Efficacy and tolerability of olsalazine (dipentum) in the treatment of patients with ulcerative colitis--results of a field study.
OBJECTIVE
In the treatment of ulcerative colitis, 5-aminosalicylic acid is the standard therapy for both acute exacerbations of the disease and the maintenance of remission. Clinical studies have shown that olsalazine (Dipentum)--a prodrug converted to two molecules of 5-ASA by colonic bacteria-induces and maintains remission. This study aimed to investigate the efficacy and tolerability of olsalazine in patients with ulcerative colitis who were being treated in daily practice by private physicians specializing in gastroenterology.


METHODS
A total of 260 patients with ulcerative colitis (aged 17-77 years, 116 men) were studied. The doses of olsalazine and the clinical data (including acute disease symptoms and the occurrence of adverse events) were recorded over a 6-month period.


RESULTS
Twenty per cent of patients had pancolitis, 48% had left-sided disease and 32% had proctitis or proctosigmoiditis. At study entry, 86% of patients had active disease; the percentages of these patients in remission after 6 weeks and 6 months were 42% and 91%, respectively. Patients with active disease received a mean dose of olsalazine - 2324mg per day initially and 1325mg per day at 6 months. The corresponding figures for patients in remission at study entry were 1386mg and 1162mg per day, respectively. Seventy-three per cent of patients took olsalazine with food, as recommended. The overall rate of adverse events was low; no serious adverse events occurred.


CONCLUSIONS
Olsalazine therapy resulted in a rapid regression in the acute symptoms of ulcerative colitis. Olsalazine was also effective in maintaining remission. The drug was well tolerated.
Singer
M V
MV
Klinikum Mannheim der Universität Heidelberg, Theodor-Kutzer-Ufer, Mannheim, Germany. manfred.v.singer@med.ma.uni-heidelberg.de
Schmausser
H
H
Schönfeld
G
G
D000328:Adult; D000368:Aged; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016896:Treatment Outcome
D000636:Aminosalicylic Acids; D000894:Anti-Inflammatory Agents, Non-Steroidal; C032587:olsalazine