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https://hdl.handle.net/2440/92266
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dc.contributor.author | Pratt, N. | - |
dc.contributor.author | Ramsay, E. | - |
dc.contributor.author | Kemp, A. | - |
dc.contributor.author | Kalisch-Ellett, L. | - |
dc.contributor.author | Shakib, S. | - |
dc.contributor.author | Caughey, G. | - |
dc.contributor.author | Ryan, P. | - |
dc.contributor.author | Graves, S. | - |
dc.contributor.author | Roughead, E. | - |
dc.date.issued | 2014 | - |
dc.identifier.citation | Drug Safety, 2014; 37(12):1021-1027 | - |
dc.identifier.issn | 0114-5916 | - |
dc.identifier.issn | 1179-1942 | - |
dc.identifier.uri | http://hdl.handle.net/2440/92266 | - |
dc.description.abstract | BACKGROUND: Ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor, is used in the treatment of age-related macular degeneration. Inhibition of VEGF has an anti-angiogenic action and is associated with thrombogenicity, thus, myocardial infarction and ischaemic stroke are potential side effects of VEGF inhibitors. OBJECTIVE: Our objective was to assess the association between use of ranibizumab and risk of hospitalisation for ischaemic stroke (IS) and myocardial infarction (MI). METHODS: The self-controlled case series design was used, including subjects exposed to ranibizumab (Anatomical Therapeutic Chemical [ATC] code S01LA04) who were hospitalized for IS (International Classification of Diseases, tenth edition [ICD-10] code I63) or the combined endpoint of stroke or transient ischaemic attack (TIA) (ICD-10 code G45) or MI (ICD-10 code I21) were identified between August 2007 and March 2013. Rate ratios in exposed periods compared with unexposed periods were calculated using conditional Poisson regression. RESULTS: A total of 323 subjects received ranibizumab and were hospitalized for IS, 490 for IS or TIA, and 391 for MI. Median period of exposure was 8-9 months with follow-up times of approximately 2.8 years. No elevated risk of IS was seen in the 1-30 days post initiation (incidence rate ratio [IRR] 1.36; 95% confidence interval [CI] 0.98-1.88); however, elevated risk was observed for those who received therapy for 31-60 days (IRR 1.91; 95% CI 1.13-3.24). Sensitivity analyses adjusting for time-varying confounders found elevated risk in both the 1-30 days and 31-60 days periods. Similar results to those for IS were observed for the combined endpoint of IS or TIA. No association was seen for MI in either time period (1-30 days IRR 0.90, 95% CI 0.65-1.23; 31-60 days IRR 0.98, 95% CI 0.54-1.79). CONCLUSION: This case-series analysis suggests an increased risk of hospitalisation for ischaemic stroke for patients receiving ranibizumab in the 31-60 days risk period. Studies with larger populations are required to confirm the risk in the 1-30 days risk period. No evidence of increased risk of hospitalisation for MI was observed. | - |
dc.description.statementofresponsibility | Nicole L. Pratt, Emmae N. Ramsay, Anna Kemp, Lisa M. Kalisch-Ellett, Sepehr Shakib, Gillian E. Caughey, Philip Ryan, Stephen Graves, Elizabeth E. Roughead | - |
dc.language.iso | en | - |
dc.publisher | Springer International Publishing | - |
dc.rights | © The Author(s) 2014. This article is published with open access at Springerlink.com | - |
dc.source.uri | http://dx.doi.org/10.1007/s40264-014-0231-2 | - |
dc.subject | Humans | - |
dc.subject | Brain Ischemia | - |
dc.subject | Macular Degeneration | - |
dc.subject | Myocardial Infarction | - |
dc.subject | Hospitalization | - |
dc.subject | Risk Factors | - |
dc.subject | Case-Control Studies | - |
dc.subject | Age Factors | - |
dc.subject | Aged, 80 and over | - |
dc.subject | Veterans | - |
dc.subject | Australia | - |
dc.subject | Female | - |
dc.subject | Male | - |
dc.subject | Antibodies, Monoclonal, Humanized | - |
dc.subject | Drug-Related Side Effects and Adverse Reactions | - |
dc.subject | Ranibizumab | - |
dc.title | Ranibizumab and risk of hospitalisation for ischaemic stroke and myocardial infarction in patients with age-related macular degeneration: a self-controlled case-series analysis | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1007/s40264-014-0231-2 | - |
dc.relation.grant | http://purl.org/au-research/grants/nhmrc/1040938 | - |
dc.relation.grant | http://purl.org/au-research/grants/nhmrc/1035889 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Pratt, N. [0000-0001-8730-8910] | - |
dc.identifier.orcid | Shakib, S. [0000-0002-7199-5733] | - |
dc.identifier.orcid | Caughey, G. [0000-0003-1192-4121] | - |
dc.identifier.orcid | Graves, S. [0000-0002-1629-319X] | - |
Appears in Collections: | Aurora harvest 2 Medical Sciences publications |
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