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From: zumone2002 on 17 Jun 2008 19:52
http://www.eurekalert.org/pub_releases/2008-06/sp-lsd061708.php

Long-term safety data on Lialda published in leading GI journal

Basingstoke, UK and Philadelphia, US – June 17, 2008 – Shire Limited
(LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical
company, today announced the publication of data from a randomized,
long-term safety and tolerability study (study 303) of ulcerative
colitis (UC) drug Lialda™ (mesalamine). The primary endpoints of this
study were to assess the safety and tolerability of Lialda in mild-to-
moderate UC patients over 12 months. Data were published in the July
issue of Gut, the official journal of the British Society of
Gastroenterology, a leading international journal in gastroenterology.

"This published data demonstrates that Lialda is generally well
tolerated and has a strong safety profile," said Gary R. Lichtenstein,
MD, co-author of study 303 and director of the Center for Inflammatory
Bowel Diseases at the Hospital of the University of Pennsylvania. "Not
only does this data demonstrate Lialda's safety and tolerability, but
secondary endpoints from the maintenance phase of the 303 study show
that a majority of patients on Lialda continued to remain in remission
through 12 months."

Specifically, the primary endpoints of the Phase III, open-label, 12-
month extension study were to evaluate the safety and tolerability of
Lialda dosed once (2.4g/day) or twice daily (1.2g twice daily) over 12
months, including adverse events (AEs), treatment exposure, and time
to withdrawal. AEs refer to any untoward medical occurrence that
happens in a clinical trial patient. AEs can be "treatment-
related" (TRAEs) and occur as a result of the study drug or they can
be considered unrelated to the study drug. In study 303, all AEs were
classified in one of three categories according to severity: mild,
moderate, or severe.

Results of the study showed Lialda demonstrated a good safety profile,
with 37.9 percent of patients (safety population n=459) experiencing
AEs, the majority of which were mild or moderate in intensity.
Treatment-related AEs were experienced by a total of 10.2 percent of
patients [11.1 percent of patients (n=225) in the once-daily group and
9.4 percent of patients (n=234) in the twice-daily group]. A total of
3.9 percent of patients experienced serious AEs [4 percent of patients
(n=225) in the once-daily group and 3.8 percent of patients (n=234) in
the twice-daily group], most of which were gastrointestinal disorders,
and only one serious AE was considered to be related to study
treatment.

The secondary endpoints of the study evaluated maintenance of
remission and relapse rates over 12 months. In the efficacy population
at entry (month 0), 78.1 percent of patients (n=219) in the once-daily
group and 82.3 percent of patients (n=232) in the twice-daily group
were in clinical and endoscopic remission. At month 12, 64.4 percent
of patients in the once-daily and 68.5 percent of patients in the
twice-daily group were in strictly defined clinical and endoscopic
remission (P=0.351). Thus, there was no significant difference between
the once-daily and twice-daily groups with respect to strictly defined
clinical and endoscopic remission at month 12. Further, 88.9 percent
and 93.2 percent of patients in each group, respectively, had
maintained clinical remission and were considered "relapse-free".
...

--
Luke
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