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Statins: Safe, Well Tolerated and Effective

June 7, 2007

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Amidst all the warnings and alarms about unforeseen side effects of popular drugs, a new study adds further evidence that statins, used to reduce cholesterol, are both safe and effective.

A review published early online and in an upcoming edition of The Lancet finds that statins are safe, well tolerated, and have a proven impact on cardiovascular disease.

Dr Jane Armitage, Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, UK, did a comprehensive review of research published between 1985 and 2006 studying the safety, efficacy, and side effects of statins.

Given at standard daily doses (which vary between different types), statins typically reduce LDL cholesterol by 30-45% in the blood. Six statins are available in most parts of the world: lovastatin, simvastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin.

Dr Armitage says: “Since statins were first approved in 1987, their ability to reduce the risks of vascular death, non-fatal myocardial infarction, stroke, and the need for arterial revascularisation has been shown by several large, high-quality randomized trials.”

The review says that adverse effects from some statins on muscle, such as myopathy (pain/weakness) and rhabdomyolosis (breakdown of muscle) are rare at standard doses.

Myopathy occurs in fewer than one in 10,000 patients at these standard doses. Adverse side effects on the liver, from increasing levels of transaminases associated with statin use, are also rare.

Also examined is the safety of statins in vulnerable groups, such as the elderly, patients who consume excess alcohol or are on warfarin.

There is no evidence to suggest people consuming excess alcohol are at greater risk of side effects from statin use, however the review warns that many such people were excluded from statin trials. Warfarin users may need to adjust the amounts of warfarin they take when statin treatment begins and again when it ends.

Evidence suggests no adjustment of dosage is needed for the elderly, since people aged up to 80 years were recruited in the various trials. However the Review cautions that the very elderly may at increased risk of myopathy.

Dr Armitage concludes: “Statins are a well-tolerated and extensively studied group of drugs. Their proven impact on cardiovascular disease risk has been driving their widespread use.

“With a few caveats and while awaiting good quality randomized data for the newer drugs, statins seem to be a remarkably safe group of drugs when used at their usual doses.”

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