TY - JOUR

T1 - Octreotide in patients with active ulcerative colitis treated with high dose corticosteroids (OPUS 1)

AU - van Bergeijk, Jeroen D

AU - Wilson, J H Paul

AU - Nielsen, Ole Haage

AU - von Tirpitz, Christian

AU - Karvonen, Anna-Lusa

AU - Lygren, I

AU - Rädler, Andreas

AU - Waldum, Helge L

AU - Mulder, Chris J J

AU - Friis, S

AU - Tefera, Solomon

AU - Hoogkamer, Johannes F W

AU - OPUS 1 study group

PY - 2002/3

Y1 - 2002/3

N2 - BACKGROUND: In ulcerative colitis the intestinal somatostatin content is reduced. Somatostatin has several immune-inhibitory effects. In vitro it diminishes activity of intestinal lymphocytes and peripheral blood monocytes. Its long-acting analogue octreotide has beneficial effects on mucosal damage in acute experimental acetic acid colitis in rats.AIMS: To determine the potential benefits of octreotide as a treatment for patients with severe ulcerative colitis treated with high dose corticosteroids.PATIENTS: Forty-two patients with severe ulcerative colitis (more than 10 points on the Powell-Tuck scoring system and mucosal disease Heatly grade III or IV).METHODS: In a multi-centre, double blind, placebo-controlled trial all patients were treated with oral 5-ASA (1.6-2.4 g daily) and high dose corticosteroids (tapering off from 60 to 80 mg daily). They were randomly assigned to receive subcutaneous placebo (n = 22) or octreotide 500 microg (n = 20) thrice daily during 21 days. Clinical and endoscopic disease activity, histology and laboratory parameters were obtained during the study period.RESULTS: Clinical disease activity for both octreotide and placebo were not significantly different at baseline and after 21 days of treatment. Endoscopic disease activities (mean +/- SD) changed from 12.5 +/- 4.7 to 7.2 +/- 5.3 for octreotide, and from 11.5 +/- 5.0 to 5.0 +/- 3.4 for placebo (NS). Seven patients from both groups received additional treatment (colectomy (n = 6), cyclosporin (n = 1)). Adverse events occurred equally in both groups.CONCLUSIONS: Subcutaneous administration of octreotide 500 microg thrice daily is not of additional benefit as adjuvant therapy to high dose corticosteroids in severe ulcerative colitis.

AB - BACKGROUND: In ulcerative colitis the intestinal somatostatin content is reduced. Somatostatin has several immune-inhibitory effects. In vitro it diminishes activity of intestinal lymphocytes and peripheral blood monocytes. Its long-acting analogue octreotide has beneficial effects on mucosal damage in acute experimental acetic acid colitis in rats.AIMS: To determine the potential benefits of octreotide as a treatment for patients with severe ulcerative colitis treated with high dose corticosteroids.PATIENTS: Forty-two patients with severe ulcerative colitis (more than 10 points on the Powell-Tuck scoring system and mucosal disease Heatly grade III or IV).METHODS: In a multi-centre, double blind, placebo-controlled trial all patients were treated with oral 5-ASA (1.6-2.4 g daily) and high dose corticosteroids (tapering off from 60 to 80 mg daily). They were randomly assigned to receive subcutaneous placebo (n = 22) or octreotide 500 microg (n = 20) thrice daily during 21 days. Clinical and endoscopic disease activity, histology and laboratory parameters were obtained during the study period.RESULTS: Clinical disease activity for both octreotide and placebo were not significantly different at baseline and after 21 days of treatment. Endoscopic disease activities (mean +/- SD) changed from 12.5 +/- 4.7 to 7.2 +/- 5.3 for octreotide, and from 11.5 +/- 5.0 to 5.0 +/- 3.4 for placebo (NS). Seven patients from both groups received additional treatment (colectomy (n = 6), cyclosporin (n = 1)). Adverse events occurred equally in both groups.CONCLUSIONS: Subcutaneous administration of octreotide 500 microg thrice daily is not of additional benefit as adjuvant therapy to high dose corticosteroids in severe ulcerative colitis.

KW - Adult

KW - Anti-Inflammatory Agents, Non-Steroidal/therapeutic use

KW - Colitis, Ulcerative/drug therapy

KW - Double-Blind Method

KW - Drug Administration Schedule

KW - Female

KW - Gastrointestinal Agents/therapeutic use

KW - Glucocorticoids/administration & dosage

KW - Humans

KW - Male

KW - Mesalamine/therapeutic use

KW - Octreotide/administration & dosage

KW - Prednisolone/administration & dosage

KW - Prednisone/administration & dosage

KW - Severity of Illness Index

M3 - Journal article

C2 - 11953688

VL - 14

SP - 243

EP - 248

JO - European Journal of Gastroenterology and Hepatology, Supplement

JF - European Journal of Gastroenterology and Hepatology, Supplement

SN - 0954-691X

IS - 3

ER -