Potential Safety Signals for Rhabdomyolysis Associated With High-Potency Statin Use With or Without Sacubitril/Valsartan

Sunaga, Tomiko; Yonezawa, Ryo

doi:10.1016/j.amjcard.2021.11.026

Cited by 7 publications

(2 citation statements)

References 12 publications

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“…In the existing literature are five case reports of rhabdomyolysis caused by the combined use of sacubitril/valsartan and statins, four of which were associated with atorvastatin ( Faber et al, 2016 ; Chan KH et al, 2020 ; Siew et al, 2022 ; Zhao FK et al, 2022 ) and one with rosuvastatin ( Previsdomini et al, 2019 ). However, the present study did not detect a statistically significant association signal with rhabdomyolysis, consistent with findings from studies like ( Sunaga and Ryo 2021 ; Tomiko and Yonezawa, 2021 ). This may be due to the relatively short time sacubitril/valsartan has been on the market, but it still warrants attention in future clinical use.…”

Section: Discussionsupporting

confidence: 92%

“…Furthermore, we observed a FAERS study conducted by ( Sunaga and Ryo 2021 ; Tomiko and Yonezawa, 2021 ), which investigated the safety of rhabdomyolysis associated with the combination of sacubitril/valsartan and statins, and the commonly used PRR method was employed for signal detection, but the PRR method is primarily intended for single drug ADR signal detection. The criteria for statistical signal index ratio differ between solo drug use and combined use, leading to potential calculation discrepancies and a higher false positive rate ( Susuta and Takahashi, 2014 ).…”

Section: Discussionmentioning

confidence: 99%

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Detection of muscular system adverse reaction signals in sacubitril/valsartan treatment combined with statins

Zhao,

Luo,

Wang

et al. 2024

Front. Pharmacol.

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

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