This study correctly shows that most labelled statin side effects lack strong RCT evidence. However, it does not address structural vascular changes like wide spread progressive arterial calcification, which are well documented in imaging studies but are not coded as 'adverse events' in trials.

For some patients – particularly those with diffuse disease who may need future revascularisation – statin-accelerated calcification can render vessels untreatable, a clinically meaningful harm that falls outside the scope of this analysis. Patients and clinicians should be aware of this limitation when interpreting trial safety data.


DR Simon Strauss
MBBS Monash