Once-daily 3g mesalazine administered as granules is superior to 9mg budesonide OD administered as capsules for achieving remission in mild-to-moderately active UC. However, it is noteworthy that remission of UC was attained in about 40% of budesonide-treated patients with a rapid onset of resolution.
SummaryBackgroundPrevious studies have reached conflicting conclusions regarding the efficacy of mesalazine in the prevention of recurrent diverticulitis.AimTo investigate the efficacy and safety of mesalazine granules in the prevention of recurrence of diverticulitis after acute uncomplicated diverticulitis.MethodsTwo phase 3, randomised, placebo‐controlled, double‐blind multicentre trials (SAG‐37 and SAG‐51) investigated mesalazine granules in patients with prior episodes (<6 months) of uncomplicated left‐sided diverticulitis. Patients were randomised to receive either 3 g mesalazine once daily or placebo (SAG‐37, n=345) or to receive either 1.5 g mesalazine once daily, 3 g once daily or placebo for 96 weeks (SAG‐51, n=330). The primary endpoint was the proportion of recurrence‐free patients during 48 weeks (SAG‐37 and SAG‐51) or 96 weeks (SAG‐51) of treatment.ResultsMesalazine did not increase the proportion of recurrence‐free patients over 48 or 96 weeks compared to placebo. In SAG‐37, the proportion of recurrence‐free patients during 48 weeks was 67.9% with mesalazine and 74.4% with placebo (P=.226). In SAG‐51, the proportion of recurrence‐free patients over 48 weeks was 46.0% with 1.5 g mesalazine, 52.0% with 3 g mesalazine and 58.0% with placebo (P=.860 for 3 g mesalazine vs placebo) and over 96 weeks 6.9%, 9.8% and 23.1% respectively (P=.980 for 3 g mesalazine vs placebo). Patients with only one diverticulitis episode in the year prior to study entry had a lower recurrence risk compared to >1 episode. Safety data revealed no new adverse events.ConclusionMesalazine was not superior to placebo in preventing recurrence of diverticulitis.
Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately active Crohn's disease.
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