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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 hurt your heart health or 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.
Myth #3: Statins Save Lives in Healthy People without Heart Disease
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 miracle drug they’ve been made out to be? Check out this article to find out more about these popular drugs.
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 percent.” But what they may not tell you is that the actual risk of having a heart attack went from 0.5 percent to 0.35 percent. 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 percent 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
- Those without pre-existing heart disease
In the medical literature, these groups are referred to as “secondary prevention” and “primary prevention,” respectively.
Secondary Prevention (Those with Pre-Existing 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 percent on the low end in MIRACL and 32 percent on the high end in 4S, with an average risk reduction of about 20 percent.
However, absolute risk reductions are much more modest. They range from 0.8 percent in MIRACL on the low end to 9 percent in 4S on the high end, with an average of 3 percent.
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 percent saw no benefit at all
- 1.2 percent (1 in 83) had their lifespan extended (were saved from a fatal heart attack)
- 2.6 percent (1 in 39) were helped by preventing a repeat heart attack
- 0.8 percent (1 in 125) were helped by preventing a stroke
- 0.6 percent (1 in 167) were harmed by developing diabetes
- 10 percent (1 in 10) were harmed by muscle damage
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)
Primary Prevention (Those without Pre-Existing Heart Disease)
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 percent saw no benefit at all
- 1.6 percent (1 in 60) were helped by preventing a heart attack
- 0.4 percent (1 in 268) were helped by preventing a stroke
- 1.5 percent (1 in 67) were harmed by developing diabetes
- 10 percent (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.
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 percent 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.
Adverse Effects of Statins
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
- Kidney failure
- Cognitive impairment
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 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 percent 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 percent increased risk of diabetes in healthy women taking statins after adjusting for other risk factors. (10)
What’s more, a 2019 study found a 38 percent increased risk of type 2 diabetes in patients who took statins over a 15-year period. (11) The study also showed:
- Even people on low doses of statins were at increased risk of developing diabetes
- The increase in risk was significantly higher in those who were overweight or obese
- Patients’ risk of diabetes climbed higher the longer they took statins
- 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 are, 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.