Retrospective Study Open Access
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. Jun 5, 2025; 16(2): 105801
Published online Jun 5, 2025. doi: 10.4292/wjgpt.v16.i2.105801
Efficacy of elobixibat for elderly patients with chronic constipation in a clinic
Yuji Sakai, Department of Gastroenterology, Sakai Clinic, Kimistu 299-1162, Japan
Yuji Sakai, Hiroshi Ohyama, Naoya Kato, Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba 260-8670, Japan
Toshio Tsuyuguchi, Department of Gastroenterology, Chiba Prefectural Sawara Hospital, Sawara 287-0003, Japan
Junichiro Kumagai, Department of Gastroenterology, Kimitsu Central Hospital, Kisarazu 292-8535, Japan
Takashi Kaiho, Department of Surgery, Kimitsu Chuo Hospital, Kisarazu 292-8535, Japan
Masayuki Ohtsuka, Department of General Surgery, Graduate School of Medicine, Chiba University, Chiba 260-8677, Japan
ORCID number: Yuji Sakai (0000-0002-1782-4829); Toshio Tsuyuguchi (0000-0003-4897-5635); Junichiro Kumagai (0000-0002-9031-0103); Hiroshi Ohyama (0000-0003-0614-581X); Masayuki Ohtsuka (0000-0002-5091-1078).
Author contributions: Sakai Y wrote the paper; Sakai Y, Tsuyuguchi T, Ohtsuka M, and Kato N were responsible for the manuscript preparation; Tsuyuguchi T and Ohtsuka M revised the manuscript; Kumagai J, Ohyama H, and Kaiho T collected the references; All authors read and approved the final version of the manuscript to be published.
Institutional review board statement: A study at this clinic was conducted after obtaining approval from all patients about the use of data. We requested the institutional review board at Kimitsu Central Hospital to review data and obtained their approval (institutional review board No. 802).
Informed consent statement: To determine the long-term prognosis, we confirmed the prognosis by directly calling the patient and the transportation hospitals in addition to obtaining information from the outpatient clinic.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
Data sharing statement: The data that support the findings of this study are available from the corresponding author, upon reasonable request.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Yuji Sakai, Department of Gastroenterology, Sakai Clinic, 9-18-8 Minamikoyasu, Kimistu 299-1162, Japan. sakai4754@yahoo.co.jp
Received: February 7, 2025
Revised: March 7, 2025
Accepted: April 1, 2025
Published online: June 5, 2025
Processing time: 116 Days and 12.9 Hours

Abstract
BACKGROUND

Elobixibat reportedly improves bowel movements in patients with chronic constipation. However, its effect on bowel movements in elderly patients with chronic constipation in clinical settings has not been examined.

AIM

To examine bowel movement frequency and stool form before and after elobixibat administration in elderly patients with chronic constipation at our clinic.

METHODS

A total of 10 mg elobixibat was administered to 35 (< 65 years old) patients and 45 (≥ 65 years old) patients with chronic constipation. The frequency of bowel movements and stool forms, assessed using the Bristol Stool Form Scale (BSFS), were compared between the two groups 1 week before and after elobixibat administration.

RESULTS

In patients aged < 65 years with chronic constipation, the pre-elobixibat frequency of bowel movements and BSFS scores were 2.167 ± 0.732 and 2.286 ± 0.742, respectively. After elobixibat administration, the frequency of bowel movements and BSFS scores improved to 2.389 ± 0.502 and 3.995 ± 0.566, respectively, showing a significant improvement in bowel movement status. In patients aged ≥ 65 years with chronic constipation, the pre-elobixibat frequency of bowel movements and BSFS scores were 2.003 ± 0.733 and 2.217 ± 0.758, respectively. After elobixibat administration, the frequency of bowel movements and BSFS scores improved to 4.402 ± 1.346 and 3.800 ± 0.704, respectively, indicating an improvement in bowel movement status (P < 0.001). No significant differences were observed in the frequency and improvement status of bowel movements or BSFS scores between patients with chronic constipation aged ≥ 65 years and < 65 years. Adverse events due to the administration of elobixibat occurred in 16 cases (20%). No significant differences were found in the incidence of adverse events between patients with chronic constipation aged < 65 years (8 cases, 22.9%) and those aged ≥ 65 years (8 cases, 17.8%).

CONCLUSION

Elobixibat is effective in improving bowel movement status in patients with chronic constipation. No significant differences were found in the improvement of bowel movement status or the incidence of adverse events between patients with chronic constipation aged < 65 years and ≥ 65 years, suggesting that the drug may be safely used in elderly patients.

Key Words: Bile acid; Elderly patients; Elobixibat; Chronic constipation; Post cholecystectomy; Constipation

Core Tip: Elobixibat was effective in improving bowel movements in patients with chronic constipation. Furthermore, there were no significant differences in treatment efficacy or incidence of adverse events between elderly patients and younger patients with chronic constipation. With its high clinical efficacy in treating chronic constipation in elderly patients and its low incidence of adverse events, elobixibat appears to be a viable treatment option for elderly patients.



INTRODUCTION

With advances in medical care, the global population is rapidly aging[1]. In the elderly, organ function typically declines with age[2,3], leading to reduced immune and infection-protective capabilities and impaired homeostasis. Therefore, elderly individuals are reported to more frequently have underlying diseases as they age[4-7]. To provide medical care, treatment with the best possible, minimally invasive, and highly useful methods is required, with few incidental findings. Incidental findings are more likely to become serious in elderly individuals because of a higher probability of having underlying diseases compared with younger people[4]. Therefore, ensuring that treatments can be performed safely and effectively is extremely important, and various considerations have been implemented to address these concerns[5-7].

A report showed that people with chronic constipation experienced not only a lower quality of life (QOL) and work productivity and activity impairment but also economic loss compared to healthy individuals[8]. Chronic constipation is also known to easily cause defecation syncope due to excess straining during defecation, which places a burden on the cardiovascular system[9]. Moreover, chronic constipation can lead to changes in intestinal metabolites due to abnormal intestinal microflora, which may be associated with the development of various diseases, including arteriosclerosis and cardiovascular diseases[10]. A report indicated that a lower frequency of bowel movements increased the risk of mortality due to cardiovascular diseases[11], and improvement of chronic constipation is extremely important for human life. As diet/exercise therapy can be challenging for elderly patients with chronic constipation, pharmacotherapy is often highly anticipated. In drug therapy, there are drugs with various mechanisms of action, and their usefulness has been reported[12-16]. Elobixibat is the world's first bile acid transporter inhibitor. It works by inhibiting ileal bile acid transporters (IBATs), which are expressed on the epithelial cells of the distal ileum. This inhibition results in increased bile acid flow into the large intestine, promoting large intestinal fluid secretion and peristaltic movement, thereby improving bowel movement status[17-23]. To our knowledge, there have been only a few studies on the use of elobixibat in elderly patients with chronic constipation[21-23]. However, it is difficult to say that elobixibat has been sufficiently studied, as there are no reports on its evaluation in clinics despite its widespread use. In this study, we aim to assess the usefulness and safety of elobixibat in elderly patients with chronic constipation at our clinic.

MATERIALS AND METHODS

Our study included 80 patients diagnosed with chronic constipation at our clinic from May 2018 to November 2024. Rome IV criteria were used to diagnose chronic constipation[24]. Elobixibat administration was compared and examined between 35 (< 65 years old) patients and 45 (≥ 65 years old) patients with chronic constipation. None of the patients had undergone ileectomy. Stool forms were assessed using Bristol Stool Form Scale (BSFS)[25]. The inclusion criteria were: (1) Patients diagnosed with chronic constipation based on the Rome IV criteria; (2) Patients who were 20 years old or older at the time of diagnosis; and (3) Patients who presented to the hospital as outpatients. The exclusion criteria were: (1) Patients diagnosed with temporary constipation; (2) Patients with extremely poor general condition; and (3) Patients whom the study doctor deemed ineligible. A total of 10 mg elobixibat was administered before the evening meal. Changes in the frequency of bowel movements and stool forms, 1 week before and after elobixibat administration, were examined.

Data for this study were used after obtaining prior consent from all patients. The use of the study data was reviewed upon our request and approved by the ethical committee of Kimitsu Central Hospital (institutional review board No. 802; Kisarazu, Japan).

Statistical analyses

Between-group comparisons were performed using Wilcoxon single-rank test, paired t-test, χ² test, and F-test. P < 0.05 was considered statistically significant. The software used was Statistical Package for the Social Sciences (version 17; IBM SPSS Statistics, Armonk, NY, United States).

RESULTS

Patient backgrounds are summarized in Table 1. The study included 29 men and 51 women, with a mean ± SD age of 66.156 years ± 13.961 years. Stool types assessed using BSFS were as follows: (1) Type 1 (18 patients); (2) Type 2 (32 patients); (3) Type 3 (30 patients); (4) Type 4 (0 patients); (5) Type 5 (0 patients); (6) Type 6 (0 patients); and (7) Type 7 (0 patients). The frequency of bowel movements 1 week before elobixibat administration was 2.013 ± 0.639. The number of drugs used to relieve chronic constipation before elobixibat administration was 0 in 28 patients, 1 in 30 patients, and 2 in 20 patients. Table 2 shows the background of patients with chronic constipation (< 65 and ≥ 65 years old). In patients aged ≥ 65 years with chronic constipation, there was a significantly higher prevalence of hypertension, diabetes mellitus, dyslipidemia, cardiac disease, and renal disease. Table 3 shows the effects of elobixibat administration. A comparison of data from 1 week before and after elobixibat administration revealed significant improvements in both the frequency of bowel movements and stool forms. In both groups (< 65 years old and ≥ 65 years old) of patients with chronic constipation, the frequency of bowel movements and stool forms were significantly improved 1 week after elobixibat administration, compared with those 1 week before administration. No significant differences were found in the improvement of bowel movement frequency or stool forms with elobixibat administration between patients with chronic constipation aged < 65 years and those aged ≥ 65 years (Table 4). Table 5 shows the adverse events due to elobixibat administration. Sixteen cases (20%) of adverse events were observed: (1) eight cases (10%) of abdominal pain; and (2) eight cases (10%) of diarrhea. One patient (1.3%) experienced frequent diarrhea and discontinued the oral treatment 3 days after administration. Other adverse events were mild and resolved with conservative treatment, allowing the continuation of treatment. No significant differences were found in the incidence of adverse events due to elobixibat administration between the patients with chronic constipation aged < 65 years and those aged ≥ 65 years.

Table 1 Patient characteristics, n (%).
Number of patients
n = 80
Sex
Male29 (36.3)
Female51 (63.8)
Age66.156 ± 13.961
Bristol Stool Form Scale
Type 118 (22.5)
Type 232 (40)
Type 330 (37.5)
Type 40 (0)
Type 50 (0)
Type 60 (0)
Type 70 (0)
1-week frequency of bowel movements before elobixibat administration 2.013 ± 0.639
Number of drugs to relieve constipation before elobixibat administration
028 (35)
1 magnesium oxide tablet32 (40)
2 magnesium oxide tablets + sennoside20 (25)
Comorbidity
Hypertension38 (47.5)
Hyperlipidemia36 (45)
Diabetes mellitus35 (43.8)
Cerebrovascular disease16 (20)
Chronic respiratory disease13 (16.3)
Cardiac disease22 (27.5)
Chronic hepatic disease18 (22.5)
Chronic renal disease10 (12.5)
Malignant disease6 (7.5)
Post cholecystectomy18 (22.5)
Table 2 Comparison of patient backgrounds by age, n (%).

< 65 years old
≥ 65 years old
P value
Number of patients3545
Sex
Male12 (34.3)17 (37.8)0.8171
Female23 (65.7)28 (62.2)0.8171
Age52.563 ± 9.64876.023 ± 6.341< 0.001
Pre-elobixibat
defecation count/1-week frequency
2.167 ± 0.7322.003 ± 0.7330.9631
Pre-elobixibat Bristol Stool Form Scale/1-week score 2.286 ± 0.7422.217 ± 0.7580.8960
Number of drugs to relieve constipation before elobixibat administration
011 (31.4)17 (37.8)0.6397
1 magnesium oxide tablet13 (37.1)19 (42.2)0.8183
2 magnesium oxide tablets + sennoside7 (20)13 (28.9)0.0536
Comorbidity
Hypertension10 (28.6)28 (62.2)0.0035
Hyperlipidemia8 (22.9)28 (62.2)< 0.001
Diabetes mellitus9 (25.7)26 (57.8)< 0.001
Cerebrovascular disease5 (14.3)11 (24.4)0.3987
Chronic respiratory disease3 (8.6)10 (22.2)0.1319
Cardiac disease5 (14.3)17 (37.8)0.0241
Chronic hepatic disease5 (14.3)13 (28.9)0.1775
Chronic renal disease1 (2.9)9 (20)0.0370
Malignant disease2 (7.7)4 (8.9)0.6945
Post cholecystectomy6 (17.1)12 (26.7)0.4203
Table 3 Changes in bowel movements before and after elobixibat administration.
Total: 80 cases

Comparison before and after elobixibat administration (P value)
Pre-elobixibat defecation count/1-week frequency2.013 ± 0.639
Post-elobixibat defecation count/1-week frequency4.394 ± 1.346< 0.001
Pre-elobixibat BSFS/1-week score2.181 ± 0.758
Post-elobixibat BSFS/1-week score3.987 ± 0.855< 0.001
< 65 years old
Pre-elobixibat defecation count/1-week frequency2.167 ± 0.732
Post-elobixibat defecation count/1-week frequency4.375 ± 1.163< 0.001
Pre-elobixibat BSFS/1-week score2.286 ± 0.742
Post-elobixibat BSFS/1-week score3.995 ± 0.566< 0.001
≥ 65 years old
Pre-elobixibat defecation count/1-week frequency2.003 ± 0.733
Post-elobixibat defecation count/1-week frequency4.402 ± 1.346< 0.001
Pre-elobixibat BSFS/1-week score2.217 ± 0.758
Post-elobixibat BSFS/1-week score3.800 ± 0.704< 0.001
Table 4 Comparison of changes in bowel movement before and after administration of elobixibat by age.

< 65 years old
≥ 65 years old
P value
Pre-elobixibat defecation count/1-week frequency2.167 ± 0.7322.003 ± 0.7330.9631
Post-elobixibat defecation count/1-week frequency4.375 ± 1.1634.402 ± 1.3460.7745
Pre-elobixibat BSFS/1-week score2.286 ± 0.7422.217 ± 0.7580.8960
Post-elobixibat BSFS/1-week score3.995 ± 0.5663.800 ± 0.7040.1063
Table 5 Comparison of adverse events to elobixibat by age, n (%).

< 65 years old
≥ 65 years old
P value
Adverse events after elobixibat administration of elobixibat
Abdominal pain4 (11.4)4 (8.9)0.7241
Diarrhea4 (11.4)4 (8.9)0.7241
Total8 (22.9)8 (17.8)0.5869
DISCUSSION

Elderly individuals often face multiple underlying diseases, take numerous medications, experience declines in physiological and cognitive functions, and encounter social limitations, which can vary significantly from person to person. In this study, patients with chronic constipation aged ≥ 65 years tended to have significantly more underlying diseases, including hypertension and diabetes mellitus, compared with patients with chronic constipation aged < 65 years. In the elderly, the risks associated with diagnostic tests and treatments can sometimes outweigh the risks posed by the diseases themselves. For individual patients, benefit and harm outcomes should be determined not only objectively but also subjectively, by including QOL improvement, to select an appropriate treatment strategy. There are various treatment methods for chronic constipation; however, pharmacotherapy is often selected for elderly individuals because diet/exercise therapy is usually difficult for them due to reduced dietary intake and the presence of other diseases. Pharmacotherapy is a minimally invasive treatment method and is easy to administer to elderly individuals. Elobixibat, the test drug in this study, inhibits IBATs in the distal ileum to suppress reabsorption of bile and increases the amount of bile acid flowing into the large intestine. Accordingly, the action of bile acid promotes intestinal fluid secretion and peristaltic movement, which increases the frequency of bowel movements and improves stool forms, as reported[17-23]. Improvements in QOL have also been reported[18].

In this study, increased frequency of bowel movements and stool form improvement were observed after elobixibat administration to patients with chronic constipation. Even elderly individuals could be effectively treated, showing no significant differences in the improvement of bowel movement frequency and stool form compared to younger patients. This drug is characterized by inhibiting IBATs to flow a large amount of bile acid into the large intestine, resulting in improved bowel movements. Considering the mechanism of action, when the bile flow to the duodenum is slow, the effects of drugs may be difficult to detect. Sufficient effects may not be observed in patients with child C hepatic cirrhosis and decreased liver function, or in patients with obstructive jaundice[20]. In patients with a history of ileectomy, IBATs are expressed in the distal ileum, and thus, the effects of this drug are less likely to occur. It should be noted that elderly people are likely to have a history of surgery and/or gallbladder stone and choledocholithiasis, which may cause obstructive jaundice. Adverse events due to the administration of elobixibat were observed in 16 patients (20%). Previous reports have indicated that there were no deaths caused by the administration of this drug[17-21]. In our study, eight cases (10%) of abdominal pain and eight cases (10%) of diarrhea were observed. However, there were no serious adverse events that rapidly worsened the patients' general condition; discontinuation of elobixibat occurred in one patient (1.3%) due to frequent diarrhea. Other adverse events were minor and no serious adverse events were observed, suggesting that elobixibat is safe to use. Additionally, its once-daily dosing frequency reduces the likelihood of missed doses compared to treatment drugs that require multiple daily administrations.

This study had several limitations. It was conducted at a single clinic, resulting in a small sample size and a retrospective design. Furthermore, the study only examined results 1 week after administration. Long-term use of constipation treatments may pose a risk of drug resistance, making long-term prognosis a critical consideration[26]. Going forward, a multicenter prospective study with long-term follow-up is necessary. It remains unclear which specific types of chronic constipation may benefit most from elobixibat or which additional drugs should be co-administered with elobixibat to enhance its effectiveness. Continuing this discussion and further research are essential to address these questions.

CONCLUSION

Elobixibat has been useful in treating chronic constipation. Furthermore, there were no significant differences in treatment efficacy or incidence of adverse events between elderly patients and younger patients with chronic constipation. With its high clinical efficacy in treating chronic constipation in elderly patients and its low incidence of adverse events, elobixibat appears to be a viable treatment option for elderly patients.

Footnotes

Provenance and peer review: Invited article; Externally peer reviewed.

Peer-review model: Single blind

Specialty type: Gastroenterology and hepatology

Country of origin: Japan

Peer-review report’s classification

Scientific Quality: Grade B, Grade B, Grade C

Novelty: Grade B, Grade B, Grade C

Creativity or Innovation: Grade C, Grade C, Grade C

Scientific Significance: Grade B, Grade C, Grade C

P-Reviewer: Shen JL; Yan J S-Editor: Luo ML L-Editor: Filipodia P-Editor: Zheng XM

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