Guest guest Posted June 16, 2008 Report Share Posted June 16, 2008 , you are right. Here is the response that I got today from Dr. Lindor. " Yes, we were disappointed, too. An official letter is at our IRB for approval and should be sent out soon. " I have been on high dose URSO for almost 10 years and I am disappointed that the study did not have positive results. The docs are not sure why but for the last 10 months all my labs have been normal. The only thing that I did differently was that I took to rounds of azithromycin (zpac) and then my results normalized. Probably only a coincidence but I did find this recently. Azithromycin may reduce cholestasis in primary sclerosing cholangitis: a case report and serendipitous observation. Int J Immunopathol Pharmacol. 2007 Oct-Dec;20(4):847-9. Department of Pediatrics, University of Verona, Italy. The newer macrolides have been shown to exert additional anti- inflammatory effects. We report the possible effect of azithromycin on primary sclerosing cholangitis in a patient treated with the drug for severe asthma. A 45-year-old woman with Crohn?s disease and primary sclerosing cholangitis, also suffering from severe asthma, was treated with azithromycin 500 mg OD for 3 consecutive days a week because of the clinical suspicion of bronchiectasis and the severity of her asthma. When the therapy was discontinued, her urine again became darker, pruritus reappeared with the usual severity and laboratory parameters, evaluated after 6 weeks without azithromycin, also worsened. For these reasons macrolide treatment was re- established. Cholestasis-related symptoms and the dark colour of the urine were again reduced 6 weeks later and laboratory parameters were again reversed. We are therefore tempted to speculate that azithromycin may have an effect on primary sclerosing cholangitis on the basis of its anti-inflammatory properties. > > I realize I have not posted for awhile and for that I apologize but I > do keep up with the messages when my schedule allows. I just wanted > to share some information I was given today as a participant in the > Multi-Center High Dose Urso Study coordinated by The Mayo Clinic > (through Dr. Lindor). This study, originally slated for 5 years (I > just finished year 5) was extended last year to gather more data. > The original plan was to go another two years. > > I was just informed that effective immediately all patients are being > taken off of the Urso or Placebo doses they have been receiving. > This is due to there being no evidence that that high dose urso was > having any benefit. They will continue to follow us for a year to > study the impact to our lab results. I asked my study coordinator if > they will continue to prescribe Urso to PSC patients outside of the > study and it appears the conclusion is there is no tangible benefit > and therefore they are not recommending PSC patients continue taking > Urso. > > While this news is dissapointing it does not come to a particular > shock to me since previous studies had been inconclusive at best. I > would be curious to know if other study participants have yet > received this news. Supposedly I will receive an official letter in > the coming days and be told if I was on " real " Urso or a placebo. > > in Seattle > UC 1991, PSC 2001 - Stage IV > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 18, 2008 Report Share Posted June 18, 2008 Hi Barb; The Mayo clinic uses a risk survival model to predict risk of death in PSC. The model uses age, bilirubin, AST, albumin and presence or absence of variceal bleeding: Kim WR, Therneau TM, Wiesner RH, Poterucha JJ, Benson JT, Malinchoc M, LaRusso NF, Lindor KD, Dickson ER 2000 A revised natural history model for primary sclerosing cholangitis. Mayo Clin. Proc. 75: 688- 694. http://www.ncbi.nlm.nih.gov/pubmed/10907383 Because high-dose urso reduces AST and bilirubin and increases albumin, it is logical to suppose that this should translate into increased survival: Harnois DM, Angulo P, nsen RA, LaRusso NF, Lindor KD 2001 High- dose ursodeoxycholic acid as a therapy for patients with primary sclerosing cholangitis. Am. J. Gastroenterol. 96: 1558-1562. http://www.ncbi.nlm.nih.gov/pubmed/11374699 Why should it be of any benefit to PSC patients to take them off ursodiol and allow their AST and bilirubin to increase, and albumin to decrease? Wouldn't it be better to maintain PSC patients on high-dose ursodiol and then look for additional therapies which result in further improvement? This is what is being done in primary biliary cirrhosis, see for e.g.: Iwasaki S, Ohira H, Nishiguchi S, Zeniya M, Kaneko S, Onji M, Ishibashi H, Sakaida I, Kuriyama S, Ichida T, Onishi S, Toda G 2008 The efficacy of ursodeoxycholic acid and bezafibrate combination therapy for primary biliary cirrhosis: a prospective, multicenter study. Hepatol. Res. 38: 557-564. http://www.ncbi.nlm.nih.gov/pubmed/18452482 Best regards, Dave (father of (23); PSC 07/03; UC 08/03) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 18, 2008 Report Share Posted June 18, 2008 Hi Barb; The Mayo clinic uses a risk survival model to predict risk of death in PSC. The model uses age, bilirubin, AST, albumin and presence or absence of variceal bleeding: Kim WR, Therneau TM, Wiesner RH, Poterucha JJ, Benson JT, Malinchoc M, LaRusso NF, Lindor KD, Dickson ER 2000 A revised natural history model for primary sclerosing cholangitis. Mayo Clin. Proc. 75: 688- 694. http://www.ncbi.nlm.nih.gov/pubmed/10907383 Because high-dose urso reduces AST and bilirubin and increases albumin, it is logical to suppose that this should translate into increased survival: Harnois DM, Angulo P, nsen RA, LaRusso NF, Lindor KD 2001 High- dose ursodeoxycholic acid as a therapy for patients with primary sclerosing cholangitis. Am. J. Gastroenterol. 96: 1558-1562. http://www.ncbi.nlm.nih.gov/pubmed/11374699 Why should it be of any benefit to PSC patients to take them off ursodiol and allow their AST and bilirubin to increase, and albumin to decrease? Wouldn't it be better to maintain PSC patients on high-dose ursodiol and then look for additional therapies which result in further improvement? This is what is being done in primary biliary cirrhosis, see for e.g.: Iwasaki S, Ohira H, Nishiguchi S, Zeniya M, Kaneko S, Onji M, Ishibashi H, Sakaida I, Kuriyama S, Ichida T, Onishi S, Toda G 2008 The efficacy of ursodeoxycholic acid and bezafibrate combination therapy for primary biliary cirrhosis: a prospective, multicenter study. Hepatol. Res. 38: 557-564. http://www.ncbi.nlm.nih.gov/pubmed/18452482 Best regards, Dave (father of (23); PSC 07/03; UC 08/03) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 20, 2008 Report Share Posted June 20, 2008 All I found this article from June 7, 2008. Reference is made to Dr. Lindor Perhaps this clarifies some link : http://www.wjgnet.com/1007-9327/14/3338.asp Gerrit ISSN 1007-9327 CN 14-1219/R World J Gastroenterol 2008 June 7; 14 (21): 3338-3349 TOPIC HIGHLIGHT Clinical features and management of primary sclerosing cholangitis Marina G Silveira, D Lindor Marina G Silveira, D Lindor, Division of Gastro-enterology and Hepatology, Miles and Shirley Fiterman Center for Digestive Diseases, Mayo Clinic and Foundation, Rochester, Minnesota, United States Correspondence to: D Lindor, MD, Division of Gastroenterology and Hepatology, Miles and Shirley Fiterman Center for Digestive Diseases, Mayo Clinic and Foundation, 200 First Street, SW, Rochester, MN 55905, United States. lindor.keith@... Abstract Primary sclerosing cholangitis is a chronic cholestatic liver disease characterized by inflammation and fibrosis of the bile ducts, resulting in cirrhosis and need for liver transplantation and reduced life expectancy. The majority of cases occur in young and middle-aged men, often in association with inflammatory bowel disease. The etiology of primary sclerosing cholangitis includes immune-mediated components and elements of undefined nature. No effective medical therapy has been identified. The multiple complications of primary sclerosing cholangitis include metabolic bone disease, dominant strictures, bacterial cholangitis, and malignancy, particularly cholangiocarcinoma, which is the most lethal complication of primary sclerosing cholangitis. Liver transplantation is currently the only life-extending therapeutic alternative for patients with end-stage disease, although recurrence in the allografted liver has been described. A PSC-like variant attracting attention is cholangitis marked by raised levels of the immunoglobulin G4 subclass, prominence of plasma cells within the lesions, and steroid responsiveness. © 2008 The WJG Press. All rights reserved. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 19, 2008 Report Share Posted October 19, 2008 My husband was in the High Dose study. He was in the placebo group. When the study ended, his hepatology Dr. put him on Urso. It is about half the dosage of the study and it is helping to lower some of the values. Quote Link to comment Share on other sites More sharing options...
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