural Health.

 

For years, the American Academy of Pediatrics has recommended statins for children as young as 8. Recently, the American Heart Association (AHA) and the American College of Cardiology (ACC) issued new cholesterol guidelines and an online risk calculator that may make 33 million healthy Americans dependent on statins.

That same day, the US Preventive Services Task Force (USPSTF) declared there is “insufficient” evidence that nutritional supplements can help prevent heart disease. Coincidence?

The message from powerful, monopolistic medical organizations is loud and clear: “preventive” heart health should come from an expensive prescription bottle. Unfortunately, the AHA and ACC’s new guidelines are based on a flawed understanding of the role of cholesterol in overall health. They champion the overuse of a damaging (but lucrative) class of drugs.

Even within the conventional medical community, the new guidelines are extremely controversial. Many doctors—including the ACC’s own past president—are calling for the delay of their implementation and the shutdown of AHA’s online risk calculator, which may overestimate a patient’s risk for heart attack or stroke by 75% to 150%! Top heart researchers warned AHA over a year ago that their calculator was fundamentally flawed, but the AHA claims they never received the researchers’ critiques.

As illustrated by the AHA’s risk calculator, the focal point of the new guidelines is to put millions more Americans on statins. Statins, the most widely prescribed class of drug in the world, are supposed to reduce LDL levels, which mainstream medicine has deemed “bad cholesterol” and the main cause of heart disease. However, as we detail below, there is an abundance of strong evidence to the contrary.

The guidelines recommend that those with a risk level of even 7.5% for either heart disease or stroke should take statins as a “precaution.” Translation: under the new guidelines, patients should be prescribed statins—drugs designed to reduce cholesterol—whether or not they actually have high cholesterol. This ignores evidence that statins not only fail to reduce the risk of death, but fail to reduce even some patients’ chance of getting heart disease.

Worse, statins are an incredibly dangerous class of drugs that should not be prescribed lightly: their side effects are well documented, to the extent that the FDA requires they be disclosed in labeling. They can cause memory loss, significantly increase your risk of type 2 diabetes, block the health benefits of omega-3 fatty acids, and cause serious muscle aches and pains that can make it impossible to sleep. We don’t always realize how critical good sleep is to our health.

Additionally, statins should not be used as a “precaution” when non-drug interventions may be more effective in preventing heart disease. For example, the Lyon Diet Heart Study found that the Mediterranean diet was three times more effective than statin drugs in preventing recurrent heart disease. This is because a holistic approach, such as a change in diet, addresses heart disease and its contributing factors. (Please see our “Natural Ways to Support Heart Health” article for more information.)

The Lyon study also supports the idea that the very premise on which statins are based—“LDL bad, HDL good”—is a gross oversimplification. In fact, LDL has some crucial health benefits—it can even provide protection from cancer. In addition, studies show that lower levels of LDL don’t necessarily lessen your risk of heart disease, and high cholesterol may not cause it:

In 2008, a major study showed that lowering LDL levels doesn’t necessarily decrease the risk of having a heart attack. Another study, released in 2011, shows that raising HDL levels does not always translate into a healthier heart.

As noted in an article by Dr. Mark Hyman, as many as 75% of people who have heart attacks have normal cholesterol.

One rigorous study showed that patients treated with two drugs that successfully lowered cholesterol did not have a reduced risk of heart attack.

Cholesterol is found everywhere in the body. As medical chemist Shane Ellison explains, if high levels of cholesterol truly caused plaque (the fatty substance that causes heart attacks and strokes) rather than simply being a component of plaque, plaque blockages would be found not just in the heart and brain, but everywhere in the body, too. This could be why there are no studies proving that high cholesterol causes heart plaque. Meanwhile, low total cholesterol has its own documented health risks, including depression.

So if there’s significant evidence that statins are neither safe nor effective, what’s behind the AHA’s new guidelines? It seems simple to us: Big Pharma’s statin industry is valued at $29 billion—and the drug industry is a major funder of the AHA. That may not be the whole story, but it is enough to warn all of us.

A glance at AHA’s 2011-2012 fiscal year shows that 25% of the AHA’s budget came from corporations—with $15,369,726 coming from Big Pharma, medical device manufacturers, and health insurance providers. Additionally, of the fifteen panelists who authored the new guidelines, six reported ties to drug makers that sell or are developing cholesterol drugs.

With the recommendations of major medical associations—and, therefore, the decisions of physicians—being influenced if not dictated by the pharmaceutical industry, it is vitally important that natural health practitioners and organizations are standing up for patients. Mainstream medicine is awash in a sea of cash-fueled “guidelines” that fail to consider even the basic science behind heart health.

December 10, 2013


Statins: Weighing the risks and benefits -By Dr. David B. Samadi,  Prescription for Health, FoxNews.com.

 

Statins are among the most commonly prescribed medications for lowering cholesterol and may be responsible for saving thousands of people plagued by heart disease.  But are statins really the miracle drugs many doctors claim for them to be?

There are some serious side effects associated with statins, which often go overlooked.  So before resorting to a long-term commitment with a pill, you should ask yourself if the benefits outweigh the potential side effects.

Statins work by blocking a substance your liver needs to make cholesterol, the waxy substance that’s found in the fat in your blood. This causes your liver to remove cholesterol from your blood. While your body needs cholesterol to build healthy cells, having high cholesterol can increase your risk of heart disease.

Having high cholesterol puts you at risk for developing deposits of fat in your blood vessels. Eventually, these deposits impede the flow of blood through your arteries increasing your risk of a heart attack.

Similarly, decreased blood flow to your brain, due to clogged arteries, can cause a stroke.  Because of the serious risks that accompany high cholesterol, statins have been a choice favorite among doctors to avoid atherosclerosis, coronary artery disease, heart attack and stroke.  What is discussed less often, are the risks and side effects of this group of drugs.

Side effects of statins can include:

Muscle pain and damage: The most common side effect of statins is muscle pain, characterized by a soreness, tiredness or weakness in your muscles. Pain varies among people who take statins from mild discomfort to severe pain which impedes daily activity. Things as simple as climbing stairs, or taking a stroll can become uncomfortable or even unbearable.

A common test used by physicians find out of there is muscle injury or muscle stress, is a CPK isoenzymes test.  This simple blood test measures CPK (creatinine phosphokinase), an enzyme found mainly in heart, brain, and skeletal muscle.  If elevated, it could mean muscle injury.

Liver damage: Statin use can occasionally cause liver damage or stress.   Signs of possible liver damage could be unusual fatigue or weakness, loss of appetite, pain in your upper abdomen, dark-colored urine, or yellowing of your skin or eyes. Because an excess of liver enzymes in the blood is usually a good indicator of compromised liver function, your doctor will most likely order a liver enzyme test either after you begin taking a statin, or if you are experiencing any severe symptoms.  In cases where liver enzymes are severely elevated, your doctor may advise you stop taking the drug all together.

Neurological side effects: The U.S. Food and Drug Administration (FDA) warns of memory loss and confusion as a side effect of statin use. These side effects are said to last only as long as you are taking the medication.  The neurological side effects have not been well studied, however if you experience either of the above symptoms consult your physician.

Increased blood sugar or type 2 diabetes: Another FDA-issued warning regarding statins that deserves attention is the increased risk of elevated blood sugar levels, which can lead to type 2 diabetes.  The risk for this is said to be small, however it is still important to take note of.

Other side-effects: Some other side effects which have been reported to accompany statin use are digestive problems such as nausea, constipation, or diarrhea and rash or skin flushing.

High cholesterol can be inherited, but it is often the result of unhealthy lifestyle choices, and thus preventable and treatable.

A healthy diet that includes many fruits, vegetables and whole grains – regular exercise, and an overall healthy lifestyle can help you keep your cholesterol in check.  There are also a number of natural alternatives to taking statins, including garlic, blond psyllium (found in Metamucil), artichoke, barley and oat bran.

A healthy lifestyle and natural alternatives should be your first line of defense against high cholesterol, but talk to your doctor about your risk and treatment options to decide what’s best for you.

October 02, 2013

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