Bleeding Disorder, A Newly Recognized Adverse Event Following Sacubitril/Valsartan Therapy
Abstract
Introduction: Sacubitril/valsartan (Entresto) is the only currently approved angiotensin receptor-neprilysin inhibitor (ARNI) drug. It demonstrates important therapeutic outcomes in heart failure patients by reducing hospitalizations and deaths. ARNI is generally safe but concerns about adverse drug reactions (ADRs) exist. This report documents a potential bleeding disorder, evidenced by elevated prothrombin time (PT) and international normalized ratio (INR), as a newly identified ADR.
Case description: Despite not receiving anticoagulant medication, three male heart failure patients had elevated PT/INR values within 14 days to four months of initiating Entresto 50 mg twice daily. Temporary discontinuation (dechallenging) of Entresto resulted in a decline in PT/INR, while it increased upon re-challenge in at least one patient. Laboratory findings showed varying degrees of anaemia, occasional renal and hepatic abnormalities, with normal platelet counts. Naranjo scores (6-8) support a probable causal relationship between Entresto and the bleeding tendency, warranting careful coagulation monitoring during treatment.
Conclusion: This case series explicitly identified a probable causal relationship between Entresto (ARNI) and a potential bleeding risk as evaluated by the Naranjo ADR probability scale. By highlighting this previously unidentified ADR, this report attempts to raise awareness among healthcare practitioners regarding the need for vigilant monitoring of coagulation…
How strong is the evidence?
Evidence Hub reads this as a case series, done in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.
Read the paper
Related studies
- The Prediction of the In Vitro Release Curves for PLGA-Based Drug Delivery Systems with Neural Networks
- Promising Ursolic Acid as a Novel Antituberculosis Agent: Current Progress and Challenges
- Proof of principle concept for the analysis and functional prediction of rare genetic variants in the CYP2C19 and CYP2D6 genes
- Fabrication, characterization, and docking studies of furosemide-loaded nanosponges using the emulsion solvent diffusion method
- The Effect of Concomitant Administration of Proton Pump Inhibitors on the Pharmacokinetics of CDK4/6 Inhibitors in Rats: Implications for the Evaluation of Hepatic and Transporter-Mediated Drug–Drug Interactions
- Mining the Metabolic Capacity of Clostridium sporogenes Aided by Machine Learning
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.