The colon-cleansing efficacy of the new 32-tablet NaP dosing regimen in this study was found to be significantly better than the 2L PEG solution plus bisacodyl tablets regimen. The 32-tablet NaP dosing regimen was associated with fewer adverse events. As expected electrolyte shifts were more common and of greater magnitude in the NaP group compared with the PEG plus bisacodyl group; however, both treatment groups demonstrated significant changes in electrolytes and creatinine.

Based on the safety, efficacy, and patient preferences, the 32-tablet RF-NaP regimen was superior to the 40-tablet RF-NaP and NaP regimen for colon cleansing prior to colonoscopy.

suMMARY Serial six hourly urine collections were made for seven days on 20 patients with acute pancreatitis. Quantitative immunoassay of urinary albumin and IgG on the first urine sample after admission showed increased excretion rates in 14 and 13 patients, respectively. Urinary protein excretion rates remained normal or approached normal by seven days in 17 patients who made uneventful recoveries. The maximum urinary excretion rates ofboth albumin and IgG within the first 36 hours correlated with the serum C-reactive protein concentration 72 hours after admission. The highest IgG excretion rates were found in three patients who later developed severe complications. These preliminary data suggest that low proteinuria is a very early response in acute pancreatitis, and that it may reflect the severity of inflammation.

Objectives A multicenter, double-blind study was conducted to evaluate the safety, efficacy and pharmacokinetics of balsalazide in pediatric patients with mild-to-moderate UC. Methods Sixty-eight patients, 5 to 17 years of age, with mild-to-moderate active UC based on the modified Sutherland UC activity index (MUCAI), were randomized to receive oral balsalazide 2.25 or 6.75 g/day for 8 weeks. The primary endpoint was clinical improvement (reduction of the MUCAI score by ≥3 points from baseline). Clinical remission (MUCAI score of 0 or 1 for stool frequency) and histological improvement after 8 weeks were also assessed. Pharmacokinetic parameters for balsalazide, 5-aminosalicylic acid, and N-acetyl-5-aminosalicylic acid were determined at 2 weeks. Adverse events and laboratory changes were monitored throughout the study. Results Clinical improvement was achieved by 45% and 37% of patients and clinical remission by 12% and 9% of patients receiving 6.75 and 2.25 g/day, respectively. Improvement in histologic grade was achieved by 8 of 16 (50%) and 3 of 10 (30%) patients receiving 6.75 and 2.25 g/day, respectively. No significant differences were seen in efficacy. Pharmacokinetics in 12 patients were characterized by large inter-subject variability and low systemic exposure. Adverse events were similar between the treatment groups, the most common being headache and abdominal pain. No clinically significant changes were observed in laboratory values, including those indicative of hepatic or renal toxicity. Conclusions Balsalazide is well-tolerated and improves the signs and symptoms of mild-to-moderate active UC in pediatric patients 5 to 17 years of age.

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