Patient Interviews in TELESTAR, a Phase 3 Study of Telotristat Etiprate, Report Meaningful Improvement in Carcinoid Syndrome Abstract #1354

Introduction: Telotristat etiprate (TE) reduces serotonin production. In TELESTAR, a phase 3 study in patients (pts) with carcinoid syndrome (CS) on somatostatin analogues with ≥4 bowel movements (BM) per day, TE significantly reduced BM frequency (freq). Overall (n=135), durable response (DR, ≥30% reduction in BMs/day for ≥50% of the study period) was observed in 44% (250 mg tid) and 42% (500 mg tid), vs 20% on placebo (PBO); p≤0.02 for each TE vs. PBO. A subset with similar demographics to the overall trial was interviewed.
Aim(s): To assess pt reported impact of treatment (tx) on CS and whether symptom changes were meaningful.
Materials and methods: Participating sites were asked to invite (prior to randomization) all eligible pts to phone interviews scheduled at the end of the double-blind tx period. Pts and interviewers were blinded to tx.
Conference: 13th Annual ENETS conference (2016)
Category: Medical treatment - Others
Presenting Author: Marianne Pavel

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