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Immune globulins and same-day thrombotic events as recorded in a large health care database during 2008 to 2012.
Transfusion. 2014 Oct; 54(10):2553-65.T

Abstract

BACKGROUND

Thrombotic events (TEs) are rare and serious adverse events after administration of immune globulin (IG) products. Our study evaluated the occurrence of same-day TEs for different IG products and ascertained potential risk factors.

STUDY DESIGN AND METHODS

This retrospective cohort study utilized HealthCore's Integrated Research Database (HIRD) to assess individuals exposed to IGs during 2008 to 2012. IG products were identified using recorded procedure codes and TEs 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 (CIs) 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 Gammagard Liquid, Gammaplex (OR, 20.96; 95% CI, 2.45-179.33) and Vivaglobin (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 Octagam, Gamunex, Privigen, and Lyophilized IG(s). An increased TE risk was also found with older age (≥45 years), prior TEs, 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.

Authors+Show Affiliations

HealthCore, Inc., Alexandria, Virginia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

24804899

Citation

Sridhar, Gayathri, et al. "Immune Globulins and Same-day Thrombotic Events as Recorded in a Large Health Care Database During 2008 to 2012." Transfusion, vol. 54, no. 10, 2014, pp. 2553-65.
Sridhar G, Ekezue BF, Izurieta HS, et al. Immune globulins and same-day thrombotic events as recorded in a large health care database during 2008 to 2012. Transfusion. 2014;54(10):2553-65.
Sridhar, G., Ekezue, B. F., Izurieta, H. S., Selvam, N., Ovanesov, M. V., Divan, H. A., Liang, Y., Golding, B., Forshee, R. A., Anderson, S. A., & Menis, M. (2014). Immune globulins and same-day thrombotic events as recorded in a large health care database during 2008 to 2012. Transfusion, 54(10), 2553-65. https://doi.org/10.1111/trf.12663
Sridhar G, et al. Immune Globulins and Same-day Thrombotic Events as Recorded in a Large Health Care Database During 2008 to 2012. Transfusion. 2014;54(10):2553-65. PubMed PMID: 24804899.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immune globulins and same-day thrombotic events as recorded in a large health care database during 2008 to 2012. AU - Sridhar,Gayathri, AU - Ekezue,Bola F, AU - Izurieta,Hector S, AU - Selvam,Nandini, AU - Ovanesov,Mikhail V, AU - Divan,Hozefa A, AU - Liang,Yideng, AU - Golding,Basil, AU - Forshee,Richard A, AU - Anderson,Steven A, AU - Menis,Mikhail, Y1 - 2014/05/08/ PY - 2013/11/12/received PY - 2014/02/03/revised PY - 2014/02/25/accepted PY - 2014/5/9/entrez PY - 2014/5/9/pubmed PY - 2015/1/1/medline SP - 2553 EP - 65 JF - Transfusion JO - Transfusion VL - 54 IS - 10 N2 - BACKGROUND: Thrombotic events (TEs) are rare and serious adverse events after administration of immune globulin (IG) products. Our study evaluated the occurrence of same-day TEs for different IG products and ascertained potential risk factors. STUDY DESIGN AND METHODS: This retrospective cohort study utilized HealthCore's Integrated Research Database (HIRD) to assess individuals exposed to IGs during 2008 to 2012. IG products were identified using recorded procedure codes and TEs 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 (CIs) 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 Gammagard Liquid, Gammaplex (OR, 20.96; 95% CI, 2.45-179.33) and Vivaglobin (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 Octagam, Gamunex, Privigen, and Lyophilized IG(s). An increased TE risk was also found with older age (≥45 years), prior TEs, 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. SN - 1537-2995 UR - https://www.unboundmedicine.com/medline/citation/24804899/Immune_globulins_and_same_day_thrombotic_events_as_recorded_in_a_large_health_care_database_during_2008_to_2012_ L2 - https://doi.org/10.1111/trf.12663 DB - PRIME DP - Unbound Medicine ER -