Coated oral 5-aminosalicylic acid (Claversal) is equivalent to sulfasalazine for remission maintenance in ulcerative colitis. A double-blind study.
In a double-blind, single-center, 1-year prospective trial, we compared a pH-dependent Eudragit L-coated formulation of oral 5-aminosalicylic acid (5-ASA) (Claversal), 0.5 g b.i.d., and sulfasalazine (SASP), 1 g b.i.d., in the prophylactic treatment of quiescent ulcerative colitis. Forty-four patients received 5-ASA and 44 received SASP. Clinical, sigmoidoscopic, and histologic findings were assessed at 6 and 12 months. The two groups were comparable in all pretrial characteristics. No significant difference was observed in the relapse rate in the two groups either after 6 months [5-ASA 20.5%, SASP 27.5%, p = 0.32, 95% confidence interval (CI) 0.28 +/- 0.13] or after 12 months (5-ASA 38.4%, SASP 51%, p = 0.18, 95% CI 0.38 +/- 0.1). We conclude that (a) 5-ASA was as effective as SASP in maintaining remission of ulcerative colitis; (b) the relapse rate was, however, higher than expected in both groups; (c) the incidence of side effects was similar with both treatments.
Ardizzone
S
S
Gastrointestinal Unit, L. Sacco Hospital, Milan, Italy.
Petrillo
M
M
Molteni
P
P
Desideri
S
S
Bianchi Porro
G
G
D000180:Acrylic Resins; D000328:Adult; D000636:Aminosalicylic Acids / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015993:Life Tables; D008297:Male; D019804:Mesalamine; D011109:Polymethacrylic Acids; D011446:Prospective Studies; D012008:Recurrence; D012460:Sulfasalazine / Q000008:administration & dosage*; D013608:Tablets, Enteric-Coated; D013997:Time Factors
D000180:Acrylic Resins; D000636:Aminosalicylic Acids; D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D011109:Polymethacrylic Acids; D013608:Tablets, Enteric-Coated; C038300:methylmethacrylate-methacrylic acid copolymer; D012460:Sulfasalazine; D019804:Mesalamine