A study of clinical characteristics and risk factors of mortality associated with tigecycline (Preprint)

Abstract

BACKGROUND Tigecycline has a broad spectrum of antimicrobial activity and become more widely used. However, in 2010, the FDA warned that tigecycline was associated with an increased risk of death. The risk factors of tigecycline-associated mortality are still controversial. OBJECTIVE The objective of this study was to explore the related factors of mortality associated with tigecycline in a tertiary university hospital and to establish the risk assessment criteria for tigecycline associated mortality METHODS In a observational retrospective study, we enrolled 240 patients who had been treated for at least 3 days with tigecycline between January 2020 and December 2020. We compared the clinical characteristics of patients who died after tigecycline therapy (79 in the non-survivor group) with those who survived within 28 days after tigecycline therapy (161 in the survivor group) during the same hospitalization. We used a logistic regression model to find risk factors of tigecycline associated mortality. RESULTS In total, 240 patients were included in the analysis, 79 patients eventually died after tigecycline treatment. The ages of the non-survivor group and survivor group were 78.3±13.9 and 68.0±11.2 years old (p = 0.022), treatment duration were 11±8.5 and 7±6.6 day (p = 0.017), and the APACHE II score were 14.8±4.0 and 9.5±2.7 (p = 0.025). The serum creatinine (SCr) was significant difference before and after treated with tigecycline only in the non-survivor group and no significant difference in the survivor group. The proportion of the kidney failure events and change in creatinine value were greater in the non-survivor group after treated with tigecycline than in the survivor group (p < 0.001).. In the multivariate analysis, age(p=0.019), ΔCre(p＜0.001) , SCr(p=0.038), APACHE II score (p=0.031) were independently associated with mortality. An age of ≥79 years, ΔCre(μmol/L)≥36, SCr≥112 and APACHE II score≥12.7 were selected as the cutoff points for predicting tigecycline associated mortality. The distribution of non-survivors at different ranges of creatinine change showed higher percentages of mortality in patients with high ΔCre after tigecycline treatment. CONCLUSIONS This study identifies the risk factors for tigecycline associated mortality, and draws attention to the fact that there is an increased mortality risk in patients treated with tigecycline . The risk assessment criteria can be helpful to identify patients with high risk of tigecycline associated mortality. CLINICALTRIAL no trial