LAUSR

AIM Recent case reports have suggested that sodium-glucose co-transporter 2 inhibitors (SGLT2i) may interact with statins to increase their risk of myotoxicity. We assessed the risk of myotoxicity reporting associated with concomitant use of SGLT2i and statins. METHODS We queried the Food and Drug Administration Adverse Event Reporting System (FAERS) from 2013 to 2021 for reports including SGLT2i, statins, or both. We estimated several measures of disproportionate reporting of myopathy and rhabdomyolysis associated with concomitant use of SGLT2i and statins: reporting odds ratio (ROR) with 95% confidence interval (CI), Ω shrinkage measure (safety signal if >0), and an extension of the proportional reporting ratio (PRR) (two-criteria set; safety signal if both criteria are met), using the full FAERS dataset as reference set. In sensitivity analyses, we focussed on specific SGLT2i-statin pairs with higher interaction potential (canagliflozin-rosuvastatin, empagliflozin-rosuvastatin) and accounted for stimulated reporting. RESULTS There were 456 myopathy and 77 rhabdomyolysis reports involving both an SGLT2i and a statin. Concomitant use of SGLT2i and statins was not associated with an increased risk of myopathy (ROR, 0.79; 95% CI, 0.70 to 0.89) or rhabdomyolysis (ROR, 0.58; 95% CI, 0.41 to 0.83) reporting. For both outcomes, Ω shrinkage measure was negative and only one criterion of the PRR extension was met. SGLT2i-statin pairs with higher interaction potential yielded potential signals for rhabdomyolysis; these signals disappeared after accounting for stimulated reporting. CONCLUSION There was no increased risk of myotoxicity reporting associated with concomitant use of SGLT2i and statins or for specific drug pairs.