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• W2119280212 abstract "To the Editor: We read with interest the article by Jokai et al1Jokai H. Szakonyi J. Kontar O. Marschalko M. Szalai K. Karpati S. et al.Impact of effective tumor necrosis factor-alfa inhibitor treatment on arterial intima-media thickness in psoriasis: results of a pilot study.J Am Acad Dermatol. 2013; 69: 523-529Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar examining the effect of tumor necrosis factor-alpha inhibitors on arterial intima-media thickness (IMT) in patients with psoriasis. Several recent studies of psoriasis have examined baseline IMT as a surrogate outcome representing the risk of cardiovascular events. While a baseline IMT measurement is a reliable marker for cardiovascular risk, there is currently little evidence supporting the use of change in IMT as a surrogate marker for cardiovascular risk in pharmaceutical clinical trials. In other words, measuring IMT before and after a pharmaceutical intervention has not been shown to accurately reflect a similar decrease in cardiovascular events. The use of surrogate markers such as IMT as endpoints offers several advantages over a morbidity and mortality studies, including decreased cost, decreased duration, and fewer participants required. There are also potential downfalls, as highlighted by the controversy surrounding Vytorin (ezetimibe/simvastatin), a cholesterol drug manufactured by Merck (White House Station, NJ). Vytorin became a top-selling drug after initial studies demonstrated a favorable impact on cholesterol, which was used as a surrogate outcome for cardiovascular risk. However, subsequent studies to demonstrate cardiovascular benefits from ezetimibe and other nonstatin cholesterol-lowering drugs have had mixed results. Recent studies have sought to evaluate the use of change in IMT as a surrogate endpoint. Costanzo et al2Costanzo P. Perrone-Filardi P. Vassallo E. Paolillo S. Cesarano P. Brevetti G. et al.Does carotid intima-media thickness regression predict reduction of cardiovascular events? A meta-analysis of 41 randomized trials.J Am Coll Cardiol. 2010; 56: 2006-2020Abstract Full Text Full Text PDF PubMed Scopus (182) Google Scholar conducted a meta-analysis of 41 trials of various pharmacologic agents in an attempt to assess the association between regression in carotid IMT and incidence of cardiovascular events. The study found no association between the two, and the authors concluded that IMT regression induced by drug therapies do not reflect reduction in cardiovascular events.2Costanzo P. Perrone-Filardi P. Vassallo E. Paolillo S. Cesarano P. Brevetti G. et al.Does carotid intima-media thickness regression predict reduction of cardiovascular events? A meta-analysis of 41 randomized trials.J Am Coll Cardiol. 2010; 56: 2006-2020Abstract Full Text Full Text PDF PubMed Scopus (182) Google Scholar However, this study had many limitations and shortcomings, as described by Taylor et al,3Taylor A.J. Bots M.L. Kastelein J.J. Vascular disease: meta-regression of CIMT trials-data in, garbage out.Nat Rev Cardiol. 2011; 8: 128-130Crossref PubMed Scopus (12) Google Scholar and the use of IMT change as a surrogate remains controversial. The Individual progression of carotid intima media thickness as a surrogate for vascular risk (PROG-IMT) project, another meta-analysis currently in progress, addresses many of the shortcomings of previous meta-analyses and may give more clarity to the issue.4Lorenz M.W. Bickel H. Bots M.L. Breteler M.M. Catapano A.L. Desvarieux M. et al.Individual progression of carotid intima media thickness as a surrogate for vascular risk (PROG-IMT): rationale and design of a meta-analysis project.Am Heart J. 2010; 159: 730-736Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar Looking at the use of IMT from a different perspective, Peters et al5Peters S.A. den Ruijter H.M. Grobbee D.E. Bots M.L. Results from a carotid intima-media thickness trial as a decision tool for launching a large-scale morbidity and mortality trial.Circ Cardiovasc Imaging. 2013; 6: 20-25Crossref PubMed Scopus (18) Google Scholar sought to evaluate the use of carotid IMT trials as a decision tool to aid in determining whether to launch a large-scale morbidity and mortality trial.5Peters S.A. den Ruijter H.M. Grobbee D.E. Bots M.L. Results from a carotid intima-media thickness trial as a decision tool for launching a large-scale morbidity and mortality trial.Circ Cardiovasc Imaging. 2013; 6: 20-25Crossref PubMed Scopus (18) Google Scholar The study found that the positive and negative predictive values of a carotid IMT trial to predict the outcome of a morbidity and mortality trial were 96% and 83%, respectively, supporting a conclusion that a carotid IMT trial may be used to help in the decision to launch such a trial.5Peters S.A. den Ruijter H.M. Grobbee D.E. Bots M.L. Results from a carotid intima-media thickness trial as a decision tool for launching a large-scale morbidity and mortality trial.Circ Cardiovasc Imaging. 2013; 6: 20-25Crossref PubMed Scopus (18) Google Scholar In summary, the evidence supporting the use of change in IMT as a surrogate for cardiovascular events is currently lacking. An IMT trial such as the one described by Jokai et al may aid in the decision to launch an extensive morbidity and mortality study evaluating the effect of tumor necrosis factor-alpha inhibitor treatment on cardiovascular risk in psoriasis patients. Dermatologists must recognize the limited role of IMT trials in evaluating a drug's effectiveness in reducing cardiac risk and further studies using endpoints such as cardiovascular events are needed. Impact of effective tumor necrosis factor-alfa inhibitor treatment on arterial intima-media thickness in psoriasis: Results of a pilot studyJournal of the American Academy of DermatologyVol. 69Issue 4PreviewPsoriasis is associated with higher incidence of atherosclerotic comorbidities. Sustained arterial wall inflammation mediated by common cytokines of psoriasis and atherogenesis precedes atherosclerotic plaque development. Increased intima-media thickness (IMT) is an accepted indicator of subclinical atherosclerosis and has been reported in severe psoriasis. Full-Text PDF" @default.
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• W2119280212 title "Change in arterial intima-media thickness: Is it an appropriate surrogate for cardiovascular risk in psoriasis patients treated with tumor necrosis factor-alpha inhibitors?" @default.
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