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Sökning: onr:"swepub:oai:DiVA.org:uu-454492" > Time to Sustained I...

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

Dillon, Joseph S. (författare)
Univ Iowa, Dept Internal Med Endocrinol & Metab, Iowa City, IA 52242 USA
Kulke, Matthew H. (författare)
Boston Med Ctr, Div Med Oncol, Boston, MA USA
Hörsch, Dieter (författare)
Zentralklin Bad Berka, Dept Gastroenterol Endocrinol, Ctr Neuroendocrine Tumors, Bad Berka, Germany
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Anthony, Lowell B. (författare)
Univ Kentucky, Div Med Oncol, Lexington, KY USA
Warner, Richard R. P. (författare)
Icahn Sch Med Mt Sinai, Div Gastroenterol, New York, NY 10029 USA
Bergsland, Emily (författare)
Univ Calif San Francisco, Dept Med, San Francisco, CA 94143 USA
Welin, Staffan (författare)
Uppsala universitet,Onkologisk endokrinologi
O'Dorisio, Thomas M. (författare)
Univ Iowa, Dept Internal Med Endocrinol & Metab, Iowa City, IA 52242 USA
Kunz, Pamela L. (författare)
Stanford Univ, Dept Med, Div Oncol, Palo Alto, CA 94304 USA
McKee, Chad (författare)
Lexicon Pharmaceut Inc, The Woodlands, TX USA
Lapuerta, Pablo (författare)
Lexicon Pharmaceut Inc, The Woodlands, TX USA
Banks, Phillip (författare)
Lexicon Pharmaceut Inc, The Woodlands, TX USA
Pavel, Marianne (författare)
Charite, Dept Hepatol & Gastroenterol, Berlin, Germany; Friedrich Alexander Univ, Div Endocrinol, Dept Med 1, Erlangen, Germany
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 (creator_code:org_t)
2021
2021
Engelska.
Ingår i: Journal of Gastrointestinal Cancer. - 1941-6628 .- 1941-6636. ; 52:1, s. 212-221
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • BackgroundTelotristat ethyl is approved to treat carcinoid syndrome diarrhea in combination with somatostatin analogs. In TELESTAR and TELECAST phase III studies, patients with carcinoid syndrome received telotristat ethyl 250 or 500 mg 3 times per day (tid) or placebo tid in addition to somatostatin analogs. The aim of this prespecified analysis was to examine the time to reductions in bowel movements (BMs) in the TELESTAR and TELECAST studies using survival analysis methods.MethodsFirst 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 double-blind treatment periods. Time to first ≥ 30% worsening in BM frequency was also measured. Treatments were compared with the log-rank test; Cox regression models provided point and confidence interval estimates of the hazard ratios for each trial.ResultsIn TELESTAR and TELECAST, majority of patients (69%) on telotristat ethyl experienced a sustained ≥ 30% improvement in BM frequency. The median time to sustained reduction of at least 30% in BM frequency was significantly faster (fewer days to onset) for telotristat ethyl compared with placebo in both TELESTAR (250 mg, HR = 2.3 [95% CI, 1.3–4.1, P = 0.004]; 500 mg, HR = 2.2 [95% CI, 1.2–3.9, P = 0.009]) and TELECAST (250 mg, HR = 3.9 [95% CI, 1.6–11.1, P = 0.003]; 500 mg, HR = 4.2 [95% CI, 1.7–11.7, P = 0.002]). In TELECAST, 42% of patients on placebo experienced sustained worsening in BM frequency compared with 20% on telotristat ethyl; no significant difference was observed in TELESTAR.ConclusionThe time of onset of sustained BM frequency improvement mean and range are important when considering use of telotristat ethyl in patients with carcinoid syndrome diarrhea. Telotristat ethyl may also reduce sustained worsening in BM frequency.

Ämnesord

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

Nyckelord

Malignant carcinoid syndrome
Tryptophan hydroxylase
Telotristat ethyl
Neuroendocrine tumors
Diarrhea
Serotonin

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