Study on Ezetimibe Safety

According to a recent study published in BMJ Medicine, ezetimibe is safe in patients who need lipid-lowering treatment.

A study was conducted to determine the harms of ezetimibe in people who need lipid-lowering treatment. Studies comparing ezetimibe with placebo, standard care, or other lipid-lowering agents in people who need lipid-lowering treatment with a follow-up duration of at least six months (or 24 weeks). The relative effects for potential harms of ezetimibe were pooled using random effect pairwise meta-analyses for randomised controlled trials. The evidence from observational studies was narratively summarised. The certainty of the evidence was assessed using the Grading of Recommendation Assessment, Development, and Evaluation.

Results

48 randomised controlled trials with 28,444 participants (median follow-up 34 weeks, range 24-312 weeks) and four observational studies with 1,667 participants (median follow-up 282 weeks, range 72-400 weeks) were included.

The meta-analyses of randomised trials showed moderate to high certainty that ezetimibe was not associated with:

• Cancer (relative risk 1.01; 95% confidence interval 0.92 to 1.11)
• Fractures (0.90; 0.74 to 1.10)
• Discontinuation due to any adverse event (0.87; 0.74 to 1.03)
• Gastrointestinal adverse events leading to discontinuation (1.34; 0.58 to 3.08)
• Myalgia or muscular pain leading to discontinuation (0.82; 0.51 to 1.33)
• Neurocognitive events (1.48; 0.58 to 3.81)
• New-onset diabetes (0.88; 0.61 to 1.28)

The narrative analysis of observational studies provided consistent findings.

No credible subgroup effects were identified for the harm outcomes, including shorter versus longer follow-up duration of trials.

Thus, ezetimibe results in little to no difference in adverse events or other undesirable effects compared with placebo, usual care, or other lipid-lowering agents.

Reference

Safety of ezetimibe in lipid-lowering treatment: systematic review and meta-analysis of randomised controlled trials and cohort studies by Yang Wang et al. published in the BMJ Medicine.