Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease.

BACKGROUND & AIMS: Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD. METHODS: We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH-modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-L-coated oral mesalamine (4.5 g/day). RESULTS: The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index ≤150), at the final visit occurred in 69.5% (107 of 154) of patients given budesonide vs 62.1% (95 of 153) of patients given mesalamine (difference, 7.4%; 95% repeated confidence interval, -4.6% to 18.0%; P = .001 for noninferiority). Clinical remission rates did not differ significantly between the 2 budesonide groups. Treatment response, defined as Crohn's Disease Activity Index of 150 or less and/or a decrease of 70 or more (Δ70) or 100 or more (Δ100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (Δ70, P = .11; Δ100, P = .15), or between the 2 budesonide groups (Δ70, P = .38; Δ100, P = .78). No other efficacy end points differed significantly between groups. Discontinuation because of adverse events occurred in 3% and 5% of budesonide- and mesalamine-treated patients, respectively. There were no clinically relevant differences in adverse events between the 2 budesonide groups. CONCLUSIONS: Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-L-coated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen.

Is moderate substance use associated with altered executive functioning in a population-based sample of young adults?

BACKGROUND: Substance use (SU) has been linked with impaired cognitive functioning. Evidence comes mainly from clinical studies or studies examining heavy users. Though, the majority of users are not involved in heavy use. This study investigates the association between moderate use and cognition in a population-based sample. METHODS: A total of 284 young adults with ecstasy, cannabis or alcohol use and a control group were sampled from the EDSP database for participation in the Munich Assessment of Young Adults (MAYA) study. Subjects completed a comprehensive battery of neuropsychological tests (executive functions, working memory and impulsivity). Multiple linear regression models were conducted to examine the relationship between use and cognitive performance. RESULTS: Increased ecstasy consumption was associated with increased error-proneness (Stroop task, CANTAB ID/ED-shift, spatial working memory). More frequent cannabis use and more extensive alcohol consumption were associated with a higher degree of impulsiveness. CONCLUSIONS: Based on mild to moderate SU, little indication of differences in executive functioning was found. For ecstasy use, an increased error-proneness was revealed. The subtle differences in relatively young individuals warrant further investigation in prospective long-term studies to identify subjects at risk, and to examine effects of prolonged patterns of use on executive functioning.