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Are adverse drug reaction patterns different between romiplostim and eltrombopag? 2009-2013 French PharmacoVigilance assessment
- Source :
- European Journal of Internal Medicine, European Journal of Internal Medicine, Elsevier, 2014, 25 (8), pp.777-80. ⟨10.1016/j.ejim.2014.09.006⟩, European Journal of Internal Medicine, 2014, 25 (8), pp.777-80. ⟨10.1016/j.ejim.2014.09.006⟩
- Publication Year :
- 2014
- Publisher :
- HAL CCSD, 2014.
-
Abstract
- Background Romiplostim and eltrombopag, the two marketed thrombopoietin receptor agonists (TPO-RAs), have distinct binding sites and might have distinct pharmacodynamic mechanisms. The aim of this study was to compare their adverse drug reaction (ADR) patterns. Methods We selected in the French PharmacoVigilance Database all ADRs associated with TPO-RAs from TPO-RA marketing until the 31st of December 2013. Medical charts were reviewed. We conducted disproportionality analyses comparing romiplostim exposure in the reports of a given ADR pattern (thrombosis, neurological, cutaneous, gastrointestinal or hematological) to romiplostim exposure in all other TPO-RA-related ADR reports. Reporting Odds Ratios (RORs) were adjusted for age and gender. We also compared the number of reports of a given ADR pattern per million daily defined doses (DDDs) dispensed in France during the study period. Results We described 45 reports (53 ADRs) with romiplostim and 26 reports (37 ADRs) with eltrombopag. There were 19 venous thromboses. At least one other risk factor was present in 83.3% of the cases. Ten (55.6%) patients had been splenectomized previously. There were eight arterial thromboses. Another risk factor was noticed in all cases. There was no signal for an excess risk of thrombosis with romiplostim versus eltrombopag (ROR: 1.45, 95% CI [0.48–4.45]). There was a signal for a higher risk of gastrointestinal ADRs with eltrombopag (ROR: 30.28, 95% CI [3.23–383.86]) and of hematological ADRs with romiplostim (ROR: 14.36, 95% CI [1.73–119.08]). Dispensing data-adjusted comparisons led to similar results. Conclusions This study suggests different ADR patterns between romiplostim and eltrombopag.
- Subjects :
- Male
medicine.medical_specialty
Recombinant Fusion Proteins
Eltrombopag
Receptors, Fc
030204 cardiovascular system & hematology
Benzoates
Pharmacovigilance
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Internal medicine
Internal Medicine
medicine
Humans
Risk factor
ComputingMilieux_MISCELLANEOUS
Aged
Romiplostim
business.industry
Absolute risk reduction
Odds ratio
Middle Aged
medicine.disease
3. Good health
Surgery
Gastrointestinal Tract
Hydrazines
Thrombopoietin
chemistry
030220 oncology & carcinogenesis
Pharmacodynamics
Pyrazoles
Female
France
business
Receptors, Thrombopoietin
Adverse drug reaction
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 09536205 and 18790828
- Database :
- OpenAIRE
- Journal :
- European Journal of Internal Medicine, European Journal of Internal Medicine, Elsevier, 2014, 25 (8), pp.777-80. ⟨10.1016/j.ejim.2014.09.006⟩, European Journal of Internal Medicine, 2014, 25 (8), pp.777-80. ⟨10.1016/j.ejim.2014.09.006⟩
- Accession number :
- edsair.doi.dedup.....8e84036e430aba41514e70b9f3577319