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.
Sandberg-Gertzén
H
H
Järnerot
G
G
Kraaz
W
W
D000293:Adolescent; D000328:Adult; D000368:Aged; D000636:Aminosalicylic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D055598:Chemical Phenomena; D002621:Chemistry; D002648:Child; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000517:prevention & control; D003967:Diarrhea / Q000139:chemically induced; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012460:Sulfasalazine / Q000009:adverse effects / Q000627:therapeutic use
D000636:Aminosalicylic Acids; D012460:Sulfasalazine; C032587:olsalazine