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- Anthony, Lowell B., et al.
(författare)
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Long-Term Safety Experience with Telotristat Ethyl Across Five Clinical Studies in Patients with Carcinoid Syndrome
- 2019
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Ingår i: The Oncologist. - : WILEY. - 1083-7159 .- 1549-490X. ; 24:8, s. E662-E670
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Tidskriftsartikel (refereegranskat)abstract
- Background Patients with neuroendocrine tumors (NETs) and carcinoid syndrome experience considerable morbidity and mortality; carcinoid syndrome may be associated with shorter survival. Carcinoid syndrome is linked to tumoral secretion of serotonin and other bioactive substances. The subsequent debilitating diarrhea and urgency to defecate pose significant health risks. In previous studies, telotristat ethyl, a tryptophan hydroxylase inhibitor, was effective and well tolerated in treating carcinoid syndrome diarrhea. We present pooled safety data from five clinical trials with telotristat ethyl in patients with carcinoid syndrome. Subjects, Materials, and Methods Adverse events reported during telotristat ethyl treatment were pooled from two phase II and three phase III clinical trials in 239 patients with carcinoid syndrome. Long-term safety of telotristat ethyl and causes of hospitalization and death were reviewed; overall survival was estimated. Results Mean (median; range) duration of exposure and follow-up was 1.3 years (1.1 years; 1 week to 5.7 years), with 309 total patient-years of exposure. Leading causes of hospitalization were gastrointestinal disorders or were related to the underlying tumor and related treatment. Survival estimates at 1, 2, and 3 years were 93%, 88%, and 77%. Nearly all deaths were due to progression or complication of the underlying disease; none were attributable to telotristat ethyl. There was one death in year 4. Conclusion Based on long-term safety data, telotristat ethyl is well tolerated and has a favorable long-term safety profile in patients with carcinoid syndrome. Implications for Practice Carcinoid syndrome can cause persistent diarrhea, even in patients treated with somatostatin analogs. Across five clinical trials in patients with carcinoid syndrome, telotristat ethyl has been well tolerated and efficacious, providing clinicians with a new approach to help control carcinoid syndrome diarrhea, in addition to somatostatin analog therapy. By reducing the stool frequency in patients with carcinoid syndrome whose diarrhea is refractory to anticholinergics, such as loperamide and atropine/diphenoxylate, and somatostatin analog dose escalation, improvement in quality of life becomes an achievable goal.
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| 2. |
- Warner, Grace, et al.
(författare)
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A systematic review examining whether community-based self-management programs for older adults with chronic conditions actively engage participants and teach them patient-oriented self-management strategies
- 2019
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Ingår i: Patient Education and Counseling. - : Elsevier. - 0738-3991 .- 1873-5134. ; 102:12, s. 2162-2182
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To identify whether community-based Self-Management Programs (SMPs) actively engaged, or taught, individuals patient-oriented strategies; and whether having these attributes led to significant differences in outcomes.METHODS: This systematic review included randomized controlled trials (RCTs)and cluster RCTs reporting on community-based SMPs with a group component for older adults with chronic conditions. The ways SMPS actively engaged participants and whether they taught patient-oriented strategies were analyzed. All study outcomes were reported.RESULTS: The 31 included studies demonstrated community-based SMP programs actively engaged participants and provided strategies to improve health behaviour or care of their condition. Few included strategies to help manage the impact of conditions on their everyday lives. Seventy-nine percent of studies reported significant differences; variations in sample sizes and outcomes made it difficult to conclude whether having these attributes led to significant differences.CONCLUSION: SMPs are not supporting older adults to use strategies to address the impact of conditions on their everyday lives, addressing the needs of older adults with multiple conditions, nor assessing outcomes that align with the strategies taught.PRACTICE IMPLICATIONS: Health-care providers delivering SMPs to older adults need to tailor programs to the needs of older adults and assess whether participants are using strategies being proposed.
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