Reporting of Drug-Induced Myopathies Associated with the Combination of Statins and Daptomycin: A Disproportionality Analysis Using the US Food and Drug Administration Adverse Event Reporting System

Abstract

Background: Myopathy is one of the most common adverse reactions of daptomycin and statins. We aimed to evaluate the muscular toxicity of the combination therapy of daptomycin and statins in a large pharmacovigilance database. Methods: This was a retrospective disproportionality analysis based on real-world data. All cases reported between the first quarter of 2004 and the fourth quarter of 2022 where daptomycin and statins were reported were gathered from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analyses were conducted by estimating the proportional reporting ratios (PRRs), reporting odds ratio (ROR), and information component (IC). Results: A total of 971,861 eligible cases were collected from the FAERS database. Data analysis showed that rosuvastatin (ROR: 124.39, 95% CI: 87.35–178.47), atorvastatin (ROR: 68.53, 95% CI: 51.93–90.43), and simvastatin (ROR: 94.83, 95% CI: 71.12–126.46) combined with daptomycin increased the reporting frequency of myopathy. Moreover, myopathy was reported more frequently with the 3-drug combination (ROR: 598.01, 95% CI: 231.81–1542.71). For rhabdomyolysis, the frequency of reports also increased when daptomycin was combined with rosuvastatin (ROR: 156.34, 95% CI: 96.21–254.05), simvastatin (ROR: 72.65, 95% CI: 47.36–111.44), and atorvastatin (ROR: 66.31, 95% CI: 44.06–99.81). Conclusions: The combination of daptomycin and statins increased the association of myopathy and rhabdomyolysis, especially with rosuvastatin, simvastatin, and atorvastatin.

A pharmacovigilance study of chronic kidney disease in diabetes mellitus patients with statin treatment by using the US Food and Drug Administration adverse event reporting system

“…Secondly, causality could not be inferred or determined because patient treatment information is often incomplete, including patient history and reported duration of drug use. We were unable to identify any other factors that might have influenced the results (Wei et al, 2023a). Finally, our study was unable to describe the mechanism behind the increased adverse effects.…”

“…Furthermore, our study showed that two or more statins history group exhibited stronger signals than the single-agent regimen. However, it was worth noting that the utilization of multiple statins in clinical practice was uncommon and typically limited to patients requiring a switch in statin therapy due to intolerance (Wei et al, 2023a). Due to the unavailability of information regarding concurrent or sequential use of multiple statins in the FAERS database, a comprehensive analysis and discussion of the data cannot be conducted.…”

Agranulocytosis and secondary infection related to JAK inhibitors and IL-6 receptor blockers: a disproportionality analysis using the US Food and drug administration adverse event reporting system

“…We collected the reports in the FAERS database from the first quarter of 2004 (inception of the database) to the fourth quarter of 2022. The data sources of the FAERS are public and self-reported for post-marketing drug safety monitoring ( Wei et al, 2023 ). ADRs were reported with anonymous patient information.…”

“…The FAERS database references the standardization and classification of ADRs in the Medical Dictionary for Regulatory Activities (MedDRA) ( Wei et al, 2023 ). Each report is coded by preferred terms (PTs) from the MedDRA terminology.…”

“…One PT may correspond to one or more High-level Terms (HLTs), High-level Group Terms (HLGTs), and System Organ Class (SOC) levels. Through standardized MedDRA queries (SMQs), different PTs can be collected to define specific ADRs ( Wei et al, 2023 ). The FAERS database contains seven modules corresponding to seven aspects of the main content, including patient demographic and administrative information (DEMO), report source (RPSR), drug information (DRUG), adverse events (REAC), patient outcomes (OUTC), indications for drug administration (INDI), and therapy start states and end dates for the reported drugs (THER).…”