There has been a lot hype in the media recently commenting on the many risks associated with the use of statins in lipid-lowering therapy. Some of the risks include liver damage, increased blood glucose, rhabdomyolysis, and memory loss.
But a new study published in the September 2016 edition of the Lancet, entitled Interpretation of the evidence for the efficacy and safety of statin therapy by Collins et al., found that the potential harms with statins have been grossly exaggerated and misleading and that the benefits on health outcomes have been underestimated.
The study looked at 10,000 patients who used atorvastatin 40 mg once daily for 5 years. They found that for every 1mmol/L reduction in LDL made using the statin therapy, the risk of coronary deaths, heart attacks and strokes were reduced by approximately 25% for every year the drug was taken after the first year. When used for primary prevention, statins were found to prevent a heart attack, stroke, and coronary bypass for 500 out of every 10,000 patients over a 5-year period. It also found that using statins would prevent major cardiovascular events in 1,000 out every 10,000 secondary prevention users.
The study also found that among the sample of 10,000 patients on atorvastatin, only 5 patients developed myopathy, 5-10 developed hemorrhagic strokes and 50-100 developed a new case of diabetes. These risks were found to be fairly low in incidence relative to the potential life-saving benefits conferred by the use of statins.
The study commented on the serious cost to public health as a result of the misleading claims about the safety and efficacy of statin therapy that may have led to under-prescribing and reduced patient compliance.
In 2014, Canadian researchers published a study that linked statins to higher diabetes risk, while a 2013 study in the JAMA Internal Medicine Journal found that statins were closely tied to muscle pain and damage.
The Lancet review comments on the serious design flaw with previous studies and the exaggerated risks they portrayed. For example, many of these studies were observed in nature, and the patients receiving the statin were made aware that they may experience muscle pain from the drug they were being given. This could lead to inherent bias as patients could attribute their aches to the drug, even though it may not be the cause.
Furthermore, a study in Denmark found that seeing negative news stories on the risks associated with statin use increased the chance of a patient stopping statin therapy by 10%. The PURE study conducted across 22 countries in 2016 showed that 66% of patients aged 35-70 with CVD were on a statin in high-income countries like Canada, yet only 27% in middle-income countries like Turkey and Brazil.
The bottom line is that patients should be educated to make informed decisions. While there are potential risks associated with statins, they should be put into context and a thorough benefit versus risk analysis should be conducted to determine the appropriateness of therapy.