Today's six month checkup - stopping Urso

[Guest guest]

I had my 6 month checkup and bloodwork today. I was

told to stop taking Urso. My hepatologist personally spoke with Dr.

Lindor on the study. I admit to some trepidation. After 7 years

without symptoms, I'm not wild about changing things.

I'll wait for the bloodwork results and then stop the Urso. I'm to get

another LFT in a month and see if anything's changed. Apparently, they

will prescribe Urso if pruritus starts immediately after terminating it

(oh joy).

I asked if the adverse results noted in the study were due to PSC being

too advanced. He has the same question. According to him, they know

that those in early stages of Primary Biliary Cirrhosis (not PSC) will

respond to Urso, but those in advanced PBC will not. Sure seems like

the same should be true of PSC.

He also had talked to the Axcan Pharma rep, as it appears another study

is needed (they apparently helped fund the Mayo study).

I did hear that the hepatologist and his staff were really impressed

with the speakers the foundation is able to arrange for the

conferences. They might actually attend the Chicago conference. He

was also impressed with the speed of communication about the study

termination. I don't think they would have heard for weeks. He had to

call Dr. Lindor directly to confirm, of course.

I'm very grateful to be a member of this group. Knowledge is power,

and you folks are doing a great job of keeping each other informed.

Thanks, and thanks to the Partners too!

Arne

[Guest guest]

Hi Arne;

ly, I'm a bit dismayed that hepatologists are making treatment

decisions based on a study and conclusions that have not been published

yet. The news article posted by Barb:

AASLD: High-Dose Ursodeoxycholic Acid Fails Test in Primary Sclerosing

Cholangitis

http://www.medpagetoday.com/MeetingCoverage/AASLD/11632

has the following " Action Point " :

" Note that this study was published as an abstract and presented orally

at a conference. These data and conclusions should be considered to be

preliminary until published in a peer-reviewed journal. "

which in my mind means ... don't take any action until the paper is

published and has been critiqued by experts in the field.

It does not make sense to me to go " cold-turkey " in stopping urso. It

would seem more reasonable to gradually lower the dose in order to

allow the body to adapt. It's recommended in PBCers that patients

gradually work up to their final urso dose, and so it would also seem

sensible to gradually work down when stopping the drug.

I am shocked by how the cancer protective effect of urso has been

dismissed. I think they have " thrown the baby out with the bath water " .

Many may disagree with these sentiments, but that's how I feel!

Dave

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

[Guest guest]

Hi Arne;

ly, I'm a bit dismayed that hepatologists are making treatment

decisions based on a study and conclusions that have not been published

yet. The news article posted by Barb:

AASLD: High-Dose Ursodeoxycholic Acid Fails Test in Primary Sclerosing

Cholangitis

http://www.medpagetoday.com/MeetingCoverage/AASLD/11632

has the following " Action Point " :

" Note that this study was published as an abstract and presented orally

at a conference. These data and conclusions should be considered to be

preliminary until published in a peer-reviewed journal. "

which in my mind means ... don't take any action until the paper is

published and has been critiqued by experts in the field.

It does not make sense to me to go " cold-turkey " in stopping urso. It

would seem more reasonable to gradually lower the dose in order to

allow the body to adapt. It's recommended in PBCers that patients

gradually work up to their final urso dose, and so it would also seem

sensible to gradually work down when stopping the drug.

I am shocked by how the cancer protective effect of urso has been

dismissed. I think they have " thrown the baby out with the bath water " .

Many may disagree with these sentiments, but that's how I feel!

Dave

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

[Guest guest]

Arne, were you on a high dose? I thought I remembered you NOT being on

high dose. I am confused because the study relates to high dose and

you were told to stop. Why not simply lower your dose?

ee

[Guest guest]

-----Original

Message-----

am shocked by how the

cancer protective effect of urso has been dismissed. I

think they have " thrown the baby out with the bath water " .

I’m (probably the only one) really

enjoying this high dose discussion!

Putting our collective minds together looking for answers makes me feel like

we’re doing *something/anything*

to try and help solve the mysteries of PSC.

Back to the discussion…… , I agree with you on waiting for the study,

but…..the article did pull direct quotes from Dr Lindor.

" We know that this higher dose shouldn't be used, based

on this study, " Dr. Lindor said. " The intermediate doses have not, in other

studies, showed a survival benefit.”

" Three studies have looked at ability of

ursodeoxycholic acid to reduce colonic dysplasia, " " There are some that think the drug may have

a place in reducing that risk of cancer. The data supporting that are from retrospective

studies, and, in my mind, aren't strong enough to lead us to recommend use on a

routine basis for that indication. "

So,

Dr Lindor himself is saying, don’t use high or even intermediate doses and

he (Dr Lindor) isn’t even recommending it for colon cancer.

Barb in Texas - Together in the Fight - Whatever it

Takes!

Son Ken (34) UC 91 PSC 99, LTX 6/21 & 6/30 2007

@ Baylor/Dallas

[Guest guest]

-----Original

Message-----

am shocked by how the

cancer protective effect of urso has been dismissed. I

think they have " thrown the baby out with the bath water " .

I’m (probably the only one) really

enjoying this high dose discussion!

Putting our collective minds together looking for answers makes me feel like

we’re doing *something/anything*

to try and help solve the mysteries of PSC.

Back to the discussion…… , I agree with you on waiting for the study,

but…..the article did pull direct quotes from Dr Lindor.

" We know that this higher dose shouldn't be used, based

on this study, " Dr. Lindor said. " The intermediate doses have not, in other

studies, showed a survival benefit.”

" Three studies have looked at ability of

ursodeoxycholic acid to reduce colonic dysplasia, " " There are some that think the drug may have

a place in reducing that risk of cancer. The data supporting that are from retrospective

studies, and, in my mind, aren't strong enough to lead us to recommend use on a

routine basis for that indication. "

So,

Dr Lindor himself is saying, don’t use high or even intermediate doses and

he (Dr Lindor) isn’t even recommending it for colon cancer.

Barb in Texas - Together in the Fight - Whatever it

Takes!

Son Ken (34) UC 91 PSC 99, LTX 6/21 & 6/30 2007

@ Baylor/Dallas

[Guest guest]

Lately I've been taking 600mg/day down from 900. As I mentioned earlier, I been on it for a long time and always wondered what good it was.

Of course I'm Post TX.

Don

Please be a blood/organ donor

[Guest guest]

Lately I've been taking 600mg/day down from 900. As I mentioned earlier, I been on it for a long time and always wondered what good it was.

Of course I'm Post TX.

Don

Please be a blood/organ donor

[Guest guest]

Lately I've been taking 600mg/day down from 900. As I mentioned earlier, I been on it for a long time and always wondered what good it was.

Of course I'm Post TX.

Don

Please be a blood/organ donor

[Guest guest]

A high dose is 28-30 mg per kg of body weight. So if your body

weight was 100 kg you would take between 2800-3000 mg of Urso per

day. These doses were divided into 250 mg or 500 mg tablets. So if

you took six 500 mg tablets, that would equal 3000 mg per day.

in Seattle

>

> Can anyone tell me what is " HIGH DOSE " for the urisidol?  The study

language is confusing:

>  

> The patients received UDCA 28 to 30 mg/kg/day in 250- or 500-mg

Urso Forte (Axcan) or matching placebo.

>  

> It sounds like anywhere from 28 - 500 mg which doesn't make sense

to me.  Is 60 mg a day high dose?

>  

> If someone could clarify this, I would appreciate it very much.

>

>