Statins: Side effects of cholesterol-lowering drugs

Cholesterol-lowering drugs (statins) are very often prescribed because high cholesterol levels are considered a risk factor for cardiovascular disease. However, cholesterol-lowering drugs can also have side effects. In addition, independent researchers repeatedly state that low cholesterol levels do not necessarily protect against heart attacks and strokes.

Statins and their side effects

Statins (cholesterol-lowering drugs) are taken by around 2.6 million people in Australia. Statins therefore represent a huge market. To ensure that even more people take them in the future, the cholesterol target values ​​have been lowered again in the medical guidelines.

According to the 2016 guidelines, the so-called bad cholesterol (LDL cholesterol) should be reduced to the following values ​​depending on the personal cardiovascular risk. The cardiovascular risk is determined depending on the patient’s risk factors (e.g. blood pressure, smoking, excess weight or waist circumference, diabetes, blood lipid levels, existing heart or vascular disease, kidney disease, etc.):

  1. If the cardiovascular risk is very high, the LDL cholesterol level should be reduced to below 3.9 mmol/l
  2. at high risk to below 5.6 mmol/l
  3. at moderate risk to below 6.4 mmol/l
  4. at low risk to below 7.2 mmol/l

The new guidelines now state the following:

  1. in case of a very high cardiovascular risk, the LDL cholesterol level should be reduced to below 3.1 mmol/l
  2. at high risk to below 3.9 mmol/l
  3. at moderate risk to below 5.6 mmol/l
  4. at low risk to below 6.6 mmol/l

With values ​​this low, it is clear that there will hardly be anyone left who does not need statins. To ensure that every patient really does take the pills reliably, as little as possible is said about their side effects. In fact, if you read through the scientific literature, you almost believe that there are no side effects at all. And you think that cholesterol-lowering drugs are the only solution to protect yourself from cardiovascular events. Far from it!

Statins only when lifestyle changes fail

Statins are medications that are prescribed to lower cholesterol levels and are said to reduce the risk of arteriosclerosis ( hardening of the arteries ) and, as a result, the risk of heart attacks and strokes.

Nowadays, you can even read that people who do not have high cholesterol levels could benefit from taking statins, because the cholesterol-lowering drugs not only lower cholesterol levels, but also have an anti-inflammatory effect – and chronic inflammation is in turn considered an important cause of cardiovascular diseases.

Officially, cholesterol-lowering drugs should only be given if lifestyle changes have not had the desired effect (change in diet, exercise, etc.). Since doctors rarely provide concrete help with such lifestyle changes, statins are usually prescribed very quickly.

How cholesterol-lowering drugs work

Statins inhibit an enzyme in the liver that is involved in cholesterol production. As a result, the liver produces less cholesterol. However, since it needs cholesterol, e.g. to produce bile acids, it draws more cholesterol from the rest of the body, with the effect that the LDL cholesterol level drops (by up to 60 percent).

Blood fats are also said to fall somewhat under the effect of cholesterol-lowering drugs, as are inflammation levels (CRP). At the same time, HDL cholesterol levels rise and plaque stability increases. The latter means that the deposits on the blood vessel walls become more stable, thus reducing the risk of a blood clot breaking loose.

Statins: The new miracle drugs?

In recent years, more and more studies have been published that confirm that statins have wonderful additional effects. The drugs are said to reduce the risk of cancer (10) (11) (12) (13) (14), have a positive effect on the intestinal flora ( 24 ) and even reduce the risk of death from Covid-19. One gets the impression that these are veritable super pills with almost exclusively positive effects.

As far as the Covid-19 issue is concerned, however, it quickly became apparent that the headline was a bit too exuberant, if not misleading. In reality, the study in question only found that cholesterol-lowering drugs did not increase the risk of death, as had initially been suspected, which can most likely be attributed to the anti-inflammatory effect of the drugs.

The side effects are trivialized

The side effects of statins are officially played down. The benefits far outweigh the risks, it is said again and again. After all, the risk of dying from a cardiovascular problem is significantly reduced, which is why you can accept a few side effects.

In a meta-study from 2018 (4), for example, researchers analyzed studies from 2000 to 2017 to determine the frequency of side effects of long-term statin use. The risk of diabetes is low, and is only higher in the case of corresponding pre-existing conditions (obesity, high blood pressure, etc.).

Treatment with cholesterol- lowering drugs does not affect cognitive functions, nor does kidney function deteriorate significantly. Not even an increased development of cataracts has been detected – and liver damage due to the drugs is very rare. Long-term treatment with cholesterol-lowering drugs is therefore extremely safe and carries only a low risk of clinically relevant side effects.

The severity and frequency of the possible side effects are extremely low and affect only 0.5 to 1 percent of patients (7) (8). Are cholesterol-lowering drugs really harmless? The overwhelming number of studies that speak positively about statins at least give this impression. Sometimes, however, one is tempted to believe that these studies may have been directed and influenced accordingly.

For study number 4, for example, there were grants from Amgen, AstraZeneca, Eli Lilly, Esperion, Merck, Pfizer and Sanofi-Regeneron – all pharmaceutical giants that have statins or other lipid-lowering drugs in their programs. In addition, the authors stated that they occasionally receive money from pharmaceutical companies, for example for lectures or consulting work.

What are the side effects?

Many side effects are known for statins, such as neurological and neurocognitive disorders, cholesterol-lowering dementia, and liver and kidney damage. Digestive problems and back, neck, chest and joint pain can also be found on the package inserts for cholesterol-lowering drugs if you look at the adverse events section.

It also includes: weight gain, fever, hair loss, skin rash, itching, general weakness, water retention, tinnitus, headaches and much more.

We present particularly important side effects below:

Possible side effect cancer

Furthermore , a 2018 systematic review (15) of ten studies involving a total of 1,881 cancer patients and 1,572 deaths found that additional intake of cholesterol-lowering drugs had no positive effects in advanced cancer.

Low cholesterol levels in connection with taking statins are even associated with an increased risk of cancer, according to the authors of a 2015 study. Most studies with this group of drugs are too short to develop cancer. A longer study found that women who took cholesterol-lowering drugs for more than 10 years had a higher incidence of breast cancer (40).

Possible side effect: dysbiosis (disturbance of the intestinal flora)

As far as the intestinal flora is concerned, there are also studies that show the opposite, that statins have a negative effect on the intestinal flora. In 2017, a study was published (39) stating that the drugs led to a disturbance of the intestinal flora (dysbiosis) and that the now disturbed intestinal flora produced fewer short-chain fatty acids (which are important for the health of the intestinal mucosa).

This study also said that cholesterol-lowering drugs increased fasting blood sugar (thereby increasing the risk of diabetes) and also led to weight gain.

Statins can therefore – like any medication – have side effects. However, the risk of side effects varies depending on the cholesterol-lowering medication and also depending on the dose used.

Possible side effect diabetes

As already mentioned above, the risk of developing diabetes increases when taking statins. A 2019 study of 228,000 patients found that the risk of diabetes and skin infections increased significantly within three months of starting to take the medication. The skin infections were so severe that antibiotics were required.

A review from 2019 (published in the Journal of the American Heart Association ) also mentions diabetes as a possible side effect. Patients who are already overweight or have impaired blood sugar levels are particularly at risk, it says.

Possible side effect nightmares

Statins can even prevent restful sleep, as nightmares can apparently be one of their side effects. A 2005 study initially found that low cholesterol levels can cause nightmares (37).

If cholesterol-lowering drugs lower cholesterol, then the drugs could also be responsible for nightmares, right? This is exactly what a case report published in the British Medical Journal in 2006 showed. In it, it was atorvastatin that caused nightmares (38). So if you suffer from sleep disorders and nightmares after taking cholesterol-lowering drugs, talk to your doctor!

Possible side effect weak tendons

Statins can also contribute to tendon disorders (43), even tendon ruptures. The Achilles tendon, the quadriceps tendon (pain above the kneecap or a feeling of weakness in the knee) and the distal biceps tendon are particularly affected. Problems with the latter often lead to load-dependent pain directly in the crook of the elbow when bending and rotating the forearm outwards.

Tendon disorders can occur, particularly in the first year of taking cholesterol-lowering medication. When the medication is stopped, the symptoms usually improve. The risk of tendon rupture increases if certain diseases are present, such as diabetes, gout, rheumatism or chronic kidney disease. In addition to cholesterol-lowering medication, corticosteroids (cortisone) and fluoroquinolones (a certain type of antibiotic, which were already mentioned above under muscle diseases) can also lead to tendon ruptures. If you experience any of these symptoms while taking medication, speak to your doctor and look for alternatives (see link at the bottom for natural cholesterol-lowering)!

Possible side effect muscle pain

Other studies indicate that up to 10 percent of patients taking cholesterol-lowering drugs report muscle pain (myalgia). In some parts the figure is even as high as 30 percent.

The symptoms are so unpleasant that many patients stop taking cholesterol-lowering drugs, according to a 2019 review. The so-called statin-associated muscle symptoms (SAMS for short) account for up to 72 percent of cholesterol-lowering drug side effects (1).

However, people like to blame the pain on the nocebo effect. Nocebo means (in contrast to placebo) that patients imagine a drug to have a harmful effect, for example because they have heard or read about the corresponding side effect. A study from 2017 claims to have proven exactly that (2). But it was financed by Pfizer, one of the world’s largest statin manufacturers.

From 2003 to 2011, Pfizer generated annual sales of between 9 and more than 12 billion dollars with the cholesterol-lowering drug Lipitor (atorvastatin) alone. Then the patent expired, so that Pfizer’s annual sales of this cholesterol-lowering drug currently amount to “only” 2 billion dollars.

Another explanation for muscle pain is that the affected people have muscle pain anyway. After all, older people in particular often have muscle pain, it is said, even if they are not taking cholesterol-lowering drugs. However, if the drugs are taken, then any muscle pain that occurs is simply attributed to the cholesterol-lowering drugs.

A muscle disease is only considered to be confirmed if elevated creatine kinase levels can be detected in the serum. This can manifest itself in muscle weakness, muscle pain, muscle stiffness and muscle cramps. Creatine kinase is an enzyme whose level increases when muscle cells break down.

Life-threatening complication under statins: rhabdomyolysis

A dangerous complication of the myopathies mentioned above is the so-called rhabdomyolysis. This disease is accompanied by a serious breakdown of muscle cells. The muscle dissolves. One of the breakdown products (myoglobin) is excreted via the kidneys and can damage the kidneys so severely that acute (and fatal) kidney failure can occur.

Although this complication is life-threatening, it is fortunately rare (1 affected person in 100,000 statin patients).

Due to deaths caused by rhabdomyolysis, the pharmaceutical company Bayer had to withdraw its cholesterol-lowering drug Lipobay (cerivastatin) from the market in 2001 – four years after it was approved. 100 people died of rhabdomyolysis after taking the cholesterol-lowering drug. 1,600 people became seriously ill, often with irreversible damage.

Bayer had to pay over 1.1 billion dollars to the victims in the USA. As recently as 2013, an Italian doctor received 350,000 euros because he had prescribed Lipobay in 1999 and only two months later became so ill with rhabdomyolysis that he was permanently unable to work and had to live on a disability pension from then on.

Be careful if you are taking other medications

Many of the Lipobay victims are said to have become ill because they had taken other medications (e.g. fibrates to lower triglycerides) in addition to cholesterol-lowering drugs. This combination is said to drastically increase the risk of muscle damage.

Lipobay disappeared, but the risk of myopathy caused by statins did not. Even today’s cholesterol-lowering drugs can trigger muscle breakdown, especially when they are taken together with other drugs, such as Lipobay.

  1. Antibiotics from the macrolide group (e.g. clarithromycin, which is often used to combat the stomach germ Helicobacter pylori, or erythromycin, which is given for bronchitis, otitis media or sinusitis.)
  2. Cyclosporine (an immunosuppressant that is even said to be used in Covid-19) (33)
  3. Fluconazole (an anti-fungal drug that is prescribed for Candida infections, for example )

Therefore, if you need to take other medications in addition to cholesterol-lowering drugs, be sure to inquire about possible interactions (34).

Not all statins are the same

However, not all cholesterol-lowering drugs are equally risky. For example, if simvastatin is taken in higher doses (80 mg per day), the risk of rhabdomyolysis increases disproportionately. Since the cholesterol-lowering drug also lowers LDL cholesterol levels even less effectively than rosuvastatin, for example, there is currently not much to be said for simvastatin ( 35 ). It is therefore worth asking more detailed questions or getting a second opinion.

Other medications that cause muscle disorders

Statins are not the only drugs that can cause myopathy. The following drugs can also lead to rhabdomyolysis (and many other side effects):

  1. Isotretinoin (strong medication against acne)
  2. Levofloxacin (antibiotic from the fluoroquinolone group)
  3. Ezetimibe (a cholesterol-lowering drug from the group of cholesterol absorption inhibitors, inhibits cholesterol absorption in the intestine)
  4. Co-trimoxazole (an antibiotic that is prescribed for bacterial urinary tract infections, for example)
  5. Venlafaxine (an antidepressant used to treat depression with anxiety and panic disorders).

We are probably not being told everything about the effects and side effects of cholesterol-lowering drugs, because independent researchers keep reporting that the drugs are not as good as we are led to believe.

In many studies the side effects are neglected!

Dr. David M. Diamond, Professor of Psychology, Molecular Pharmacology and Physiology at the University of South Florida and Dr. Uffe Ravnskov, independent health researcher and expert on cholesterol and cardiovascular diseases, criticize the fact that in many studies the side effects are neglected and, above all, many studies have been statistically “beautified” in order to make the cholesterol-lowering drugs appear better than they actually are (17) (18).

Although the drugs can dramatically lower cholesterol levels, they do not significantly prevent cardiovascular events. The claims that cholesterol-lowering drugs are real lifesavers because they prevent strokes, heart attacks and other heart-related deaths are exaggerated.

In addition, side effects are more common than reported in the media or conferences, and so the balance is no longer so in favor of statins when it comes to weighing side effects and effects (40) (41).

Cholesterol-lowering drugs do not work as well as expected

Numerous studies, reviews and meta-analyses show how well statins can lower cholesterol levels and how well they subsequently appear to reduce the risk of heart attack. In a meta-study from 2003 (5), for example, British researchers examined over 200 studies and found the following:

The results in 164 of the studies showed that LDL levels could be reduced by between 40 and 60 percent, depending on the drug. 58 studies indicated a reduction in the risk of heart attack of 11 percent in the first year, 24 percent after two years, 33 percent after 3 to 5 years, and 36 percent beyond that. If the dose of cholesterol-lowering drugs is increased, the risk of heart attack can be reduced by a further 15 percent (compared to the lower dose), according to a 2010 study (6).

With these numbers, you would actually want to immediately take the next best cholesterol-lowering drug in the highest possible dose. But there are also other studies, such as a study (9) from 2016 with 17,082 subjects. They had an average LDL cholesterol level of 108 mg/dl and were given 20 mg of rosuvastatin or a placebo daily.

Study: Cholesterol-lowering drugs fail in one in ten patients

In the statin group, the drug reduced LDL cholesterol levels by 50 percent or more in 3,640 people. In another 3,365 people, it reduced levels by less than 50 percent (but more than 0 percent). However, in 851 participants (10.8 percent), levels did not change or even worsened, which would indicate that cholesterol-lowering drugs fail in one in ten patients.

Study: Cholesterol-lowering drugs do not work as hoped for half of patients

A study from spring 2019 of over 165,000 patients found that cholesterol-lowering drugs did not lower cholesterol levels as well as had been hoped in half of all patients. According to this study, many patients had not yet achieved the desired low cholesterol level even after taking the medication for two years.

In addition, cardiovascular disease occurred in 22,798 patients despite taking cholesterol-lowering drugs – even though the drugs had optimally reduced cholesterol levels in 10,656 of these patients, which shows that the prevention of cardiovascular disease should certainly not only be about cholesterol levels.

Lower cholesterol levels without statins and without side effects

Statins do not seem to be the miracle cure after all. And so the question arises as to how the goal – a longer and heart-healthy life – could be achieved in another way, namely one without side effects?

If you were to take the holistic approach instead of taking medication, your cardiovascular risk would be reduced by two or three times. Your blood pressure would also drop, your blood sugar level would be regulated, excess weight would disappear, chronic fatigue would disappear, joint pain would subside, your digestion would improve, your fitness would increase and much more. And all of this without the sword of Damocles of side effects that constantly hangs over your head when you are under conventional medical “care”.

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