ArticleClinical drug investigation2009
Venous thromboembolism in myelodysplastic syndrome patients receiving lenalidomide: results from postmarketing surveillance and data mining techniques.
Article in Clinical drug investigation, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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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.
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Who cites it
13 citing papers in PubMed, 31 citations in OpenAlex.
- Inflammation, TNFα and endothelial dysfunction link lenalidomide to venous thrombosis in chronic lymphocytic leukemia.American journal of hematology · 2011Trial
- Thrombosis in Myeloid Malignancies: From CHIP to AML.Cardiovascular & hematological disorders drug targets · 2024Review
- An industry perspective on the use of machine learning in drug and vaccine safety.Frontiers in drug safety and regulation · 2023Article
- Isolated duodenal ischemia of unknown etiology: a case report.BMC surgery · 2021Article
- Synthesis of Tri- and Difluoromethoxylated Compounds by Visible-Light Photoredox Catalysis.Angewandte Chemie (International ed. in English) · 2019Review
- Splenic infarction secondary to myelodysplastic syndrome: unravelling more etiologies.AME case reports · 2019Article
- Erythropoiesis-stimulating agents and cardiovascular events in patients with myelodysplastic syndrome and multiple myeloma.Clinical epidemiology · 2018Article
- Acute Cerebral Infarction as a Rare Thrombotic Event in Myelodysplastic Syndrome: A Case Report.Annals of rehabilitation medicine · 2016Article
- Endothelial progenitor cell dysfunction in myelodysplastic syndromes: possible contribution of a defective vascular niche to myelodysplasia.Neoplasia (New York, N.Y.) · 2015Article
- Analysis of the efficacy of lenalidomide in patients with intermediate-1 risk myelodysplastic syndrome without 5q deletion.Experimental and therapeutic medicine · 2013Article
- Review
- Erythropoiesis-stimulating agents are not associated with increased risk of thrombosis in patients with myelodysplastic syndromes.Haematologica · 2012Article
- Venous thromboembolism in the patient with cancer: focus on burden of disease and benefits of thromboprophylaxis.Cancer · 2011Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesMultiple myeloma treatment with lenalidomide-based regimens is associated with risk of venous thromboembolism (VTE), particularly during concomitant use with erythropoiesis-stimulating agents (ESAs). The risk of VTE in myelodysplastic syndrome (MDS) patients treated with lenalidomide is not well characterized and the background risk in untreated patients is not known. This study set out to determine the reporting rate of VTE in MDS patients on lenalidomide in the two years of postmarketing experience in the US, and to investigate whether there is a disproportional signal of VTE in MDS patients on lenalidomide by screening the US FDA Adverse Event Reporting System (AERS) safety database.
methodsThe MDS population exposed to lenalidomide was obtained from RevAssist, the company's proprietary restrictive distribution programme. VTE reports were identified from the company's postmarketing surveillance safety database. The FDA AERS database was used for disproportionality analysis, and signal scores computed using three algorithms: multi-item gamma Poisson shrinker (MGPS), proportional reporting ratio (PRR), and reporting odds ratios (ROR).
resultsA total of 7764 MDS patients were prescribed lenalidomide during the first two years of commercial use in the US. VTE representing deep vein thrombosis and pulmonary embolism was reported in 41 patients, a reporting rate of 0.53%. The computed signal scores did not exceed the statistical threshold for identification of a significant disproportional signal for VTE in MDS reports involving use of lenalidomide without concomitant use of ESAs. However, a disproportional signal of VTE was detected in MDS reports where lenalidomide was concurrently used with ESAs.
conclusionThe VTE reporting rate for MDS patients receiving lenalidomide during the first two years of postmarketing exposure was low (0.53%). Disproportionality analysis demonstrated a statistically meaningful association of VTE with lenalidomide concomitantly used with ESAs in MDS patients, but the association was not statistically significant when lenalidomide was used in the absence of ESAs.
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