The Truth about Statin Drugs

Cardiovascular disease (CVD) is still the leading cause of death in the United States, claiming 350,000 lives annually. (2) Medical authorities and doctors claim that statins reduce the risk of CVD and vascular deaths by lowering levels of total cholesterol and proclaimed “bad” low-density lipoprotein (LDL)-cholesterol.

But are statins really as safe and effective as mainstream medical authorities claim? The unequivocal answer is NO.

Statin drugs are not always safe or effective, despite what mainstream medicine claims. Check out this article to find out the truth about statins, when they work, and when they don’t. #chriskresser #healthylifestyle #wellness

The Side Effects of Statin Drugs

The pharmaceutical industry and the medical establishment have spent considerable effort trying to convince people that statins drugs are safe and sadly, they’ve been largely successful (you can read more about that in this blog post from Dr. John Briffa). Some time ago a physician in the UK by the name of Dr. John Reckless (you can’t make this stuff up) suggested that statins are so safe that they should be put in the water supply!

That’s ridiculous, of course. Statins are dangerous drugs.

There’s no denying that statins are effective at lowering blood cholesterol levels. Depending on the dose and circumstance, LDL-cholesterol (LDL-C) can be lowered by 30 to 60 percent. (3)

However, high cholesterol in the blood is just one of many factors that contribute to heart disease, and the evidence is mixed on how strong of a CVD risk predictor LDL and total cholesterol are. As I discuss below, LDL particle number (LDL-P) may be a better indicator of heart disease risk. For more information on this topic, check out my article “The Diet-Heart Myth: Why Everyone Should Know Their LDL Particle Number.”

It’s important to note that cholesterol is vital for our bodies to function properly—it doesn’t exist just to give us heart disease. Cholesterol provides structure to our cell membranes, and cholesterol is a precursor to many biologically necessary products, including: (3)

• Sex steroids
• Corticosteroids
• Bile acid
• Vitamin D

Statins work by inhibiting beta-hydroxy-beta-methylglutaryl-CoA (HMG-CoA) reductase—an enzyme involved in cholesterol synthesis. But this enzyme has other jobs, too, such as aiding in the synthesis of coenzyme Q10 (CoQ10), a key mitochondrial antioxidant needed for cellular energy metabolism. (4)

Therefore, tinkering with cholesterol synthesis via statins can yield unwanted side effects. The most common statin-related side effects are muscle-related issues, including:

• Pain
• Lethargy
• Weakness
• Myopathy, in rare cases

Muscle problems are reported in 10 to 30 percent of patients from observational studies, and in up to 5 percent in randomized controlled trials (RCTs). (5, 6)

New-onset diabetes while taking statins occurs most often in women and in people who already have some metabolic risk factors. (7, 8) Some studies have found no association with statins and diabetes, (9) while a meta-analysis of 13 RCTs found that statin use was associated with a 9 percent relative increased risk of diabetes. (10)

Other less common side effects associated with statin use have been reported, but not all have been proven to be caused by statins themselves:

• Hemorrhagic stroke (11)
• Liver dysfunction (12)
• Cognitive disturbances (13)
• Depression and mood instability (14)
• Skin infections (15)
• Decreased libido and impotence (16)
• Rhabdomyolysis (very rare, but can lead to life-threatening kidney failure) (17)

Are the Claims about Statins Overstated? Absolute vs. Relative Risk

“Statins reduce deaths from coronary heart disease by 28 percent in men.” This is a headline from 2017 reporting the results from a long-term study on cholesterol-lowering statins. (18) Sounds pretty impressive, doesn’t it?

An important thing to understand about drug clinical trials and medical claims is the difference between relative risk and absolute risk. For example, imagine that your risk of developing Condition A is one-half of 1 percent—0.5 percent. That’s your absolute risk, and it’s quite low. Now, imagine that Drug B reduces your chance of developing Condition A down from one-half of 1 percent to one-quarter of 1 percent.

We could report this reduction in one of two ways:

• Your relative risk of developing Condition A was reduced by a whopping 50 percent, from 0.5 percent to 0.25 percent, from Drug B.
• Your absolute risk was reduced by a mere one-quarter of 1 percent, or 0.25 percent, for an already low-risk event.

Reporting relative risk reduction without acknowledging absolute risk reduction can overinflate the benefits of a drug or treatment. Many statin studies and claims perfectly exemplify this phenomenon.

In a large meta-analysis from The Lancet that summarized and evaluated 26 RCTs, the authors report that all-cause mortality is reduced with statin treatment by 10 percent each year for every 39 mg/dL reduction in LDL-C. (19) They are reporting relative risk. 

However, the data from tables and figures reveal something much less impressive. Taking all trials together, the per annum death rate for overall mortality went from 2.3 percent to 2.1 percent for every 39 mg/dL reduction in LDL-C. That’s an absolute risk reduction of a mere 0.2 percent. The absolute risk reduction for all vascular-related deaths across all studies was only reduced from 1.3 percent per year to 1.2 percent with statin treatment.

It’s difficult to put numbers and cost on even a single life saved, but it’s hard to argue the fact that a 10 percent relative risk reduction sounds a lot more “impressive” and worth it than a 0.2 percent absolute risk reduction.

What the Media Isn’t Telling You About Statin Drugs

Press releases and media reports about statin drugs often dramatically overstate their effectiveness, while understating their risk.

For example, consider this quote regarding the Heart Protection Study (HPS):

“In this trial, 10 thousand people were on a statin. If now, an extra 10 million high-risk people worldwide go onto statin treatment, this would save about 50,000 lives each year—that’s a thousand a week.”

That sounds pretty compelling, doesn’t it? It’s hard to argue against saving 50,000 lives a year.

But that’s not what the study showed at all. In fact, the following would be a more accurate report on the results of this study, couched in the context of what we know from other statin drug trials:

• Out of 100 high-risk people taking a statin for five years, 98.2 will not see any benefit to their heart health at all—but they will be exposed to significant side effects and complications.
• The 1.8 people that do benefit will live an average of six months (and a maximum of one year) longer than those who didn’t take the statin.
• These results only apply to the people at highest risk for a future heart attack: middle-aged men who’ve already had a heart attack. There is little compelling evidence that statins extend lifespan at all in men without pre-existing heart disease or women with or without heart disease (more on this below).

It’s misleading to claim that the HPS study showed that statins “save lives.” According to the HPS data, even in the highest risk populations, the best that statins can do is extend lifespan for a few months for less than two out of 100 people who take them.

For more on this topic, I recommend checking out Dr. Malcolm Kendrick’s fantastic article about how deceptive and misleading media reporting on statin drug trials can be.

Statins Don’t Benefit Otherwise Healthy People

Initially, statins were prescribed only to people who had very high LDL-C and a history of atherosclerotic cardiovascular disease (ASCVD). This is referred to as “secondary prevention.” Over the years, treatment standards have expanded to include people who are “at risk” of developing ASCVD based on a number of criteria, but don’t actually have it. (20, 21) This strategy is called “primary prevention.”

Many studies have been conducted to justify prescribing statins for primary prevention. Although statins moderately reduce cardiovascular events such as heart attack in people without heart disease, the research doesn’t indicate that statins reduce overall mortality in these populations.

• The WOSCOPS study found a slight reduction in death from cardiovascular causes, but no significant effect on death from non-cardiovascular causes or death from all causes was found compared to placebo. (22)
• In the AFCAPS/TexCAPS study, men and women with high total cholesterol and LDL-C levels but no heart disease were prescribed statins. Major coronary events at the end of the study were slightly reduced, but overall deaths did not differ between drug and placebo. (23)
• In patients with elevated C-reactive protein (CRP) levels, an indicator of chronic inflammation, either placebo or statins were given to otherwise healthy men and women. Although statins reduced death from both cardiovascular causes and all causes, a higher incidence of diabetes was reported in the statin-treated group. (24)

Although a handful of studies have found significant reductions in death from any cause by prescribing statins to people without heart disease, the absolute benefits are extremely small. (25, 26) The majority of the literature fails to demonstrate clear benefits of statins for primary prevention. (27, 28, 29) For more on this topic, check out my article “The Diet-Heart Myth: Statins Don’t Save Lives in People without Heart Disease.”

Statins Don’t Increase Survival in the Elderly

Despite the fact that the vast majority of people who die from heart disease are over age 65, there is limited evidence that statins benefit this population. (30) In the PROSPER trial, a study that dealt exclusively with the elderly, statins reduced the incidence of death from heart disease. (31) However, this decrease was almost entirely negated by a corresponding increase in cancer deaths. As a result, overall mortality between the statin and placebo groups after over three years was nearly identical.

Another study analyzed the effects of statins vs. standard care in patients over age 65 without CVD, as a secondary analysis of a previous study. (32) The authors reported that over six years of treatment, patients treated with statins actually lived an average of 33 days fewer than those receiving usual care—a very small absolute change, but not at all in favor of statin treatment.

Although outlier data exist (33), the bulk of the evidence suggests that statins don’t extend life in the elderly, regardless of whether they have heart disease or not. And, in fact, the highest death rates in the elderly, especially those over age 80, are associated with the lowest cholesterol levels. (34, 35)

Mixed Evidence on Statins for Women

Drug trials have a long history of underrepresenting women as participants. Statins are no exception. Even as recent as 2017, a review paper admits that “up-to-date evidence shows that statins have not been adequately tested in women, especially in primary prevention trials.” (36) As of 2016, women comprised less than 25 percent of all statin trial participants to date. (37)

For primary prevention of CVD, studies have consistently reported that, although statins may reduce the risk of a coronary event and even vascular-related deaths, overall mortality is unchanged compared to placebo for women, even when overall mortality is reduced significantly (but marginally) in men. (38, 39, 40)

For secondary prevention of CVD, reports have been somewhat mixed. One large meta-analysis of 11 RCTs found that in women, statins reduced the risk of all cardiovascular events, but not overall mortality. (41) Another meta-analysis looked at eight primary prevention and 10 secondary prevention trials, and found that statins did benefit women in terms of cardiovascular events and death from all causes. (42)

Do Statins Help Anyone?

To sum up thus far:

1. Statins can lower cholesterol levels and moderately decrease the risk of CVD-related deaths in some populations.
2. There is little to no evidence that statins increase life expectancy in women, in the elderly, or in people without pre-existing heart disease.
3. Statins carry non-negligible risks.

So whom do they help?

Studies consistently show that statins benefit middle-aged men who already have heart disease (secondary prevention). Many large controlled trials, including 4S, CARE, LIPID, HPS, TNT, MIRACL, and PROVE-IT, have shown relative risk reductions in vascular events and cardiac death between 7 percent on the low end and 32 percent on the high end, with an average risk reduction of around 20 percent. (43, 44, 45, 46, 47, 48, 49)

However, absolute risk reductions were much more modest, ranging from 0.8 percent to 9 percent. And, importantly, not every trial found that statins improved overall mortality. (44)

LDL-P: A Better Marker for Cardiovascular Risk?

Cardiologists and other doctors consider LCL-C the enemy and a great predictor for CVD later in life. In my clinical experience, I have found that LDL-P is a much better marker for CVD risk than LDL-C. The two sometimes are correlated, but often they can be discordant, leading to unnecessary or harmful treatment. (50, 51) Peer-reviewed research has confirmed that LDL-P is a much better predictor of CVD and vascular events compared to LDL-C. (52, 53, 54)

It’s beyond the scope of this article, but I wrote about the four main causes of high LDL-P in a previous article. The cause dictates appropriate treatment, which doesn’t often involve statins.

What’s an Alternative to Statin Drugs?

So what if you are at risk for heart disease and you’d prefer not to take a statin? There are many clinically proven ways to prevent heart disease naturally by adjusting your diet and lifestyle. In fact, the INTERHEART study, which looked at the incidence of heart disease in 52 countries, revealed that over 90 percent of heart disease is preventable by diet and lifestyle modifications. (55)

How to Live a Heart-Healthy Lifestyle

To prevent heart disease, the American Heart Association recommends a so-called “heart-healthy diet,” which emphasizes nutrient-poor foods like industrial seed oils and whole grains while restricting nutrient-dense foods like red meat, animal fat, and cholesterol.

A better dietary approach to heart health should include foods like:

• Cold water, fatty fish
• Monounsaturated fats from avocados, macadamia nuts, olives, and olive oil
• Antioxidant-rich foods, like colorful fruits and vegetables
• Soluble fiber

Other lifestyle factors that have a profound effect on lower CVD risk include:

• Exercise
• Better sleep
• Stress management

For more on how to live a heart-healthy lifestyle, check out my article “The Diet-Heart Myth: How to Prevent and Reverse Heart Disease Naturally.” 

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