The Lancet is the leading medical journal in Great Britain. Actually, it’s one of the most respected medical journals in the world, so when they publish a study you can be certain it is evidence-based and scientifically sound. Recently, they published a large study on the adverse effects of statin drugs. The researchers compiled information from 23 large studies involving 154,000 patients, and identified 66 non-muscle “outcomes” that labels and package inserts claimed are caused by statins. What that means is these 66 adverse effects had been reported by patients during the 23 clinical trials they reviewed.
Statin drugs have a history of being blamed for all kinds of adverse effects. Many physicians have questioned these claims and have had doubts about their validity. Complaints such as “cognitive problems, depression, sleep issues, kidney injury, sexual dysfunction, liver disease, and many others” have been alleged.
Of the 66 undesirable outcomes identified in this study, only four were found to occur at a frequency which could be considered of concern. Those four were abnormal liver enzymes, mild proteinuria (the loss of protein in the urine), swelling of the lower extremities, and other liver function test abnormalities. The risk for these 4 outcomes was a mere 0.2% annually, meaning even these 4 were not very common.
The study very importantly found “no causal link between statins and commonly assumed adverse effects including cognitive impairment, memory loss, dementia, depression, anxiety, sleep disturbance, peripheral neuropathy, acute kidney injury, or sexual dysfunction.” Researchers were unable to prove that statins were the cause of the problems patients were having. In fact, many of the 66 adverse events were found to almost never occur.
Liver enzyme elevations, the most common adverse event, were more likely to occur when higher doses of the more potent statins were prescribed. It was thus a “dose-response relationship.” The higher the intensity (strength) and dose of statin, the more the liver enzymes were affected. But jaundice, liver failure, and hepatitis—serious liver problems—were not reported leading researchers to conclude that liver enzyme elevations were “biochemical laboratory abnormalities rather than clinically significant liver disease.” In other words, statins merely have a chemical irritant effect, not a true inflammatory effect. Thus, patients need not worry statins are “damaging” their liver. The enzyme elevations are reversible with lower doses or intensity or discontinuation of the drug.
Statins have had a considerable impact on cardiovascular disease and deaths. Therefore, the authors went to considerable lengths to point out the major benefits of statin therapy. One such comment stated that “moderate-intensity statin use for 5 years would typically prevent about 1000 major vascular events per 10,000 patients who had known cardiovascular disease and about 500 per 10,000 high-risk patients without prior events.” Meaning that while the patient is complaining about some adverse event he thinks is caused by the statin, it is continually “behind the scenes” working to slow or stop the progression of arteriosclerosis and prolong the patient’s life.
This study proves the nocebo effect and also shows how susceptible many patients are to suggestion. (The Nocebo effect is the negative reaction a patient feels in anticipation of, or beginning, a new drug or treatment and is responsible for most of the 66 adverse effects blamed on statins.) The authors state “We hope this research will help people better understand that the substantial benefits of statins in preventing cardiovascular events…..far outweigh their risks….we hope this [research] will help both patients and clinicians make informed decisions about statin therapy.”
Dr. G’s Opinion: For the almost 40 years statins have been in use, I was always skeptical of the many adverse effects patients thought they were having. I tried hard to get patients to continue these drugs despite their complaints. Over the long term, however, patients have gained many positive benefits from continuing statins. They just didn’t realize it, choosing to focus on the minor annoyances statins allegedly cause rather than prolongation of life. When an adverse event, such as sudden cardiac death, doesn’t happen, we don’t actually realize how a statin is helping us, until we compare the number of sudden deaths that occurred in 2000 to the number in 2025. The decline is remarkable.
Reference: Levine LA. Good News for Patients Worried About Statin Side Effects: Study finds most never happen. Medscape 2026 February 9.
