Signal for Thrombosis with Eltrombopag and Romiplostim: A Disproportionality Analysis of Spontaneous Reports Within VigiBase®

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Thi-Thanh Loan NguyenGuillaume Moulis

Abstract

Eltrombopag and romiplostim are thrombopoietin receptor agonists (TPO-RAs) marketed for immune thrombocytopenia (ITP). Thrombotic events have been reported with both drugs. This study was aimed at assessing whether there is a signal for differential risks of thrombosis between these two TPO-RAs. We carried out a disproportionality analysis in the World Health Organization global individual case safety report (ICSR) database (VigiBase(®)). We selected all ICSRs with exposure to a TPO-RA between January 2011 and December 2014. We searched for exposures to eltrombopag or romiplostim in thrombosis reports as compared with other ICSRs, and we calculated adjusted reporting odds ratios (aRORs). We identified 5850 ICSRs, including 764 cases of thrombosis. In multivariate analyses, there was a signal for an increased risk of thrombosis (venous or arterial; aROR 1.72, 95 % confidence interval [CI] 1.47-2.02), venous thrombosis (aROR 1.88, 95 % CI 1.53-2.31), arterial thrombosis (aROR 1.54, 95 % CI 1.18-2.00), ischaemic stroke (aROR 1.65, 95 % CI 1.13-2.42) and myocardial infarction (aROR 1.50, 95 % CI 1.05-2.13) with eltrombopag as compared with romiplostim. Restriction to ICSRs reported by physicians led to similar results. However, wor...Continue Reading

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Dec 17, 2015·Drugs·Esther S Kim
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