Double blind trial of oral fluticasone propionate v prednisolone in the treatment of active ulcerative colitis.

Abstract

Fluticasone propionate is a corticosteroid with the potential for topical treatment of ulcerative colitis because of low systemic bioavailability. The drug was compared with prednisolone in the management of active left sided or total ulcerative colitis. Two hundred and five patients were studied in the multicentre four week double blind study. Prednisolone was given in a dose of 40 mg daily orally, reducing over four weeks to 10 or 20 mg. Fluticasone propionate was given in an oral daily dose of 20 mg. The primary end point was the investigator's overall assessment of response. Patient's assessment, sigmoidoscopic appearance, and histology were also studied. Patients improved more rapidly with prednisolone. Differences between the two groups were significant at two weeks. At four weeks differences were not significant, but there was a trend in favour ofprednisolone. Corticosteroid side effects were minimal in the fluticasone propionate group, and there was minimal suppression of the hypothalamic pituitary adrenal axis. Fluticasone propionate 20 mg daily is not as effective in the treatment of active ulcerative colitis as prednisolone tapering from 40 mg daily to 10 or 20 mg. The complete absence of suppression of the corticoadrenal axis by fluticasone propionate was encouraging, however, and a higher dosage schedule should be assessed. (Gut 1993; 34: 125-128) Corticosteroid drugs are the most effective and widely used treatment for acute relapse ofulcerative colitis. High dosage or prolonged treatment is associated with a range of side effects. Topically active corticosteroids, with reduced systemic bioavailability, should have fewer side effects, and there is evidence that enema preparations of corticosteroid drugs with metabolism in gut wall or liver are effective in distal colitis. [1][2][3]

Glucocorticosteroids in the treatment of inflammatory bowel disease and approaches to minimizing systemic activity

“…After 4 weeks of treatment, there was no difference between the clinical response observed in patients receiving fluticasone propionate or placebo. Furthermore, in the second study, fluticasone propionate appeared less effective than tapering of prednisolone in a study of 250 patients with active ulcerative colitis [Hawthorne et al 1993]. After 2 weeks, the treatment response was significantly greater with prednisolone than fluticasone propionate; this difference was no longer significant by the end of the 4-week treatment period, possibly due to rapid tapering of the prednisolone dose, but there remained a trend towards significance (Table 2).…”

Adverse events of low- to medium-dose oral glucocorticoids in inflammatory diseases: a meta-analysis

“…The relative potency of budesonide is 0.83 12. No relative potency was known to the authors for beclometasone and fluticasone, which are mainly used topically (enema or aerosol) but, since these drugs were not more efficacious in the included studies,13 14 it was assumed that the dosages of these compounds were of equal or less potency than equal dosages of prednisone. Quality: as described in fig 2.…”

Treatment of Ulcerative Colitis in the Elderly: A Systematic Review

“…Hawthorne et al compared oral fluticasone to prednisolone taper in patients with active left sided or pancolitis. 44 Clinical remission, as judged by the investigator's overall assessment, was seen in 25.5% of fluticasone patients and 29% receiving placebo. The mean age was 41 and the age range 18-72 years.…”

“…[39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58] All 20 studies reported a mean age. The composite mean age was 38.5 years, with a mean range of 30.5 to 46.4 years.…”