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Advances in Therapy

, Volume 18, Issue 6, pp 261–271 | Cite as

Oral beclomethasone dipropionate in patients with mild to moderate ulcerative colitis: A dose-finding study

  • F. Rizzello
  • P. Gionchetti
  • R. Galeazzi
  • G. Novelli
  • D. Valpiani
  • A. D’Arienzo
  • F. Manguso
  • G. Castiglione
  • G. Varoli
  • M. Campieri
Article

Abstract

Systemic glucocorticosteroids have demonstrated efficacy in ulcerative colitis (UC) but cause undesired systemic side effects. Beclomethasone dipropionate (BDP) has potent topical activity and is extensively metabolized. This randomized doubleblind study investigated an oral gastroresistant controlled-release preparation of BDP in 57 patients with mild to moderately severe extensive or left-sided UC. Patients were assigned to receive BDP 5 or 10 mg/d; a third group took a clinically inactive dose (1.6 g/d) of 5-aminosalicylic acid (5-ASA). Both BDP doses displayed excellent efficacy confirmed by results of endoscopy, biopsy, and clinical evaluation. Significant improvement from baseline occurred in most signs and symptoms of UC, particularly stool frequency, rectal bleeding, and mucus in the stool (P<.01). Tolerability was good in both BDP groups. Morning plasma cortisol levels decreased significantly from baseline with BDP 10 mg, but no significant changes in vital signs were observed at the end of treatment. Despite a small sample size and the open comparison with 5-ASA, this multicenter study showed the therapeutic equivalence of BDP 5 and 10 mg/d in alleviating clinical symptoms and improving endoscopic and biopsy scores in patients with mild to moderate UC. BDP 5 mg/d displayed better general tolerability and less reduction of plasma cortisol levels, however, and may be preferable to the higher dose in this indication.

Keywords

beclomethasone ulcerative colitis glucocorticoids 

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References

  1. 1.
    Cello JP. Ulcerative colitis. In:Gastrointestinal Disease (Pathophysiology, Diagnosis, Management). 3rd ed. Philadelphia, Pa: WB Saunders; 1986:1122–1162.Google Scholar
  2. 2.
    Geier DL, Miner PB Jr. New therapeutic agents in the treatment of inflammatory bowel disease.Am J Med. 1992;93:199–208.PubMedCrossRefGoogle Scholar
  3. 3.
    Harris DM. Some properties of beclomethasone dipropionate and related steroids in man.Postgrad Med J. 1975;51(suppl 4):20–25.PubMedGoogle Scholar
  4. 4.
    Fourtillan JB, Decourt JP, Girault J, Ingrand I, Gobin P, Malgouyant JM. Assay of beclomethasone 17, 21-dipropionate (BDP), beclomethasone 17-monopropionate (BMP) and beclomethasone alcohol (BOH) by combined HPLC/NICI/MS to evaluate systemic absorption in young healthy volunteers following 2 single rectal administrations (enemas and suppositories) and a single oral dosing as enteric coated tablets. CEMAF study No. AD 868 H J AD 873 H; March 21, 1990.Google Scholar
  5. 5.
    Vignotti D, Ranzi T, Campanini MC, Lisciandrano D, Monti GB, Bianchi PA. Topical treatment of active ulcerative colitis with beclomethasone dipropionate.Curr Ther Res. 1992;52:659–665.CrossRefGoogle Scholar
  6. 6.
    Halpern Z, Sold O, Baratz M, Konikoff F, Halak A, Gilat T. A controlled trial of beclomethasone versus betamethasone enemas in distal ulcerative colitis.J Clin Gastroenterol. 1991;13:38–41.PubMedCrossRefGoogle Scholar
  7. 7.
    Levine DS, Rubin CE. Topical beclomethasone dipropionate enemas improve distal ulcerative colitis and idiopathic proctitis without systemic toxicity.Gastroenterology. 1985;88:1473.Google Scholar
  8. 8.
    Tytgat GNJ, van der Heide H, van den Brandt-Gradel V, Endert E, Wiersinga W. Comparison of beclomethasone dipropionate (BDP) and prednisolone 21-phosphate (PP) enemas in distal ulcerative colitis. A double blind study.Gastroenterology. 1985;88:1620.Google Scholar
  9. 9.
    Van der Heide H, van den Brandt-Gradel V, Tytgat GNJ, et al. Comparison of beclomethasone dipropionate and prednisolone 21-phosphate enemas in the treatment of ulcerative proctitis.J Clin Gastroenterol. 1988;10:169–172.PubMedCrossRefGoogle Scholar
  10. 10.
    Mulder CJJ, Fockens P, Meijer JWR, van der Heide H, Wiltink EH, Tytgat GNJ. Beclomethasone dipropionate (3 mg) versus 5-aminosalicylic acid (2 g) versus the combination of both (3 mg/2 g) as retention enemas in active ulcerative proctitis.Eur J Gastroenterol Hepatol. 1996;8:549–553.PubMedCrossRefGoogle Scholar
  11. 11.
    Campieri M, Gionchetti P, Belluzzi A, et al. Topical treatment of ulcerative colitis using enemas containing 5-aminosalicylic acid and beclomethasone dipropionate.Can J Gastroenterol. 1990; 4:481–483.Google Scholar
  12. 12.
    Sutherland LR, May GR, Shaffer EA. Sulfasalazine revisited: a meta-analysis of 5-aminosalicylic acid in the treatment of ulcerative colitis.Ann Intern Med. 1993;118:540–549.PubMedGoogle Scholar
  13. 13.
    Steed KP, Hooper G, Ventura P, Musa R, Wilding IR. The in vivo behaviour of a colonic delivery system: a pilot study in man.Int J Pharm. 1994;112:199–206.CrossRefGoogle Scholar
  14. 14.
    Baron JH, Cornell AH, Lennard-Jones JE. Variation between observers in describing mucosal appearances in proctocolitis.BMJ. 1964;i:89–96.CrossRefGoogle Scholar
  15. 15.
    Truelove SC, Richard WCD. Biopsy studies in ulcerative colitis.BMJ. 1956;ii:1315–1318.CrossRefGoogle Scholar
  16. 16.
    Sutherland LR, Martin F, Greer S, et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis.Gastroenterology. 1987;92:1894–1898.PubMedGoogle Scholar

Copyright information

© Springer Science and Business Media and LLC 2001

Authors and Affiliations

  • F. Rizzello
    • 1
  • P. Gionchetti
    • 1
  • R. Galeazzi
    • 2
  • G. Novelli
    • 2
  • D. Valpiani
    • 3
  • A. D’Arienzo
    • 4
  • F. Manguso
    • 4
  • G. Castiglione
    • 5
  • G. Varoli
    • 5
  • M. Campieri
    • 1
  1. 1.Institute of Clinical MedicineS. Orsola-Malpighi HospitalBolognaItaly
  2. 2.Department of GastroenterologyUmberto I HospitalAnconaItaly
  3. 3.Department of Internal MedicineG. Morgagni HospitalForliItaly
  4. 4.Department of GastroenterologyUniversity of Naples “Federico II”NaplesItaly
  5. 5.Medical DepartmentChiesi Farmaceutici SpAParmaItaly

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