ArticleDrug safety2015
Signal for Thrombosis with Eltrombopag and Romiplostim: A Disproportionality Analysis of Spontaneous Reports Within VigiBase®.
Article in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Efficacy and Safety of Avatrombopag in Patients With Thrombocytopenia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Frontiers in pharmacology · 2019Pooled it
- Eltrombopag versus romiplostim in treatment of children with persistent or chronic immune thrombocytopenia: a systematic review incorporating an indirect-comparison meta-analysis.Scientific reports · 2018Pooled it
- Pooled it
- Comparative thromboembolic risk of romiplostim versus eltrombopag in immune thrombocytopenia: a propensity score-matched cohort study.Annals of hematology · 2026Article
- Development and Validation of a Novel Thrombosis Prediction Model for Adult Immune Thrombocytopenia (ITP-THROMBO).Journal of blood medicine · 2026Article
- Thrombotic Complications in Immune Thrombocytopenia Patients Treated with Avatrombopag.Hematology reports · 2023Article
- Safety of non‑peptide thrombopoietin receptor agonists in patients with immune thrombocytopenia: A systematic review and meta‑analysis of short‑term double‑blind randomized clinical trials.Experimental and therapeutic medicine · 2023Article
- Current Concepts in the Diagnosis and Management of Adult Primary Immune Thrombocytopenia: Our Personal View.Medicina (Kaunas, Lithuania) · 2023Article
- Risk of Thromboembolism With Eltrombopag: A Case Report of Deep Vein Thrombosis and Bilateral Pulmonary Embolism.Cureus · 2023Article
- Immune Thrombocytopenic Purpura and Paradoxical Thrombosis: A Systematic Review of Case Reports.Cureus · 2022Review
- Consensus guidelines for the management of adult immune thrombocytopenia in Australia and New Zealand.The Medical journal of Australia · 2022Article
- Refractory Coronary Stent Thrombosis in a Patient with Chronic Immune Thrombocytopenia on Eltrombopag.Acta Cardiologica Sinica · 2021Article
- Successful outcome with eculizumab treatment in a patient with antiphospholipid syndrome presenting with an unusual thrombotic storm.Journal of thrombosis and thrombolysis · 2021Article
- Eltrombopag-related renal vein thromboembolism in a patient with immune thrombocytopenia: A case report.World journal of clinical cases · 2021Article
- Optimal use of thrombopoietin receptor agonists in immune thrombocytopenia.Therapeutic advances in hematology · 2019Review
- A sticky situation: myocardial infarction in a young woman with immune thrombocytopenia on eltrombopag and a history of mediastinal radiation.Journal of thrombosis and thrombolysis · 2018Article
- Lusutrombopag: First Global Approval.Drugs · 2016Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEltrombopag 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.
methodsWe 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).
resultsWe 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, worldwide dispensing data for romiplostim and eltrombopag were not accessible, so the rates of thrombosis with both drugs were not normalized by the daily defined doses and the generalizability of the results is limited.
conclusionThis study suggests the presence of a signal for an increased risk of thrombosis with eltrombopag compared with romiplostim. These results must be confirmed and quantified by large aetiological pharmacoepidemiological studies.
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Registered trials
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