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Benefits of statins outweigh risk of adverse events, study finds

Heart in hand

By Rebecca Jenkins
Freelance Journalist

27 Jul 2021

The benefits of statins for primary cardiovascular disease (CVD) prevention outweigh a small risk of adverse events, a large meta-analysis finds.

Although the efficacy of statins in preventing CVD had been well defined, their potential adverse effects had been inconclusive, researchers wrote in the BMJ.

Analysing 62 randomised controlled trials of 120,456 adults without a history of CVD, they found statins were associated with a small increased risk of self-reported muscle symptoms, liver dysfunction, renal insufficiency and eye conditions, but were not associated with clinically confirmed muscle disorders or diabetes.

The absolute risk equalled 15 more events of self-reported muscle symptoms, eight more of liver dysfunction, 12 more of renal insufficiency and 14 more of eye conditions per 10,000 patients treated with statins for a year, compared with controls.

The increased risk did not outweigh the reduction in the risk of major cardiovascular events, the researchers concluded, with statins estimated to prevent 19 heart attacks, nine strokes, and eight deaths from CVD per 10,000 patients treated for a year.

‘The low risk of adverse events caused by statins reported in this review should reassure patients and physicians that the potential harms of statins are small and should not deter their use for primary prevention of cardiovascular disease,’ they wrote.

‘In particular, given the observed benefits of treatment in preventing major cardiovascular events, the slightly increased risk of self-reported muscle symptoms, which have no confirmed effect on physiological function, should not delay starting treatment with statins.’

Their analysis showed a smaller absolute increased risk of muscle symptoms than reported in observational studies, they noted, supporting the view that ‘most muscle symptoms reported by users of statins are nocebo effects and not actually caused by statins’.

If a patient experienced muscle symptoms after starting therapy, they recommended looking at patients’ misconceptions about statin intolerance and considering behavioural interventions to minimise unnecessary treatment withdrawal.

‘The increased risk of liver dysfunction with statins suggests that routine monitoring of liver function during treatment is probably warranted in primary prevention, as recommended by the manufacturers in the statin product information,’ the study authors concluded.

However, the data did not support tailoring the type of statin or dosage to reduce adverse events in patients taking statins for primary CVD prevention.

It comes after a study two years ago found that the benefits of statins for primary prevention in healthy patients were unclear and a ‘waste of healthcare resources’ in some cases.


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