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      Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis.

      Inflammatory Bowel Diseases
      Acute Disease, Adult, Anti-Inflammatory Agents, Non-Steroidal, therapeutic use, Colitis, Ulcerative, drug therapy, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, International Agencies, Male, Maximum Tolerated Dose, Mesalamine, Prognosis, Remission Induction, Sigmoidoscopy, Treatment Outcome

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          Abstract

          Many patients with ulcerative colitis (UC) respond to mesalamine therapy within 8 weeks. Those not achieving remission after 8 weeks are often treated with steroids or other immunosuppressive therapies. This study aimed to determine the effect of 8 weeks' high-dose MMX mesalamine extension therapy in patients with active, mild-to-moderate UC who had previously failed to achieve complete remission in 2 phase III, double-blind, placebo-controlled studies of MMX mesalamine (SPD476-301 and -302). Patients with active, mild-to-moderate UC who did not achieve clinical and endoscopic remission after or=1 point reduction from baseline in sigmoidoscopy score. Overall, 304 patients who entered this acute extension study were evaluated; 59.5% achieved remission at week 8. Remission rates were similar irrespective of prior treatment in the initial acute phase III studies. Most patients with mild-to-moderate UC who fail to achieve remission with up to 8 weeks' initial mesalamine therapy can achieve clinical and endoscopic remission following a further 8 weeks' treatment with high-dose MMX mesalamine therapy, thereby avoiding step-up therapy.

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