![]() The design and results of TELESTAR have been previously described. The primary objective of TELESTAR was to confirm that at least 1 or more doses of telotristat ethyl was effective in reducing the number of daily BMs from baseline averaged over the 12-week double-blind period (Treatment Period). The TELESTAR study was conducted to psychometrically assess meaningful change in bowel movement (BM) frequency and evaluate the efficacy and safety of telotristat ethyl in CS patients with diarrhea not adequately controlled by somatostatin analogs (SSA) (TELESTAR study NCT01677910). Large amounts of serotonin (5-hydroxytryptamine ) release is believed to cause diarrhea, endocardial and mesenteric fibrosis. Carcinoid syndrome (CS) is caused by bioactive compounds released into the circulation, occurring in almost 20% of NETs patients. The overall 5-year survival rate is 67.2%. These NETs usually occur in the small intestine and represent about 0.5% of all newly diagnosed malignancies with an annual incidence of approximately 2 per 100,000 persons. Advanced disease is associated with a reduced health-related quality of life (HRQoL) related to diarrhea, fatigue, and flushing symptoms, besides family, social, and financial issues. Trial registrationĬarcinoid tumors are well-differentiated neuroendocrine tumors (NETs) that originate in neuroendocrine cells. ![]() In this study, carcinoid syndrome patients experienced clinically meaningful reductions in bowel movement frequency of ≥30% over 12 weeks with telotristat ethyl treatment. Meaningful change derivation is critical to interpret patient outcomes for evaluating treatment efficacy. Exit interview data for meaningful change yielded effect size estimates of − 1.57 for overall change during the Double-blind Treatment Period and − 1.97 for change between Baseline and Week 12. Anchor-based analysis indicated a large effect size among patients who reported adequate relief at Week 12 (− 1.58 n = 18 P = 0.014), the QLQ-C30 Diarrhea domain responders (− 1.24 n = 40 P < 0.001), and the GI.NET21 GI Symptoms Domain responders (− 1.49 n = 25 P = 0.005). A distribution-based method yielded meaningful change estimates of 0.62 bowel movements a day for overall frequency and 0.83 bowel movements a day at Week 12. There were 135 carcinoid syndrome patients with a mean baseline frequency of 5.7 bowel movements a day. Parameters included within-group mean change from baseline to Week 12, t-tests of the change (Wilcoxon rank sum for adequate relief), and effect size. These included the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core Questionnaire (QLQ-C30) Diarrhea Symptom responders, the EORTC Gastrointestinal NET questionnaire (GI.NET21) GI Symptom responders, and reported adequate relief at Week 12 (≥ 10-point score decrease from Day 1 to Week 12). MethodsĪn anchor-based approach for deriving meaningful change thresholds consisted of mapping change from baseline bowel movement frequency to other patient-reported assessments of change. This study was conducted to psychometrically assess meaningful change in bowel movement frequency among carcinoid syndrome patients using data from the TELESTAR clinical study. Drink extra water for the next few days.Carcinoid syndrome is associated with a reduced quality of life that can be attributed to symptoms such as diarrhea and fatigue as well as social and financial issues. You will probably be able to go back to most of your usual activities in 1 or 2 days. These symptoms should get better in 1 or 2 days. You may feel the need to urinate more often, and you may have some blood in your urine. Your doctor may have shown you how to do dilation at home.Īfter dilation, your urethra may be sore at first. After dilation, urine should be able to pass more freely from your bladder. The catheter is removed after a few days. The doctor then may have placed a thin, soft tube (catheter) in the urethra to drain urine and to keep the urethra open. To open the narrowed part, the doctor used one or more thin tools to stretch the stricture. Dilation often can relieve symptoms by widening the urethra. When the urethra is narrow, it's hard for urine to pass through and out of your body. Sometimes scar tissue narrows the urethra. The urethra is the tube that carries urine from your bladder to outside your body. Urethral dilation is a procedure to stretch the sides of the urethra.
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