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Re: Vancomycin and primary sclerosing cholangitis

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i can speak to this as my son is in dr. cox's vanco study at lpch in palo alto. travis was diagnosed with psc in feb. with severe portal hypertension and cirrhosis. we started him on the vanco in march and his enzymes have continued to fall. last month his numbers did not go down as much as hoped le so we are looking for better results the end of this month. he has been listed for tx with a current inactive status. most of the children with psc without cirrhosis have done well. the latest study will be published shortly. the vanco has been our only hope and so far it has kept travis out of transplant. my son was 6 months from total liver failure with no overt sx's. the portal hypertension was discovered incidently during a routine endoscoopy for his reflex disease. he does not have uc. he is 16 years old and has always been very healthy. it was a complete surprise. dr. cox and his team have been great!

rita

-------------- Original message --------------

Dear All;I'd like to initiate a discussion about this rather obscure paper:J Pediatr Gastroenterol Nutr. 1998 Nov;27(5):580-3. Oral vancomycin: treatment of primary sclerosing cholangitis in children with inflammatory bowel disease. KL, KMDepartment of Pediatrics, Lucile Salter Packard Children's Hospital at Stanford University, Palo Alto, California 94304, USA.PMID: 9822326You can access the full text at:www.jpgn.org/pt/re/jpgn/fulltext.00005176-199811000-00015.htmThe paper describes "three children with sclerosing cholangitis and inflammatory bowel disease whose liver tests and symptoms improved when treated with oral vancomycin".As I understand it, Dr. is currently treating a larger number of patients with this antibiotic. Is anyone in this group enrolled in this study, and if so, are they willing to comment about it?Many tha

nks,Best regards,Dave (father of (21); PSC 07/03; UC 08/03)

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i can speak to this as my son is in dr. cox's vanco study at lpch in palo alto. travis was diagnosed with psc in feb. with severe portal hypertension and cirrhosis. we started him on the vanco in march and his enzymes have continued to fall. last month his numbers did not go down as much as hoped le so we are looking for better results the end of this month. he has been listed for tx with a current inactive status. most of the children with psc without cirrhosis have done well. the latest study will be published shortly. the vanco has been our only hope and so far it has kept travis out of transplant. my son was 6 months from total liver failure with no overt sx's. the portal hypertension was discovered incidently during a routine endoscoopy for his reflex disease. he does not have uc. he is 16 years old and has always been very healthy. it was a complete surprise. dr. cox and his team have been great!

rita

-------------- Original message --------------

Dear All;I'd like to initiate a discussion about this rather obscure paper:J Pediatr Gastroenterol Nutr. 1998 Nov;27(5):580-3. Oral vancomycin: treatment of primary sclerosing cholangitis in children with inflammatory bowel disease. KL, KMDepartment of Pediatrics, Lucile Salter Packard Children's Hospital at Stanford University, Palo Alto, California 94304, USA.PMID: 9822326You can access the full text at:www.jpgn.org/pt/re/jpgn/fulltext.00005176-199811000-00015.htmThe paper describes "three children with sclerosing cholangitis and inflammatory bowel disease whose liver tests and symptoms improved when treated with oral vancomycin".As I understand it, Dr. is currently treating a larger number of patients with this antibiotic. Is anyone in this group enrolled in this study, and if so, are they willing to comment about it?Many tha

nks,Best regards,Dave (father of (21); PSC 07/03; UC 08/03)

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i can speak to this as my son is in dr. cox's vanco study at lpch in palo alto. travis was diagnosed with psc in feb. with severe portal hypertension and cirrhosis. we started him on the vanco in march and his enzymes have continued to fall. last month his numbers did not go down as much as hoped le so we are looking for better results the end of this month. he has been listed for tx with a current inactive status. most of the children with psc without cirrhosis have done well. the latest study will be published shortly. the vanco has been our only hope and so far it has kept travis out of transplant. my son was 6 months from total liver failure with no overt sx's. the portal hypertension was discovered incidently during a routine endoscoopy for his reflex disease. he does not have uc. he is 16 years old and has always been very healthy. it was a complete surprise. dr. cox and his team have been great!

rita

-------------- Original message --------------

Dear All;I'd like to initiate a discussion about this rather obscure paper:J Pediatr Gastroenterol Nutr. 1998 Nov;27(5):580-3. Oral vancomycin: treatment of primary sclerosing cholangitis in children with inflammatory bowel disease. KL, KMDepartment of Pediatrics, Lucile Salter Packard Children's Hospital at Stanford University, Palo Alto, California 94304, USA.PMID: 9822326You can access the full text at:www.jpgn.org/pt/re/jpgn/fulltext.00005176-199811000-00015.htmThe paper describes "three children with sclerosing cholangitis and inflammatory bowel disease whose liver tests and symptoms improved when treated with oral vancomycin".As I understand it, Dr. is currently treating a larger number of patients with this antibiotic. Is anyone in this group enrolled in this study, and if so, are they willing to comment about it?Many tha

nks,Best regards,Dave (father of (21); PSC 07/03; UC 08/03)

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Dear Rita;

Thanks for responding about this trial. I hope that continues

to show improvement on the vancomycin. I look forward to seeing the

new study results! If they are as dramatic as the original study

(1998) then this would seem to be a significant development in

halting this disease.

Best regards,

Dave

(father of (21); PSC 07/03; UC 08/03)

>

> i can speak to this as my son is in dr. cox's vanco study at lpch

in palo alto. travis was diagnosed with psc in feb. with severe

portal hypertension and cirrhosis. we started him on the vanco in

march and his enzymes have continued to fall. last month his numbers

did not go down as much as hoped le so we are looking for better

results the end of this month. he has been listed for tx with a

current inactive status. most of the children with psc without

cirrhosis have done well. the latest study will be published

shortly. the vanco has been our only hope and so far it has kept

travis out of transplant. my son was 6 months from total liver

failure with no overt sx's. the portal hypertension was discovered

incidently during a routine endoscoopy for his reflex disease. he

does not have uc. he is 16 years old and has always been very

healthy. it was a complete surprise. dr. cox and his team have been

great!

>

> rita

>

>

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----Original Message-----

I'd like to initiate

a discussion about this rather obscure paper:

Oral vancomycin: treatment of primary sclerosing cholangitis in children with

inflammatory bowel disease.

I found these 2

studies -

Ann

Pharmacother. 2006 Jun;40(6):1186-9. Epub 2006 May 23.

Vancomycin-induced elevation of

liver enzyme levels.

Cadle

RM, Mansouri

MD, Darouiche

RO.

Pharmacy Service and Section of Infectious Diseases,

E DeBakey

Veterans Affairs

Medical Center

and Baylor College of Medicine,

Houston, TX

OBJECTIVE: To report a case of oral vancomycin-induced

elevation of liver enzyme levels.

CASE SUMMARY: A 57-year-old man with multiple medical conditions

requiring systemic antibiotic therapy developed numerous Clostridium difficile-associated enterocolitis

episodes. The patient did not respond adequately to oral metronidazole,

as evidenced by his continuing diarrhea. He was treated with oral vancomycin on 5 separate occasions (with doses from 125 to

500 mg/day), each of which resulted in significant elevations in alanine aminotransferase (to 371

U/L) and aspartate aminotransferase

(to 203 U/L) levels. The elevations resolved on each occasion with

discontinuation of vancomycin. DISCUSSION: Vancomycin, a glycopeptide antibiotic,

has primary activity against gram-positive bacteria. Oral vancomycin

can be used for the treatment of C. difficile-associated

enterocolitis in patients who fail to respond to or

are intolerant to metronidazole therapy. Oral vancomycin has very poor bioavailability and, as of May 4, 2006, has not been associated

with hepatic toxicity. Inflammatory bowel disease processes can result in

increased absorption of oral vancomycin. CONCLUSIONS:

This is the first reported case of oral vancomycin-induced

elevation of hepatic enzyme levels. Use of the Naranjo

probability scale indicated that this was a probable adverse drug-associated

event.

PMID:

16720708 [PubMed - indexed for MEDLINE]

------------------------------------------------------

Then there is this……

Clin Pharmacokinet. 1993 Jan;24(1):46-58.

Clinical pharmacokinetics of newer

antibacterial agents in liver disease.

Westphal

JF, Brogard

JM.

Department of Internal Medicine B, Hospitalo-University Center, Strasbourg, France.

Liver disease may produce significant, albeit highly variable, effects

on the pharmacokinetic behaviour of antibiotics in

serum. Drug disposition may be altered through several pathophysiological

mechanisms including reduced hepatobiliary clearance,

and modifications in the volume of distribution induced by albumin synthesis

deficiency or portal hypertension-related ascites. Antibacterial agents are not

affected by potential alteration in hepatic first-pass effects. Only liver

cirrhosis-induced effects on serum pharmacokinetics of antibiotics have been

extensively studied, unlike those possibly produced by other forms of liver

disease. In liver cirrhosis, pharmacokinetic alterations of nearly all beta-lactam or quinolone agents appear

not to be marked enough to require dosage adjustment, provided that renal

function stays normal. Adaptation in therapeutic schedule, however, is

warranted for those drugs that are substantially cleared by the hepatobiliary system, namely mezlocillin,

clindamycin, erythromycin, pefloxacin,

enoxacin, antituberculous

agents or nitroimidazole derivatives. Special caution should also be exercised

when using aminoglycosides or vancomycin

because of the wide interpatient variability of their

pharmacokinetic disposition and their toxic potential. When renal

function is impaired and there is an increased volume of distribution due to

ascites, as frequently observed in severe liver insufficiency, the elimination

half-life of most antibiotics is markedly prolonged, resulting in potential side

effects due to drug accumulation. Accordingly, dosage adjustment applies to all

drugs. In this regard, it should be remembered that delineating the dosage

guidelines for a given antibiotic on the basis of reported pharmacokinetic

parameters in patients with liver cirrhosis is awkward and probably of limited

value. This pattern is ascribed to large interpatient

variability in the active hepatic cell mass, the degree of portal hypertension

and the alteration of serum binding capacity. Furthermore, there is no way of

predicting accurately the extent of liver insufficiency in an individual

patient. Dosage reduction is thus done empirically in most cases. Whenever

possible, direct measurements of serum antibiotic concentrations should be the

reasonable approach to manage antibiotic therapy in this kind of clinical

condition.

PMID:

8448972 [PubMed - indexed for MEDLINE]

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Are these studies only in children with PSC or has vancomycin been

tested for adults as well?

> >

> > i can speak to this as my son is in dr. cox's vanco study at

lpch

> in palo alto. travis was diagnosed with psc in feb. with severe

> portal hypertension and cirrhosis. we started him on the vanco in

> march and his enzymes have continued to fall. last month his

numbers

> did not go down as much as hoped le so we are looking for better

> results the end of this month. he has been listed for tx with a

> current inactive status. most of the children with psc without

> cirrhosis have done well. the latest study will be published

> shortly. the vanco has been our only hope and so far it has kept

> travis out of transplant. my son was 6 months from total liver

> failure with no overt sx's. the portal hypertension was discovered

> incidently during a routine endoscoopy for his reflex disease. he

> does not have uc. he is 16 years old and has always been very

> healthy. it was a complete surprise. dr. cox and his team have

been

> great!

> >

> > rita

> >

> >

>

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the study focuses on children but i do believe they are diong it for adults too through stanford.

rita

-------------- Original message --------------

Are these studies only in children with PSC or has vancomycin been tested for adults as well? > >> > i can speak to this as my son is in dr. cox's vanco study at lpch > in palo a

lto. travis was diagnosed with psc in feb. with severe > portal hypertension and cirrhosis. we started him on the vanco in > march and his enzymes have continued to fall. last month his numbers > did not go down as much as hoped le so we are looking for better > results the end of this month. he has been listed for tx with a > current inactive status. most of the children with psc without > cirrhosis have done well. the latest study will be published > shortly. the vanco has been our only hope and so far it has kept > travis out of transplant. my son was 6 months from total liver > failure with no overt sx's. the portal hypertension was discovered > incidently during a routine endoscoopy for his reflex disease. he > does not have uc. he is 16 years old and has always been very > healthy. it was a complete surprise. dr. cox and his team have been > great!> > > > rit

a> > > >>

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the study focuses on children but i do believe they are diong it for adults too through stanford.

rita

-------------- Original message --------------

Are these studies only in children with PSC or has vancomycin been tested for adults as well? > >> > i can speak to this as my son is in dr. cox's vanco study at lpch > in palo a

lto. travis was diagnosed with psc in feb. with severe > portal hypertension and cirrhosis. we started him on the vanco in > march and his enzymes have continued to fall. last month his numbers > did not go down as much as hoped le so we are looking for better > results the end of this month. he has been listed for tx with a > current inactive status. most of the children with psc without > cirrhosis have done well. the latest study will be published > shortly. the vanco has been our only hope and so far it has kept > travis out of transplant. my son was 6 months from total liver > failure with no overt sx's. the portal hypertension was discovered > incidently during a routine endoscoopy for his reflex disease. he > does not have uc. he is 16 years old and has always been very > healthy. it was a complete surprise. dr. cox and his team have been > great!> > > > rit

a> > > >>

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>

> Dear All;

>

> I'd like to initiate a discussion about this rather obscure paper:

>

I've read the other posts on this and I'd like to add that vancomycin

is an aminoglycoside (like my dreaded gentamicin) and can cause

vestibular damage, as well as renal damage, in SOME individuals. For

those who don't know my story: " gent " has caused permanent damage to

the hair cells in my inner ears and it has resulted in a permanent

loss of balance. While I have no other daily reminders of my illness

(other than a colorful and necessary collection of pills), my cane and

loss of balance plague me daily. Perhaps the oral vanco is less

damaging to patients????

Penny

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the vanco is not absorbed in the blood but only goes to the gut. it has few side effects.

rita

-------------- Original message --------------

>> Dear All;> > I'd like to initiate a discussion about this rather obscure paper:> I've read the other posts on this and I'd like to add that vancomycinis an aminoglycoside (like my dreaded gentamicin) and can causevestibular damage, as well as renal damage, in SOME individuals. Forthose who don't know my story: "gent" has caused permanent damage tothe hair cells in my inner ears and it has resulted in a permanentloss of balance. While I have no other daily reminders of my illness(other than a colorful and necessary collection of pills), my cane andloss of balance plague me daily. Perhaps the oral vanco is lessdamaging to patients????Penny

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the vanco is not absorbed in the blood but only goes to the gut. it has few side effects.

rita

-------------- Original message --------------

>> Dear All;> > I'd like to initiate a discussion about this rather obscure paper:> I've read the other posts on this and I'd like to add that vancomycinis an aminoglycoside (like my dreaded gentamicin) and can causevestibular damage, as well as renal damage, in SOME individuals. Forthose who don't know my story: "gent" has caused permanent damage tothe hair cells in my inner ears and it has resulted in a permanentloss of balance. While I have no other daily reminders of my illness(other than a colorful and necessary collection of pills), my cane andloss of balance plague me daily. Perhaps the oral vanco is lessdamaging to patients????Penny

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--Original Message-- the

vanco is not absorbed in the blood but only goes to

the gut.

http://www.labcorp.com/datasets/labcorp/html/chapter/mono/td024700.htm

States:

Vancomycin is poorly absorbed

from the gastrointestinal tract.

Vancomycin is eliminated by the

kidneys, primarily by glomerular filtration; 80% to

90% of a dose appears in the urine of healthy subjects as unchanged drug within

24 hours. The usual elimination half-life in adults with normal renal function

ranges from three to nine hours (mean, six hours). In one study, longer

elimination half-lives were reported for men older than 60 years compared to

men between 20 and 26 years (mean half-lives, 12.1 and 7.2 hours,

respectively). Elimination half-lives are 5.9-9.8 hours in newborns, 4.1 hours

in older infants, and 2.2-4 hours in children. In anuric

patients, the half-life may be prolonged to eight or nine days. Dosage

reductions are necessary in patients with renal insufficiency. Although it has

been reported that elimination is prolonged in patients with impaired hepatic

function, the consensus is that nonrenal elimination

is minor and dosage reductions are unnecessary.

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--Original Message-- the

vanco is not absorbed in the blood but only goes to

the gut.

http://www.labcorp.com/datasets/labcorp/html/chapter/mono/td024700.htm

States:

Vancomycin is poorly absorbed

from the gastrointestinal tract.

Vancomycin is eliminated by the

kidneys, primarily by glomerular filtration; 80% to

90% of a dose appears in the urine of healthy subjects as unchanged drug within

24 hours. The usual elimination half-life in adults with normal renal function

ranges from three to nine hours (mean, six hours). In one study, longer

elimination half-lives were reported for men older than 60 years compared to

men between 20 and 26 years (mean half-lives, 12.1 and 7.2 hours,

respectively). Elimination half-lives are 5.9-9.8 hours in newborns, 4.1 hours

in older infants, and 2.2-4 hours in children. In anuric

patients, the half-life may be prolonged to eight or nine days. Dosage

reductions are necessary in patients with renal insufficiency. Although it has

been reported that elimination is prolonged in patients with impaired hepatic

function, the consensus is that nonrenal elimination

is minor and dosage reductions are unnecessary.

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--Original Message-- the

vanco is not absorbed in the blood but only goes to

the gut.

http://www.labcorp.com/datasets/labcorp/html/chapter/mono/td024700.htm

States:

Vancomycin is poorly absorbed

from the gastrointestinal tract.

Vancomycin is eliminated by the

kidneys, primarily by glomerular filtration; 80% to

90% of a dose appears in the urine of healthy subjects as unchanged drug within

24 hours. The usual elimination half-life in adults with normal renal function

ranges from three to nine hours (mean, six hours). In one study, longer

elimination half-lives were reported for men older than 60 years compared to

men between 20 and 26 years (mean half-lives, 12.1 and 7.2 hours,

respectively). Elimination half-lives are 5.9-9.8 hours in newborns, 4.1 hours

in older infants, and 2.2-4 hours in children. In anuric

patients, the half-life may be prolonged to eight or nine days. Dosage

reductions are necessary in patients with renal insufficiency. Although it has

been reported that elimination is prolonged in patients with impaired hepatic

function, the consensus is that nonrenal elimination

is minor and dosage reductions are unnecessary.

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Thanks for the heads up. Although I am always seriously concerned about that class of drugs, I also believe that some drugs and procedures work better (and more safely) for some people than others. is a perfect example of: "if it ain't broke, don't fix it."

Penny

Re: Re: Vancomycin and primary sclerosing cholangitis

the vanco is not absorbed in the blood but only goes to the gut. it has few side effects.

rita

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Thanks for the heads up. Although I am always seriously concerned about that class of drugs, I also believe that some drugs and procedures work better (and more safely) for some people than others. is a perfect example of: "if it ain't broke, don't fix it."

Penny

Re: Re: Vancomycin and primary sclerosing cholangitis

the vanco is not absorbed in the blood but only goes to the gut. it has few side effects.

rita

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Thanks for the heads up. Although I am always seriously concerned about that class of drugs, I also believe that some drugs and procedures work better (and more safely) for some people than others. is a perfect example of: "if it ain't broke, don't fix it."

Penny

Re: Re: Vancomycin and primary sclerosing cholangitis

the vanco is not absorbed in the blood but only goes to the gut. it has few side effects.

rita

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wrote:

> Posted by: " " rhodesdavid@... rhodesdavidwl

> Tue Sep 12, 2006 9:43 pm (PST)

>

> Dear All;

>

> I'd like to initiate a discussion about this rather obscure paper:

>

> J Pediatr Gastroenterol Nutr. 1998 Nov;27(5):580-3.

>

> Oral vancomycin: treatment of primary sclerosing cholangitis in

> children with inflammatory bowel disease.

>

> KL, KM

>

> Department of Pediatrics, Lucile Salter Packard Children's Hospital

> at Stanford University, Palo Alto, California 94304, USA

My son, who has PSC, participated in this study. His condition

neither improved or worsened as a result of the medication.

According to some of the doctors we spoke with, the drug has shown

real promise with some patients. They are not certain why.

Harold Stuart

San , California

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I acttually participatied in the Vanco study as an adult in the late

90s. In my case no change was noted, and I took it for a good year.

I had no side effects from the Vanco.

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I acttually participatied in the Vanco study as an adult in the late

90s. In my case no change was noted, and I took it for a good year.

I had no side effects from the Vanco.

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>

> Thanks for responding to this. Do you have an idea of how the other

> adults in the study responded?

I have no idea about anyone else in the study. It was very informal.

They asked me to try taking Vanco to see if it worked. It didn't

really help.

>Also, have you had bacterial

> cholangitis attacks or a transplant since?

I had a hell of a time with infections prior to my tx in June 2004.

At the time of transplant, I had an MRSA infection.

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