Dataset Information

Effects of Elobixibat in Patients with Diabetes and Concomitant Chronic Constipation: an 8-week, Prospective, Single-center, Single-arm Study.

ABSTRACT:

Aims

To evaluate the efficacy and safety of elobixibat in patients with diabetes and concomitant chronic constipation.

Methods

This was a single-center, single-arm study. Thirty-three patients with diabetes and chronic constipation, as defined by the Rome IV criteria, were treated with elobixibat (10 mg/day) for 8 weeks. Patients recorded stool properties, including spontaneous bowel movements (SBMs) and stool consistency, according to the Bristol Stool Form Scale (BSFS). Quality of life for constipation was evaluated with the Japanese version of the Patient Assessment of Constipation Quality of Life (JPAC-QOL).

Results

Of the 33 eligible patients, 30 completed the study. Elobixibat significantly increased the median (interquartile range) frequency of SBMs per week, from 5.0 (3.0-7.0) at baseline to 6.0 (4.0-7.0] at week 8 (p = 0.030). After 8 weeks, the BSFS score approached 4; the score for normal stool consistency and the JPAC-QOL score significantly improved from 1.05 ± 0.40 at baseline to 0.94 ± 0.53 (p = 0.048); and glycated albumin and serum lipid profiles significantly improved. Stratified analysis revealed that SBMs increased especially in patients with low SBM frequency, in particular in women, older adults, patients without overweight, patients with a long duration of constipation, and patients with diabetic neuropathy. No serious adverse events occurred.

Conclusions

Among patients with diabetes who met the Rome IV criteria for constipation, elobixibat was effective, especially in those with few SBMs at baseline. Improvements in lipid profiles could be an advantage of elobixibat compared with other laxatives.

Clinical trial registry

Japan Registry of Clinical Trials registration number: jRCTs031190092.

SUBMITTER: Hishida Y

PROVIDER: S-EPMC9402500 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

Effects of Elobixibat in Patients with Diabetes and Concomitant Chronic Constipation: an 8-week, Prospective, Single-center, Single-arm Study.

Hishida Yoshiaki Y Nagai Yoshio Y Tsukiyama Hidekazu H Nakamura Yuta Y Nakagawa Tomoko T Ishizaki Sonoko S Tanaka Yasushi Y Sone Masakatsu M

Advances in therapy 20220722 9

<h4>Aims</h4>To evaluate the efficacy and safety of elobixibat in patients with diabetes and concomitant chronic constipation.<h4>Methods</h4>This was a single-center, single-arm study. Thirty-three patients with diabetes and chronic constipation, as defined by the Rome IV criteria, were treated with elobixibat (10 mg/day) for 8 weeks. Patients recorded stool properties, including spontaneous bowel movements (SBMs) and stool consistency, according to the Bristol Stool Form Scale (BSFS). Quality ...[more]

PMID: 35867276

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Project description:BackgroundChronic constipation is a common digestive complication of Parkinson's disease (PD).ObjectivesTo verify the usefulness of elobixibat, an ileal bile acid transporter inhibitor, for chronic constipation in PD.MethodsThis double-blind, placebo-controlled study consisted of a 2-week observation/washout period and a 4-week treatment period. All patients received a Bowel Movement Diary at Week -2 and were allocated to elobixibat (10 mg) or placebo at Week 0. Patients visited at Weeks 2 and 4 to report daily spontaneous bowel movements (SBM), stool form, drug use, quality of life (QOL), and safety. Changes in these parameters were assessed.ResultsThe study included 38 patients in the elobixibat group and 39 in the placebo group, and 37 each completed the study. SBM frequency/week (mean ± standard deviation) increased significantly from 4.2 ± 2.6 at baseline to 5.9 ± 3.2 at Week 4 in the elobixibat group (P = 0.0079), but not in the placebo group (4.5 ± 2.7 to 5.3 ± 3.5; P = 0.0889). On analysis of covariance, the between-group difference in frequency changes at Week 4 (primary endpoint) was not significant after adjustment by baseline and sex (point estimate = 0.8; 95% confidence interval = -0.57 to 2.09, P = 0.2601), although a significant difference (P = 0.0011) was evidenced at Week 1 by a similar analysis. Stool form and scores of satisfaction and stigma were improved by elobixibat. Adverse events were as previously reported.ConclusionsElobixibat improved the SBM frequency, though the defined primary endpoint was not evidenced. QOL parameters (stool consistency and treatment satisfaction) were also improved. Elobixibat may have therapeutic benefits in PD patients suffering from chronic constipation.Trial registration informationTrial Registration Number: JPRN-jRCTs031200172 (submitted: October 26, 2020; first patient enrolment: December 23, 2020; https://jrct.niph.go.jp/en-latest-detail/jRCTs031200172).

Project description:BackgroundConstipation is a common, distressing complication in patients with cancer receiving palliative care. Elobixibat is a novel inhibitor of the ileal bile acid transporter that is used to treat chronic constipation by stimulating bowel function. However, its efficacy in patients with cancer has not been examined. This study investigated the drug's effectiveness in patients with cancer with chronic constipation.Patients and methodsThis prospective-sampling, single-center, observational study included hospitalized patients with cancer diagnosed, using the Rome IV criteria, with chronic constipation. Within 2 weeks of hospitalization, each participant was administered elobixibat (5-15 mg) daily until discharge. Spontaneous bowel movements (SBMs), complete spontaneous bowel movements (CSBMs), Bristol stool form scale (BSFS) scores, and the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) scores were assessed before and after elobixibat administration. We also evaluated the relationship between the amount of food consumed and the SBM frequency.ResultsAmong the 83 participants, the mean pre- and post-treatment frequencies of daily SBMs were 0.3 and 1.2 (p < .0001) and those of CSBMs were 0.1 and 0.6 (p < .0001), respectively. The mean pretreatment BSFS score was 1.6, whereas the post-treatment value was 3.5 (p < .0001); the mean PAC-QOL score (overall) improved from 1.01 to 0.74 (p = .01). There was no significant change in the daily SBM frequency between fasting and feeding states (1.2 vs. 1.3; p = .8), and there was no correlation between the amount of food intake and the SBM frequency after elobixibat administration (r = .03). Serious adverse events were not observed.ConclusionThis study showed that elobixibat is safe and effective for patients with cancer with chronic constipation, regardless of the food intake amount.Implications for practiceElobixibat was effective at relieving chronic constipation in patients with various cancers. Serious adverse events were not observed, and the relief of constipation was independent of variation in food intake.

Project description:ObjectiveAn interim analysis of postmarketing surveillance reported the safety and efficacy of elobixibat, a laxative medication that inhibits the ileal bile acid transporter, at 4 weeks in approximately 1000 patients with chronic constipation in Japan. However, its long-term safety and efficacy in elderly patients remain unclear. This study aimed to conclude and report the final analysis of postmarketing surveillance, including 52-week safety and efficacy profiles in a clinical practice setting, using approximately 3000 patients.MethodsThe overall survey period spanned from June 2018 to May 2022. Observation periods were set at 4 weeks (4-week treatment period) and 52 weeks (52-week treatment period). Adverse drug reactions and efficacy outcomes, including defecation frequency, Bristol Stool Form Scale scores, and patient satisfaction, were analyzed.ResultsThe 4-week safety analysis set included 3638 patients with a mean age of 70.8 years, and 73.7% were aged ⩾65 years. Most patients (62.5%) were treated with elobixibat alone, while the rest received concomitant laxatives. In total, 231 patients (6.35%) experienced adverse drug reactions, with gastrointestinal disorders (6.02%) such as diarrhea (3.35%) and abdominal pain (2.06%), being the most common adverse drug reaction. The adverse drug reaction incidence in elderly patients aged ⩾65, ⩾75, and ⩾85 years was 5.49%, 4.85%, and 2.80%, respectively. In the 52-week treatment period, adverse drug reaction incidence was 5.40% (71/1315 patients), similar to that in the 4-week treatment period. Regarding efficacy, defecation frequency and Bristol Stool Form Scale scores significantly improved from week 2 onward, regardless of the age group and administration timing (before breakfast, lunch, or dinner). Most patients reported satisfaction from week 2 onward (6.0%, 66.9%, 78.6%, and 90.4% at baseline, weeks 2, 4, and 52, respectively).ConclusionThis study confirmed the long-term safety and efficacy of elobixibat in patients with chronic constipation, including many elderly ones, in routine clinical practice.

Project description:IntroductionFrequent self-monitoring of blood glucose (SMBG) is usually required in patients with type 1 diabetes (T1D). However, the fear of self-testing, hygiene, and social obstacles may deter some patients from SMBG. Flash glucose monitoring (FGM), a less-invasive glucose monitoring method, was launched in Japan in September 2017. The aim of this study was to evaluate patient satisfaction and the clinical efficacy of FGM in Japanese patients with T1D.MethodsPatient satisfaction with FGM was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire before (baseline) and 4 and 12 weeks after initiating FGM use in 20 Japanese patients with T1D. Clinical parameters related to glucose metabolism, such as glycated hemoglobin (HbA1c) levels, were assessed, and glucose fluctuations were evaluated using the FGM data. Values at 4 and 12 weeks after initiating FGM were compared with baseline data using the Wilcoxon signed-rank test. The mean absolute relative difference (MARD) between glucose values detected using the FGM device and by SMBG was also calculated.ResultsThe DTSQ scores significantly improved 12 weeks after initiating FGM (P < 0.001). The DTR-QOL scores related to "burden in social activities" and "treatment satisfaction" also significantly improved 12 weeks after initiating FGM (P = 0.024 and 0.007, respectively). The HbA1c values and the percentage of time within the target glucose range (3.9-7.8 mmol/L) at the 12-week time point also improved, from 58 ± 5 (baseline) to 54 ± 4 mmol/mol (P = 0.002) and from 36% (interquartile range [IQR] 25-44.5%) (baseline) to 43% (IQR 39-50%) (P = 0.016), respectively. The MARD between glucose values detected using FGM and those detected using SMBG was 12.2% throughout the study period.ConclusionsFlash glucose monitoring contributed to improved patient satisfaction and the adjustment of blood glucose levels in patients with T1D.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR): UMIN000029673.

Project description:BackgroundAntibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population.Settings and designAn open-label, randomised, parallel, superiority clinical trial.MethodsWe randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment.ResultsThirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454-4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394-3.774]. We didn't report serious adverse effects.ConclusionsLevofloxacin concomitant therapy wasn't superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population.Trial registrationWe registered this study as a standard randomized clinical trial ( Clinicaltrial.gov , identifier- NCT04348786 , date:29-January-2020).

Dataset Information

Effects of Elobixibat in Patients with Diabetes and Concomitant Chronic Constipation: an 8-week, Prospective, Single-center, Single-arm Study.

Aims

Methods

Results

Conclusions

Clinical trial registry

Publications

Effects of Elobixibat in Patients with Diabetes and Concomitant Chronic Constipation: an 8-week, Prospective, Single-center, Single-arm Study.

Similar Datasets

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