Statin enthusiasts are committed to convincing patients that these cholesterol-lowering drugs do not cause side effects. The United States Preventive Services Task Force (USPSTF) published statin guidelines in JAMA (Aug. 23/30, 2022). These experts concluded that statins are unlikely to cause serious side effects such as diabetes or muscle pain. Then the Cholesterol Treatment Trialists’ Collaboration (CTTC) published its assessment of statin side effects in The Lancet (Aug. 29, 2022). The bottom line: reports of most statin side effects are imaginary! Statin “intolerance,” especially symptoms of muscle pain, are not caused by the drugs.
The researchers insist that people who complain about muscle pain, muscle weakness or other musculoskeletal side effects are anticipating such adverse drug reactions. According to these statin advocates, reports of muscle pain after taking drugs like atorvastatin, rosuvastatin or simvastatin are “not due to the statin.” Could it be that statin side effects are a fantasy triggered by a biased press?
Now that there is a “new” cholesterol-lowering drug, bempedoic acid (Nexletol), some doctors are singing a different tune. They are actually suggesting that poeple can be statin “intolerant.” Read on to discover what may seem more than a bit cynical.
The Statin Bandwagon Gathers Steam!
The first statin-type cholesterol-lowering drug was approved by the FDA in 1987. Lovastatin (Mevacor) changed the way doctors treated people with high cholesterol levels.
Since then, this class of medication has dominated prescribing. Physicians have prescribed drugs like atorvastatin (Lipitor), pravastatin (Pravachol), rosuvastatin (Crestor) and simvastatin (Zocor) to tens of millions of patients. Doctors expect that lowering blood cholesterol will reduce the risk of cardiovascular complications such as heart attacks and strokes.
The American College of Cardiology (ACC) recommends preventive statins for people with LDL cholesterol of 190 or over. It also urges doctors to prescribe a statin for anyone with a coronary artery calcium score of 100 (Progress in Cardiovascular Diseases, Nov-Dec. 2022).
Nearly 50 million Americans are currently taking a statin. We suspect that the ACC would like to see that number go up by another 10 or 20 million people. Statins are relatively inexpensive drugs and cardiologists believe it would be unethical to deprive anyone of the chance to reduce their risk of a heart attack.
Statin Side Effects Are Interfering with the Plan:
If these drugs had no side effects, that argument would be compelling. But that is where the controversy really heats up.
When the CTTC published its analysis of statin side effects, it concluded that more than 90 percent of the muscle pain patients report is not due to the statin they are taking (Lancet, Sept. 10, 2022).
That’s why we were surprised to read in the New England Journal of Medicine (March 4, 2023) that as many as 29 percent of statin users report debilitating muscle pain associated with these drugs.
The researchers were singing the praises of the cholesterol-lowering drug Nexletol as an alternative:
“Because the incidence of reports of muscle-related adverse effects in the bempedoic acid group and placebo group was similar, the findings support the use of bempedoic acid as an alternative LDL cholesterol–lowering therapy in patients who are unable or unwilling to take statins.”
The lead author, Dr. Steve Nissen, chair of cardiovascular medicine at the Cleveland Clinic, told the Washington Post (March 4, 2023):
“Statins are still the cornerstone. But if you cannot tolerate statins, and there are millions out there, then we’ve established an effective alternative for reducing morbidity.”
It would appear, now that there is another way to treat high cholesterol, some doctors are admitting that statins do indeed cause intolerable side effects. We have heard from thousands of readers who have suffered from muscle pain and weakness. Too often, prescribers insisted that the drugs were not responsible. Here is just the tiniest tip of the iceberg:
Some Patient Stories:
Kirk shares his belief that statin side effects are real:
“I have tried taking statins a couple of times, and I do not like their effects. To those who argue that a vast majority of people taking statins have no side effects, I find that highly improbable. People simply haven’t linked symptoms with the drug they are taking, because, after all, the drugs are ‘safe and effective’ according to the FDA and doctors. They may never make the connection if they are on several medications.
“My experience with atorvastatin mirrors the experience others have had with statins. While on it, I initially attributed the muscle aches and pains, spasms and personality change to old age. However, when I put 2 + 2 together, I realized it might well be the culprit, and I stopped taking it.
“While I was taking it, I felt like an 80 year-old (I was 61 at the time); my fasting blood sugar went into the abnormal range; and I had nocturnal muscle spasms. I even lost some range of movement in my left arm (I have regained that dexterity since stopping taking a statin). The worst effect for me was that I became negative and grouchy. I hated everything, and I didn’t like myself. My memory also became less reliable.”
Tafari was a gym rat until…
“I was on a statin and lost my ability to run long distances, then to jog or even walk long distances (3 miles or more) due to muscles cramping and lungs feeling like they were on fire. Although I tried to continue going to the gym and do weightlifting like before taking statins, my left chest muscles tore away doing simple weights.
“Even worse, I had really bad brain fog. It took 2 years off the meds to recover.”
Deloris was also very active prior to statins:
“When I reported muscle weakness after I took a statin, I was told I was out of shape and should exercise it out of my system. All this after spending 2.5 years in the gym and having abnormal nerve tests and a muscle biopsy that indicated denervation atrophy (muscle wasting).”
Don has trouble climbing stairs:
“About 5 years ago, my doctor put me on a statin. Now after almost 5 years, I still have muscle weakness that I did not have before taking statins even though I exercise. I never know when my knee will collapse. Without a strong banister, I can’t go up or down steps. I also have trouble standing from a sitting position.”
Jake says statin side effects are real:
“About 15 years ago my doctor put me on statins due to a family history of heart disease. I had severe muscle and joint pain, weakness, rash, and neuropathy. The doctor changed brands at least 5 times. I had the same reaction to all brands: pain all over body, down to toes and fingertips. They sent me to different specialists to treat individual side effects, as if these were unrelated.
“The doctor prescribed ibuprofen for pain, antihistamines for rash, etc. Doctors said it couldn’t possibly be statins! I fell down stairs 3 times because my muscles were so stiff. What’s more, I could not rise or walk without assistance. I needed to use a cane and banisters. Eventually I needed a wheelchair.
“Finally, the doctor stopped the statins, but it took a year to walk without assistance. I still have some difficulty with stairs.”
Why Do So Many Doctors Maintain Statin Side Effects Are Imaginary?
We do not understand why doctors feel that they must downplay drug side effects. All one has to do is watch a few drug commercials on television and you will hear a long list of complications associated with pharmaceuticals. It’s not a secret.
The authors of The Lancet study concluded:
“Statin therapy caused a small excess of mostly mild muscle pain. Most (>90%) of all reports of muscle symptoms by participants allocated statin therapy were not due to the statin.”
The authors go on to state that when a patient reports muscle symptoms while taking a statin, they are unlikely to be caused by the drug. The message to patients: muscle pain experienced during statin treatment is mostly imaginary or due to aging and not brought on by the drugs.
The Media Amplifies the Message: Statin Side Effects Are Imaginary:
Hear are some headlines based on these journal articles:
“Many patients stop taking statins because of muscle pain, but statins aren’t causing it, new study says” CNN Health, Aug. 30, 2022
“Statin pills rarely cause muscle pain or problems, study finds” BBC News, Aug. 29, 2022
“Scientists find no association between statins and pain, urge patients to continue taking pills” WISHTV.COM8, Aug. 30, 2022
“Statin myths debunked: Cholesterol-busting pills don’t cause memory loss or diabetes” Daily Mail, Aug. 31, 2022
This is not the first time the media has advanced the message that:
Statin Side Effects Are Not Real
Here are some headlines from 2014:
“Statin Side-Effects Questioned”
“Statins do NOT have major side effects, claims study”
“Statins Have Virtually No Side-Effects, Study Finds”
“Statins have ‘fewer side effects than placebo’, suggests UK study”
These older headlines all resulted from an article published in The European Journal of Preventive Cardiology (March, 2014).
The authors concluded:
“At the doses tested in these 83,880 patients, only a small minority of symptoms reported on statins are genuinely due to the statins: almost all reported symptoms occurred just as frequently when patients were administered placebo. New-onset diabetes mellitus was the only potentially or actually symptomatic side effect whose rate was significantly higher on statins than placebo; nevertheless, only 1 in 5 of these new cases were actually caused by statins.”
Do Statin-Type Cholesterol-Lowering Drugs Cause ANY Side Effects?
So, what are we to make of all this? Clearly, the media has announced to the world that statin-type drugs do not cause side effects. Reporters have gone so far as to suggest that sugar pills (placebos) cause more complications than statins.
In other words, if you think your atorvastatin (Lipitor), lovastatin (Mevacor), rosuvastatin (Crestor) or simvastatin (Zocor) could be responsible for your muscle pain, weakness, mental confusion, elevated blood sugar, nerve discomfort or cataracts, you are wrong. Such symptoms are all in your head. The only possible drug-induced complication of statins (according to these authors) is diabetes. Even that is questionable, according to the United States Preventive Services Task Force.
The press has pretty much ignored a section in the article in the European Journal of Preventing Cardiology titled: “Comparison with real-live clinical experience.”
The authors admit that:
“Many real-world patients report muscle-related symptoms with statins. This contrasts with the low placebo subtracted rate in blinded trials shown in this meta-analysis. Several explanations are possible. First, commercial sponsors of clinical trials may not be motivated to search exhaustively for potential side effects…Second, many trials do not state clearly how and how often adverse effects were assessed…”
This is a really important caveat. Other researchers have noted that “myopathy” (muscle pain, cramps and weakness) has been defined in all sorts of different ways in statin clinical trials. In some cases, it was restricted to enzyme elevation. In other words, a patient might suffer pain, but if their enzyme levels were within “reasonable” limits, this might not be counted as actual myopathy.
Increased Muscle Pain:
An article in BMJ (October 22, 2013) noted that “the prevalence of muscle pain in statin users is 50% greater than in non-users. In absolute terms, this increase in muscle pain is 100 times greater than that reported in clinical trials…”
Put another way, the gold-standard randomized controlled trials that were analyzed in journal articles may not have collected accurate data about muscle pain and weakness. The authors even admit that such studies may have underestimated the true incidence of new cases of diabetes attributable to statins (1 in 5 patients).
As they point out:
“This means that, of all new diabetes diagnoses on statins, 20% were directly pharmacologically attributable to statins…[though] new diagnosis of diabetes was only documented in three of the 29 trials.”
Read between the lines and you will immediately realize that this serious complication of statin therapy was completely missed by the vast majority of clinical trials.
See No Evil, Speak No Evil:
Think of it this way. If you are not looking for something, you may not find it. We cannot tell you how many adverse drug reactions have been overlooked over the decades because researchers did not make a connection.
Statin Side Effects Are Real…or Imaginary?
People’s Pharmacy Analysis:
Randomized clinical trials, especially those designed to obtain FDA approval, are not really set up for detecting adverse drug reactions. As a result, they don’t do it very well. They are really designed to demonstrate drug effectiveness rather than risk. A little-realized fact about such trials is that the way in which side effect information is collected may actually affect the study results.
This was revealed in a landmark report by Jerry Avorn, MD, and his colleagues in a fascinating study titled: “Differences in Adverse Effect Reporting in Placebo Groups in SSRI and Tricyclic Antidepressant Trials: A Systematic Review and Meta-Analysis” (Drug Safety, Nov. 2009).
Dr. Avorn and his co-authors concluded that:
“Conclusion: Adverse effect profiles reported in clinical trials are strongly influenced by expectations from investigators and patients. This difference cannot be attributed to ascertainment methods. Adverse effect patterns of the drug group are closely related to adverse effects of the placebo group. These results question the validity of the assumption that adverse effects in placebo groups reflect the ‘drug-unspecific effects’.”
In other words, the side effects reported in the placebo groups were seemingly affected by the kind of antidepressant being studied. If the drug itself caused dizziness, constipation and dry mouth in a high proportion of patients, the people getting the placebo in that trial magically had a high incidence of dizziness, constipation and dry mouth.
Doctors might conclude, as a result, that since the symptoms were similar for both the placebo group and the drug group, there is no difference between them. But this is a trap. By comparing the side effects experienced only by people taking placebos in antidepressant trials, the truth was revealed. You would imagine that people getting inactive placebos for the same condition (depression) would have similar side effects. But Dr. Avorn’s study shows that the placebo side effects vary enormously depending upon the type of antidepressant being studied.
Priming the Pump:
There is another often-ignored factor that may skew results in clinical trials. If the investigators ask all the patients in a clinical trial if they have experienced a headache, a lot of people will say yes. Just priming the pump, so to speak, can trigger an affirmative answer. That’s true for both the placebo arm as well as the drug arm. Headaches are quite common and asking about them can get people thinking about the possibility of a recent headache.
We suspect that this may also be relevant for statin trials. If researchers influence side effect reports by the way they ask the questions or collect the data, it may be more difficult to determine the true incidence of adverse reactions to statins. We find it difficult to imagine that statins actually have no side effects. What do you think?
Here are some complications listed in the official prescribing information:
STATIN SIDE EFFECTS:
Muscle aches, muscle cramps, muscle pain, spasms:
(anywhere in the body, including legs, shoulders, back, arms or neck)
Arthritis, joint pain, joint stiffness
Abdominal pain, digestive upset, nausea, diarrhea, flatulence
Blood sugar elevation, diabetes
Sore throat, flu symptoms, sinusitis
Itching, rash, hives
Liver damage, liver failure, kidney damage
Insomnia, sleeping difficulties, nightmares
Forgetfulness, memory problems, amnesia, confusion, cognitive dysfunction
Peripheral neuropathy, nerve tingling, nerve burning
Sexual problems, erectile dysfunction, low libido
What Do You Think?
We would love your feedback. Tell your story below. To read others, click here. Many of the comments you will read below were posted after the original article was published in The European Journal of Preventive Cardiology (March, 2014). Now that there are new articles published in JAMA (Aug. 23/30, 2022) and in The Lancet (Aug. 29, 2022) discounting statin side effects, we suspect that many physicians will dismiss reports of adverse reactions to statins.
Please share your experience with statins in the comment section. If you have never experienced any adverse reactions we want to hear from you. That is also true if you believe that statin side effects are real.
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We are pleased that medicine is finally recognizing patient suffering linked to statins. Hopefully, bempedoic acid will prevent heart attacks without causing undue harm. We find it sad, though, that it took a newer drug with fewer side effects to get some doctors to admit that there is such a thing as statin “intolerance.”