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Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Gastroenterology | Family Medicine

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Entocort EC (budesonide)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: AstraZeneca
Approval Status: Approved October 2001
Treatment Area: Crohn's disease

General Information

Entocort EC has been approved by the FDA for the treatment of mild-to-moderate, active Crohn's disease involving certain sections of the small and large intestines (ileum and/or ascending colon). This once-daily medication targets the intestines and is then quickly metabolized, this reduces the amount of drug entering the systemic circulation, potentially reducing side effects.

According to the Crohn's & Colitis Foundation of America, there may be up to 1,000,000 Americans with inflammatory bowel disease (IBD). The category of IBD includes both Crohn's disease and ulcerative colitis, two similar disorders of unknown origin. Crohn's disease typically occurs in the ileum and colon, but it can take place in any section of the gastrointestinal tract. Symptoms of the disorder can include diarrhea, crampy abdominal pain, fever and sometimes bleeding from the rectum.

Clinical Results

Entocort EC was evaluated in five randomized, double-blind trials that included 994 subjects with mild-to-moderate, active Crohn's disease of the ileum and/or ascending colon. In these studies, clinical improvement was defined as achievement of a Crohn's Disease Activity Index (CDAI) score of less than or equal to 150.

One of the trials was designed to compare treatment with Entocort EC 9 mg every morning to a comparator. At baseline, the median CDAI was 272. Entocort EC produced a 69% clinical improvement rate after eight weeks of treatment compared to 45% for the comparator.

Two of the trials were designed to compare Entocort EC to treatment with a placebo. In the first trial, which included 258 subjects, increasing doses of Entocort EC (1.5 mg bid, 4.5 mg bid or 7.5 mg bid) were evaluated. At baseline, the median CDAI was 290. Treatment with 9 mg per day produced statistically significant results compared to placebo, and no additional benefit was seen with an increased dose of 15 mg per day. In the second trial, the median CDAI at baseline was 263. Neither 9 mg qd or 4.5 mg bid dose levels produced statistically significant results compared to placebo.

Two additional trials were designed to compare Entocort EC with oral prednisolone. In the first trial, the clinical improvement rates were equal (60%) between the Entocort EC 9 mg qd and prednisolone groups. In the second trial, clinical response rates were 52% for Entocort EC 9 mg qd and 65% for prednisolone. In both trials, the proportion of subjects with normal plasma cortisol values was significantly higher in the Entocort EC groups than in the prednisolone groups at week eight.

Side Effects

The most common adverse events reported by subjects in Entocort EC clinical trials include the following:

  • Headache
  • Respiratory infection
  • Nausea
  • Symptoms of hypercorticism

According to trial data, the frequency of glucocorticosteroid-associated adverse events was substantially reduced with Entocort EC capsules compared to prednisolone (at equivalent doses).

Mechanism of Action

Budesonide has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of budesonide to glucocorticosteroid receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone.

Entocort EC contains granules that are coated to prevent dissolution in gastric juice, but which dissolve at pH>5.5, i.e., normally when the granules reach the duodenum. Thereafter, a matrix of ethylcellulose with budesonide controls the release of the drug into the intestinal lumen in a time-dependent manner. (from Entocort EC Prescribing Information)

Additional Information

For additional information on this medication, please visit the Entocort EC product web site or AstraZeneca.

Further information on Crohn's disease can be obtained through the National Institute of Diabetes & Digestive & Kidney Diseases.