Integrated Safety Analysis of Telotristat Ethyl in Patients with Carcinoid Heart Disease
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Introduction: Release of serotonin by neuroendocrine tumors is associated with carcinoid heart disease (CaHD), which may pose challenges for carcinoid syndrome (CS) treatment.
Aim(s): We aimed to examine the safety of telotristat ethyl (TE), a novel tryptophan hydroxylase inhibitor, in a subgroup of CS patients (pts) with a medical history of CaHD.
Materials and methods: Adverse event (AE) data were pooled from 2 Phase 3 studies in CS in which 211 pts were randomly assigned 1:1:1 to placebo (pbo), TE 250 mg, or TE 500 mg 3×/day (tid) for 12 weeks and offered open-label 500 mg tid TE in a 36-week extension.
Conference: 14th Annual ENETSConcerence (2017)
Presenting Author: Lapuerta P
Authors: Lapuerta P, Kulke M, Pavel M, Biran T, Fleming R,
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