Clinical profile of acute pancreatitis following treatment with protease inhibitors: a real-world analysis of post-marketing surveillance data

ABSTRACT

Backgrounds

Acute pancreatitis (AP) has been reported in patients treated with protease inhibitors (PIs), but there are few real-world studies comparing the occurrence and characteristics of AP after different PI regimens.

Research design and methods

Disproportionality analysis and Bayesian analysis were utilized for data mining of the Food and Drug Administration’s Adverse Event Reporting System (FAERS) database for suspected adverse events involving AP after PI. The times to onset and fatality rates of AP following different PI regimens were also compared.

Results

Based on 33,832 reports related to PIs, 285 cases were associated with AP, involving with 12 out of the 15 studied PIs. Of all the reported AP events related to PIs, 64.56% occurred in men and the median time to onset of AP was 103 (IQR: 26–408) days after the initiation of PI treatment with a fatality rate of 14.02%. Among all PI therapies, indinavir was notably associated with AP, and ritonavir and lopinavir/ritonavir-induced AP cases appeared to be associated with a higher risk of death.

Conclusions

Most of PIs were associated with AP-related adverse events, among which indinavir has a stronger association with AP but there is no significant difference in fatality rates.

KEYWORDS:

• Acute pancreatitis
• adverse drug events
• data mining
• medication safety
• post-marketing surveillance
• protease inhibitors
• risk management

Notes on contributions

Wangjun Qin participated in the study design, plotted figures and writing of the manuscript draft. Bin Zhao designed the research, participated in the interpretation of data, and corrected the manuscript. Yongguang Shang participated in the interpretation of data and writing of the manuscript draft. Lei Zhang designed the research, analyzed and interpreted data, and wrote and revised the manuscript draft. All authors have approved of the version to be published and agree to be accountable for all aspects of the work.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

The present study was supported by the Capital’s Funds for Health Improvement and Research (CFH) (2020-3-4069).