Re: Latest high-dose urosdeoxycholic acid study in PSC

[Guest guest]

Thanks Dave,I notice though that the dose was 17 to 23 mg/kg which might be why Dr. Chapman is advocating at least 30mg/kg.I think I might talk to Bill's Dr. to make sure that he is taking at least this much.Let's get that funding for research! We need it soon!Lee Dear All; The latest high-dose ursodeoxycholic acid study in PSC has just been submitted for publication in Gastroenterology. If you go to: http://journals.elsevierhealth.com/periodicals/ygast then click on "Articles in Press", look for the following article: Accepted August 10, 2005 High-dose ursodeoxycholic acid in primary sclerosing cholangitis. A five year multicenter randomised controlled study Rolf Olsson, Kirsten M. Boberg, Ove Schaffalitsky de Muckadell, Stefan Lindgren, Rolf Hultcrantz, Geir Folvik, Helge Bell, Magnhild Gangsøy-Kristiansen, Jon Matre, s Rydning, Ola Wikman, Ake sson, Hanna Sandberg-Gertzen, Kjell-Arne Ung, Anders sson, Lars Loof, Hanne Prytz, Hanns-Ulrich Marschall, Ulrika Broome The .pdf file of the article appears to be "free"! Unfortunately, the news is not so good. Here's the abstract [i hope I am not violating Gastroenterology's press embargo rule by posting this?]: _______________ Abstract: Background & Aims: There is no medical treatment of proved benefit in primary sclerosing cholangitis. The present study aimed at studying the effect of a higher dose of ursodeoxycholic acid than previously used on survival, symptoms, biochemistry and quality of life in this disease. Methods: A randomised placebo-controlled study performed in tertiary and secondary gastroenterology units. 219 patients were randomised to 17 to 23 mg /kg bw/day of ursodeoxycholic acid (n=110) or placebo (n=109) for 5 years. Follow-up data are available from 97 patients randomised to ursodeoxycholic acid and 101 randomised to placebo. Quality of life was assessed using SF-36. Results: The combined endpoint "death or liver transplantation" occurred in 7/97 (7.2%) patients in the ursodeoxycholic acid group vs. 11/101 (10.9%) patients in the placebo group (p=0.368, 95%-CI [- 12.2; 4.7%]). Occurrence of liver transplantation as a single endpoint showed a similar positive trend for ursodeoxycholic acid treatment (5/97 (5.2%) vs. 8/101 (7.9%), 95%-CI [-10.4; 4.6%]). Three ursodeoxycholic acid and 4 placebo patients died from cholangiocarcinoma, one placebo patient died from liver failure. ALP and ALT tended to decrease during the first 6 months. There were no differences between the two groups in symptoms, or quality of life. Analyses of serum ursodeoxycholic acid concentration gave no evidence that non-compliance may have influenced the results. Conclusions: The present study found no statistically significant beneficial effect of a higher dose of ursodeoxycholic acid than previously used, on survival or prevention of cholangiocarcionoma in primary sclerosing cholangitis. _______________ Sorry to be the bearer of this not so good news. I have been pinning some of my hopes on high-dose ursodiol. Best regards to all; Dave (father of (20); PSC 07/03; UC 08/03)

[Guest guest]

NICE TIMING! 

We go today to discuss with our doctor.

From: [mailto: ] On Behalf Of

Sent: Thursday, August 25, 2005

9:30 AM

To:

Subject: Latest

high-dose urosdeoxycholic acid study in PSC

Dear All;

The latest high-dose ursodeoxycholic acid study in

PSC has just been

submitted for publication in Gastroenterology. If

you go to:

http://journals.elsevierhealth.com/periodicals/ygast

then click on " Articles in Press " , look

for the following article:

Accepted August 10, 2005

High-dose ursodeoxycholic acid in primary

sclerosing cholangitis. A

five year multicenter randomised controlled study

Rolf Olsson, Kirsten M. Boberg, Ove Schaffalitsky

de Muckadell,

Stefan Lindgren, Rolf Hultcrantz, Geir Folvik, Helge

Bell, Magnhild

Gangsøy-Kristiansen, Jon Matre, s Rydning,

Ola Wikman, Ake

sson, Hanna Sandberg-Gertzen, Kjell-Arne

Ung, Anders sson,

Lars Loof, Hanne Prytz, Hanns-Ulrich Marschall,

Ulrika Broome

The .pdf file of the article appears to be

" free " !

Unfortunately, the news is not so good. Here's the

abstract [i hope I

am not violating Gastroenterology's press embargo

rule by posting

this?]:

_______________

Abstract:

Background & Aims: There is no medical

treatment of proved benefit in

primary sclerosing cholangitis. The present study

aimed at studying

the effect of a higher dose of ursodeoxycholic

acid than previously

used on survival, symptoms, biochemistry and

quality of life in this

disease.

Methods: A randomised placebo-controlled study

performed in tertiary

and secondary gastroenterology units. 219 patients

were randomised to

17 to 23 mg /kg bw/day of ursodeoxycholic acid

(n=110) or placebo

(n=109) for 5 years. Follow-up data are available

from 97 patients

randomised to ursodeoxycholic acid and 101

randomised to placebo.

Quality of life was assessed using SF-36.

Results: The combined endpoint " death or

liver transplantation "

occurred in 7/97 (7.2%) patients in the

ursodeoxycholic acid group

vs. 11/101 (10.9%) patients in the placebo group

(p=0.368, 95%-CI [-

12.2; 4.7%]). Occurrence of liver transplantation

as a single

endpoint showed a similar positive trend for

ursodeoxycholic acid

treatment (5/97 (5.2%) vs. 8/101 (7.9%), 95%-CI

[-10.4; 4.6%]). Three

ursodeoxycholic acid and 4 placebo patients died

from

cholangiocarcinoma, one placebo patient died from

liver failure. ALP

and ALT tended to decrease during the first 6

months. There were no

differences between the two groups in symptoms, or

quality of life.

Analyses of serum ursodeoxycholic acid

concentration gave no evidence

that non-compliance may have influenced the

results.

Conclusions: The present study found no

statistically significant

beneficial effect of a higher dose of ursodeoxycholic

acid than

previously used, on survival or prevention of

cholangiocarcionoma in

primary sclerosing cholangitis.

_______________

Sorry to be the bearer of this not so good news. I

have been pinning

some of my hopes on high-dose ursodiol.

Best regards to all;

Dave

(father of (20); PSC 07/03; UC 08/03)

[Guest guest]

Dave,

More reason to give them heck down at NIH. I hope the Mayo study some of us are on will prove different. I am at approx. 28mg/kg based on my 150lbs to 2000mgs of Urso.

Omaha Tim

[Guest guest]

Hi Tim;

Yes, let's hope that the U.S. and U.K. studies will prove different!

I will try to ask as many questions as possible at the NIH conference,

and hope to be able to write up the highlights in a future newsletter?

Best regards,

Dave

(father of (20); PSC 07/03; UC 08/03)

> Dave,

>

> More reason to give them heck down at NIH. I hope the Mayo study some

of us are on will prove different. I am at approx. 28mg/kg based on my

150lbs to 2000mgs of Urso.

>

> Omaha Tim