Corrigendum

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Nov 16, 2010 - Effects of succinobucol (AGI-1067) after an ... In the light of the withdrawal and the EMA's advice to patients taking Thelin (not to stop medication ...
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Editorial

11. Boekholdt SM, Keller TT, Wareham NJ, Luben R, Bingham SA, Day NE, Sandhu MS, Jukema JW, Kastelein JJ, Hack CE, Khaw KT. Serum levels of type II secretory phospholipase A2 and the risk of future coronary artery disease in apparently healthy men and women: the EPIC-Norfolk Prospective Population Study. Arterioscler Thromb Vasc Biol 2005;25:839 –846. 12. Mallat Z, Benessiano J, Simon T, Ederhy S, Sebella-Arguelles C, Cohen A, Huart V, Wareham NJ, Luben R, Khaw KT, Tedgui A, Boekholdt SM. Circulating secretory phospholipase A2 activity and risk of incident coronary events in healthy men and women: the EPIC-Norfolk study. Arterioscler Thromb Vasc Biol 2007;27:1177–1183. 13. Divchev D, Grothusen C, Luchtefeld M, Thoenes M, Onono F, Koch R, Drexler H, Schieffer B. Impact of a combined treatment of angiotensin II type 1 receptor blockade and 3-hydroxy-3-methyl-glutaryl-CoA-reductase inhibition on secretory phospholipase A2-type IIA and low density lipoprotein oxidation in patients with coronary artery disease. Eur Heart J 2008;29:1956 –1965. 14. Shaposhnik Z, Wang X, Trias J, Fraser H, Lusis AJ. The synergistic inhibition of atherogenesis in apoE–/– mice between pravastatin and the sPLA2 inhibitor varespladib (A-002). J Lipid Res 2009;50:623 –629. 15. Leite JO, Vaishnav U, Puglisi M, Fraser H, Trias J, Fernandez ML. A-002 (Varespladib), a phospholipase A2 inhibitor, reduces atherosclerosis in guinea pigs. BMC Cardiovasc Disord 2009;9:7. 16. Rosenson RS, Hislop C, McConnell D, Elliott M, Stasiv Y, Wang N, Waters DD. Effects of 1-H-indole-3-glyoxamide (A-002) on concentration of secretory

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phospholipase A2 (PLASMA study): a phase II double-blind, randomised, placebocontrolled trial. Lancet 2009;373:649–658. Rosenson RS, Elliott M, Stasiv Y, Hislop C, for the PLASMA II Investigators. Randomized trial of an inhibitor of secretory phospholipase A2 on atherogenic lipoprotein subclasses in statin-treated patients with coronary heart disease. Eur Heart J 2011;32:999 –1005. First published on 16 November 2010. doi:10.1093/ eurheartj/ehq374. Rosenson RS, Hislop C, Elliott M, Stasiv Y, Goulder M, Waters D. Effects of varespladib methyl on biomarkers and major cardiovascular events in acute coronary syndrome patients. J Am Coll Cardiol 2010;56:1079 –1088. Kastelein JJ, Akdim F, Stroes ES, Zwinderman AH, Bots ML, Stalenhoef AF, Visseren FL, Sijbrands EJ, Trip MD, Stein EA, Gaudet D, Duivenvoorden R, Veltri EP, Marais AD, de Groot E. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med 2008;358:1431 –1443. Arsenault BJ, Lemieux I, Despre´s JP, Wareham NJ, Luben R, Kastelein JJ, Khaw KT, Boekholdt MS. Cholesterol levels in small LDL particles predict the risk of coronary heart disease in the EPIC-Norfolk prospective population study. Eur Heart J 2007;28:2770 –2777. Tardif JC, McMurray JJ, Klug E, Small R, Schumi J, Choi J, Cooper J, Scott R, Lewis EF, L’Allier PL, Pfeffer MA. Effects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial. Lancet 2008;371:1761 –1768.

doi:10.1093/eurheartj/ehr046

............................................................................................................................................................................. Corrigendum to: ‘Guidelines for the diagnosis and treatment of pulmonary hypertension’ [European Heart Journal (2009) 30, 2493– 2537]. The Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Authors/Task Force Members: Nazzareno Galie` (Chairperson) (Italy); Marius M. Hoeper (Germany); Marc Humbert (France); Adam Torbicki (Poland); Jean-Luc Vachiery (France); Joan Albert Barbera (Spain); Maurice Beghetti (Switzerland); Paul Corris (UK); Sean Gaine (Ireland); J. Simon Gibbs (UK); Miguel Angel Gomez-Sanchez (Spain); Guillaume Jondeau (France); Walter Klepetko (Austria) Christian Opitz (Germany); Andrew Peacock (UK); Lewis Rubin (USA); Michael Zellweger (Switzerland); Gerald Simonneau (France). Withdrawal of sitaxentan in the treatment of pulmonary arterial hypertension The 2009 ESC Practice Clinical Guidelines for the diagnosis and treatment of pulmonary hypertension included the endothelin receptor antagonist sitaxentan in an algorithm of evidence-based treatment for pulmonary arterial hypertension. Sitaxentan was recommended with a Class I/Level A grade of evidence in WHO functional class III patients and Class IIa/Level C grade of evidence in WHO functional clsses II and IV. Sitaxentan was initially authorized by the European regulatory agency as Thelin in 2006 but in December 2010, after the manufacturer withdrew Thelin from the worldwide market following new information on two cases of fatal liver injury, marketing authorization was also withdrawn by the EMA. In the light of the withdrawal and the EMA’s advice to patients taking Thelin (not to stop medication but review treatment at the next scheduled appointment), the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the ESC and the European Respiratory Society (ERS) has issued its own recommendations for treating physicians. This has been published in the European Heart Journal in February as a CardioPulse article (Eur Heart J 2011:32:386 – 387). The Task Force recommends:

(1) For the time being, no PAH patient should start de novo therapy with Thelin (2) For patients already on treatment with Thelin, transition to another endothelin receptor antagonist such as bosentan (Tracleer) or ambrisentan (Volibris) should be considered.

(3) In cases where a PAH patient was treated with Thelin because of previous adverse reactions with Tracleer and Volibris, the transition to another class of PAH-approved drugs should be considered (prostanoids or PDE-5 inhibitors) The Task Force is monitoring the status of sitaxentan, along with all other clinical developments relevant to pulmonary hypertension. This information will be incorporated in the next update of the ESC Practice Clinical Guidelines. The online version of the Guidelines has been updated with a note added to the title page bringing attention to the fact that the drug has been withdrawn. The occurrences of ‘sitaxentan’ have also been highlighted where they occur throughout the text. Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2011. For permissions please email: [email protected]

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Corrigendum