Benefits of Statins Outweigh the Harm from Adverse Events

Pavankumar Kamat


July 20, 2021


  • A meta-analysis found that statin use was associated with an increased risk of self-reported muscle symptoms, liver dysfunction, renal insufficiency and eye conditions.

  • However, the increased risk of adverse events (AEs) did not outweigh the reduction in cardiovascular disease events.

Why this matters

  • Findings indicate that the benefit-to-harm ratio favours the use of statin for primary prevention of cardiovascular diseases.

Study details

  • UK researchers conducted a systematic review and meta-analysis of 62 randomised controlled trials (RCTs).

  • Primary outcome: AEs including muscle problems, liver dysfunction, eye conditions, diabetes and renal insufficiency.

  • Funding: British Heart Foundation.

Key results

  • Overall, included studies comprised 120,456 participants with a mean follow-up of 3.9 years.

  • Statin use was associated with an increased risk of:

    • self-reported muscle symptoms (OR, 1.06; 95% CI, 1.01-1.13; I2, 1%);

    • liver dysfunction (OR, 1.33; 95% CI, 1.12-1.58; I2, 0%);

    • renal insufficiency (OR, 1.14; 95% CI, 1.01-1.28; I2, 0%); and

    • eye conditions (OR, 1.23; 95% CI, 1.04-1.47; I2, 0%).

  • However, statin use was not associated with

    • clinically confirmed muscle disorders (OR, 0.88; 95% CI, 0.62-1.24; I2, 0%); or

    • diabetes (OR, 1.01; 95% CI, 0.88-1.16; I2, 50%).

  • Statins significantly reduced (P<.001 for all) the risk of

    • myocardial infarction (OR, 0.72; 95% CI, 0.66-0.78; I2, 33%);

    • stroke (OR, 0.80; 95% CI, 0.72-0.89; I2, 20%); and

    • death from cardiovascular disease (OR, 0.83; 95% CI, 0.76-0.91; I2, 27%).


  • Some analyses may be underpowered.

  • Results may not be generalisable to the primary prevention population.


Cai T, Abel L, Langford O, Monaghan G, Aronson JK, Stevens RJ, Lay-Flurrie S, Koshiaris C, McManus RJ, Hobbs FDR, Sheppard JP. Associations between statins and adverse events in primary prevention of cardiovascular disease: systematic review with pairwise, network, and dose-response meta-analyses. BMJ. 2021;374:n1537. doi: 10.1136/bmj.n1537. PMID: 34261627.  View full text

This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.


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