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Posted 9/15/2011 12:49 PM (GMT 0)
What does it mean that Asacol HD is "Not Bioequivalent to Asacol"?  My daughter has been doing great and her doctor is looking to change her from reg. Asacol to HD and I don't want to mess with anything since she is doing so great.

Thank you for your help.

Posted 9/16/2011 5:01 PM (GMT 0)
I wish I had an answer for you, but I literally just returned from my Dr. with samples plus a prescription for Asacol-HD with no clear reason for the change. (I, too, have been on regular Asacol with no issues).

I wonder why suddenly the push for the HD version from Dr.'s??? And, I also noticed the 'not bioequivalent' notice on the box. The nurse told me not to worry about it...??? Perhaps she didn't know the answer either. Strange. Time to Google!
Posted 9/16/2011 5:19 PM (GMT 0)
I don't like that "not bioequivalent" statement. I would love to switch for convenience but I am worried about upsetting my UC.
Posted 9/16/2011 7:10 PM (GMT 0)
In order to get a new patent for Asacol HD, the makers of asacol had to change it enough to get the FDA to accept it as not the bioequivlent of asacol. The coating which is a plastic is slightly different. They intentionally did not do clinical trials of high dose asacol(4.8 grams a day) and produced a new HD drug. It's a really bogus game all the makers of coated mesalimine pills are playing. Just a new version of the new purple pill game.

There is some possibility that one drug might work better.For most people it probably won't matter.

As too drug preference by GIs, some doctors may think a pill has worked better on their patients and some may be selling your patient records to a drug company. This is perfectly legal as long as identifying information(name, SS address etc.) is removed. Scientific evidence doesn't point to any difference between regular and HD . Some of the other pills(lialda, pentasa...) do have back up that they place more drug in different areas of the intestines.

Incidentally the plastic used contains phthalates which makes me glad I am on colazal.
Posted 9/16/2011 7:56 PM (GMT 0)
They did do trial at 4.8g.

http://www.medicalnewstoday.com/releases/224508.php
Posted 9/16/2011 11:27 PM (GMT 0)
I should have been clearer. They intentionally used 800 MG asacol HD tablets not 400 MG asacol tablets in the trial at the higher dosage. Asacol HD is approved only for high dose (4.8gr) for 6 weeks for active disease. Asacol(400mg) is approved at 2.4 gr for 6 weeks for active disease. 1.6 gr indefinitely for maintenance while in remission. That is just because P&G choose to do trials for those uses at those dosages.

They could have done FDA trials with 400 mg asacol at 4.8 gms but didn't because it is going generic soon.

Not a big deal if you go to most GIs but primary care doctors really don't want to write RXs for drugs for off label use. I know because colazal is off label for maintenance. I have no trouble getting asacol at any walk in clinic but it costs me $125 month copay and colazal is $20. I finally had to pay a GI $150 to tell my primary care to use colazal.
Posted 9/17/2011 4:36 AM (GMT 0)
Below is my Dr. response to my question:

Message body

"One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets. In a single dose, cross-over pharmacokinetic study in 20 healthy volunteers, the mean mesalamine C max was 36% lower and the mean mesalamine AUC was 25% lower with administration of one Asacol HD 800 mg tablet relative to two Asacol 400 mg tablets. Because the mechanism of action of mesalamine appears to be topical, the impact of these differences in measures of systemic exposure on clinical efficacy is not known. " So they showed the circulating amounts were different but the studies that show each agent with equal amounts of actual drug given show no significant difference in clinical outcomes...ie equal response at equal dose. The major thing I think of beyond response and thus why this form exists is that multiple studies show that majority of people do not take there medications over time and the with less dosing frequency and or less doses daily(ie pill numbers) the greater the chance that meds will be taken and thus actually work. If you don't want to change to the HD form it is fine. We can always change back if any issues of disease activity. This was my thought. So long but hard to explain in writing. Tell me your thoughts and will proceed however you want.
Posted 9/18/2011 5:51 PM (GMT 0)
My doc wanted me to switch to HD, but I turned him down because lower dose asacol worked just fine.

If he switches my meds, I have to get checked by him again, so to me it was another way for him to get me in sooner. He's been wanting to see me a lot more than I want to see him. I finally put a stop to the follow up visits. Haven't seen him in several months and doing fine on lower dose Asacol.
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