Overall, a total of 341 patients with active, mild to moderate UC were analyzed as part of this post hoc analysis of an 8-week study. Patients in the Kamm study received LIALDA 2.4g/day once daily (n=84), 4.8g/day once daily (n=85), Asacol 2.4g/day three times daily (n=86); or placebo (n=86).
The post hoc analysis found that regardless of the definition used for
remission, treatment with LIALDA 2.4g/day, or 4.8g/day, or Asacol 2.4g/day
resulted in similar median times to symptom resolution that were shorter
than placebo. The Kamm study was not designed to compare LIALDA to Asacol.
Asacol was included in the study as a reference arm only.
-- Symptom resolution of rectal bleeding at the first day and first of
three days, respectively:
-- LIALDA 2.4g/day: 9 days and 18 days
-- LIALDA 4.8g/day: 9 days and 17 days
-- Placebo: 14 days and 35 days
-- Normalization of stool frequency at the first day and first of three
-- LIALDA 2.4g/day: 20 days and 33 days
-- LIALDA 4.8g/day: 23 days and 38 days
-- Placebo: 38 days and 53 days
-- Resolution of both rectal bleeding and normalization of stool
frequency at the first day and first of three days, respectively:
-- LIALDA 2.4g/day: 27 days and 37 days
-- LIALDA 4.8g/day: 29 days and 45 days
-- Placebo: 44 days and 56 days
Important Safety Information for LIALDA
LIALDA tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of LIALDA beyond 8 weeks have not been established.
LIALDA is contraindicated in patients with hypersensitivity to
salicylates (including mesalamine) or to any of the components of LIALDA.
Caution should be exercised
|SOURCE Shire plc|
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