Impact of Concomitant Medication on Efficacy of Telotristat Ethyl – A Post Hoc Subgroup Analysis of the Phase 3 TELESTAR Study in Carcinoid Syndrome

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Introduction: The tryptophan hydroxylase inhibitor telotristat ethyl (TE) significantly reduced bowel movement (BM) frequency versus placebo (pbo) in patients (pts) with carcinoid syndrome (CS) in the TELESTAR study.

Aim(s): We aimed to explore TE efficacy in subgroups defined by concomitant therapy.

Materials and methods: 135 pts with CS and ≥4 BMs/day despite somatostatin analog (SSA) therapy were randomly assigned to receive pbo, TE 250 mg, or TE 500 mg 3×/day. Change from Baseline in BM frequency averaged over the 12-week double-blind treatment (DBT) period was analyzed in subgroups defined by use of high or standard stable dose (SSD) of long-acting (LA) SSA and by concomitant use (yes/no [Y/N]) of short-acting (SA) rescue SSAs, antidiarrheals, and narcotics. High LA SSA was defined as octreotide >30 mg/4 weeks, lanreotide >120 mg/4 weeks, or more frequent dosing of either drug.

Conference: 14th Annual ENETSConcerence (2017)

Presenting Author:

Authors: Anthony L, Kulke M, Hörsch D, Bergsland E, Öberg K,

Keywords: serotonin, diarrhea ,