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05-13-2012, 10:56 PM   #1
David
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The Role of Mesalamine in Crohn's Disease

The article, "The Role of Mesalamine in Crohn's Disease" by Cosimo Prantera and Alessandro Armuzzi is found on pages 643-647 of the book, "Advanced Therapy in Inflammatory Bowel Disease" and is supported by 15 references. For any of you interested in the deeper medical side of Crohn's Disease, this book is fantastic. This thread will contain information I feel is useful in the article and I also open it up for discussion.

Mesalamine (Mesalazine - 5ASA) is commonly used for patients with Ulcerative Colitis but its use in patients with Crohn's Disease is quite controversial. The authors of this article explore its use in Crohn's Disease.

- There are doubts about how well it works for people with Crohn's Disease but many GIs use it because it works well for Ulcerative Colitis and is relatively safe.

- Mesalamine acts topically. It's like putting lotion on your skin but you're putting it on your intestines. As Crohn's Disease can extend through every layer of the gut, it doesn't make sense that Mesalamine would work that well. Conversely, Ulcerative Colitis only affects surface mucosa so it can work well for it.

- 5-ASA is the active therapeutic moiety of sulfasalazine. Sulfasalazine is split by colonic bacteria into 5-ASA and Sulfapyridine

Formulations, Solubility, and Area of Release

- Asacol is mesalamine that dissolves at pH 7 and releases in the terminal ileum and colon.
- Asacol microgranular is mesalamine that is encapsulated is small granules and dissolves at pH 7 and is released in the terminal ileum and right colon.
- Claversal, Mesasal, and Salofalk are mesalamine that dissolve at pH 6 and are released in the jejunum, ileum, and colon.
- Rowasa is mesalamine that dissolves at pH 6 and is released in the jejunum, ileum, and colon.
- Pentasa is mesalamine that is time released and released throughout the intestinal tract.
- Salazopyrin is Sulfasalazine that is dissolved by colonic bacteria and released in the colon.
- Dipentum is Olsalazine dissolved by colonic bacteria and released in the colon.

Treatment with Mesalamine

- Early studies of 1-2g of Pentasa showed a lack of efficacy. 4g trials had conflicting results.
- A trial with 2g of Olsalazine showed no therapeutic affect and 22% of patients withdrew due to diarrhea.
- Salofalk versus corticosteroids showed steroids to be much more affective.
- In a study of patients with mild to moderate disease in the terminal ileum, patients were assigned asacol, asacol microgranules, or methylprednisone. Remission rates were about the same across the group.
- Pentasa versus Budesonide - Pentasa was less effective than Budesonide but as effective as 1g of ciproflaxin in inducing clinical remission.

Mesalamine for Maintaining Remission After Treatment with Other Medications
- In three studies with Pentasa in trying to maintain remission after treatment with other medications, there was no statistical significant between it and placebo.
- Two our of three studies with Claversal were negative.
- Salofalk and Asacol showed slight improvements over placebo.
- A Cochrane review (very strict) of 1420 patients found there was no improvement over placebo and didn't feel further study was justified. Ouch.
- Another study of 1305 patients found some benefit over placebo. A 6% benefit.

Mesalamine for Maintaining Remission After Surgery
- New lesions appear at the anastomotic site in 60% of patients within 1 year.
- In five trials one reached statistical significance and showed a 10% reduction in relapse rate.
- Six other trials showed an 18% reduction in reappearance of lesions.

Other Stuff
- Mesalamine in conjunction with Azathioprine or 6-MP seems to increase 6-TGN levels which can lead to Leukopenia. However, the benefit there is it could be used to reach the therapeutic level of 6-TGN if it is monitored.

Conclusion
The author states, "Currently, the evidence is in favor of maintaining mesalamine in the CD therapeutic armamentarium, despite criticism from some authors". Reasons include:

- It's pretty safe.
- Crohn's Disease is diverse so it could have thrown off studies.
- Sometimes CD is just in the mucosa such as early in disease history.
- Different drugs work in different locations
- Mesalamine can help Azathioprine/6-MP reach therapeutic levels.
- Higher doses may be more effective.
- Mesalamine may reduce the risk of cancer and is supported (and refuted) by a couple studies.
05-13-2012, 11:04 PM   #2
David
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Pretty dire numbers overall I didn't realize it was that bad. Dusty, when you get your copy of the book, I'd love to see if you interpret this differently than I did in any way because wow.
05-14-2012, 01:56 AM   #3
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what are the chances of CD turning into cancer ?? how can that be avoided ??
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05-14-2012, 08:17 AM   #4
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Whoops its not very good is it.
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05-14-2012, 12:26 PM   #5
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All I can say is that it's worked for me. However, I'm in the category of being diagnosed pretty quickly and while in the early, mild stages of disease. Also, as far as can be determined by colonoscopy, mine is all in the colon, and was almost entirely symptomatic of UC (Crohn's diagnosis was determined by patchy inflamed areas found with healthy areas inbetween), so perhaps that's why it's been helpful in my case.

Also, I had better results with Mesavant, than with Pentasa. Pentasa never fully stopped the bleeding, but (fingers crossed) the Mesavant has pretty much done away with it completely, perhaps because it targets the colon more than the small bowel.

So far, so good, and no side effects for me either. I count myself very lucky!
05-14-2012, 01:42 PM   #6
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very interesting! And something my gastro is always harping on about, that it doesn't work for CD, he's even told me to just stop taking it, even tho it was him that prescribed it in the beginning!
I've been taking Pentasa for 7 years now, dunno if it's helped or not, but I still take it every day, habit I think!
But...when I did stop taking it for a few months 2 years ago I ended up in hospital blocked and infected.
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05-14-2012, 03:19 PM   #7
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This seems to be stirring up a bit of controversy

David, does the book give references to back up the statements re: the treatment comparisons? The problem when these sorts of statements are taken out of context is you don't get any feel for the way the studies were conducted. For example "In three studies with Pentasa in trying to maintain remission after treatment with other medications, there was no statistical significant between it and placebo." Failing to reach statistical significance doesn't necessarily mean an important biological difference doesn't exist, it could be that the sample size was too small to detect the size of difference they were looking for, or simply random chance (most statistical tests are based on 80% or 90% power, which is the probability to detect a significant result where one exists - i.e. 10 or 20% of significant results will be missed just by chance). It would also be useful to see the variability (standard error or confidence intervals) rather than just point estimates (not sure if you are copying the book directly or giving us a nice digested version).

I've had a lot of success with Pentasa in the past although recently it hasn't been doing it's job quite so well. I used to be able to tell if I'd missed a dose of Pentasa as my tum would start hurting a few hours later....

p.s. thanks for these little book snippets, I've found them very interesting so far and looking forward to the next one
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Symptoms from the age of 12. Mis-diagnosed with UC at the age of 13, and later diagnosed with Crohn's in January 2012 at 24 years old. Disease mainly in terminal ileum.


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05-14-2012, 03:26 PM   #8
David
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David, does the book give references to back up the statements re: the treatment comparisons?
I'm providing a digested version. There are 15 references for this article. I was going to list them but then I realize that would be hard to correlate what inference they're backing up. I don't have time to provide all of that, sorry.
05-14-2012, 03:31 PM   #9
David
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All I can say is that it's worked for me. However, I'm in the category of being diagnosed pretty quickly and while in the early, mild stages of disease. Also, as far as can be determined by colonoscopy, mine is all in the colon, and was almost entirely symptomatic of UC (Crohn's diagnosis was determined by patchy inflamed areas found with healthy areas inbetween), so perhaps that's why it's been helpful in my case.

Also, I had better results with Mesavant, than with Pentasa. Pentasa never fully stopped the bleeding, but (fingers crossed) the Mesavant has pretty much done away with it completely, perhaps because it targets the colon more than the small bowel.
I believe it. I do believe they work for some people and your case sounds like a perfect fit from what I have learned thus far. I think what we can do is point people who join the forum and post stories along the lines of, "I have ulcerations and inflammatory strictures throughout my ileum and I'm on Sulfasalazine" to this thread.
05-14-2012, 04:17 PM   #10
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I was on pentasa since diagnosis and I really liked it. (I didn't feel like I had any side effects and I suppose I assumed it worked). I saw my new GI two weeks ago and he told me to come off it. (I had to completely move the box, sometimes I remembered I was stopping it when I had just pored the sachet into my mouth! Four years of habit is hard to break!) I have to say I haven't noticed a difference in my symptoms. All I am taking now for crohns is 40mg azathioprine.
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05-30-2012, 08:31 PM   #11
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before Pentasa can be ruled out the location of the disease needs to be considered as well as an individuals gut PH and retention time, I am sure we all know it can be short. My GI switched me from Asacol to Pentasa based on the fact that I could regularly see whole Asacol tablets in my shit, so to speak. My Crohns was in the large intestine, so to get the medication there we switched to pentasa, I was on it for more then 6 years with no flares. I do not believe any ASA5 drug will by itself induce remmission, however, even though Crohns is a deep tissue issue, rhyme on purpose, I think ASA5 my prevent the initial Crohns from taking root, after all any Crohns leision has to start at inner surface of the intesinal wall, and if ASA5 helps prevent that then great and side effects are minimal for most.



Just my thoughts...

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Still yearly colons...
05-31-2012, 06:31 AM   #12
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Does this study apply to all ASA's or just mesalamine? Are there any mild crohns meds that have shown some efficacy?
05-31-2012, 09:58 AM   #13
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Does this study apply to all ASA's or just mesalamine?
My understanding is that 5-ASA is Mesalamine? Someone please correct me if I'm wrong.

Are there any mild crohns meds that have shown some efficacy?
Enteral nutrition

Mesalamine HAS shown SOME efficacy, just not all that much. But for those it seems to work for, I'm sure it's a great option.
05-31-2012, 11:27 AM   #14
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After my resection and rediagnosed as having Crohn's not Ulcerative Colitis my GI took me off Pentasa as he said it had little evidence of working for Crohn's.
05-31-2012, 11:37 AM   #15
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I've been on both Pentasa and Asacol Hd in the past year. Pentasa worked or a week or two, in helping me have semi formed bms, but after the first coup,e of weeks all I noticed was significant hairloss and no relief in my bowels. I just started Asacol HD about a month ago, and it has the same results. Starting week three a little bit more solid bms, but within a week or two I've gone back to my wonderful watery bms, and fun hairloss. My doctors have been quite conservative in treatment, wanting to try the 5-Asa's before jumping right into the big guns. I already have some health issues due to having a traumatic brain injury. I go back to my GI today thank god, and see what our next plan of action is. I can see from a medical standpoint why physicians want to try melasamine first since technically it has the least amount of side effects, but on the other hand in my opinion it's like putting a bandaid on a compound fracture haha. Plus I have suffered severe hairloss from both which I wouldn't have minded if the actual meds had worked
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05-31-2012, 11:42 AM   #16
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nikimazur, where is your Crohn's Disease located? Only in the colon? Or is there small intestine involvement as well?

I agree with you that in many cases when it comes to Crohn's Disease, Mesalamine is simply putting on a band-aid. Problem with Crohn's Disease is then you walk on that fractured leg and do more damage over time which results in even bigger problems down the line because you weren't properly treated initially.
05-31-2012, 02:12 PM   #17
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Quick question for you David: I realize that you're not a doctor, but let's say you're me, you have a mild case of Crohn's in the TI, and no scarring or narrowing as of yet. If Pentasa seems to work, do you think that it's still a "band-aid" for that kind of case? I'm of the (optimistic) opinion that although it's fairly topical, 5-ASAs can help mild cases stay mild, and/or help flares either recur less frequently, or be less severe when they do recur.

Not sure what you think about all this. I'm not particularly interested in constantly being on and off corticosteroids, but I'm also not in a huge rush to hop on an immunosuppressant if Pentasa can help keep things under control. Let me know what your thoughts are (and anyone else, please feel free to weigh in).
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Hi, I'm Jesse!

Current meds:
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Diagnosis:
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05-31-2012, 02:19 PM   #18
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Hi JDTM,
The research does portray limited options available for those with mild Crohns. The step up in medication from 5-ASA's is a tall one. If Pentasa keeps you under control (whether it's placebo effect or actual topical protection does not matter) then stay with it, and keep monitoring your condition. There are people with mild illness who swear it keeps them in remission.
all the best.
05-31-2012, 02:31 PM   #19
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If I was you the first thing I'd do is play the guitar for a couple days straight and enjoy what it must feel like to have more than four active neurons in the right side of my brain.

I realize you asked a more specific question but I'm going to tell you exactly what I would do. I hope you don't mind

I would get down and dirty and have them really evaluate the true extent of my disease. For example, your signature states that you had duodenal ulcers in 2011. There's a decent chance that's Crohn's Disease and in my opinion, that would throw out the "mild" diagnosis.

I would then get the data for every single test I have ever had conducted and enter it into a spreadsheet so I could monitor my levels over time and correlate it with other variables.

I would get every single vitamin and mineral level tested that they have a test for and supplement where necessary to get to IDEAL ranges, not just within the low level of reference ranges.

I would spend plenty of time in the sun yet avoid burning.

If the my doctor felt that my Crohn's Disease was still "mild" and wanted me just to take Pentasa, I would also, at the very least, supplement with enteral nutrition. I would more likely do at least a six week course of total enteral nutrition until I was in remission and then move to supplemental enteral nutrition along with a strict elimination diet. All organic and natural.

While on Pentasa I would regularly have them monitor various regular blood levels, inflammatory markers, and either fecal lactoferrin or fecal calprotectin.

I would likely vaporize marijuana if I was in a medical marijuana state.

I might try low dose naltrexone.

I would get regular massages and partake in low impact exercise such as yoga.

If at any point there was even a minor pop in anything I was monitoring, I would switch back to total enteral nutrition for at least a month. If that didn't calm things down then I would want my disease reevaluated and would likely move to stronger medications if I had active inflammation and my intestinal mucosa wasn't 100%. The medication I utilized would be one that is statistically shown to help induce mucosal healing.

I think it's incredibly important not to let mild become more than that. The problem is "mild" can mean active inflammation that isn't causing much if any symptoms until it causes scarring and narrowing and then things get real. We see it time and time again on this site and it breaks my heart

Let's reaffirm that I'm not a doctor Just some guy who reads every reputable study, paper, and book he can get his hands on regarding IBD and is potentially more opinionated and vocal than he should be It's also much easier for me to say I'd do this rather than actually do it Having another form of IBD (Lymphocytic Colitis) let's me cheat more than if I had Crohn's Disease. At least that's what I tell myself
05-31-2012, 03:03 PM   #20
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Ha! Well, I'm sure that colitis isn't exactly a walk in the park, so yeah. I appreciate you reading up on all this stuff and taking the time to answer my question!

Fortunately, my doc is pretty on top of this, and I think we have a good handle on the extent of the disease. 10cm section, confirmed by colonoscopy and MRI, no narrowing, inflammation was present but mild. The duodenal stuff is troublesome for me as well, and I'm with you as far as whether or not that takes me out of the "mild" category. We'll see.

Working on getting the data. I actually just asked my doctor for my vitamin levels on Tuesday, which she provided (sweet!), and I know my vitamin D levels were super low. I'm going back in 2 months, barring any turn for the worse (in which case I'll go back sooner). Not sure how often to ask for levels to be checked, but I'll keep an eye.

I also just signed up for OSCCAR, which sounds a lot like what you're doing on the site collecting data, here in Rhode Island. I think it stands for "Ocean State Crohn's Colitis Area Registry," and they've got over 300 patients participating thus far. Once a year questionaire, along with stool/urine/blood samples, a two-hour interview, periodic 6-month phone calls for updates, that type of thing. Seems cool, and it's a small way for me to help. I'm waiting for my forms to show up in the mail and I'll be meeting with someone later in June.

Doc just took another blood test to check on how my body is handling the Pentasa (kidney-related issues, I'm guessing).

As far as everything else you mentioned, my doctor said she'd be supportive of me trying elemental nutrition followed by a LOFFLEX diet or something like that, only cautioning me that it's hard to stick to and when I asked her about whether or not she could prescribe elemental nutrition, she said that she had tried and it's not available. Ensure is hardly organic, but I could do it if needs be. We'll see. I like food, so I want to see if the Pentasa holds once I've tapered off the steroids. I'll mention LDN if we're moving onto something else, medication-wise; I also live in a medical-marijuana state, which is great, but unfortunately my wife is super anti-marijuana, so that sucks for me. (In truth, I think she'd accept it but I'd really have to be way worse off... we've discussed it a few times. I'm into the idea partially because I've cut out alcohol, and I'll admit that it'd also be nice in other respects... My wife can have all the beer and wine she wants, it's only fair!)

Anyways, thanks again man! All of this helps, and if you have any advice as far as what other levels to get checked and how to ask for them/how often to do it, let me know. I know I had a Prometheus test, but I didn't get the results from that (not that I could make heads or tails of it anyways).
05-31-2012, 04:01 PM   #21
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It sounds like you're taking a very active and proactive role in your disease management. Good for you!

It's sad that your wife is against you utilizing a proven medication with very few side effects. Your health is much more important than her socially induced, unfounded biases.
05-31-2012, 04:24 PM   #22
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Meh, my wife would likely accept it if things got dire... but even as it stands, I'm not experiencing a lot of physical pain, and my appetite is good... I'm not sure if I could even justify it myself, actually. (I'd be willing to bet if I asked about it, my gastroenterologist would laugh at me. And I don't mean that as a dis either -- she's great!)

I think it's unfortunate too, but she's supportive in many other ways... and besides, I know that this can be a fairly widespread attitude here in the States. People are told all their lives that marijuana is bad, and that sticks with a lot of people, even when they're presented with evidence to the contrary.

I also did experiment a bit recreationally when I was in my early 20s, and even then, I didn't handle it all that well (paranoia, etc.). Then again, who knows what the hell I was smoking.
06-01-2012, 09:24 AM   #23
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JDTM, at 5:57am this morning I lay in bed wide awake and you popped into my head.

Have you had any tests to check between the duodenum and the terminal ileum to make sure nothing is going on in there?
06-01-2012, 09:37 AM   #24
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Not a pillcam, but the MRI was to see what was going on (if anything) beyond the terminal ileum. They saw mild inflammation in the ileum, and were able to identify the 10cm section of it, but the rest of the small intestine looked good -- no other inflammation, no narrowing. Which is good. I do take some comfort in knowing that if things take a turn for the worse, the pill cam should be another option; apparently my doctor has capsule endoscopies listed as one of her interests on the gastro clinic website, so that's pretty cool.

Speaking of which, do you know offhand what it's called when they give you a "test capsule" -- something that's roughly the same size and shape, but will dissolve if there's a blockage or narrowing?

Also, full disclosure: When I first had symptoms, an upper endoscopy revealed duodenal ulcers. By the time January of 2012 rolled around, I had my third spike in pain/trip to the hospital, and when I went to the doctor for a follow-up, she said that I shouldn't be having those pains (the omeprazole should have handled the ulcers by that point), and that she wanted to do another scope. I still had mild gastritis and duodenitis, but the duodenal ulcers were gone by that point. It was around this time that I also started experiencing lower GI issues, which is what eventually led to a bunch more tests, and finally a colonoscopy and a Crohn's diagnosis.
06-01-2012, 09:40 AM   #25
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Sounds good

The test capsule is called a patency capsule.

http://gitract.mngastro.com/mngi.nsf...GI-7YURCU.html
07-29-2012, 05:07 PM   #26
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All I can say is that it's worked for me. However, I'm in the category of being diagnosed pretty quickly and while in the early, mild stages of disease. Also, as far as can be determined by colonoscopy, mine is all in the colon, and was almost entirely symptomatic of UC (Crohn's diagnosis was determined by patchy inflamed areas found with healthy areas inbetween), so perhaps that's why it's been helpful in my case.

Also, I had better results with Mesavant, than with Pentasa. Pentasa never fully stopped the bleeding, but (fingers crossed) the Mesavant has pretty much done away with it completely, perhaps because it targets the colon more than the small bowel.

So far, so good, and no side effects for me either. I count myself very lucky!

Well, so much for that!! Since I wrote that post things gradually went downhill. Tried doubling the Mesavant but no improvement, only side-effects. Now on Prednisolone while the Azathioprine takes effect. I guess it was all too good to be true. Another 5-ASA failure
07-29-2012, 05:10 PM   #27
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I'm sorry to hear that nitty

I hope things turn around for you soon!
07-29-2012, 05:21 PM   #28
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Thanks, David.

It is disappointing, and I had a rough few weeks, but I suppose it's also an important realisation that I have to take this seriously and that it's not just a case of popping a few minor pills.
It's made me put myself first for the time being, selfishly I feel sometimes, but I felt so crumby that I was hardly able to look after my kids properly. If I don't look after me, then I'll not be well enough to care for them and we all lose out.

I'm feeling loads better already, so feeling more positive again!
08-15-2012, 06:56 AM   #29
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Hey David......
I ended up on this thread after you commented about the lack of studies of efficacy of pentasa.....Am I reading correctly that you speak mostly of Crohns and not UC?
My reason is our case is a severe UC case affecting the entire large Intestine and assumedly nothing else. Do you know if the studies suggest a strong efficacy for UC?
My understanding via the GI is that pentasa is fairly mild...tolerated very well....and is extremely supportive of therapys like 6mp ..kind of "boosting" the 6mp as it works. Do you agree with this concept?
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08-15-2012, 09:43 AM   #30
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Don, I speak just of Crohn's and NOT UC. Mesalamine is definitely useful in the treatment of Ulcerative Colitis for many. I'll be more clear about that in the future, my apologies.

As for your GI stating that Pentasa "boosts" how 6-MP works, that's simplifying things. Mesalamine is shown to increase 6-TGN levels. 6-TGN is the therapeutic metabolite for 6-MP and Azathioprine. If its levels are too low, then chances are the medication isn't going to work. So if it's too low then mesalamine can boost it to therapeutic levels which is great. HOWEVER, too much 6-TGN is bad too. So if your 6-TGN is high and you're put on mesalamine, it could kick you up into the bad range and cause serious side effects. Point being, you want to have your metabolite levels tested to find out what is the best course of action.
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Crohn's Disease Forum » Books, Multimedia, Research & News » The Role of Mesalamine in Crohn's Disease
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