Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome.

Journal of Gastrointestinal Cancer
Joseph S DillonMarianne Pavel

Abstract

Telotristat ethyl is approved to treat carcinoid syndrome diarrhea in combination with somatostatin analogs. In TELESTAR and TELECAST phase III studies, patients with carcinoid syndrome received telotristat ethyl 250 or 500 mg 3 times per day (tid) or placebo tid in addition to somatostatin analogs. The aim of this prespecified analysis was to examine the time to reductions in bowel movements (BMs) in the TELESTAR and TELECAST studies using survival analysis methods. First occurrence of sustained response was defined as the time to the first day of 2 consecutive weeks with a mean BM frequency improvement of ≥ 30% from baseline during the 12-week double-blind treatment periods. Time to first ≥ 30% worsening in BM frequency was also measured. Treatments were compared with the log-rank test; Cox regression models provided point and confidence interval estimates of the hazard ratios for each trial. In TELESTAR and TELECAST, majority of patients (69%) on telotristat ethyl experienced a sustained ≥ 30% improvement in BM frequency. The median time to sustained reduction of at least 30% in BM frequency was significantly faster (fewer days to onset) for telotristat ethyl compared with placebo in both TELESTAR (250 mg, HR = 2.3 [95% CI, ...Continue Reading

References

Sep 23, 1997·Scandinavian Journal of Gastroenterology·S J Lewis, K W Heaton
May 9, 2006·Gastroenterology·George F LongstrethRobin C Spiller
Jul 4, 2009·Alimentary Pharmacology & Therapeutics·C ToumpanakisM E Caplin
Mar 20, 2013·Pancreas·April E BoydJames C Yao
Nov 29, 2014·European Journal of Endocrinology·T Alonso-GordoaE Grande
Apr 24, 2016·The Oncologist·Javier Molina-CerrilloEnrique Grande
Dec 6, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Matthew H KulkeMarianne Pavel
May 10, 2017·Endocrine-related Cancer·Wouter T ZandeeWouter W de Herder
Jan 14, 2018·Endocrine-related Cancer·Marianne PavelRocio Garcia-Carbonero

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