Safety assessment of neurokinin-1 receptor antagonist: real-world adverse event analysis from the FAERS database
Chuanli Yang1,2,3, Pengyang Xu1, Teng Wu1
1Department of General Surgery, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China.
Background:
Aprepitant, fosaprepitant, and netupitant are three common neurokinin-1 receptor antagonists (NK-1RAs) used to prevent chemotherapy-induced nausea and vomiting, following highly or moderately emetogenic chemotherapy. Understanding their different adverse event (AE) profiles may help clinicians make appropriate treatment decisions.
Methods:
All data collected from the FDA Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the fourth quarter of 2023 underwent disproportionality analysis to detect, evaluate, and compare AE signals of the three NK-1RAs.
Results:
A total of 3,904, 1,123, and 243 AE reports related to aprepitant, fosaprepitant, and netupitant, respectively, were extracted from the FAERS database. Of these, more than 50% of respondents were female, and most of them were aged 45-65 years. General disorders and administration-site conditions, and gastrointestinal disorders were the most frequent signals in the system organ class of the three NK-1RA drugs. In addition, aprepitant was strongly associated with joint deposit (ROR = 26.27) and fosaprepitant was closely related to seizure-like phenomena (ROR = 26.90); two preferred terms (PTs) were not mentioned in the manual. Statistically, netupitant was likely to induce death (N = 63, ROR = 8.78, 95% CI: 6.75-11.42). Additionally, neutropenic colitis, colitis, and stomatitis were unique to netupitant. Furthermore, the AE profiles of the three NK-1RA drugs were different by gender.
Conclusion:
The AE profiles for aprepitant, fosaprepitant, and netupitant were different. In addition to paying attention to common AEs, clinicians need to pay attention to new emerging AEs, such as joint deposit, seizure-like phenomena, neutropenic colitis, colitis, and stomatitis, regarding the three NK-1RA drugs. Furthermore, the AE compositions of the three NK-1RA drugs were different in different genders, and clinicians should take these factors into account when selecting NK-1RAs for CINV treatment.
Insights
Neurokinin-1 receptor antagonists (NK-1RAs) like aprepitant, fosaprepitant, and netupitant have distinct adverse event profiles. Clinicians should consider these differences, including emerging risks and gender-specific effects, when managing chemotherapy-induced nausea and vomiting (CINV).
Area of Science:
- Pharmacovigilance
- Oncology Supportive Care
- Drug Safety
Background:
- Aprepitant, fosaprepitant, and netupitant are key neurokinin-1 receptor antagonists (NK-1RAs) used for preventing chemotherapy-induced nausea and vomiting (CINV).
- Understanding the distinct adverse event (AE) profiles of these NK-1RAs is crucial for informed clinical decision-making in CINV management.
Purpose of the Study:
- To analyze and compare the adverse event (AE) profiles of three common NK-1RAs: aprepitant, fosaprepitant, and netupitant.
- To identify specific and emerging safety signals associated with each NK-1RA to aid clinicians in treatment selection for CINV.
Main Methods:
- Disproportionality analysis was conducted on data from the FDA Adverse Event Reporting System (FAERS) database.
- The analysis covered AE reports for aprepitant, fosaprepitant, and netupitant from Q1 2004 to Q4 2023.
- Comparison of AE signals, including specific preferred terms (PTs) and organ class frequencies, was performed.
Main Results:
- A total of 3,904, 1,123, and 243 AE reports were analyzed for aprepitant, fosaprepitant, and netupitant, respectively.
- Common AEs included general disorders and gastrointestinal issues; aprepitant showed association with joint deposit, fosaprepitant with seizure-like phenomena, and netupitant with increased mortality risk.
- Netupitant exhibited unique AEs such as neutropenic colitis, colitis, and stomatitis, with differing AE profiles observed across genders.
Conclusions:
- The adverse event profiles of aprepitant, fosaprepitant, and netupitant differ significantly.
- Clinicians must be aware of both common and emerging AEs, including joint deposit, seizure-like phenomena, and specific gastrointestinal conditions, associated with these NK-1RAs.
- Gender-specific AE patterns necessitate consideration when selecting NK-1RAs for CINV prophylaxis.
More Related Videos
08:36Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
Published on: April 19, 2024
08:31Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
Related Concept Videos
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:28Chemotherapy-Induced Nausea and Vomiting: Neurokinin-1 Receptor Antagonists
01:25Drug Regulation
01:28Structure-Activity Relationships and Drug Design
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
01:12Local Anesthetics: Adverse Effects
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...