To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Anti-VEGF Therapies Show Low Incidence of Systemic Side Effects: Presented at AAO URL: http://www.pslgroup.com/dg/2174E2.htm Doctor's Guide November 16, 2007
By Cameron E. Johnston NEW ORLEANS, LA -- November 16, 2007 -- Anti-vascular endothelial growth factor (VEGF) therapies, including pegaptanib sodium, ranibizumab and bevacizumab, are now being used worldwide to treat a large number of ocular conditions, primarily choroidal neovascularisation secondary to age-related macular degeneration. And while systemic side effects from Avastin, which was originally used in the treatment of colorectal cancer, are well known, the systemic side effects of these therapies when used for ocular purposes have never been studied in any significant way. In a presentation at the Retina Sub-specialty Day symposium of the American Academy of Ophthalmology (AAO), Diane Do, MD, Assistant Professor, Wilmer Eye Institute and Johns-Hopkins University School of Medicine, Baltimore, Maryland, United States, discussed the systemic safety of these drugs and concluded that the evidence does not exist to say that they present any kind of significant systemic risks. Nor are they entirely safe. Two 24-month trials involving 379 patients who received either sham treatment or photodynamic therapy (PDT), and 379 who received ranibizumab, showed largely inconsistent results. For example, one trial showed more myocardial infarction (MI) among patients who received the sham treatment compared with those who received ranibizumab (1.7% vs 1.3%), while the other trial showed more than twice as many heart attacks in patients receiving ranibizumab compared with those treated with PDT (3.6% vs 1.4%) Overall, there were more cases of death from all causes and vascular deaths among patients treated with PDT than in patients treated with Lucentis. The two studies showed rates of thromboembolic events of 3.8% in the sham arm, and 4.6% in the Lucentis arm of one trial, and 4.2% among patients receiving PDT compared with 5.0% of those receiving Lucentis in the other trial. Dr. Do said these differences were not statistically significant, but she predicted that in order to conduct a trial that would show significant differences in these outcomes, more than 10,000 patients would be needed in each arm. The same studies have shown increased rates of stroke among patients who were receiving either the 0.3 mg or 0.5 mg dose of ranibizumab (P =.02), and this risk was greater among patients who had had a prior stroke. There were no differences in the rates of death or MI between the two doses of Lucentis. The pivotal trial for pegaptinib reported no differences in the rates of hypertensive disorders, thromboembolic events, any kind of haemorrhagic events, or death. As for the systemic side effects of bevacizumab, three studies of up to 12 months and involving 692 patients reported five cases of serious hypertension, one fatal stroke, two fatal MIs, and one transient ischemic attack. Overall, Dr. Do said, these data do not show the use of intravitreal anti-VEGF therapy produces an unacceptable level of risk of systemic side effects, although most of the trials were limited by either short followup time, or small numbers of patients. Also, there is the question of whether results from clinical trials can be safely translated into "real-world" practice, and the feeling is that often, this is not the case, she said. The limited experience with this class of drugs has reported only a low incidence of adverse systemic side effects, Dr. Do added, but good postmarketing surveillance is needed to follow up these drugs over a longer period of time. In addition, more thorough and more detailed definitions of exactly what would constitute a systemic adverse event need further refinement so they can be included in future prospective studies of these drugs. [Presentation title: Systemic Complications of VEGF Therapy. Retina Subspecialty Day] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.