Study: Statin drug benefits understated, risks overstated


Fears over potential side effects of taking statin drugs to lower cholesterol are overblown, say researchers, and for some patients may obscure the much larger benefits of preventing heart attack or other adverse cardiovascular health event.

While side effects are possible from statin drugs, researchers at the University of Oxford report in a new study the benefits of the drugs are being undersold while side effects developed by some patients can be correctly simply by halting use of the drug.

The point, they say, is that accepting the risk of side effects — myopathy, new-onset diabetes and, possibly, hemorrhagic stroke — that occur in a very small number of patients is worth the longer term benefit of the drug on heart attacks, strokes and other vascular health events.

Observational studies have claimed statins increase risk for memory loss, cataracts, kidney injury, liver disease, sleep disturbance, aggression, suicidal desire, erectile disjunction and neuropathy. Evidence from the researchers’ recent review, however, does not link the health effects to statins.

“The best available scientific evidence tells us that statins are effective, safe drugs that have a crucial role in helping prevent cardiovascular disease: the leading cause of morbidity and mortality worldwide,” Liam Smeeth, a professor at the London School of Hygiene and Tropical Medicine, said in a press release.

For the study, published in the journal The Lancet, the researchers reviewed about 30 years of trials, both randomized, controlled ones where patients and doctors are unsure who is actually on a drug, as well as observational studies where patients know they are on the drug and are aware of side effects.

For randomized trials, the researchers said the benefits compared to side effects are generally favorable for most people on the drugs.

Treating 10,000 patients with the drugs would, over the course of five years, prevent about 1,000 major cardiovascular events such as heart attacks, ischaemic strokes and artery bypasses in patients at high risk and another 500 in those who are at increased risk. At the same time, about five cases of myopathy, five to 10 haemmorhagic strokes, 50 to 100 new cases of diabetes and up to 50 to 100 cases of symptomatic adverse events.

In patients participating in observational studies, the rate of side effects increases, most notably in myopathy and other symptomatic adverse events, but some portion of this has to do with patients being more aware of the potential and paying attention for them.

Overall, however, the researchers say statin drugs are not only overwhelmingly safe, but effective at improving health conditions.

“Our review shows that the numbers of people who avoid heart attacks and strokes by taking statin therapy are very much larger than the numbers who have side-effects with it,” said Rory Collins, a researchers at the University of Oxford. “In addition, whereas most of the side-effects can be reversed with no residual effects by stopping the statin, the effects of a heart attack or stroke not being prevented are irreversible and can be devastating. Consequently there is a serious cost to public health from making misleading claims about high side-effect rates that inappropriately dissuade people from taking statin therapy despite the proven benefits.”