Dr. Lindor's Presentation at the Amsterdam Meeting

[Guest guest]

Dear All;

I was able to get copies of Dr. Lindor's abstract and presentation at

the Amsterdam meeting (don't ask how!); I was hoping that these would

give some clarification of the " adverse effects " associated with the

recent high-dose ursodiol trial. However, the abstract and

presentation contain no details about this issue. Sorry!

The presentation was just uploaded in the previous message, and the

the abstract is below:

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Falk Symposium 165: XX International Bile Acid Meeting. Bile Acid

Biology and Therapeutic Actions. June 13-14, 2008, Amsterdam,

Netherlands, p. 83 (2008)

Ursodeoxycholic acid for PSC - an update.

Lindor KD

D. Lindor, M.D.

Mayo Clinic, Rochester, MN, USA

Ursodeoxycholic acid continues to be a popular therapy for patients

with primary sclerosing cholangitis, although data supporting its use

are sparse. Open-labeled studies with doses of ursodeoxycholic acid

around 25 mg/kg/day show an enhanced biochemical improvement over

what was seen with standard doses of 13-15 mg/kg/day. A large

Scandinavian trial reported with 219 patients using a dose of

17-23 mg/kg/day failed to detect improvement in the rate of death or

transplantation. The choice of rigorous endpoints, the recruitment of

less than two-thirds of the expected patients, and the lower dose

used may have been responsible for the negative results. Currently,

there is a large ongoing study in the United States with 150 patients

entered receiving a dose of 28-30 mg/kg/day with endpoints of

cirrhosis, varices, cancer, liver transplantation, and death that are

being followed for another three years. Information about the use of

ursodeoxycholic acid lessening the risk of cancer and dysplasia in

patients with PSC and colitis are also controversial with studies

both supporting a reduced risk of dysplasia and carcinoma, and others

not finding such an advantage at the present time. Ursodeoxycholic

acid use, although a popular choice because of its safety and

tolerability, is not yet supported by firm data demonstrating

efficacy at endpoints other than biochemistries.

____________________________

Best regards,

Dave

(father of (23); PSC 07/03; UC 08/03)