Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Two Phase 3 Studies in Carcinoid Syndrome

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Introduction: Telotristat ethyl (TE) is a treatment for carcinoid syndrome (CS) diarrhea used in combination with somatostatin analog (SSA) therapy. In the Phase 3, randomized, placebo-controlled, double-blind TELESTAR and TELECAST studies, CS patients received TE at 250 mg 3 times per day (tid), 500 mg tid, or placebo tid in addition to SSAs.

Aim(s): To examine time to sustained improvement in bowel movement (BM) frequency during the double-blind treatment (DBT) periods.

Materials and methods: The 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 DBT period. Treatments were compared with the log-rank test, and Cox regression provided hazard ratios.

Conference: 15th Annual ENETSConcerence (2018)

Presenting Author:

Authors: Dillon J, Kulke M, Warner R, Bergsland E, Welin S,

Keywords: telotristat ethyl, somatostatin analogs, carcinoid syndrome,