New formulation

Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Entocort (Astra)
3 mg controlled release capsules
Approved indication: Crohn's disease
AMH Section 12.6

Corticosteroids are often used to control episodes of inflammatory bowel disease. This treatment is effective, but has many potential adverse reactions. Therefore, there is a need for a drug which will induce remission, but cause few systemic effects.

Budesonide is a corticosteroid which has been used in the treatment of asthma. This new formulation was devised to release the drug close to its site of action in the ileum. As budesonide undergoes extensive first-pass metabolism to less potent metabolites, systemic effects may be reduced.

To induce remission in patients with Crohn's disease in the ileum or ascending colon, a dose of 9 mg is given each morning. The total duration of therapy should not exceed 12 weeks, including 2-4 weeks for tapering off the dose. Budesonide is not approved for maintenance treatment.

A randomised double-blind trial has compared budesonide with prednisolone.1 Of the 88 patients given budesonide, 29 had adverse effects due to treatment compared with 48 of the 88 people given prednisolone. Although budesonide caused significantly fewer adverse effects, it induced remission in fewer (39) patients than prednisolone(48).

The adverse effects associated with budesonide resemble those of other steroids. Caution is required when prescribing budesonide for patients with conditions such as diabetes mellitus, hypertension or glaucoma. The response of the hypothalamic-pituitary axis to stress may be reduced.

As budesonide is likely to be more expensive than prednisolone, prescribers will have to judge whether the lower efficacy is offset by the reduction in adverse effects.