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Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance
BACKGROUND/AIMS: Elobixibat, an ileal bile acid transporter (apical sodium-dependent bile acid transporter) inhibitor, was recently launched in Japan for the treatment of chronic idiopathic constipation. We conducted an interim analysis of post-marketing surveillance to evaluate the safety and effic...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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The Korean Society of Neurogastroenterology and Motility
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9274463/ https://www.ncbi.nlm.nih.gov/pubmed/35799237 http://dx.doi.org/10.5056/jnm20263 |
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author | Nakajima, Atsushi Fujimaki, Mio Arai, Yuki Emori, Kento |
author_facet | Nakajima, Atsushi Fujimaki, Mio Arai, Yuki Emori, Kento |
author_sort | Nakajima, Atsushi |
collection | PubMed |
description | BACKGROUND/AIMS: Elobixibat, an ileal bile acid transporter (apical sodium-dependent bile acid transporter) inhibitor, was recently launched in Japan for the treatment of chronic idiopathic constipation. We conducted an interim analysis of post-marketing surveillance to evaluate the safety and efficacy of elobixibat in elderly patients with chronic constipation and compared the efficacy according to administration time. METHODS: Safety and efficacy outcomes were evaluated through patient interviews for 4 weeks. RESULTS: Adverse drug reactions (ADRs) were observed in 5.24% of the 1049 patients analyzed; diarrhea (2.19%) and abdominal pain (1.81%) were the most common. A serious ADR of death was reported in one patient (0.10%). The incidence of ADRs in the ≥ 65-year old or ≥ 75-year-old subpopulation was similar to that in the total patient population. Mean bowel movements per week significantly increased from 2.9 ± 2.5 at baseline to 5.0 ± 3.1 (P < 0.001) at Week 2 and 5.3 ± 2.6 (P < 0.001) at Week 4. The mean Bristol Stool Form Scale score significantly increased from 2.3 ± 1.4 at baseline to 3.8 ± 1.3 (P < 0.001) at Week 2 and 3.9 ± 1.1 at Week 4 (P < 0.001). Bowel movements significantly increased in the elderly population and subpopulations receiving elobixibat before breakfast, lunch, or dinner. The median time to bowel movement was 5 hours. Conclusion The results suggested that elobixibat was well-tolerated and efficacious in elderly patients with chronic constipation and can be administered before any meals. |
format | Online Article Text |
id | pubmed-9274463 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | The Korean Society of Neurogastroenterology and Motility |
record_format | MEDLINE/PubMed |
spelling | pubmed-92744632022-07-30 Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance Nakajima, Atsushi Fujimaki, Mio Arai, Yuki Emori, Kento J Neurogastroenterol Motil Original Article BACKGROUND/AIMS: Elobixibat, an ileal bile acid transporter (apical sodium-dependent bile acid transporter) inhibitor, was recently launched in Japan for the treatment of chronic idiopathic constipation. We conducted an interim analysis of post-marketing surveillance to evaluate the safety and efficacy of elobixibat in elderly patients with chronic constipation and compared the efficacy according to administration time. METHODS: Safety and efficacy outcomes were evaluated through patient interviews for 4 weeks. RESULTS: Adverse drug reactions (ADRs) were observed in 5.24% of the 1049 patients analyzed; diarrhea (2.19%) and abdominal pain (1.81%) were the most common. A serious ADR of death was reported in one patient (0.10%). The incidence of ADRs in the ≥ 65-year old or ≥ 75-year-old subpopulation was similar to that in the total patient population. Mean bowel movements per week significantly increased from 2.9 ± 2.5 at baseline to 5.0 ± 3.1 (P < 0.001) at Week 2 and 5.3 ± 2.6 (P < 0.001) at Week 4. The mean Bristol Stool Form Scale score significantly increased from 2.3 ± 1.4 at baseline to 3.8 ± 1.3 (P < 0.001) at Week 2 and 3.9 ± 1.1 at Week 4 (P < 0.001). Bowel movements significantly increased in the elderly population and subpopulations receiving elobixibat before breakfast, lunch, or dinner. The median time to bowel movement was 5 hours. Conclusion The results suggested that elobixibat was well-tolerated and efficacious in elderly patients with chronic constipation and can be administered before any meals. The Korean Society of Neurogastroenterology and Motility 2022-07-30 2022-07-30 /pmc/articles/PMC9274463/ /pubmed/35799237 http://dx.doi.org/10.5056/jnm20263 Text en © 2022 The Korean Society of Neurogastroenterology and Motility https://creativecommons.org/licenses/by-nc/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Nakajima, Atsushi Fujimaki, Mio Arai, Yuki Emori, Kento Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance |
title | Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance |
title_full | Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance |
title_fullStr | Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance |
title_full_unstemmed | Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance |
title_short | Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance |
title_sort | safety and efficacy of elobixibat, an ileal bile acid transporter inhibitor, in elderly patients with chronic idiopathic constipation according to administration time: interim analysis of post-marketing surveillance |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9274463/ https://www.ncbi.nlm.nih.gov/pubmed/35799237 http://dx.doi.org/10.5056/jnm20263 |
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