Are Statins Safe?
There are few topics out there that touch such a raw nerve like the topic of “statins”. I probably spend half my day discussing the pros and cons of statin therapy (I spend the other half trying to convince people that controlling cholesterol is even important).
But what really are these compounds, and why do they have such a bad reputation?
“Statins” are a class of medication called HMGCoA Reductase Inhibitors. What does THAT mean? It means that they inhibit an enzyme that is used by the liver to create cholesterol molecules. By turning off this enzyme, we fool the liver into thinking that it doesn’t have as much cholesterol as it wants. So the liver responds by activating pathways to pull more cholesterol OUT of the blood stream (increasing LDL receptors).
The end result: We have less cholesterol in our blood stream, which means there is less that can accumulate in the walls of our arteries.
This is actually genius! And guess what? It has always been recognized as genius: In 1964 Konrad Bloch and Feodor Lynen received the Nobel Prize for identifying this complex biosynthetic pathway of cholesterol. And in 1985 Michael Brown and Joseph Goldstein won the Nobel Prize for their discovery of the LDL Receptor, explaining how cells regulate cholesterol, ultimately leading to statin development. The scientist Akira Endo is actually credited with discovering statins, which were naturally found in some molds, and while he won a lot of awards, he never won the Nobel for his discovery.
At this point in time, statins are the most well-studied class of drugs in the history of medicine. There have been over 250,000 patients studied in randomized, controlled clinical trials. There are actually 7 different statins; each has different chemical structure, and as a result they are all handled and metabolized by the body very differently.
Decades of research have shown that 90% of people have NO side effects from statins, and that 98-99% of people are able to find a statin that doesn’t cause them side effects.
Yet people still believe that they always cause side effects and that the side effects are terrible, and therefore are afraid of these medications.
Recently, a study was published that looked at statin side effects. This study combined the results of 19 randomized controlled trials of almost 125,000 people and was notably NOT funded by “Big Pharma”. It was funded by the British Heart Foundation, UK Medical Research Council, and Australian National Health and Medical Research Council.
The study asked the question: Do the many “potential side effects” listed in official product labels for statins actually show up as side effects in the most reliable form of evidence: large, double-blind randomized trials?
What they found was that out of 66 “potential side effects”, only 4 were statistically related to statin use: Abnormal liver function test abnormalities, alteration in urinary composition, and edema. Additionally, only the liver enzyme abnormalities were really convincingly caused by statin use, as there was a “dose-response” effect (meaning that the incidence of abnormal liver enzymes went up as the dose of the statin went up). But while these researchers showed that these side effects really can happen, the absolute risks were very small, on the order of <0.1% per year excess for each outcome.
In this analysis of blinded, randomized controlled trial evidence, most possible side effects were NOT supported as being caused by statins.
Importantly, the rates of cognitive decline, depression, sleep disturbance, peripheral neuropathy, & sexual dysfunction were similar on statin vs placebo in these trial datasets.
Statins are extremely safe, and we have a lot of experience with them. They have been on the market since 1987, when the first one (lovastatin) was approved for use by the FDA. In that time (almost 40 years!), there has never been any sign of an increase in any horrible outcome.
What are the real risks?
After nearly 40 years of use, we can say with high confidence that statins have a small number of real but uncommon risks:
- Muscle injury (myopathy) – rare, but real
- New-onset diabetes – modest increase, mostly in people already at risk
- Mild liver enzyme elevations – usually dose-related and reversible
The diabetes risk is often misunderstood. In people with pre-diabetes, treating ~250 patients for 4–5 years leads to one additional case of diabetes, while preventing 10–20 heart attacks or strokes over the same period. That is a trade most clinicians—and most patients—would accept.
Severe liver injury from statins is exceptionally rare—on the order of 1–2 cases per 100,000 person-years.
By contrast:
- Acetaminophen (Tylenol) overdose is the leading cause of acute liver failure in the U.S., responsible for ~50% of cases and tens of thousands of emergency visits annually.
- Herbal and dietary supplements now account for a rapidly growing share of drug-induced liver injury—rising from ~7% of cases in the mid-2000s to ~20% in more recent data. The majority come from non-bodybuilding products such as turmeric, green tea extract, and weight-loss supplements.
In other words, substances often perceived as “natural” or “safe” cause far more liver harm than statins.
Statins have never been shown in randomized trials to worsen memory. Rare anecdotal reports exist, but when symptoms occur, they are typically reversible.
This research study hopes to reframe the conversation about statins: Many feared symptoms are not reliably attributable to statins when expectation and confounding are removed.
The bottom line
Statins are remarkably safe, extraordinarily well-studied, and highly effective at preventing heart attacks and strokes. When expectation bias and confounding are removed, most feared side effects simply do not hold up.
They are not perfect—but few therapies in medicine offer as much benefit for such a small and well-characterized risk.
At Wisconsin Cardiology Associates, we have specialized and advanced training in cholesterol management. If you need to be on cholesterol medication or just aren't sure, come for a consultation and we can help you find the best option for your situation.
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