AUTHOR=Zhao Fukun , Luo Min , Wang Yuanmin , Su Mu , Tang Fei TITLE=Detection of muscular system adverse reaction signals in sacubitril/valsartan treatment combined with statins JOURNAL=Frontiers in Pharmacology VOLUME=15 YEAR=2024 URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1393616 DOI=10.3389/fphar.2024.1393616 ISSN=1663-9812 ABSTRACT=Objective

To detect muscular system adverse reaction signals of sacubitril/valsartan treatment combined with statins (atorvastatin, rosuvastatin, simvastatin) to provide a reference for clinical administration.

Methods

Multiplicative and additive models were used to mine the FDA’s spontaneous reports database to detect signals of drug-drug interactions between sacubitril/valsartan and statins. SAS 9.4 software was used to conduct statistical tests for suspicious signals to determine whether the signals were statistically significant.

Results

A total of 8,883,870 adverse reaction reports were analyzed. The combinations “sacubitril/valsartan - simvastatin - musculoskeletal muscle pain” had statistically significant correlation signals in both models (P < 0.05). The combination “sacubitril/valsartan - atorvastatin - myopathy” and “sacubitril/valsartan–simvastatin - myopathy” had statistically significant correlation signal in the multiplicative model (P < 0.05).

Conclusion

Compared with a single drug, coadministration of sacubitril/valsartan with atorvastatin may increase safety risks to myopathy, with simvastatin may increase safety risks to the musculoskeletal pain and myopathy, which should be closely monitored in clinical practice.