Balsalazide is a novel azo-bonded 5-aminosalicylic acid treatment for mild-to-moderate ulcerative colitis.
In this study, researchers from the United States compared symptomatic remission rates with balsalazide and mesalamine.
|46% of balsalazide- and 44% of mesalamine-treated patients achieved symptomatic remission.|
|American Journal of Gastroenterology|
They controlled for extent of disease and time since diagnosis in patients with active, mild-to-moderate ulcerative colitis.
The team randomized 173 patients with ulcerative colitis to 8 weeks of double-blind treatment with balsalazide 6.75 g/day or mesalamine 2.4 g/day.
Both groups received 2.4 g/day of oral 5-aminosalicylic acid.
Patients maintained symptom diaries throughout the treatment period.
The team found that, overall, 46% of balsalazide- and 44% of mesalamine-treated patients achieved symptomatic remission.
However, higher response rates were noted in newly diagnosed patients with ≤ 40 cm of disease (68% versus 61%), than in recently relapsed patients with > 40 cm of disease (36% versus 25%).
The researchers determined that the median time to symptomatic remission was 12 days shorter with balsalazide (25 days) than with mesalamine (37 days).
Furthermore, more balsalazide patients showed sigmoidoscopic, stool frequency, rectal bleeding, and physician’s global assessment score improvement, by 14 days, than mesalamine patients.
In addition, a similar number of patients reported adverse events (54% versus 64%).
These were most commonly related to the gastrointestinal and central and peripheral nervous systems.
Dr Ronald Pruitt’s team concluded, “Balsalazide is an effective and safe treatment for mild-to-moderate ulcerative colitis”.
“Improvement of symptoms occurs considerably earlier with balsalazide than with mesalamine”.