questions 2006

questions and answers 2006

A. Well, I’m not convinced that 30mg is a great advance (over 25mg) to be honest with you. If you look at the data in terms of the saturation of Urso in the bile (the saturation point) comes probably at 22-25mg/kg. Although it isn't licensed for PSC. In the UK at the moment, it's used throughout the world. In terms of what dose you need to have protective effects on the colon, we tried to look at that but our numbers are too small to answer that. We hope to get data from Professor Schrumpf's group. We've probably used Urso longer than anybody else and shall continue to use it and that's maybe why we've seen so few problems with cancer of the colon and bile ducts. I personally believe that it is so. Professor Schrumpf has not been convinced of the value of Urso. He's changed his mind in the past year, I'm glad to say. He's seen the light and he now believes in it. But they've got 300 patients who haven't had Urso for the last 20 years. They're a group we can study and perhaps answer some questions. He's now using Urso for his patients.

Q. You have to take a lot of pills during the day. Can you combine it with foods etc. Does it matter what time of day?

A. A (Dutch) study has been done with PBC patients. You can take them all in one great slug at night, in the morning or spread through the day. It doesn't matter much. You only have to be careful if you are using —Questran (Cholestyramin) for itching. (You have to space it carefully). Questran aside, it really doesn't matter at all.
Q. Is there any protocol on PSC ... ... e.g. there are consultants who don't or won't prescribe Urso.

A. That's true. All the data really runs the same way. Urso, helps biochemistry, reduces risk of cancer, has no side-effects. I just don't see how you would not use it for PSC. That's a personal view.

Q. Why would you hesitate to go for 30mg/kg of Urso if there's anecdotal evidence?

A. You don't seem to achieve very much more Urso in the bile acids by giving 50mg over 20-25mg/kg. But it does confirm a previous study that high dose is better than low dose..
Sue. We prescribe at least 20mg/kg. We know that we're not going to do any harm if we prescribe up to 30mg. But I think that the really important thing is the liver histology which showed in the 25mg group ~ there was only one patient who got worse in that group.
Dr. Chapman. Which was exactly the case in our previous study. So we've shown twice now that there seems to be a difference over the two doses. Beware the enthusiastic! And I am an enthusiast for Urso. There's also the Scandinavian study which we discussed before, that clearly showed the difference between doses..

Q. A question on Urso and colon cancer.

Dr. Chapman. It has to be said that amongst all researchers there is agreement that Urso does protect against colon cancer which is a major effect. In our centre anyway, we have low rates of colon cancer. That may be because you're taking Asacol etc. which also appears to be cancer protective, (protective against getting cancer of the bowel). What we don't know and may not be able to find out for a year or so, is whether there's an added effect to the Asacol with Urso. We have a large study under way with Professor Schrumpf in Norway ~ to double our numbers and eventually have 300 to 400 patients involved. But I have no doubt that Urso does reduce colonic dysplasia and may have a good effect on the bile ducts, as well.

Q. Does the outcome of the Oxford and other trials mentioned enable a recommendation about the dosage of Urso to be taken?