Oral microemulsion cyclosporine in the treatment of steroid-refractory attacks of ulcerative and indeterminate colitis.

BACKGROUND

To assess the efficacy of oral microemulsion cyclosporine (CyA Neoral) in the treatment of steroid-refractory attacks of ulcerative an indeterminate colitis.

METHODS

In this non-randomized study on the use of oral microemulsion cyclosporine in steroid refractory ulcerative colitis, we used CyA Neoral in 10 patients suffering from ulcerative colitis and in 1 patient suffering from indeterminate colitis with a steroid-refractory attack. The initial dose was 7-7.5 mg kg-1 day-1 adjusted to maintain whole blood cyclosporine levels between 250 and 350 ng/mL, as measured by RIA using monoclonal antibodies.

RESULTS

Nine patients presented a favourable response in a mean time of 3.6 days, that is, 81.8% of cases. One initial responder developed megacolon on the 11th day and another did not respond; surgical treatment was performed in both cases. The remaining nine patients, followed for a mean period of 14.6 months (2-36 months). Nine patients presented side effects, the most frequent being slight hand tremor with hypomagnesaemia, followed by hypertension, slight increase in creatinine and hirsutism. No one needed to withdraw from treatment, but the dose was lowered in three cases.

CONCLUSIONS

Oral microemulsion cyclosporine is an effective drug in the initial management of patients suffering from a steroid-refractory attack of ulcerative and indeterminate colitis. Additional controlled studies with the new oral formulation are required to confirm these results.