Risk Factors for Doxorubicin-Induced Serious Hyperglycaemia-Related Adverse Drug Reactions

INTRODUCTION: Mortality rates from various cancer types are higher in patients with hyperglycaemia-associated pathologies. Among antineoplastics for treating pancreatic carcinoma, doxorubicin was found to be top of the list for inducing hyperglycaemia-related adverse drug reactions. METHODS: Individual case safety reports of doxorubicin-induced hyperglycaemia-related adverse drug reactions (HG-ADRs) submitted during the period 2000–2017 were extracted from VigiBase(®). Factors influencing outcome seriousness in these cases were analyzed using bivariate correlation and logistical regression. Age was stratified into five groups. RESULTS: Among the 558 cases with high blood glucose included in this study, with an average patient age of 55.9 ± 14.3 years, 71.1% had serious outcomes and 10.9% died. Three factors—died, age, and gender—were all found to be significantly correlated with outcome seriousness (P < 0.01), while five factors—year reported, ADR duration, latency, treatment duration, and dosage—showed no correlation with outcome seriousness (P > 0.05). Identical conclusions were reached upon analyzing only the cases that did not involve corticosteroid use. CONCLUSION: Age and gender are risk factors for doxorubicin-induced serious HG-ADRs; males and older patients are more likely to suffer a serious outcome following such a reaction.