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 (R)) in the treatment of steroid-refractory attacks of ulcerative an d indeterminate colitis. Methods: In this non-randomized study on the use o f oral microemulsion cyclosporine in steroid refractory ulcerative colitis, we used CyA Neoral in 10 patients suffering from ulcerative colitis and in I patient suffering from indeterminate colitis with a steroid-refractory a ttack. The initial dose was 7-7.5 mg kg(-1) day(-1) adjusted to maintain wh ole blood cyclosporine levels between 250 and 350ng/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 r esponder developed megacolon on the 11th day and another did not respond; s urgical treatment was performed in both cases. The remaining nine patients, followed for a mean period of 14.6 months (2-36 months). Nine patients pre sented side effects, the most frequent being slight hand tremor with hypoma gnesaemia, followed by hypertension, slight increase in creatinine and hirs utism. No one needed to withdraw from treatment, but the dose was lowered i n three cases. Conclusions: Oral microemulsion cyclosporine is an effective drug in the initial management of patients suffering from a steroid-refrac tory attack of ulcerative and indeterminate colitis. Additional controlled studies with the new oral formulation are required to confirm these results .