Statins don’t cause the majority of ‘side effects’ on the label

The cholesterol-lowering drugs statins do not cause the vast majority of so-called “side effects” listed on their packaging, including memory loss, sexual dysfunction and depression, a major review of the most robust evidence shows.

The findings of a meta-analysis published on Friday shatter the diehard misinformation responsible for tens of thousands of Australians stopping or refusing to start taking the life-saving medication, leading to potentially preventable heart attacks and strokes.

The UK- and Australia-led research team behind the meta-analysis now wants regulators to change the drugs’ labels.

Their meta-analysis compiled 19 randomised double-blind controlled trials that compared the effects of statins, and four trials comparing more and less intensive statin regimens. The analysis included more than 154,000 participants and 38 million symptom reports.

“We found there is no significant excess risk with statins for almost all the conditions listed in statin package leaflets as possible side effects,” said lead author, Associate Professor Christina Reith at Oxford Population Health.

There was no increase in memory loss or dementia, depression, sleep disturbance, erectile dysfunction, weight gain, nausea, fatigue or headache, and several other conditions, the Cholesterol Treatment Trialists’ Collaboration reported in The Lancet on Friday.

“We can say now that statins are not the cause of the vast majority of medical issues listed as potential side effects in statin patient information leaflets, and this means that the benefits of statins in reducing major events like heart attacks and strokes significantly outweigh their risks,” Reith said.

“That’s not to say that people taking statins don’t or didn’t experience these symptoms – some of them did,” Reith said, but they were not more likely to experience these symptoms than those who did not take the medication.

For example, the proportion of people reporting cognitive or memory impairment each year was 0.2 per cent in both groups.

An estimated 6.5 million Australians have high cholesterol. More than 2 million Australians are prescribed statins, which work by lowering levels of low-density lipoprotein (LDL), or bad cholesterol, to significantly reduce the risk of heart attacks, stroke and other conditions when prescribed in line with clinical guidelines.

Anthony Keech, a co-author, cardiologist and Professor of Medicine, Cardiology and Epidemiology at the University of Sydney, said blaming statins for a patient’s symptoms stops doctors and patients from finding the real cause of the problem.

“If someone has depression or erectile dysfunction, then don’t look at the statin, go and find the real cause and treat it effectively,” Keech said.

The meta-analysis found a small increased risk (about 0.1 per cent) for liver blood test abnormalities with statins, but no increase in liver disease, such as hepatitis or liver failure.

Reith said the team had discussions with national regulators to revise statin drug labels and information leaflets. The Therapeutic Goods Administration has been contacted for comment.

Professor Garry Jennings, chief medical adviser at the Heart Foundation, said people’s decisions about whether to take statins were being driven by conversations with friends and relatives at pubs and barbecue.

“As soon as you say ‘I’m on a statin’, someone’s going to say, ‘Oh, my God, I had terrible muscle pains’ or something like that,” Jennings said.

He pointed to several studies that found disinformation or misinformation in media reports about statins’ side effects had led to an increase in heart attack rates after people stopped taking their statins.

One study found a 2013 ABC report critical of statins – subsequently removed for breaching impartiality standards – led to an immediate 2.6 per cent drop in statins dispensing, roughly 60,897 fewer Australians taking statins over eight months and a projected 1500-2900 preventable and potentially fatal heart attacks and strokes over five years.

“The potential for this disinformation to actually cost lives is there and really important,” Jennings said.

One line of questioning Keech poses to patients hesitant about statins: “Do you want to see your kids get married? Do you want to be around for the grandkids?”

“Well, please keep taking your statin because it’s so important to you still being here in a good condition, no strokes, no disability, no heart failure, no more heart attacks,” he tells them.

The collaborative previously reported that statins caused muscle symptoms in only 1 per cent of people, largely during the first year of treatment, and a small increase in blood sugar levels, so people already at high risk of diabetes may develop the condition sooner on statins.

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