od biomarker (9).
09/06/2009 17:58:49
Dec 08: STEPS (Study of TEduglutide in PN-dependent Short-bowel syndrome) PIII study in patients with SBS commenced. The study will have an initial three to eight week PN optimization and stabilization period, after which patients will be randomised to receive SC teduglutide 0.05 mg/kg or placebo daily for 24 weeks. The primary efficacy measure will be the percentage of patients who achieve a 20% or greater reduction in weekly PN volume at week 20 and maintain that response at week 24 compared with baseline (8).
24/03/2009 16:23:57
Oct 08: Results of a P3 28 wk, extension study presented at the American College of Gastroenterology Annual Scientific Meeting. The study enrolled 65 of 71 patients who had completed a 24-week randomised P3 study of low-dose teduglutide 0.05 mg/kg/day or high-dose teduglutide 0.10 mg/kg/day vs. placebo. Patients who received placebo in the original study received teduglutide in the extension study. There were no major differences in safety (primary endpoint) between groups except for a higher rate of injection site reactions with high-dose teduglutide. 12 of 16 patients, and 6 of 8 patients, who had responded to low-dose and high-dose teduglutide, respectively, maintained their response in the extension phase, with 10 and 2 patients, respectively, achieving further reductions in parenteral nutrition volumes. A mean weekly reduction in parenteral nutrition of 4.9L and 3.3L was achieved with low and high dose teduglutide (7).
19/10/2008 16:02:08
Failed to meet primary endpoint in clinical study but lower dose showed benefit (5)
27/03/2008 10:51:08
s.c. inj shown to stimulate intestinal lining growth and nutrient absorption. PIII studies designed to show reduction in use of IV feeding(2). 80 pts PIII double-blind efficacy study -randomised to receive 0.05 or 0.10 mg/kg/day of teduglutide, or a placebo for six months, with a six-month follow up study (3).
Evidence Based eva luations
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