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Kris V. Kowdley, MD
Questions 1 - 6
Question 1
Some claim Actigall reduces the lab numbers in those with PBC, but there are no long term studies as to the effect of talking this drug long term. Even if the numbers go down, is the disease still progressing?What does Acitgall do exactly? What are the long term effects of taking this drug?
Answer
There are early concerns that ursodiol may "whitewash" the lab tests in PBC without change in outcome. We no know that ursodiol therapy improves survival in PBC (especially those with moderately advanced disease), delays progression of liver damage on liver biopsy and may reduce the development of varices. We dont know exactly how ursodil works in PBC, but we think that it replaces the toxic bile acids which can worsen liver injury. There are no known long term complications associated with taking this medication although a few patients comlain of loose stool.
Question 2
I get 400 mg of Vit D in my daily multivitamin. I also take Calcium with Vit D so I get an additional 400 mg of Vit D daily with my calcium. If 400 mg is the recommended daily dosage, at what levels does Vit D start to become toxic? Is 800 mg per day too much?
Answer
There is no role for supplementation with vitamin D if you are not deficient. Most patients in fact are not deficient. I would suggest checking the serum level and adjusting the dose based on serum level.
Question 3
Is there a specific lab test showing a person has a deficiency of vitamin D? What is the name of the test? And - is there a way to test whether someone is taking too much? Would it be the same test?
Answer
See above. The best measure of vitamin D status in PBC is the 25-hydroxy-vitamin D level.
Question 4
If one's weight is such that the Actigall or URSO dosage formula doesn't hit exactly, should the dosage be rounded up or down? And--with the recommended dose at 13-15mg. per kilo of weight should it be 13, 14, or 15 mgs?
Answer
I favor a dose of 15 mg/kg and would adjust up not down unless there were side effects (diarrhea).
Question 5
How ouwld a person know if Actigall or URSO are working for them? Would their labs go to normal or would the symptoms improve?
Answer
If you have a response to urso it is usually seen by a reduction of liver tests of >50% or normalization.
Question 6
What determines whether a patient has PBC and AIH. Is the presence of anti-smooth-muscle antibodies (along with the PBC-related elev. enzymes, etc.) usually a good indicator? What damage do the anti-smooth-muscle antibodies inflict?
Answer
Anti-smooth muscle antibodies are more representative of autoimmune hepatitis; if soemone has a biopsy and liver tests suggestive of PBC but no anti-mitochondrial antibody and has an anti-smooth muscle antibody, we call this condition "autoimmune cholangitis". This is a complicated area and it is my opinion that such patients should be under the care of a liver specialist. The antibodies do not cause any specific liver damage that we know of.
