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Re: High Dose Urso Study

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Hi

Thanks for that.

Down here in New Zealand Urso is not prescribed for us with PSC. One

of the people I am in contact within New Zealand wanted to push for

it to be prescribed. I told her of the study you took part in and to

wait for the results. I will pass your comments onto her.

thanks again

> 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

>

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-----Original

Message-----

I was just informed

that effective immediately all patients are being taken off of the Urso or

Placebo doses they have been receiving.

I’m actually happy

to hear this latest news. So much

time and money has been wasted while they try to prove over and over again something

they knew years ago. At least now

(hopefully) research teams can focus on new therapies and drugs. Thank you for letting us know and

thank you so much for allowing yourself to be used as a lab rat. How have you been doing?

Barb in Texas - Together in the Fight.... Whatever it

Takes!

,_._,___

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Guest guest

-----Original

Message-----

I was just informed

that effective immediately all patients are being taken off of the Urso or

Placebo doses they have been receiving.

I’m actually happy

to hear this latest news. So much

time and money has been wasted while they try to prove over and over again something

they knew years ago. At least now

(hopefully) research teams can focus on new therapies and drugs. Thank you for letting us know and

thank you so much for allowing yourself to be used as a lab rat. How have you been doing?

Barb in Texas - Together in the Fight.... Whatever it

Takes!

,_._,___

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Guest guest

-----Original

Message-----

I was just informed

that effective immediately all patients are being taken off of the Urso or

Placebo doses they have been receiving.

I’m actually happy

to hear this latest news. So much

time and money has been wasted while they try to prove over and over again something

they knew years ago. At least now

(hopefully) research teams can focus on new therapies and drugs. Thank you for letting us know and

thank you so much for allowing yourself to be used as a lab rat. How have you been doing?

Barb in Texas - Together in the Fight.... Whatever it

Takes!

,_._,___

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Guest guest

I've been conducting my own private URSO study and what I've found is that USRO is vital for keeping my LFT numbers down. I've been tracking my LFT numbers since I was diagnosed with PSC in 1989. The first tens years after my diagnoses and bile duct operation was without URSO. My LFT numbers have always been high since my operation, but in 1999 my liver numbers started to rise dramatically. I figured I'd be needing a liver transplant soon, but with a round of antibiodics and the introduction to USRO my LFT numbers have been greatly improved. I've tried stopping taking the URSO (a couple of times), but my next blood test the LFT numbers were up.

Averages

alk phos

(<125)

ast

(<36)

bilirub.

(<25)

ALT

(<50)

Gamma GT

(<49)

target values

date

1990-94

208.1

61.1

13.0

299.8

alkphos - obstruction - (<125)

1995-99

291.4

93.0

20.8

260.5

771.6

ast (SGOT) - cell condition - (<36)

2000-04

173.2

38.7

11.1

40.4

132.8

Gamma GT - (<49)

2005-09

169.5

36.8

9.0

36.5

110.0

billirub - (<25)

current URSO Dosage 500mg/day (5.3 mg/kg/day) as of June 9, 2008

I'm a Canadian and the number count they use for Bilirubum is different from that they use in the USA (about 17 x higher). My Bilirubim counts are within normal range.I'm on a low dosage USRO, only 500mg/day (5.3 mg/kg/day), but even if they declare USRO to be uneffective I will continue my study which shows that USRO is effective.

Ian (52) PSC 89

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.

_,_._,___ -- Ian Cribb

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Guest guest

I've been conducting my own private URSO study and what I've found is that USRO is vital for keeping my LFT numbers down. I've been tracking my LFT numbers since I was diagnosed with PSC in 1989. The first tens years after my diagnoses and bile duct operation was without URSO. My LFT numbers have always been high since my operation, but in 1999 my liver numbers started to rise dramatically. I figured I'd be needing a liver transplant soon, but with a round of antibiodics and the introduction to USRO my LFT numbers have been greatly improved. I've tried stopping taking the URSO (a couple of times), but my next blood test the LFT numbers were up.

Averages

alk phos

(<125)

ast

(<36)

bilirub.

(<25)

ALT

(<50)

Gamma GT

(<49)

target values

date

1990-94

208.1

61.1

13.0

299.8

alkphos - obstruction - (<125)

1995-99

291.4

93.0

20.8

260.5

771.6

ast (SGOT) - cell condition - (<36)

2000-04

173.2

38.7

11.1

40.4

132.8

Gamma GT - (<49)

2005-09

169.5

36.8

9.0

36.5

110.0

billirub - (<25)

current URSO Dosage 500mg/day (5.3 mg/kg/day) as of June 9, 2008

I'm a Canadian and the number count they use for Bilirubum is different from that they use in the USA (about 17 x higher). My Bilirubim counts are within normal range.I'm on a low dosage USRO, only 500mg/day (5.3 mg/kg/day), but even if they declare USRO to be uneffective I will continue my study which shows that USRO is effective.

Ian (52) PSC 89

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.

_,_._,___ -- Ian Cribb

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Share on other sites

Guest guest

I've been conducting my own private URSO study and what I've found is that USRO is vital for keeping my LFT numbers down. I've been tracking my LFT numbers since I was diagnosed with PSC in 1989. The first tens years after my diagnoses and bile duct operation was without URSO. My LFT numbers have always been high since my operation, but in 1999 my liver numbers started to rise dramatically. I figured I'd be needing a liver transplant soon, but with a round of antibiodics and the introduction to USRO my LFT numbers have been greatly improved. I've tried stopping taking the URSO (a couple of times), but my next blood test the LFT numbers were up.

Averages

alk phos

(<125)

ast

(<36)

bilirub.

(<25)

ALT

(<50)

Gamma GT

(<49)

target values

date

1990-94

208.1

61.1

13.0

299.8

alkphos - obstruction - (<125)

1995-99

291.4

93.0

20.8

260.5

771.6

ast (SGOT) - cell condition - (<36)

2000-04

173.2

38.7

11.1

40.4

132.8

Gamma GT - (<49)

2005-09

169.5

36.8

9.0

36.5

110.0

billirub - (<25)

current URSO Dosage 500mg/day (5.3 mg/kg/day) as of June 9, 2008

I'm a Canadian and the number count they use for Bilirubum is different from that they use in the USA (about 17 x higher). My Bilirubim counts are within normal range.I'm on a low dosage USRO, only 500mg/day (5.3 mg/kg/day), but even if they declare USRO to be uneffective I will continue my study which shows that USRO is effective.

Ian (52) PSC 89

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.

_,_._,___ -- Ian Cribb

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Guest guest

-----Original

Message-----

I've been conducting my own private URSO study and what I've

found is that USRO is vital for keeping my LFT numbers down.

You’re right

Ian, URSO does keep your LFT’s lab numbers down,

but low LFT’s (on paper only) isn’t what we’re looking

for. The problem is, URSO doesn’t do anything to slow the disease or

reduce the damage already done by PSC. We want a cure and in the meantime a

treatment that works. What we do

know for sure is that URSO is protective against colon cancer and that IMHO makes

it an important medicine to take for that reason.

Barb in Texas - Together in the Fight.... Whatever it

Takes!

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Guest guest

-----Original

Message-----

I've been conducting my own private URSO study and what I've

found is that USRO is vital for keeping my LFT numbers down.

You’re right

Ian, URSO does keep your LFT’s lab numbers down,

but low LFT’s (on paper only) isn’t what we’re looking

for. The problem is, URSO doesn’t do anything to slow the disease or

reduce the damage already done by PSC. We want a cure and in the meantime a

treatment that works. What we do

know for sure is that URSO is protective against colon cancer and that IMHO makes

it an important medicine to take for that reason.

Barb in Texas - Together in the Fight.... Whatever it

Takes!

Link to comment
Share on other sites

Guest guest

-----Original

Message-----

I've been conducting my own private URSO study and what I've

found is that USRO is vital for keeping my LFT numbers down.

You’re right

Ian, URSO does keep your LFT’s lab numbers down,

but low LFT’s (on paper only) isn’t what we’re looking

for. The problem is, URSO doesn’t do anything to slow the disease or

reduce the damage already done by PSC. We want a cure and in the meantime a

treatment that works. What we do

know for sure is that URSO is protective against colon cancer and that IMHO makes

it an important medicine to take for that reason.

Barb in Texas - Together in the Fight.... Whatever it

Takes!

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Share on other sites

Guest guest

There is no question that Urso lowers your liver panel values. I saw

significant decreases in my liver numbers as well which is why I

believe I am on the " real " thing. What has not been demonstrated and

is not supported by the data is that this decrease translates into

extending the time before one needs a transplant or that it impacts

symptoms or progression.

With that being said, Urso is generally a well tolerated drug with

little or no side effects for most people so if you and your doctor

are in agreement, go for it.

in Seattle

>

> 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.

>

>

> > _,_._,___

> >

>

>

>

> --

> Ian Cribb

>

>

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Guest guest

There is no question that Urso lowers your liver panel values. I saw

significant decreases in my liver numbers as well which is why I

believe I am on the " real " thing. What has not been demonstrated and

is not supported by the data is that this decrease translates into

extending the time before one needs a transplant or that it impacts

symptoms or progression.

With that being said, Urso is generally a well tolerated drug with

little or no side effects for most people so if you and your doctor

are in agreement, go for it.

in Seattle

>

> 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.

>

>

> > _,_._,___

> >

>

>

>

> --

> Ian Cribb

>

>

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Guest guest

There is no question that Urso lowers your liver panel values. I saw

significant decreases in my liver numbers as well which is why I

believe I am on the " real " thing. What has not been demonstrated and

is not supported by the data is that this decrease translates into

extending the time before one needs a transplant or that it impacts

symptoms or progression.

With that being said, Urso is generally a well tolerated drug with

little or no side effects for most people so if you and your doctor

are in agreement, go for it.

in Seattle

>

> 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.

>

>

> > _,_._,___

> >

>

>

>

> --

> Ian Cribb

>

>

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Guest guest

Barb,

Thanks for asking. I am doing quite well. I went through a battery

of tests in December since that was the 5 year mark of study

including colonsocopy, endoscopy, ERCP, liver biopsy, MRI, etc. I

had a little scare with a tiny area of low-grade dysplasia in my

colon and discussed colectomy but my follow up colonscopy came back

clear so I am just being watched closely.

Liver wise, although my tests show cirrohsis my symptoms don't match

that and I continue to live a full, normal life. Except for the

occasional ERCP every couple of years to clean things out I am doing

fine and getting ready to go to my oldest daughters kindergarten

graduation this week.

in Seattle

>

> -----Original Message-----

> I was just informed that effective immediately all patients are

being

> taken off of the Urso or Placebo doses they have been receiving.

>

>

> I'm actually happy to hear this latest news. So much time and

money has

> been wasted while they try to prove over and over again something

they

> knew years ago. At least now (hopefully) research teams can focus

on

> new therapies and drugs. Thank you for letting us know and

thank

> you so much for allowing yourself to be used as a lab rat. How

have you

> been doing?

>

> Barb in Texas - Together in the Fight.... Whatever it Takes!

> ,_._,___

>

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Guest guest

Barb,

Thanks for asking. I am doing quite well. I went through a battery

of tests in December since that was the 5 year mark of study

including colonsocopy, endoscopy, ERCP, liver biopsy, MRI, etc. I

had a little scare with a tiny area of low-grade dysplasia in my

colon and discussed colectomy but my follow up colonscopy came back

clear so I am just being watched closely.

Liver wise, although my tests show cirrohsis my symptoms don't match

that and I continue to live a full, normal life. Except for the

occasional ERCP every couple of years to clean things out I am doing

fine and getting ready to go to my oldest daughters kindergarten

graduation this week.

in Seattle

>

> -----Original Message-----

> I was just informed that effective immediately all patients are

being

> taken off of the Urso or Placebo doses they have been receiving.

>

>

> I'm actually happy to hear this latest news. So much time and

money has

> been wasted while they try to prove over and over again something

they

> knew years ago. At least now (hopefully) research teams can focus

on

> new therapies and drugs. Thank you for letting us know and

thank

> you so much for allowing yourself to be used as a lab rat. How

have you

> been doing?

>

> Barb in Texas - Together in the Fight.... Whatever it Takes!

> ,_._,___

>

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Guest guest

Barb,

Thanks for asking. I am doing quite well. I went through a battery

of tests in December since that was the 5 year mark of study

including colonsocopy, endoscopy, ERCP, liver biopsy, MRI, etc. I

had a little scare with a tiny area of low-grade dysplasia in my

colon and discussed colectomy but my follow up colonscopy came back

clear so I am just being watched closely.

Liver wise, although my tests show cirrohsis my symptoms don't match

that and I continue to live a full, normal life. Except for the

occasional ERCP every couple of years to clean things out I am doing

fine and getting ready to go to my oldest daughters kindergarten

graduation this week.

in Seattle

>

> -----Original Message-----

> I was just informed that effective immediately all patients are

being

> taken off of the Urso or Placebo doses they have been receiving.

>

>

> I'm actually happy to hear this latest news. So much time and

money has

> been wasted while they try to prove over and over again something

they

> knew years ago. At least now (hopefully) research teams can focus

on

> new therapies and drugs. Thank you for letting us know and

thank

> you so much for allowing yourself to be used as a lab rat. How

have you

> been doing?

>

> Barb in Texas - Together in the Fight.... Whatever it Takes!

> ,_._,___

>

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Guest guest

I've also seen very normal LFTs with Urso, so that -- coupled with the

fact that it keeps bile moving (like " bran for the bile " as my

infectious disease doctor said)-- and some beneficial numbers

regarding the incidence of colon cancer being reduced is enough for me

to keep taking the Urso.

Penny

>

> There is no question that Urso lowers your liver panel values. I saw

> significant decreases in my liver numbers as well which is why I

> believe I am on the " real " thing. What has not been demonstrated and

> is not supported by the data is that this decrease translates into

> extending the time before one needs a transplant or that it impacts

> symptoms or progression.

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Guest guest

I've also seen very normal LFTs with Urso, so that -- coupled with the

fact that it keeps bile moving (like " bran for the bile " as my

infectious disease doctor said)-- and some beneficial numbers

regarding the incidence of colon cancer being reduced is enough for me

to keep taking the Urso.

Penny

>

> There is no question that Urso lowers your liver panel values. I saw

> significant decreases in my liver numbers as well which is why I

> believe I am on the " real " thing. What has not been demonstrated and

> is not supported by the data is that this decrease translates into

> extending the time before one needs a transplant or that it impacts

> symptoms or progression.

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Share on other sites

Guest guest

I've also seen very normal LFTs with Urso, so that -- coupled with the

fact that it keeps bile moving (like " bran for the bile " as my

infectious disease doctor said)-- and some beneficial numbers

regarding the incidence of colon cancer being reduced is enough for me

to keep taking the Urso.

Penny

>

> There is no question that Urso lowers your liver panel values. I saw

> significant decreases in my liver numbers as well which is why I

> believe I am on the " real " thing. What has not been demonstrated and

> is not supported by the data is that this decrease translates into

> extending the time before one needs a transplant or that it impacts

> symptoms or progression.

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Guest guest

,

I have not recvd this news as of yet. I had my 5 yr studies done back in Dec.

and Lindor told me just what you have suggested. When I told him that Dr.

Chapman thought it should be in the drinking water and I asked about the benefit

urso has on colon cancer, Lindor said there has been no clinical proof of that.

Disappointing for sure.

Tarheel Tim

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Guest guest

,

I have not recvd this news as of yet. I had my 5 yr studies done back in Dec.

and Lindor told me just what you have suggested. When I told him that Dr.

Chapman thought it should be in the drinking water and I asked about the benefit

urso has on colon cancer, Lindor said there has been no clinical proof of that.

Disappointing for sure.

Tarheel Tim

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Guest guest

,

I have not recvd this news as of yet. I had my 5 yr studies done back in Dec.

and Lindor told me just what you have suggested. When I told him that Dr.

Chapman thought it should be in the drinking water and I asked about the benefit

urso has on colon cancer, Lindor said there has been no clinical proof of that.

Disappointing for sure.

Tarheel Tim

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Guest guest

I have also been involved with the URSO study for the last five and a

half years. I am very dissapointed in that even though I may be on the

placebo I have spent quite a bit of money on co-pays for some of the

additional testing. I was more than willing to join the study and take

the chance that I was getting the placebo in that Dr. Lindor was so

hopeful that this was going to be a success. I looked at the

possibility of getting the placebo as a chance for the study to help

others that came after. I am very bummed.

I wonder what is next?

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Guest guest

,

Here in Brisbane, the drs can (and do) prescribe URSO for PSC, but it's not

covered by the pbs system (cheaper govt sponsored medications). My dr sent a

big prayer to heaven when he was last getting pbs authorization for me, and

told a big fib about me having primary biliary cirrhosis to get it at

discount rate.

Love Penny T

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Guest guest

,

Here in Brisbane, the drs can (and do) prescribe URSO for PSC, but it's not

covered by the pbs system (cheaper govt sponsored medications). My dr sent a

big prayer to heaven when he was last getting pbs authorization for me, and

told a big fib about me having primary biliary cirrhosis to get it at

discount rate.

Love Penny T

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