Efficacy of Telotristat Etiprate in Refractory Carcinoid Syndrome: Results of a Randomized, Placebo-controlled, Multicenter Study

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Introduction: Diarrhea associated with carcinoid syndrome (CS) has been attributed to excess serotonin. Telotristat etiprate is an oral serotonin synthesis inhibitor that decreases peripheral serotonin production.

Aim(s): This randomized study assessed safety, tolerability, and efficacy of telotristat etiprate in CS-associated diarrhea.

Materials and methods: Carcinoid patients with octreotide-refractory diarrhea (>4 bowel movements (BM)/day on stable-dose octreotide) were randomly assigned 3:1 to receive telotristat etiprate or placebo. Patients were dosed in sequential, escalating dose cohorts of 150, 250, 350, or 500mg tid, with an expansion cohort (500 mg tid). Endpoints included safety, reduction in BMs, 24-hour urinary 5-HIAA (u5-HIAA), and self-reported clinical improvement.

Conference: 9th Annual ENETSConcerence (2012)

Presenting Author:

Authors: Kulke M, O'Dorisio T, Phan A, Bergsland E, Freiman J,

Keywords: carcinoid syndrome, telotristat etiprate,