For many patients grappling with high cholesterol, the decision to start statin therapy isn’t straightforward. Concerns about potential side effects, often detailed in lengthy package inserts and discussed during doctor’s visits, can create significant barriers. But a new analysis published , offers reassurance, suggesting that many commonly feared side effects associated with these widely prescribed medications are not supported by reliable evidence.
Statins are a cornerstone of preventive cardiology, working by reducing levels of low-density lipoprotein (LDL), often referred to as “bad” cholesterol, and preventing the buildup of plaque in arteries. This, in turn, lowers the risk of heart attacks and strokes. Generic versions of statins are also relatively inexpensive, costing around $40 per year in the United States.
The new meta-analysis, published in The Lancet, reviewed data from 19 large randomized clinical trials involving over 122,000 people. Researchers examined 66 potential adverse health outcomes listed as possible side effects of statins. The findings revealed that strong evidence supported only four: changes in liver tests, minor liver abnormalities, changes in urine tests, and tissue swelling. These risks, the authors emphasized, are very small.
“What we found is there’s no significant excess risk with statins for almost all the conditions listed in statin packaging as potential side effects,” said Christina Reith, associate professor at Oxford Population Health and lead author of the study, in a media briefing. The analysis showed no increased risk for a wide range of conditions, including memory loss, depression, sleep disturbance, erectile dysfunction, weight gain, nausea, fatigue, and headache.
The study’s findings challenge the perception that statins are inherently dangerous. While acknowledging that some individuals may experience muscle pain or a slight increase in blood sugar levels, the researchers found that these issues are relatively uncommon. Muscle pain affects approximately 1% of people taking statins, and the increase in blood sugar is most often observed in those already close to the diagnostic threshold for type 2 diabetes.
The authors recognize that drug labeling requires listing potential harms, even if the evidence is limited. Kausik Ray, a professor of public health at Imperial College London who was not involved in the study, noted that warning labels often stem from post-marketing observations without a control group, which can be biologically misleading.
The findings come as updated guidelines for statin use are expected from the American College of Cardiology and the American Heart Association in the second quarter of . These guidelines are based on new equations, known as PREVENT, which estimate cardiovascular risk over a 30-year period, rather than the more traditional 10-year timeframe.
A recent analysis applying these 30-year estimates found that 9% of adults aged 30 to 59 had an estimated risk of heart attack or stroke of 20% or greater, potentially qualifying an additional 2.5 million adults for statin therapy. Another 44% were found to have an intermediate risk, suggesting they might also benefit from earlier intervention.
Timothy Anderson, a primary care physician and assistant professor of medicine at the University of Pittsburgh Medical Center, explained that the question isn’t just whether statins reduce relative risk by about 25%, but *when* to start them. “Is it worth it to start it when you’re 40, or is it fine to wait 10 years until that 10-year risk has crept up?” he asked.
Despite the clear benefits and the growing body of evidence supporting their safety, statins continue to be plagued by public reluctance. This hesitancy extends to other long-term medications, like those for blood pressure and obesity, but fears surrounding muscle soreness and a rare condition called rhabdomyolysis have been particularly persistent with statins.
Rhabdomyolysis, a serious condition involving muscle tissue breakdown, is rare. Should it occur, alternative cholesterol-lowering agents are available. The Lancet analysis confirmed that statins caused only a 0.1% increased risk of abnormal liver blood test results, without increasing the incidence of liver diseases like hepatitis or liver failure. Similarly, there was no increase in abnormal urine test results.
“We were able to show there’s been no increase in memory loss, depression, sleep disturbance, erectile dysfunction, weight gain, nausea, fatigue or headache, and numerous other conditions,” Reith said. “That’s not to say that people taking statins did not experience these medical events. We now have really good evidence that although these things may well happen to people while they take statins, that statins are not the cause of these problems.”
experts emphasize the importance of open communication between doctors and patients. Building trust and addressing individual concerns are crucial for overcoming hesitancy and ensuring that those who could benefit from statin therapy receive it. As Rory Collins, emeritus professor of medicine and epidemiology at Oxford Population Health, recalled, even a physician was initially questioned about the potential side effects by his own general practitioner.
“The GP said to me, ‘are you sure? What about all the nasty side effects?’” Collins recounted. “So this is happening all the time. This is why doctors and their patients are not starting these treatments. And it’s why patients are at high risk of having a heart attack or stroke.”
