New Studies On Longer Treatments With Entocort

ant · Post by **ant** » Sun Nov 22, 2009 6:48 am

Dear All

I found this link interesting (apologies if it was already posted)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2778111/

The relapse rate is high after cessation of successful short-term budesonide therapy in CC and 61%-80% of treated patients will have a recurrence of symptoms[91-93]. In clinical practice, tapering doses of budesonide to 3-6 mg/d have been used as maintenance therapy and may well control clinical symptoms. There is now evidence for such a strategy in CC, and two studies have proven maintenance therapy with budesonide 6 mg/d for 6 mo is well-tolerated and superior to placebo[97,98]. A total of 80 patients, who had responded to open-label budesonide, were randomized to budesonide 6 mg/d or placebo for 6 mo. Clinical response was maintained in 33/40 (83%) patients who received budesonide compared to 11/40 (28%) patients who received placebo (P = 0.0002). Pooled odds ratio was 8.40 (95% CI, 2.73-25.81) with a number needed to treat of two patients for maintenance of clinical response with budesonide. Histological response was seen in 48% of patients who received budesonide compared to 15% of patients who received placebo (P = 0.002)[94]. However, 6 mo maintenance therapy did not alter the subsequent course, as the relapse risk after withdrawal of 24 wk maintenance treatment was similar to that observed after 6 wk induction therapy, and the median time to relapse was equal in the two groups (39 d versus 38 d)[97].

And from this referenced study

http://www.ncbi.nlm.nih.gov/pubmed/18669576

Long-term budesonide treatment of collagenous colitis: a randomised, double-blind, placebo-controlled trial.

Bonderup OK, Hansen JB, Teglbjaerg PS, Christensen LA, Fallingborg JF.

Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 1, Randers, Denmark. obo@rc.aaa.dk

Comment in:

* Gut. 2009 Jan;58(1):3-4.

OBJECTIVE: To evaluate the efficacy and safety of long-term budesonide therapy for the maintenance of clinical remission in patients with collagenous colitis. DESIGN: Randomised, placebo-controlled study with a 24-week, blinded follow-up period without any treatment. SETTING: Three gastroenterology clinics in Denmark. PATIENTS: Forty-two patients with histologically confirmed collagenous colitis and diarrhoea (more than three stools/day). INTERVENTIONS: Patients in clinical remission after 6 weeks' open-label therapy with oral budesonide (Entocort CIR capsules, 9 mg/day) received 24 weeks' double-blind maintenance therapy with budesonide 6 mg/day or placebo. Thereafter, patients entered the 24-week, blinded follow-up period. MAIN OUTCOME MEASURE: The proportion of patients in clinical remission (three or fewer stools/day) at the end of maintenance therapy. Findings: A total of 34 patients in remission at week 6 were randomly assigned to budesonide 6 mg/day (n = 17) or placebo (n = 17). After 24 weeks' maintenance treatment, the proportions of patients in clinical remission were 76.5% (13 of 17) with budesonide and 12% (2 of 17) with placebo (p<0.001). At 48 weeks (the end of the follow-up period, without any treatment) these values were 23.5% (4 of 17) and 12% (2 of 17), respectively (p = 0.6). The median times to relapse after stopping active treatment (6 plus 24 weeks in the budesonide group; 6 weeks in the placebo group) were 39 and 38 days, respectively. Long-term treatment with budesonide was well tolerated. CONCLUSIONS: Long-term maintenance therapy with oral budesonide is efficacious and well tolerated for preventing relapse in patients with collagenous colitis. The risk of relapse after 24 weeks' maintenance treatment is similar to that observed after 6 weeks' induction therapy.

My colour red. With such evidence I wonder why many doctors try and take their patients off Entocort so early.

All best, Ant

harma · Post by **harma** » Sun Nov 22, 2009 8:18 am

When I read the data of both studies well (and please correct if I am wrong) there is not much difference in relapse of CC if you compare the use over 6 weeks with 6 months. So however, as long as you take the pills you are free of the symptoms, as soon as you stop CC comes back in about 80% of the cases.

From my point of few, when I see figures like this, what is the difference, six week, six months, it is just a matter of time I need the meds again (well a change of 8 out of 10). Not a very cheerful prospective!!!

I have read other articles or summaries where they advice to use a maintenance dose of Budesonide of 3 g a day, after doing a cure of a six or eight weeks.

But on the other hand, what do this data prove?? At least it give the impression, how well the enterolab food intolerances diets works. Or it must be big coincidence and are all the remmision people here are part of the 20%.

Ant thank you for posting this information. Yhese things are a great motivation to continue with my diet. Also when peope ask me critical questions about it.

Post by **tex** » Sun Nov 22, 2009 10:17 am

Ant,

I definitely haven't seen either of those articles, and it's good to see that a little progress is being made. The problem that most researchers seem to face, (or the mental block, if you will), is their prevailing attitude that drugs are a "cure" for diseases. Most drugs are not "cures", they merely help to control symptoms, as we on this board are well aware. Why the GI docs cannot grasp this simple concept, I have no idea. Most mainstream doctors have no problem prescribing various drugs for a patient's lifetime. GI docs seem to be baffled at that prospect, though.

About 5 to 10 years from now, it will probably occur to some research group to try a trial with budesonide for a full year, and the outcome will be similar. Will it ever occur to them that the treatment must continue indefinitely?

They're slowly learning, apparently.

As to why most doctors take their patients off Entocort too soon: That's what the label instructions advise them to do, and they're apparently not prone to think for themselves, (of course, in all fairness, liability issues have a lot to do with that). Those articles were published last year, so it will take a while for GI docs to incorporate any of that thinking into their treatment program. As a group, they're not known for cutting-edge utilization of new technology.

I hope you don't mind, but I split your post, (and the responses), off Gloria's long thread, in order to create a new topic, so that it wouldn't get lost, due to being buried in that long thread. This information also needs to be posted in the "Current Research" forum. Thanks for the links.

Tex

Gloria · Post by **Gloria** » Sun Nov 22, 2009 3:50 pm

Thanks for posting these two research articles, Ant. Those of us who take Entocort know that it is a maintenance drug until the diet is modified sufficiently to allow the gut to heal. Hopefully the light bulb will turn on with some of these GIs and they will finally understand that.

You've provided ammunition for members with ignorant GIs who are in a hurry to wean their patients off Entocort. They should copy the report and bring it to their GI.

Gloria

ant · Post by **ant** » Mon Nov 23, 2009 3:51 am

Dear Gloria

Hope things are improving for you after your latest setback?

You've provided ammunition for members with ignorant GIs who are in a hurry to wean their patients off Entocort. They should copy the report and bring it to their GI.

Funny you should say that because it is an upcoming visit to my GI that prompted the search (I am running out of Entocort and need to persuade him to prescribe more). I have the documents printed and ready..... Let's see ...

Best wishes, Ant

Post by **tex** » Mon Nov 23, 2009 9:39 am

Ant,

Necessity is the mother of invention, as they say.

If your GI doc will not renew your Entocort script, remember that many members have found that their PCP will do it.

Good luck,
Tex

ant · Post by **ant** » Mon Nov 23, 2009 9:57 am

Dear Tex,

Necessity is the mother of invention, as they say.

This evening I also set in motion "plan c" and ordered a small amount of the generic "Budez CR 3mg" from "AllDayChemist". I will let you know if the package arrives safely in Hong Kong.

Best, Ant

ant · Post by **ant** » Mon Dec 07, 2009 4:30 am

Well, I saw my GI this afternoon. (A Monday afternoon may not be the best time to see a Doctor.

)

Anyway, I showed him a excel sheet of all BM movements since June 28th. It showed a gradual improvement (with peaks and troughs representing flares for the first 4 and half months) and what now looks like a constant of 1 or 2 MBs per day - either firm, firmish, soft or D. My last "D" was 22nd November my last "Soft" was 6 Dec. So hope but no obvious recent trend.

He took this to mean that I was not fully cured and that therefor Entocort while helpful was not necessarily the only drug I should consider. I pointed out that without Entocort I could have been back to the situation I was in when I first saw him. I asked him if there was any more research that had come out to help understand the disease. He said "no" and then he said that for the last 30 years people had been saying there could be a cure in the next 6 months, but none have come. Then he said not to worry since the disease was just "a nuisance"....it was basically benign and would not turn into anything else. If he had not been the one to DX my MC and I did not still need something from him I would have hit him

- verbally, of course.

So, he started to suggest Asacol. I said are you sure? I am happy with Entocort and hear that Asacol has some side effects, especially as I have a number of diverticula. He said it was probably safer then Entocort. (He did not seem in a mood for me to present him with any research reports - and of course I have already learnt not to mention diet). So, then he said it was my choice......and I could stay on Entocort, but strongly recommended I try to taper off Entocort while staying on Asacol. I said what if I have a reaction to Asacol and he said that was very rare, but obviously to stop the Asacol if that happened and stay with the Entocort.

So this is where it ended up. I have a prescription for Salofalk (different format of Asacol) - sachets 1gm one morning and one at nights - for the next 3 months AND a prescription of Entocort (300x 3gms) for the next 3 months to use as I choose.... but he wants me to try and taper off Entocort while staying on Salofalk. The idea is, if Salofalk works I would come off Entocort and stay on Asacol, if necessary as the maintenance drug.

So, now I am not sure what to do. I am thinking I should go to my GP and ask what he thinks, specially about Asacol side effect versus Entocort?

But, what really hurts about all this is the cost of this "double" prescription for the next 3 months - approx US$1320

None covered by my Bupa insurance.

Now, for plan "C": about 10 days ago I ordered 200x3mg of Budez CR (generic Entocort EC) from All Day Chemists for about US$100. According to the delivery tracking it should arrive in the next couple of days...... lets see.

I hate being in the power of my GI doctor like this. I know I can try and bye-pass him by going to my GP, but my GP referred me to the GI and they correspond on all meetings I have.

Sorry this has been a bit rambling...needed to get it off my chest.

All the best, Ant

Post by **tex** » Mon Dec 07, 2009 11:30 am

Ant,

I hear you. Just as you begin to sail into calmer waters, your GI doc wants to rock the boat. His premise is, of course, that this is all part of a well-established and proven treatment plan. Unfortunately, we all know from experience, that with this disease, any treatment plan can prove to be fickle, and dump us right back at square one, in our recovery. Basically, though, that plan does work for some people with MC, though I'm not sure that you've healed enough to be able to safely start tapering the entocort.

I'm curious as to why they refer to the Salofalk "pills" as granules and/or sachets, (rather than tablets, or capsules). A granule is defined as a little grain, a small particle, or pellet, while a sachet is generally considered to be a small bag, case, or pad. So what the heck are they? Aren't they tablets?

Here is what they contain:

Salofalk® 1000mg granules contain 1000 mg mesalazine, as the active ingredient. The other ingredients are aspartame (E 951); carmellose sodium; cellulose, microcrystalline; citric acid, anhydrous; silica, colloidal anhydrous; hypromellose; magnesium stearate; methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100); methylcellulose; polyacrylate dispersion 40 per cent (Eudragit NE 40 D containing 2 per cent nonoxynol 100); povidone K 25; simeticone; sorbic acid; talc; titanium dioxide (E 171); triethyl citrate; vanilla custard flavour (containing propylene glycol).

The red items may, or may not be a problem for you. As you know, some of us get D from aspartame and/or citric acid. All that Eudragit stuff refers to the enteric coating used on the "sachets", (or their contents, if they truly are sachets). At least it does not contain lactose.

That cost is a mighty big pill to swallow, without insurance. Interestingly, even though the 5-ASA drugs are "as old as the hills", the pharmaceutical companies keep coming out with new versions of them, and so they manage to keep the price jacked up in a range comparable with Entocort EC, in most parts of the world. They are vastly overpriced, (but, of course, what drugs aren't vastly overpriced?).

Well, at least he left you with a choice - that's better than no choice at all.

Good luck, however you choose to handle it.

Tex

harma · Post by **harma** » Mon Dec 07, 2009 1:28 pm

sorry to hear ant about your stressful visit to the GI. I don't no much about asacol, probably another medicine they use normally for Crohn and colitis ulcerosa. You could give it a try and if it doesn't work or you experience side effect you can always stop. On the other hand if you are happy the way it is going now, with entocort and your diet, stick to that. Most important in these things is (in my opinion) do what you think is right for you, what gives you the feeling this is what I want. I mean than not because is just 'feels right', but in combination with logical thinking. Don't start taking pills "because the doctor told you so", it is your body (and your case also your money)

And something totally different, at had to laugh when I read in your message about a spread sheet with bowel movements

I know it all comes with this disease, but before all this happened you never would have thought, you would make a BM spread sheet. The same feeling I get when I tell people about my food intolerance testing and they ask questions on how and what. Yes my shi* is in bowl in a box sent to the U, per express mail. This makes us probably the potty people.

Gloria · Post by **Gloria** » Mon Dec 07, 2009 7:03 pm

I hate being in the power of my GI doctor like this.

Isn't that the truth? They don't know anything about this disease, but they control our ability to treat it by hanging the prescription over our heads. The only reason I communicate with my GI is to keep the Entocort coming.

I would stay on the Entocort if I were you. If the generic version works as well, you're in business. My insurance pays for all but $40 of my Entocort, but I know that the cost is about US$1320 - that seems to be the going rate. I hope a generic version is more easily available in the future.

Gloria

adelie · Post by **adelie** » Tue Dec 08, 2009 6:32 am

Another mail order site for those with trouble finding affordable medication is:
http://www.inhousepharmacy.com

My GI gave me the site for domperidone for gastroparesis, which isn't sold in the US. They're based in Vanuatu and sourced out of New Zealand. For Entocort, they aren't as cheap as alldaychemist, but they only carry the brand name Entocort EC - no generic. They have some generics for other meds that are only available by brand name in the US and my sister found out she could order generics from them and save quite a bit of money even with insurance.

Karen

Post by **tex** » Tue Dec 08, 2009 10:24 am

Karen,

That appears to be an excellent source of low-cost, quality medications. I think I'll add that link to the "Information On Medications" Forum. Kudos to your GI doc.

Thanks for posting that.

Tex

ant · Post by **ant** » Tue Dec 08, 2009 11:15 am

Tex, Gloria, Harma, Karen,

Thanks so much for your responses.

Tex wrote

I'm not sure that you've healed enough to be able to safely start tapering the entocort.

Harma wrote

Don't start taking pills "because the doctor told you so", it is your body (and your case also your money)

Gloria wrote

I would stay on the Entocort if I were you. If the generic version works as well, you're in business.

I have decided to DISOBEY and stay with Entocort alone for, at least, another month. I may be entering a remission period

and so could cut down without introducing the new variable of Asacol. I will see how it goes. One objective was to get three more months of Entocort, which I have got, and if the generic arrives I will have five months and a proven supply route.

I pick up the new prescription in two days, so will find out the details of Salofalk "sachets" then. But the GI said it was something easy to travel with and was dissolved in water. I will post on that when I know.

Karen wrote

Another mail order site for those with trouble finding affordable medication is:
http://www.inhousepharmacy.com

Just went to their site. Great option if I get worried about the quality of generic or the All Day Chemist dispatch fails. This is "Plan D" - feeling more empowered already, thanks so much.

Harma wrote

you never would have thought, you would make a BM spread sheet.

huh.. so true!

All the best, Ant

PS. My recent general health check up was done in Thailand (Bumrungrad Hospital) and am still awaiting the detailed results. I am keeping the Hong Kong based and Thai based sets of Doctors apart, at least for now. If I told my GI about possible osteoporosis he may will have taken me right off Entocort, even though the vitamin D deficiency and bone loss was likely to have been started well before my going on Entocort.

teagirl · Post by **teagirl** » Wed Dec 09, 2009 5:58 pm

Hi Ant,
I'm on Pentasa, another 5-ASA form like Asacol. I've never been on Entocort - my GI refused to prescribe it as he said it was a steroid and he doesn't prescribe it first. Actually his first "meds" are Imodium and Pepto. 2nd is 5-ASA Pentasa. Entocort is his 3rd choice if 5-ASA doesn't work. I notice on the label it says nothing about MC; well, it wouldn't would it, after all, we only have a nuisance disease! It says it's for Crohn's and UC.

I take 3x2 tabs a day, each 500mg. This is down from 4x2 a few months ago. In Jan if I continue to progress, I can go down to 2x2.

The trouble is, I can't really say 100% what the drug does. Last visit I discussed this with the GI as what truly made the difference was once I went GF DF SF, so what was the medication for. With almost normal bms including frequency, how do I really know what the Pentasa does for me? His answer was that it is healing my gut, and if I didn't take it, I'd have more pain and bad d if I slipped up on my diet or got glutenated. He theorised that with no meds it could be years before I could have raw veggies, cooked broccoli and cauli (I miss you two!), and fresh fruit. With the 5-ASA meds I could be looking at 18 -24 months and I'd be able to try reintroducing problem foods.

The one thing I have noticed is that if I have a food issue, although I get pain it doesn't last as long as it used to (it can still be quite bad though), and I get soft and squishy bms, not as much D as before. Is this because of the 5-ASA... who the heck knows...

I've had no side effects that I know of. All my little problems seem to be par for the course with MC - brain fog, tired, etc.

Maxine