Azodisal sodium in the treatment of ulcerative colitis. A study of tolerance and relapse-prevention properties

One hundred sixty patients intolerant of or allergic to sulfasalazine (Salazopyrin, Azulfidine) participated in an open tolerance study of azodisal sodium (Dipentum). More than 4 of every 5 patients tolerated azodisal sodium well, but 12.5% of patients stopped medication because of diarrhea. Even after 7 patients who had also experienced diarrhea when taking sulfasalazine were excluded, there still remained a group of patients (9.8%) who had to discontinue azodisal sodium because of diarrhea. Apart from this, only minor side effects occurred. No serious drug‐related changes were seen in hematologic or biochemical parameters. Male fertility appeared to be unaffected. One hundred two patients, who were in clinical and sigmoidoscopic remission, took part in a double‐blind, placebo‐controlled maintenance trial. Of these, 23.1% of the patients treated with azodisal sodium and 44.9% of the patients treated with placebo had a clinical and sigmoidoscopic relapse during a 6‐mo trial period (p = 0.02). Azodisal sodium appears to be an effective agent for the maintenance treatment of ulcerative colitis.