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Immune globulins and same‐day thrombotic events as recorded in a large health care database during 2008 to 2012
Author(s) -
Sridhar Gayathri,
Ekezue Bola F.,
Izurieta Hector S.,
Selvam Nandini,
Ovanesov Mikhail V.,
Divan Hozefa A.,
Liang Yideng,
Golding Basil,
Forshee Richard A.,
Anderson Steven A.,
Menis Mikhail
Publication year - 2014
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.12663
Subject(s) - medicine , confidence interval , odds ratio , logistic regression , cohort , retrospective cohort study , cohort study , adverse effect , database , computer science
Background Thrombotic events ( TE s) are rare and serious adverse events after administration of immune globulin ( IG ) products. Our study evaluated the occurrence of same‐day TE s for different IG products and ascertained potential risk factors. Study Design and Methods This retrospective cohort study utilized H ealth C ore's I ntegrated R esearch D atabase ( HIRD ) to assess individuals exposed to IG s during 2008 to 2012. IG products were identified using recorded procedure codes and TE s were ascertained using ICD ‐9‐ CM diagnosis codes. The unadjusted same‐day TE rates (per 1000 persons exposed) were estimated overall and by IG products, age, and sex. Multivariable logistic regression analyses were used to estimate odds ratios ( ORs ) and 95% confidence intervals ( CI s) for same‐day TEs by IG products. Results Of 14,944 individuals exposed to IG products, 233 (15.6 per 1000 persons) had TE diagnosis code(s) recorded on the same‐day as the IG exposure. Compared to G ammagard L iquid, G ammaplex ( OR , 20.96; 95% CI , 2.45‐179.33) and V ivaglobin ( OR , 2.74; 95% CI , 1.19‐6.32) users had a significantly increased same‐day TE risk. Elevated, but nonsignificant TE risks were identified for O ctagam, G amunex, P rivigen, and Lyophilized IG (s). An increased TE risk was also found with older age (≥45 years), prior TE s, and other health conditions. Conclusion Our claims‐based cohort study suggests a potentially elevated TE risk with different IG products and shows importance of recipient factors such as older age, previous TE , hypercoagulable state(s), and other health conditions. The results of this study suggest the need for continuous evaluation of procoagulant activity and manufacturing processes for IG products to further assure their safety.