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Adverse events with intravitreal injection of vascular endothelial growth factor inhibitors: nested case-control study.

https://arctichealth.org/en/permalink/ahliterature122863
Source
BMJ. 2012;345:e4203
Publication Type
Article
Date
2012
Author
Robert J Campbell
Sudeep S Gill
Susan E Bronskill
J Michael Paterson
Marlo Whitehead
Chaim M Bell
Author Affiliation
Department of Ophthalmology, Queen's University, Kingston, ON, Canada.
Source
BMJ. 2012;345:e4203
Date
2012
Language
English
Publication Type
Article
Keywords
Aged
Angiogenesis Inhibitors - administration & dosage - adverse effects
Antibodies, Monoclonal, Humanized - administration & dosage - adverse effects
Brain Ischemia - chemically induced - epidemiology
Case-Control Studies
Female
Heart Failure - chemically induced
Humans
Intravitreal Injections - adverse effects
Logistic Models
Male
Myocardial Infarction - chemically induced - epidemiology
Ontario - epidemiology
Retinal Diseases - drug therapy
Risk factors
Stroke - chemically induced - epidemiology
Vascular Endothelial Growth Factor A - antagonists & inhibitors
Venous Thromboembolism - chemically induced - epidemiology
Abstract
To assess the risk of systemic adverse events associated with intravitreal injections of vascular endothelial growth factor inhibiting drugs.
Population based nested case-control study.
Ontario, Canada.
91,378 older adults with a history of physician diagnosed retinal disease identified between 1 April 2006 and 31 March 2011. Cases were 1477 patients admitted to hospital for ischaemic stroke, 2229 admitted for an acute myocardial infarction, 1059 admitted or assessed in an emergency department for venous thromboembolism, and 2623 admitted for congestive heart failure. Event-free controls (at a ratio of 5:1) were matched to cases on the basis of year of birth, sex, history of the outcome in the previous 5 years, and diabetes.
Exposure to vascular endothelial growth factor inhibiting drugs identified within 180 days before the index date.
After adjustment for potential confounders, participants who had ischaemic stroke, acute myocardial infarction, congestive heart failure, or venous thromboembolism were not more likely than control participants to have been exposed to either bevacizumab (adjusted odds ratios of 0.95 (95% confidence interval 0.68 to 1.34) for ischaemic stroke, 1.04 (0.77 to 1.39) for acute myocardial infarction, 0.81 (0.49 to 1.34) for venous thromboembolism, and 1.21 (0.91 to 1.62) for congestive heart failure) or ranibizumab (adjusted odds ratios 0.87 (0.68 to 1.10) for ischaemic stroke, 0.90 (0.72 to 1.11) for acute myocardial infarction, 0.88 (0.67 to 1.16) for venous thromboembolism, and 0.87 (0.70 to 1.07) for congestive heart failure). Similarly, a secondary analysis of exclusive users of bevacizumab or ranibizumab showed no differences in risk between the two drugs (adjusted odds ratios for bevacizumab relative to ranibizumab of 1.03 (0.67 to 1.60) for ischaemic stroke, 1.23 (0.85 to 1.77) for acute myocardial infarction, 0.92 (0.51 to 1.69) for venous thromboembolism, and 1.35 (0.93 to 1.95) for congestive heart failure). These findings were consistent for all but one outcome in subgroup analyses.
Intravitreal injections of bevacizumab and ranibizumab were not associated with significant risks of ischaemic stroke, acute myocardial infarction, congestive heart failure, or venous thromboembolism.
Notes
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PubMed ID
22763393 View in PubMed
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[Experience of Lucentis use in patients with wet age-related macular degeneration].

https://arctichealth.org/en/permalink/ahliterature118433
Source
Vestn Oftalmol. 2012 Sep-Oct;128(5):26-31
Publication Type
Article

Identifying systemic safety signals following intravitreal bevacizumab: systematic review of the literature and the Canadian Adverse Drug Reaction Database.

https://arctichealth.org/en/permalink/ahliterature142189
Source
Can J Ophthalmol. 2010 Jun;45(3):231-8
Publication Type
Article
Date
Jun-2010
Author
Jonathan A Micieli
Andrew Micieli
Andrew F Smith
Author Affiliation
Faculty of Medicine, McGill University, Montreal, Que.
Source
Can J Ophthalmol. 2010 Jun;45(3):231-8
Date
Jun-2010
Language
English
Publication Type
Article
Keywords
Adverse Drug Reaction Reporting Systems
Angiogenesis Inhibitors - administration & dosage - adverse effects
Antibodies, Monoclonal - administration & dosage - adverse effects
Antibodies, Monoclonal, Humanized
Canada
Databases, Factual
Humans
Injections
Vascular Endothelial Growth Factor A - antagonists & inhibitors
Vitreous Body
Abstract
As the off-label use of intravitreal bevacizumab continues for an increasing number of ocular conditions, a systematic review of the literature aimed at detecting temporally associated systemic adverse events was undertaken.
Systematic review of the literature and a health regulatory database.
A total of 22 different clinical studies representing 12,699 patients.
A systematic review indexed by Ovid MEDLINE, EMBASE, ISI Web of Science, the Cochrane database (CENTRAL), and the Canadian Adverse Drug Reaction Information System Database was performed. All clinical studies with at least 100 eyes injected with bevacizumab and case reports documenting suspected events were included for review.
A total of 22 different clinical studies were reviewed, including an international internet survey, 6 retrospective studies assessing the safety of intravitreal bevacizumab, and 15 clinical trials. The most common adverse systemic event reported in these studies, representing 12,699 patients was an increase in blood pressure (0.46% of patients), followed by cerebrovascular accidents (0.21% of patients), and myocardial infarction (0.19% of patients). The 6 case reports documented suspected events not previously identified and only 1 systemic event from the Health Canada database was retrieved.
The systemic events temporally associated with intravitreal bevacizumab are mainly of cardiovascular and neurological origin and can be predicted from an exaggerated pharmacology, although a causal association cannot be established at this time. Health Canada's spontaneous drug reporting system is an underutilized resource and a more active surveillance system such as a patient registry may be better suited to establish the low rates of systemic adverse events following bevacizumab use in ophthalmology.
Notes
Comment In: Can J Ophthalmol. 2010 Jun;45(3):215-720628419
PubMed ID
20628421 View in PubMed
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[Molecular targeted therapy in colorectal cancer]

https://arctichealth.org/en/permalink/ahliterature87719
Source
Tidsskr Nor Laegeforen. 2008 Jan 17;128(2):190-3
Publication Type
Article
Date
Jan-17-2008
Author
Ree Anne Hansen
Bratland Ase
Dueland Svein
Author Affiliation
Akershus universitetssykehus, Universitetet i Oslo og Tumorbiologisk avdeling, Rikshospitalet, 0310 Oslo. a.h.ree@medisin.uio.no
Source
Tidsskr Nor Laegeforen. 2008 Jan 17;128(2):190-3
Date
Jan-17-2008
Language
Norwegian
Publication Type
Article
Keywords
Angiogenesis Inhibitors - administration & dosage - adverse effects - therapeutic use
Antibodies, Monoclonal - administration & dosage - adverse effects - therapeutic use
Antineoplastic Agents - administration & dosage - adverse effects - therapeutic use
Antineoplastic Combined Chemotherapy Protocols - administration & dosage - adverse effects - therapeutic use
Colorectal Neoplasms - drug therapy - mortality - secondary
Cytostatic Agents - administration & dosage - adverse effects - therapeutic use
Humans
Receptor Protein-Tyrosine Kinases - antagonists & inhibitors - drug effects
Receptor, Epidermal Growth Factor - antagonists & inhibitors - drug effects
Receptors, Vascular Endothelial Growth Factor - antagonists & inhibitors - drug effects
Abstract
BACKGROUND: A diversity of cytotoxic and molecularly targeting agents are now offered for colorectal cancer; 5-fluorouracil was until recently the only available therapy. Molecular targeting agents inhibit cellular signalling mechanisms that govern tumour cell proliferation and survival. MATERIAL AND METHODS: The article is mainly based on publications identified by searching PubMed, as well as abstracts and presentations at recent international congresses. RESULTS AND INTERPRETATION: Receptor tyrosine kinases are involved in cellular processes such as proliferation and angiogenesis, and signalling activities evoked by these enzymes are targets for pharmacological inhibition. The antibody bevacizumab inhibits angiogenesis. Randomized studies have shown that survival or time to progression of metastatic disease is improved when bevacizumab is combined with cytotoxic drugs (5-fluorouracil with or without irinotecan or oxaliplatin). The antibody cetuximab inhibits activation of a tumour cell growth factor receptor, and was approved for therapy on the basis of a large randomized phase 2 study. A wide array of small-molecular inhibitors of signalling by receptor tyrosine kinases are under clinical investigation, but their therapeutic contribution in metastatic colorectal cancer needs to be clarified. According to Nordic recommendations on the use of molecular targeted agents in combination with chemotherapy for metastatic colorectal cancer, bevacizumab should be considered in the first-line treatment of patients with a good performance status and cetuximab in third-line treatment.
PubMed ID
18202731 View in PubMed
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6 records – page 1 of 1.