Clinical Manifestations and Risk Factors of Tigecycline-Associated Thrombocytopenia

Abstract

Background

Thrombocytopenia, characterized by a diminished platelet count, emerged as the most frequently reported coagulation dysfunction event according to the FDA Adverse Event Reporting System (FAERS) database. In recent years, numerous clinical studies have investigated the potential link between tigecycline usage and the occurrence of hypofibrinogenemia. However, a research gap remains in comprehensively examining the association between tigecycline and thrombocytopenia in real-world settings.

Methods

This study was conducted to explore the incidence and clinical manifestations of tigecycline-associated thrombocytopenia. A retrospective case-control study of patients treated with tigecycline was conducted between January 2018 and June 2022.

Results

In total, 373 patients were included in this study. Among these patients, 12.3% experienced thrombocytopenia. The onset of thrombocytopenia occurred within a range of 2 to 22 days after the initiation of tigecycline, with a median period (25–75th percentile) of 9 (6–11) days. Among the patients manifesting thrombocytopenia, 60.9% exhibited mild-to-moderate cases (grades 1–2) while 39.1% endured severe cases (grades 3–4). Multivariate analysis delineated several factors as independent risk factors for thrombocytopenia. Notably, advanced age (≥74 years) (p=0.028), risk of malnutrition (p<0.001), tigecycline therapy for ≥7 days (p=0.003), DBIL>8.1μmol/L (p<0.001)), BUN>8.1mmol/L (p=0.002) emerged as independent risk factors associated with thrombocytopenia. When comparing the control group to the thrombocytopenia group, 70.7% of patients in the control group exhibited 0–2 risk factors, while all patients in the thrombocytopenia group demonstrated risk factors. Specifically, 95.7% of patients in the thrombocytopenia group presented with three to five risk factors, with only 4.4% having 0–2 risk factors.

Conclusion

Tigecycline administration is associated with thrombocytopenia. Healthcare professionals should exercise vigilance, particularly in cases of severe tigecycline-associated thrombocytopenia, and undertake routine monitoring of patients’ platelet counts, especially for those who possess three or more risk factors.

Keywords:

• tigecycline
• thrombocytopenia
• risk factor
• pharmacovigilance
• coagulation disorder

Data Sharing Statement

The datasets used and/or analyzed during this study are available from the corresponding author on reasonable request.

Ethics Approval and Consent to Participate

This study, which was in compliance with the Declaration of Helsinki, received ethical approval from the Ethics Committee of Beijing Hospital (Permit Number: 2022BJYYEC-312-02).

The manuscript strictly omits any identifying information of human participants. As neither individual data were published nor any intervention was performed on patients, patient consent was waived by the Ethics Committee of Beijing Hospital.

Our research received ethical exemption from patient informed consent, granted by the Ethics Committee of Beijing Hospital (Permit Number: 2022BJYYEC-312-02).

Consent for Publication

All authors approved the final manuscript and the submission to this journal.

Acknowledgments

The author is indebted to Dr. Hu for his constructive suggestions, to Mr. Li for assisting in shaping the outline of this paper.

Disclosure

The authors declare the absence of known competing financial interests or personal relationships that could potentially influence the work reported in this paper.

Additional information

Funding

This manuscript was supported by funding from National High Level Hospital Clinical Research Funding (BJ-2022-173).