Showing posts with label Without. Show all posts
Showing posts with label Without. Show all posts

Monday, May 20, 2013

The Diet-Heart Myth: Statins Don’t Save Lives in People Without Heart Disease

statins

To read more about heart disease and cholesterol, check out the special report page.

Cardiovascular disease is one of the most misdiagnosed and mistreated conditions in medicine. In the first article in this series, I explained the evidence suggesting that eating cholesterol and saturated fat does not increase the risk of heart disease. In the second article, I explained it’s not the amount of cholesterol in your blood that drives heart disease risk, but the number of LDL particles. In the third article, I discussed the five primary causes of elevated LDL particle number.

In this article, I will debunk the myth that statin drugs save lives in healthy people without heart disease, and discuss some of the little known side effects and risks associated with these drugs.

Statins have been hailed by many in the conventional medical establishment as wonder drugs, with some physicians going as far as suggesting they should be added to the water supply. (The doctor that made that particular suggestion is named John Reckless – I kid you not.) But are statins really the wonder drugs they’ve been made out to be?

Are statins really the wonder drugs they’ve been made out to be?Tweet This

Before we dive into the statistics on statins, I need to briefly explain the difference between relative and absolute risk reduction. Researchers and pharmaceutical companies often use relative risk statistics to report the results of drug studies. For example, they might say “in this trial, statins reduced the risk of a heart attack by 30%”. But what they may not tell you is that the actual risk of having a heart attack went from 0.5% to 0.35%. In other words, before you took the drug you had a 1 in 200 chance of having a heart attack; after taking the drug you have a 1 in 285 chance of having a heart attack. That’s not nearly as impressive as using the 30% relative risk number, but it provides a more accurate picture of what the actual, or “absolute” risk reduction is.

With that in mind, let’s take a closer look at the efficacy of statins in two broad groups of people: those with pre-existing heart disease, and those without pre-existing heart disease. In the medical literature, these groups are referred to as “secondary prevention” and “primary prevention”, respectively.

There’s little doubt that statins are effective in reducing heart attacks and deaths from heart disease in people who already have heart disease. Several large controlled trials including 4S, CARE, LIPID, HPS, TNT, MIRACL, PROV-IT and A to Z have shown relative risk reductions between 7% on the low end in MIRACL and 32% on the high end in 4S, with an average risk reduction of about 20%.

However, absolute risk reductions are much more modest. They range from 0.8% in MIRACL on the low end to 9% in 4S on the high end, with an average of 3%.

An analysis by Dr. David Newman in 2010 which drew on large meta-analyses of statins found that among those with pre-existing heart disease that took statins for 5 years (1):

96% saw no benefit at all1.2% (1 in 83) had their lifespan extended (were saved from a fatal heart attack)2.6% (1 in 39) were helped by preventing a repeat heart attack0.8% (1 in 125) were helped by preventing a stroke0.6% (1 in 167) were harmed by developing diabetes10% (1 in 10) were harmed by muscle damage

A heart attack or stroke can have a significant negative impact on quality of life, so any intervention that can decrease the risk of such an event should be given serious consideration. But even in the population for which statins are most effective—those with pre-existing heart disease—83 people have to be treated to extend one life, and 39 people have to be treated to prevent a repeat heart attack.

Moreover, these results do not apply to all populations across the board. Most studies have shown that while statins do reduce cardiovascular disease (CVD) events and deaths from CVD in women, they do not reduce the risk of death from all causes (“total mortality”). (2)

Nor do these results apply to men or women over the age of 80. Statins do reduce the risk of heart attack and other CVD events in men over the age of 80, and especially at this age, these events can have a significant negative impact on quality of life. However, the bulk of the evidence suggests that statins don’t extend life in people over 80 years of age, regardless of whether they have heart disease, and the highest death rates in people over 80 are associated with the lowest cholesterol levels. (3), (4)

Statins do reduce the risk of cardiovascular events in people without pre-existing heart disease. However, this effect is more modest than most people assume. Dr. Newman also analyzed the effect of statins given to people with no known heart disease for 5 years (5):

98% saw no benefit at all1.6% (1 in 60) were helped by preventing a heart attack0.4% (1 in 268) were helped by preventing a stroke1.5% (1 in 67) were harmed by developing diabetes10% (1 in 10) were harmed by muscle damage

These statistics present a more sobering view on the efficacy of statins in people without pre-existing heart disease. They suggest that you’d need to treat 60 people for 5 years to prevent a single heart attack, or 268 people for 5 years to prevent a single stroke. These somewhat unimpressive benefits must also be weighed against the downsides of therapy, such as side effects and cost. During that hypothetical 5 year period, 1 in 67 patients would have developed diabetes and 1 in 10 patients would have developed muscle damage (which can be permanent in some cases, as we’ll see later in this section).

In addition, while statins do moderately reduce cardiovascular events such as heart attack in people without heart disease, they’ve never been shown to extend lifespan in this population. This is true even when the risk of heart disease is high. In a large meta-analysis of 11 randomized controlled trials by Kausik Ray, MD and colleagues published in the Archives of Internal Medicine, statins were not associated with a significant reduction in the risk of death from all causes. (6)

This trial included 65,000 people without pre-existing heart disease but with intermediate to high risk of heart disease. It was important because it was the first review that only included participants without known heart disease. Previous studies suggesting that statins are effective in reducing death in people without pre-existing heart disease included some people that did have heart disease, which would have skewed the results.

The lack of significant effect on mortality is even more interesting in light of the fact that LDL cholesterol levels did decrease significantly in the statin group; the average LDL level in those taking placebo was 134 mg/dL and the average in the statin-treated patients was 94 mg/dL—roughly 30% lower. Yet in spite of this marked reduction in LDL cholesterol in the statin group, there was no difference in lifespan between the two groups. This is yet another line of evidence suggesting that the amount of cholesterol in LDL particles is not the driving factor in heart disease.

A meta-analysis of statin trials in people without heart disease by the prestigious Cochrane Collaboration came to a similar conclusion. (7) They also observed that all but one of the clinical trials providing evidence on this issue were sponsored by the pharmaceutical industry. This is significant because research clearly indicates that industry-sponsored trials are more likely than non-industry-sponsored trials to report favorable results for drugs because of biased reporting, biased interpretation, or both. (8)

If statins were harmless and free, then it wouldn’t matter how many people need to be treated to prevent a heart attack or extend someone’s lifespan. But statins are not free, nor are they harmless. Statin use has been associated with a wide range of side effects, including myopathy (muscle pain), liver damage, cataracts, kidney failure, cognitive impairment, impotence and diabetes.

Unfortunately, studies show that physicians are more likely to deny than affirm the possibility of statin side effects, even for symptoms with strong evidence in the scientific literature. (9) Assuming that physicians would likely not report the adverse reaction in these circumstances, it’s probable that the incidence of statin side effects is much higher than the reported rates.

One of the most troubling side effects of statins that has only recently become apparent is their potential to increase the risk of diabetes, especially in women. A study by Dr. Naveed Sattar and colleagues published in The Lancet in 2010 examined 13 randomized clinical trials involving over 90,000 patients taking statins. They found that statin use was associated with a 9% increased risk in developing diabetes. Note that this is a relative risk, so the absolute risk of developing diabetes while taking a statin is very low. That said, observational data from the Women’s Health Initiative found a 48% increased risk of diabetes in healthy women taking statins after adjusting for other risk factors. (10)

To summarize:

The only population that statins extend life in are men under 80 years of age with pre-existing heart disease.In men under 80 without pre-existing heart disease, men over 80 with or without heart disease, and women of any age with or without heart disease, statins have not been shown to extend lifespan.Statins do reduce the risk of cardiovascular events in all populations. A heart attack or stroke can have a significant, negative impact on quality of life—particularly in the elderly—so this benefit should not be discounted.However, the reductions in cardiovascular events are often more modest than most assume; 60 people with high cholesterol but no heart disease would need to be treated for 5 years to prevent a single heart attack, and 268 people would need to be treated for 5 years to prevent a single stroke.Statins have been shown to cause a number of side effects, such as muscle pain and cognitive problems, and they are probably more common than currently estimated due to under-reporting.

My intention here is not to suggest that statins have no place in the treatment of heart disease, but rather to give you the objective information you need to decide (along with your doctor) whether they are appropriate for you. The decision whether to take them should be based on whether you have pre-existing heart disease, what your overall risk of a heart attack is, how healthy your diet and lifestyle is, what other treatments you’ve already tried, and your own risk tolerance and worldview. It’s clear that statins reduce heart disease as well as the risk of death in those that have already had a heart attack, so if you’re in this group and you’ve already tried diet and lifestyle interventions without much impact on your lipid or inflammatory markers, you are more likely to benefit.

In the next and final article of this series, I’ll discuss three steps to preventing and reversing heart disease naturally, without drugs.

Tagged as: cardiovascular, cholesterol, drugs, Heart Disease, myths, statins, treatment

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Friday, March 30, 2012

Lowering Cholesterol Without Medication

Wikipedia Fenofibrate – Wikipedia, The Free Encyclopedia
The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, which is the largest Care 2009, showed that fenofibrate significantly reduced CVD events in those with low HDL cholesterol was associated with a lower risk of amputations, particularly minor amputations without known … Read Article

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If the cholesterol level remains below 150 mg/dl without medication, I feel even more confident that the patient will do well (another guess). The Diet Is Forever A no-cholesterol, low-fat diet (The McDougall Diet) is the first step to lowering elevated cholesterol and cleaning out the arteries. … Access Doc

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A. Welchol™ (colesevelam HCl) is the first and only LDL cholesterol (LDL-C) lowering medication also indicated to improve glycemic control in adults in lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without … Access Document


About High Triglycerides – How To Lower High Triglycerides
If you try the above interventions and your triglyceride levels are still high, you can talk to your doctor about whether you should take a medication to help lower your triglycerides. Nicotinic acid (also known as niacin) and cholesterol-lowering drugs called fibrates can help lower … Read Article

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Medications that increase this risk include the transplant anti-rejection drug cyclosporine ( Sandimmune ), niacin at cholesterol-lowering doses, and An antacid such as Maalox TC taken at the same time as Lipitor can lower levels of the cholesterol medication without reducing its effect on LDL … Read Here

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PDF file Cholesterol-Lowering Drugs Will Wreck Your Muscles
How to Normalize Your Cholesterol Without the Use of Drugs Just about every person, other than the tiny minority with the recommend a low-fat diet and exercise as the first step in lowering cholesterol, with the next step being medication. More than 30 million prescriptions for cholesterol lowering … Document Retrieval

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When diet and exercise fail to lower high cholesterol enough, then a cholesterol-lowering medication may be prescribed. Nicotinic Acid —Available without a prescription, this vitamin can lower total cholesterol, LDL cholesterol and triglycerides, and raise HDL cholesterol. … Document Retrieval

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LOWERING YOUR CHOLESTEROL WITHOUT MEDICATIONS. Mark Sockell MD. Many people choose to lower their cholesterol levels without medications because they want to avoid We use several of them in our practice, sometimes instead of medication, and sometimes to enhance the effect of medication. … Read Content

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The Dangers of Statin Drugs: What You Haven\’t Been Told About Cholesterol-Lowering Medication By Sally Fallon and Mary G. Enig, PhD Originally printed at Every cell membrane in our body contains cholesterol because cholesterol is what makes our cells waterproof–without cholesterol we could not have … Read Content

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Lowering Cholesterol with a Healthier Way of Eating How is high cholesterol this JAMA article is entitled, “Diet first, then medication for hypercholesterolemia (high cholesterol).” Cholesterol is Not Inherently Bad for the Body: In fact, without cholesterol, your body would be unable to make … Get Document

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*Volume 26, number 1, 2008• CliniCal Diabetes FEaturE articlE LDL Cholesterol Lowering in Type * Diabetes: What Is the Optimum Approach? with CHD and diabetes are still 26% less likely to have had a lipid profile and 17% less likely to receive lipid-lowering medication than are patients with CHD but without … Get Doc

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PDF file Chapter 12. Lipid Lowering Agents
A minimum of six weeks without LLA is needed before randomization. New drug phase III trials should not be restrictive in terms of concomitant medication in order to Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian … Access Document

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All patients should adhere to alow cholesterol diet. In many cases additional lipid lowering with medication will be required. Cholesterol absorption inhibitors area new class of cholesterol lowering drugs which block absorption of cholesterol at the brush border of the intestine without … Visit Document

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• Use a pillbox with seven sections, one for each day of the week. • Record your medication on a wallet card or calendar. • Can you think of others? What sort of follow up will I need? Periodic blood tests will make sure the Slo-Niacin is lowering your cholesterol without irritating your liver. … Read More

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