Most listed statin side effects not backed by evidence: Study

Only a fraction of the listed side effects for statins, one of the world’s most prescribed medications, are backed by evidence, according to the results of a large-scale review published this month in The Lancet.
 
Using data from 23 randomised trials involving the most common statins, researchers found only four of 66 listed statin side effects are supported by evidence, alongside previously known side effects of muscle pain and increased diabetes risk.
 
These include liver test changes, minor liver abnormalities, urine changes, and tissue swelling, with the associated risks ‘very small’, according to the article authors.
 
Authors of the study say the analysis is the most comprehensive review of adverse effects of the cholesterol-lowering medication.
 
They only considered trials if they included at least 1000 participants and involved a treatment period of at least two years, as well as a double-blind comparison.
 
‘What we have found is there’s 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.
 
‘This includes, for example, no increase observed in memory loss, depression, sleep disturbance, erectile dysfunction, weight gain, nausea, fatigue, or headache.
 
‘This means that we now have really good evidence that although these things may well happen when people are taking statins, statins are not the cause of these problems.’
 
She said the study is further evidence the benefits of statins in reducing heart attacks and strokes ‘significantly outweigh their risks’.
 
Co-author Professor Anthony Keech, the Director of Cardiovascular Research at the National Health and Medical Research Council (NHMRC) Clinical Trials Centre at the University of Sydney, said the study has important implications for both doctors and patients.
 
‘It means that patients shouldn’t consider stopping their statins without clear discussions with their doctors as to why they’re worried about that,’ he said.
 
‘But the second thing is that when the focus is targeted on the statins as the explanation for a symptom, it prevents the doctor and the patient actually finding the real cause of that problem.
 
‘So, if someone has depression or erectile dysfunction, then don’t look at the statin – go and find the real cause and treat it effectively.
 
‘Taking away the focus from statins as the explanation for all of these things and refocusing on the real causes of the symptoms that the patients suffer can give them an opportunity to actually have them fixed.’
 
The research is part of Cholesterol Treatment Trialists’ Collaboration, a joint project run by Oxford Population Health, and the NHMRC Clinical Trials Centre at the University of Sydney.
 
Its researchers have previously reported that the medication likely causes muscle symptoms in around 1% of people, mostly during the first year of treatment.
 
They also found statins can cause a small increase in blood sugar levels, which can lead to people already at high risk of diabetes developing the condition sooner.
 
Statin drugs are among the most widely taken medications in Australia, with rosuvastatin and atorvastatin topping the list of the most prescribed drugs under the Pharmaceutical Benefits Schedule and Repatriation Pharmaceutical Benefits Scheme in recent years.
 
The Lancet article authors say many of the potential treatment-related effects listed so far are ‘based mainly on non-randomised and non-blinded studies, which might be subject to bias’.
 
While previous studies have also raised questions about evidence for many side effects, authors said doubts still remained.
 
‘Unfortunately, there’s been ongoing confusion and concern, not only in patients, but also doctors, regarding potential statin side effects,’ Associate Professor Reith said.
 
‘And this has led to many people not being willing to start statins or stopping them, even if they’re at high risk of an event such as a heart attack or stroke, and hence might benefit from them.
 
‘We hope this prompts calls for revision of statin drug labels and related health information available through other sources to enable doctors and patients to make informed decisions in the future.’

Log in below to join the conversation.

cardiovascular high cholesterol statins