URSODEOXYCHOLIC ACID IN PATIENTS WITH CHRONIC HEART FAILURE. A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSSOVER TRIAL

1. Anker S.D., von Haehling S. Inflammatory mediators in chronic heart failure: an overview. Heart 2004;90:464 –70.

2. Anker S.D., Volterrani M., Egerer K.R. et al. Tumour necrosis factor alpha as a predictor of impaired peak leg blood flow in patients with chronic heart failure. QJM 1998;91:199 –203.

3. von Haehling S., Morley J.E., Anker S.D. An overview of sarcopenia: facts and numbers on prevalence and clinical impact. J Cachexia Sarcopenia Muscle 2010;1:129 –33.

4. von Haehling S., Anker S.D. Cachexia as a major underestimated and unmet medical need: facts and numbers. J Cachexia Sarcopenia Muscle 2010;1:1–5.

5. Mann D.L., McMurray J.J., Packer M. et al. Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL). Circulation 2004;109:1594–602.

6. Chung E.S., Packer M., Lo K.H., Fasanmade A.A., Willerson J.T. Anti-TNF Therapy Against Congestive Heart Failure Investigators. Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-alpha, in patients with moderate-to-severe heart failure: results of the anti-TNF Therapy Against Congestive Heart Failure (ATTACH) trial. Circulation 2003;107:3133– 40.

7. von Haehling S., Anker S.D. Future prospects of anticytokine therapy in chronic heart failure. Expert Opin Investig Drugs 2005;14:163–76.

8. Anker S.D., Egerer K.R., Volk H.D., Kox W.J., Poole-Wilson P .A, Coats A.J. Elevated soluble CD14 receptors and altered cytokines in chronic heart failure. Am J Cardiol 1997;79:1426 –30.

9. Sandek A., Bauditz J., Swidsinski A. et al. Altered intestinal function in patients with chronic heart failure. J Am Coll Cardiol 2007;50:1561–9.

10. Niebauer J., Volk H.D., Kemp M. et al. Endotoxin and immune activation in chronic heart failure: a prospective cohort study. Lancet 1999;353:1838–42.

11. Leuschner U., Leuschner M., Sieratzki J., Kurtz W., Hubner K. Gallstone dissolution with ursodeoxycholic acid in patients with chronic active hepatitis and two years follow-up. A pilot study. Dig Dis Sci 1985;30:642–9.

12. Aouad K., Calmus Y ., Nordlinger B., Myara A., Weill B., Poupon R. Immunosuppressive effects of endotoxins and bile acids in vivo in the rat. Eur J Clin Invest 1996;26:45– 8.

13. Talwalkar J.A., Lindor K.D. Primary biliary cirrhosis. Lancet 2003;362: 53–61.

14. Ikegami T., Matsuzaki Y . Ursodeoxycholic acid: mechanism of action and novel clinical applications. Hepatol Res 2008;38:123–31.

15. Iwasaki T. U¨ ber die Konstitution der Ursodeoxycholsäure. Z Physiol Chem 1936;244:181–93.

16. Makino I., Shinozaki K., Yoshino K., Nakagawa S. Dissolution of cholesterol gallstones by long-term administration of ursodeoxycholic acid. Nippon Shokakibyo Gakkai Zasshi 1975;72:690 –702.

17. Dickstein K., Cohen-Solal A., Filippatos G. et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J 2008;29:2388–442.

18. Clavien P .A., Sharara A.I., Camargo C.A. Jr ., Harland R.C., Fitz J.G. Evidence that ursodeoxycholic acid prevents steroid-resistant rejection in adult liver transplantation. Clin Transplant 1996;10:658–62.

19. Söderdahl G., Nowak G., Duraj F ., Wang F .H., Einarsson C., Ericzon B.G. Ursodeoxycholic acid increased bile flow and affects bile composition in the early postoperative phase following liver transplantation. Transpl Int 1998;11 Suppl 1:S231– 8.

20. Fleckenstein J.F ., Paredes M., Thuluvath P .J. A prospective, randomized, double-blind trial evaluating the efficacy of ursodeoxycholic acid in prevention of liver transplant rejection. Liver T ranspl Surg 1998;4: 276–9.

21. Stojakovic T ., Putz-Bankuti C., Fauler G. et al. Atorvastatin in patients with primary biliary cirrhosis and incomplete biochemical response to ursodeoxycholic acid. Hepatology 2007;46:776–84.

22. Volterrani M., Clark A.L., Ludman P .F . et al. Predictors of exercise capacity in chronic heart failure. Eur Heart J 1994;15:801–9.

23. Hills M., Armitage P . The two-period cross-over clinical trial. Br J Clin Pharmacol 1979;8:7–20.

24. Wilson J.R., Martin J.L., Schwartz D., Ferraro N: Exercise intolerance in patients with chronic heart failure: role of impaired nutritive flow to skeletal muscle. Circulation 1984;69:1079–87

25. Bomzon A., Ljubuncic P . Bile acids as endogenous vasodilators. Biochem Pharmacol 1995;49: 581–9.

26. Sinoway L., Minotti J., Musch T. et al. Enhanced metabolic vasodilation secondary to diuretic therapy in decompensated congestive heart failure secondary to coronary artery disease. Am J Cardiol 1987;60: 107–11.

27. Doehner W., Schoene N., Rauchhaus M. et al. Effects of xanthine oxidase inhibition with allopurinol on endothelial function and peripheral blood flow in hyperuricemic patients with chronic heart failure: results from 2 placebo-controlled studies. Circulation 2002; 105:2619 –24.

28. Allen L.A., Felker G.M., Pocock S. et al. Liver function abnormalities and outcome in patients with chronic heart failure: data from the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) program. Eur J Heart Fail 2009;11:170 –7.

29. Shinagawa H., Inomata T ., Koitabashi T . et al. Prognostic significance of increased serum bilirubin levels coincident with cardiac decompensation in chronic heart failure. Circ J 2008;72:364 –9.

30. Sinisalo J., Vanhanen H., Pajunen P ., Vapaatalo H., Nieminen M.S. Ursodeoxycholic acid and endothelialdependent, nitric oxideindependent vasodilatation of forearm resistance arteries in patients with coronary heart disease. Br J Clin Pharmacol 1999;47:661–5.

31. Rauchhaus M., Doehner W., Francis D.P . et al. Plasma cytokine parameters and mortality in patients with chronic heart failure. Circulation 2000;102:3060 –7.

32. Güldütuna S., Deisinger B., Weiss A. et al. Ursodeoxycholate stabilizes phospholipid-rich membranes and mimics the effect of cholesterol: investigations on large unilamellar vesicles. Biochim Biophys Acta 1997;1326:265–74.

33. Ninomiya R., Matsuoka K., Moroi Y . Micelle formation of sodium chenodeoxycholate and solubilization into the micelles: comparison with other unconjugated bile salts. Biochim Biophys Acta 2003;1634: 116–25.

34. Paumgartner G. Medical treatment of cholestatic liver diseases: from pathobiology to pharmacological targets. World J Gastroenterol 2006; 12:4445–51.

35. Bährle S., Szabo´ G., Stiehl A. et al. Adjuvant treatment with ursodeoxycholic acid may reduce the incidence of acute cardiac allograft rejection. J Heart Lung Transplant 1998;17:592– 8.

36. Rodrigues C.M., Steer C.J. The therapeutic effects of ursodeoxycholic acid as an anti-apoptotic agent. Expert Opin Investig Drugs 2001;10: 1243–53.