A REAL-WORLD PHARMACOVIGILANCE STUDY OF SACUBITRIL\VALSARTAN IN OLDER PEOPLE
2024

Study on Sacubitril/Valsartan Safety in Older Adults

Sample size: 94210 publication Evidence: moderate

Author Information

Author(s): Kuai Zheng, Hu Yu

Primary Institution: Zhongshan Hospital, Fudan University, Shanghai, China

Hypothesis

There is a lack of systematic studies on sacubitril/valsartan-related adverse events in older people.

Conclusion

The study identified potential new adverse event signals associated with sacubitril/valsartan in older adults.

Supporting Evidence

  • 94,210 sacubitril/valsartan-associated cases were retrieved.
  • 86 preferred terms with significant disproportionality were identified in older adults.
  • Adverse events like angioedema and hypotension were reported at rates similar to clinical trials.
  • Unexpected safety signals were detected only in older adults.

Takeaway

This study looked at older people taking a heart medication and found some unexpected side effects that doctors should watch for.

Methodology

Disproportionality analyses were used to quantify adverse event signals.

Potential Biases

There may be reporting bias in the adverse event data collected.

Limitations

The study may not cover all potential adverse events due to the nature of reporting databases.

Participant Demographics

Older adults aged 65 and above.

Digital Object Identifier (DOI)

10.1093/geroni/igae098.0425

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