Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to -moderate ulcerative colitis

Ronald Pruitt, John Hanson, Michael Safdi, Lawrence Wruble, Robert Hardi, John Johanson, George Koval, Dennis Riff, Barry Winston, Amanda Cross, Pamela Doty, Lorin K. Johnson

    Research output: Contribution to journalArticle

    87 Citations (Scopus)

    Abstract

    OBJECTIVE: Balsalazide is a novel azo-bonded 5-aminosalicylic acid treatment for mild-to-moderate ulcerative colitis. The study objective was to compare symptomatic remission rates with balsalazide and mesalamine while controlling for extent of disease and time since diagnosis in patients with active, mild-to-moderate ulcerative colitis. METHODS: A total of 173 patients with sigmoidoscopically verified ulcerative colitis were randomized to 8 wk of double-blind treatment with balsalazide 6.75 g/day or mesalamine 2.4 g/day. Both treatments provided 2.4 g/day of oral 5-aminosalicylic acid. Patients maintained symptom diaries throughout the treatment period. RESULTS: Overall, 46% of balsalazide- and 44% of mesalamine-treated patients achieved symptomatic remission. Higher response rates were noted in newly diagnosed patients with ≤40 cm of disease (68% vs 61%) than in recently relapsed patients with >40 cm of disease (36% vs 25%). The median time to symptomatic remission was 12 days shorter with balsalazide (25 days) than with mesalamine (37 days). Significantly more balsalazide patients showed sigmoidoscopic (p = 0.002), stool frequency (p = 0.006), rectal bleeding (p = 0.006), and physician's global assessment score (p = 0.013) improvement by 14 days than did mesalamine patients. Similar proportions of patients reported adverse events (54% vs 64%), which were most commonly related to the gastrointestinal and central and peripheral nervous systems. CONCLUSIONS: Balsalazide is an effective and safe treatment for mild-to-moderate ulcerative colitis. Improvement of symptoms occurs considerably earlier with balsalazide than with mesalamine.

    Original languageEnglish (US)
    Pages (from-to)3078-3086
    Number of pages9
    JournalAmerican Journal of Gastroenterology
    Volume97
    Issue number12
    DOIs
    StatePublished - Dec 1 2002

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    Mesalamine
    Ulcerative Colitis
    Signs and Symptoms
    Therapeutics
    balsalazide
    Peripheral Nervous System
    Central Nervous System
    Hemorrhage
    Physicians

    All Science Journal Classification (ASJC) codes

    • Hepatology
    • Gastroenterology

    Cite this

    Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to -moderate ulcerative colitis. / Pruitt, Ronald; Hanson, John; Safdi, Michael; Wruble, Lawrence; Hardi, Robert; Johanson, John; Koval, George; Riff, Dennis; Winston, Barry; Cross, Amanda; Doty, Pamela; Johnson, Lorin K.

    In: American Journal of Gastroenterology, Vol. 97, No. 12, 01.12.2002, p. 3078-3086.

    Research output: Contribution to journalArticle

    Pruitt, R, Hanson, J, Safdi, M, Wruble, L, Hardi, R, Johanson, J, Koval, G, Riff, D, Winston, B, Cross, A, Doty, P & Johnson, LK 2002, 'Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to -moderate ulcerative colitis', American Journal of Gastroenterology, vol. 97, no. 12, pp. 3078-3086. https://doi.org/10.1016/S0002-9270(02)05520-X
    Pruitt, Ronald ; Hanson, John ; Safdi, Michael ; Wruble, Lawrence ; Hardi, Robert ; Johanson, John ; Koval, George ; Riff, Dennis ; Winston, Barry ; Cross, Amanda ; Doty, Pamela ; Johnson, Lorin K. / Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to -moderate ulcerative colitis. In: American Journal of Gastroenterology. 2002 ; Vol. 97, No. 12. pp. 3078-3086.
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    abstract = "OBJECTIVE: Balsalazide is a novel azo-bonded 5-aminosalicylic acid treatment for mild-to-moderate ulcerative colitis. The study objective was to compare symptomatic remission rates with balsalazide and mesalamine while controlling for extent of disease and time since diagnosis in patients with active, mild-to-moderate ulcerative colitis. METHODS: A total of 173 patients with sigmoidoscopically verified ulcerative colitis were randomized to 8 wk of double-blind treatment with balsalazide 6.75 g/day or mesalamine 2.4 g/day. Both treatments provided 2.4 g/day of oral 5-aminosalicylic acid. Patients maintained symptom diaries throughout the treatment period. RESULTS: Overall, 46{\%} of balsalazide- and 44{\%} of mesalamine-treated patients achieved symptomatic remission. Higher response rates were noted in newly diagnosed patients with ≤40 cm of disease (68{\%} vs 61{\%}) than in recently relapsed patients with >40 cm of disease (36{\%} vs 25{\%}). The median time to symptomatic remission was 12 days shorter with balsalazide (25 days) than with mesalamine (37 days). Significantly more balsalazide patients showed sigmoidoscopic (p = 0.002), stool frequency (p = 0.006), rectal bleeding (p = 0.006), and physician's global assessment score (p = 0.013) improvement by 14 days than did mesalamine patients. Similar proportions of patients reported adverse events (54{\%} vs 64{\%}), which were most commonly related to the gastrointestinal and central and peripheral nervous systems. CONCLUSIONS: Balsalazide is an effective and safe treatment for mild-to-moderate ulcerative colitis. Improvement of symptoms occurs considerably earlier with balsalazide than with mesalamine.",
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    T1 - Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to -moderate ulcerative colitis

    AU - Pruitt, Ronald

    AU - Hanson, John

    AU - Safdi, Michael

    AU - Wruble, Lawrence

    AU - Hardi, Robert

    AU - Johanson, John

    AU - Koval, George

    AU - Riff, Dennis

    AU - Winston, Barry

    AU - Cross, Amanda

    AU - Doty, Pamela

    AU - Johnson, Lorin K.

    PY - 2002/12/1

    Y1 - 2002/12/1

    N2 - OBJECTIVE: Balsalazide is a novel azo-bonded 5-aminosalicylic acid treatment for mild-to-moderate ulcerative colitis. The study objective was to compare symptomatic remission rates with balsalazide and mesalamine while controlling for extent of disease and time since diagnosis in patients with active, mild-to-moderate ulcerative colitis. METHODS: A total of 173 patients with sigmoidoscopically verified ulcerative colitis were randomized to 8 wk of double-blind treatment with balsalazide 6.75 g/day or mesalamine 2.4 g/day. Both treatments provided 2.4 g/day of oral 5-aminosalicylic acid. Patients maintained symptom diaries throughout the treatment period. RESULTS: Overall, 46% of balsalazide- and 44% of mesalamine-treated patients achieved symptomatic remission. Higher response rates were noted in newly diagnosed patients with ≤40 cm of disease (68% vs 61%) than in recently relapsed patients with >40 cm of disease (36% vs 25%). The median time to symptomatic remission was 12 days shorter with balsalazide (25 days) than with mesalamine (37 days). Significantly more balsalazide patients showed sigmoidoscopic (p = 0.002), stool frequency (p = 0.006), rectal bleeding (p = 0.006), and physician's global assessment score (p = 0.013) improvement by 14 days than did mesalamine patients. Similar proportions of patients reported adverse events (54% vs 64%), which were most commonly related to the gastrointestinal and central and peripheral nervous systems. CONCLUSIONS: Balsalazide is an effective and safe treatment for mild-to-moderate ulcerative colitis. Improvement of symptoms occurs considerably earlier with balsalazide than with mesalamine.

    AB - OBJECTIVE: Balsalazide is a novel azo-bonded 5-aminosalicylic acid treatment for mild-to-moderate ulcerative colitis. The study objective was to compare symptomatic remission rates with balsalazide and mesalamine while controlling for extent of disease and time since diagnosis in patients with active, mild-to-moderate ulcerative colitis. METHODS: A total of 173 patients with sigmoidoscopically verified ulcerative colitis were randomized to 8 wk of double-blind treatment with balsalazide 6.75 g/day or mesalamine 2.4 g/day. Both treatments provided 2.4 g/day of oral 5-aminosalicylic acid. Patients maintained symptom diaries throughout the treatment period. RESULTS: Overall, 46% of balsalazide- and 44% of mesalamine-treated patients achieved symptomatic remission. Higher response rates were noted in newly diagnosed patients with ≤40 cm of disease (68% vs 61%) than in recently relapsed patients with >40 cm of disease (36% vs 25%). The median time to symptomatic remission was 12 days shorter with balsalazide (25 days) than with mesalamine (37 days). Significantly more balsalazide patients showed sigmoidoscopic (p = 0.002), stool frequency (p = 0.006), rectal bleeding (p = 0.006), and physician's global assessment score (p = 0.013) improvement by 14 days than did mesalamine patients. Similar proportions of patients reported adverse events (54% vs 64%), which were most commonly related to the gastrointestinal and central and peripheral nervous systems. CONCLUSIONS: Balsalazide is an effective and safe treatment for mild-to-moderate ulcerative colitis. Improvement of symptoms occurs considerably earlier with balsalazide than with mesalamine.

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