Prevalence of substances with OATP1B1 inhibitory properties in individual case safety reports of suspected statin-associated myopathy – an analysis of Swiss pharmacovigilance data

PURPOSE: Statin associated musculoskeletal symptoms (SAMS) are common adverse drug reactions reported by 20% of statin users and are assumed to be dose dependent. The organic anion transporting polypeptide 1B1 (OATP1B1), a hepatocellular uptake transporter, modulates the systemic exposure of statins. The concurrent use of OATP1B1 inhibitors can increase systemic statin exposure and thus increase the risk of SAMS. METHODS: Individual case safety reports (ICSRs) of suspected adverse drug reactions (ADRs), like SAMS, are an important data source to monitor the safety of marketed drugs. We used the Swissmedic database to analyse the prevalence of potential OATP1B1 involving interactions in cases of suspected SAMS. RESULTS: In 54% of the ICSRs analysed, at least one substance with OATP1B1 inhibiting properties was used together with a statin. Antidiabetic and cardiovascular drugs were the most commonly reported substances with OATP1B1 inhibiting properties. CONCLUSION: Our findings could indicate clinically relevant OATP1B1 involving interactions in SAMS, which should be further investigated.