A Rare Adverse Event of Rhabdomyolysis Caused by Sacubitril/Valsartan

Rawla, Prashanth; Raj, Jeffrey Pradeep; George, Sheba; Nathala, Pavani; Vellipuram, Anantha

doi:10.3390/diseases7020038

Cited by 3 publications

(2 citation statements)

References 8 publications

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“… 8–10 Rawla et al . 11 had recorded a case with similar underlying risk factors for rhabdomyolysis reported sacubitril/valsartan as the only drug that could account for rhabdomyolysis ( Table 2 ).…”

Section: Discussionmentioning

confidence: 99%

Approaches to management of rhabdomyolysis as the adverse effect of drug interaction between atorvastatin and sacubitril/valsartan: a case report

Siew

Hafidz

Zaidan

et al. 2022

European Heart Journal - Case Reports

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Background Atorvastatin and sacubitril/valsartan (EntrestoTM) have been cornerstones in managing patients with coronary artery disease and heart failure. We report a case of life-threatening rhabdomyolysis associated with the co-administration of atorvastatin and sacubitril/valsartan. Case Summary A 58-year-old male with coronary heart disease and chronic heart failure treated with the optimal dose of atorvastatin and other cardiovascular medications was frequently admitted for acute decompensation of heart failure. We decided to optimise his condition by adding sacubitril/valsartan to his treatment regime. He presented to our outpatient clinic with worsening myalgia and oliguria six days later. He was readmitted with markedly elevated serum creatinine kinase (94,850 U/L; normal range 32–294 U/L), deranged liver function tests and acute kidney injury. We withheld atorvastatin and sacubitril/valsartan and treated him with renal replacement therapy. Discussion Sacubitril inhibits the excretion of statins, thereby elevating serum statin concentration and increasing the likelihood of developing muscle-related toxicity. Co-administration of atorvastatin and sacubitril/valsartan should be monitored closely with laboratory investigations of creatinine kinase and liver and renal function. The physician may consider starting low-dose atorvastatin at 20 mg daily in combination with sacubitril/valsartan 24 mg/26 mg twice daily and titrating accordingly to optimal doses. Rosuvastatin could be an alternative to atorvastatin, as it has less drug–drug interaction with sacubitril, thereby reducing the adverse effect.

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Section: Discussionmentioning

confidence: 99%

Approaches to management of rhabdomyolysis as the adverse effect of drug interaction between atorvastatin and sacubitril/valsartan: a case report

Siew

Hafidz

Zaidan

et al. 2022

European Heart Journal - Case Reports

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show abstract

“…Safety assessment of sacubitril/valsartan appears a neglected clinical issue and, to the best of our knowledge, only a few case reports/series have preliminary described specific toxicities, mainly limited to muscular-, renal-and cognition-related AEs [3,[7][8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system

Gatti

Antonazzo

Diemberger

et al. 2020

European Journal of Preventive Cardiology

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Aims The aim of this study was to characterise clinical priority of adverse events with sacubitril/valsartan for targeting preventive measures. Methods We used the US Food and Drug Administration adverse event reporting system (worldwide pharmacovigilance database) to compare adverse events recording sacubitril/valsartan as suspect with other cardiovascular drugs. Disproportionality analyses were performed by calculating the reporting odds ratios, deemed significant when the lower limit of the 95% confidence interval was greater than 1. Clinical priority was assigned to adverse events with significant disproportionality by scoring (range 0–10 points) five features (number of events, magnitude of the lower limit of the 95% confidence interval, mortality frequency, important/designated medical event, biological plausibility). Results Sacubitril/valsartan was recorded in 20,021 reports, with 178 adverse events associated with significant disproportionality: 71.9%, 25.9% and 2.2% were classified as weak, moderate and strong clinical priorities, respectively. Increased reporting emerged for several cardiovascular adverse events, including ‘renal failure’ ( N = 388; lower limit of the 95% confidence interval 2.26), ‘hyperkalaemia’ (314; 2.42) and ‘angioedema’ (309; 1.56). Sudden cardiac death (priority score 9 points) was the only designated medical event with strong clinical priority. Notably, sudden cardiac death occurred early after sacubitril/valsartan administration (average onset 124 days), with concomitant drugs known for pro-arrhythmic potential (e.g. amiodarone, escitalopram, mirtazapine, loop diuretics) in 26.2% of records. Conclusion The increased cardiovascular reporting of sacubitril/valsartan in the real world was largely predictable from pre-approval evidence, underlying disease and likely patients’ comorbidities. The unexpected reporting of sudden cardiac death occurred well before the complete development of positive electrical remodelling induced by sacubitril/valsartan, and calls for stringent clinical monitoring (to reduce the pro-arrhythmic burden related to co-medications), and further investigation on appropriate combination with other preventive measures.

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

Sunaga

Yonezawa

2022

The American Journal of Cardiology

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A Rare Adverse Event of Rhabdomyolysis Caused by Sacubitril/Valsartan

Cited by 3 publications

References 8 publications

Approaches to management of rhabdomyolysis as the adverse effect of drug interaction between atorvastatin and sacubitril/valsartan: a case report

Approaches to management of rhabdomyolysis as the adverse effect of drug interaction between atorvastatin and sacubitril/valsartan: a case report

Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system

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

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