How long are suffers of MC typically on Entocort?

[Roger]

Hi, All,

Again, I'm writing on behalf of a relative who was recently diagnosed with MC. She's been on Entocort since May 2007 and expressed concern about being on the prescription for 2-3 months. Among the concerns are the general effects associated with most steroids, but also possible impact on vision, effect on skin, nausea, etc.

What might be a typical length of time to be on Entocort for MC? What might be a maximum time to be on it, after which a patient may be advised to stop taking it regardless of whether that person is in remission or not? I found a couple PowerPoint presentations by medical professionals, both of which suggested a two month treatment period. I wonder then if this may be a hard and fast rule, or just a guideline.

Below I have the basic information about Entocort from http://www.rxlist.com/entocort-drug.htm

If anyone has questions about the active ingredient or the non-active ones, you're welcome to post. As a still new member of this community I hope to contribute some of my knowledge as a chemist; however, be advised that I am not a pharmacist or an expert in the medical field.

Thanks!

Roger

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Budesonide, the active ingredient of ENTOCORT® EC capsules, is a synthetic corticosteroid. It is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is (below).

Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 103 ionic strength 0.01.

Each capsule contains 3 mg of micronized budesonide with the following inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres. The capsule shells have the following inactive ingredients: gelatin, iron oxide, and titanium dioxide.

Last updated on RxList: 11/12/2008

Entocort EC (budesonide) structural formula illustration

[Gloria]

Hi Roger,
What the doctors think and reality are two different things. My GI told me that I should begin weaning off Entocort after taking it for 3 1/2 months. Wishful thinking. It took me a year before I could successfully reduce to 1 pill a day. After a couple of failed attempts to get off it completely, I'm pretty resigned to being on it for quite a while longer. I will have been on it for two years next month. You're new to the board and may not realize that some here have a more difficult time achieving remission than others, and I happen to fall into that category.

The good news is that I haven't had any bad side effects. I sleep as I always have, haven't gained any weight - in fact I've lost about 10 lbs. due to a change in my diet, and I'm not high-strung like I was when I took Prednisone one time. I think Entocort is a miracle drug because it has allowed me to get my life back.

My understanding is that Entocort is encapsulated and thus doesn't activate until it reaches the colon, so it isn't a systemic drug. Only about 15% of it reaches the rest of the body, which explains the relatively low side effects. Generally, persons who have reactions to Entocort will experience a problem within a few days of taking it.

There are many of us on the board who have been taking Entocort for 1-2 years or more. I'm not aware of anyone who has had any problems taking it for that long.

Gloria

[tex]

Roger,

Gloria is quite correct, and I agree with everything that she said. To expand on what she posted, I might add that the treatment period for Entocort/budesonide, as generally recommended by most GI docs, is for 8 weeks. Why? Because that was the length of the initial trials to gain FDA approval, and so that is the treatment interval recommended on the label, by the manufacturer. The trials were for Crohn's disease patients, and the reason why 8 weeks was selected, is because 9mg will typically bring remission in about 65% of Crohn's cases, or better, in that length of time. For meds, in general, 65% or better control, is considered to be effective treatment. If I recall correctly, in similar trials, 6mg per day, for 8 weeks, typically brought 45 to 55% remission, depending on the trial being considered. Anyway, that's why 9mg daily, for 8 weeks, was originally selected as the recommended treatment regimen. Some GI docs seem to have trouble getting past those initial recommendations, possibly due to lack of experience with the drug, and a fear that it carries the same risk of adverse side effects as the other corticosteroids, (which is not true, of course).

Performance is similar, for MC patients. Doubling the dose, (to 18mg daily), will typically increase remission rates to about 75% or better, with no significant increase in the risk of side effects. Unfortunately, though, regardless of the dosage rate, in the case of MC, a few days, to a week or so, after the treatment is discontinued, the patient will virtually always suffer a relapse of symptoms. Because of that, IMO, the typical 8 week prescription is virtually worthless for treating MC. A more realistic approach, is to begin a diet free of gluten, dairy, and soy, (even trace amounts), in conjunction with a treatment period using Entocort, for a minimum of six months to a year, at full strength. Remission will typically arrive in 4 to 6 weeks, and if the gut is allowed to heal sufficiently, before the treatment is stopped, then the diet will usually be able to maintain the remission, except in the most difficult of cases, (where additional foods must be withdrawn from the diet).

As Gloria mentioned, only about 10 to 15% of budenoside is absorbed into the bloodstream, when it is administered in the form of Entocort EC, so Entocort has only a fraction of the risk of the side effects so typical of the other corticosteroids. Normally, after taking the drug for a year or so, with or without the diet, the dose can be tapered to about 3 mg per day, or every other day, and this rate can be safely used indefinitely, for most individuals, without undue risk of osteoporosis, or any of the other Draconian side effects of other corticosteroids. We are all different, though, in our response to meds, so that obviously isn't chiseled in stone, and everyone here who has tried taking it, has their own unique experiences with it.

Most GI docs, don't have a good working knowledge of what it takes to bring a patient with MC into remission, and keep her or him there. Their goal is typically to achieve remission, and then see what happens, and when the patient relapses, prescribe another 8 week or so course of treatment. That, IMO, is a poor way to go about it, because relapse is virtually guaranteed, with that plan.

If Entocort EC is causing your friend to have nausea, and/or neurological issues, (such as vision problems, dizziness, peripheral neuropathy, etc.), then she is allergic to it, and should not be taking it. In the absence of such adverse effects, however, especially at reduced doses, it can apparently be taken for years, without serious consequences, as Gloria, and others here, can verify.

Tex

[Roger]

Dear Gloria and Tex,

Thank you both so much for your prompt and in-depth responses to my questions! I'm sure my friend will find the information extremely valuable and helpful.

Please watch for any follow-up questions that may arise.

Sincerely,

Roger