Efficacy of Acotiamide in Combination with Esomeprazole for Functional Dyspepsia Refractory to Proton-Pump Inhibitor Monotherapy

Kishino, Maiko; Kitagawa, Yuko; Sunamura, Makoto

doi:10.1620/tjem.234.237

Cited by 19 publications

(16 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…However, the sample size was small and there was no control arm in this study. 25 We observed that the response rate to mono-or combination therapy of DA-9701 or PPIs was not different between the subtypes of FD according to the ROME III criteria. This finding is consistent with the previous studies.…”

Section: Discussionmentioning

confidence: 65%

Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study

Jung

Lee

Choi

et al. 2016

J Neurogastroenterol Motil

View full text Add to dashboard Cite

Background/AimsThe effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Western countries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. MethodsIn this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among 3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. The primary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. ResultsThe global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptom improvement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups. Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes and dyspepsia-related quality of life (P < 0.001), but there were no significant differences among the 3 groups.

show abstract

Section: Discussionmentioning

confidence: 65%

Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study

Jung

Lee

Choi

et al. 2016

J Neurogastroenterol Motil

View full text Add to dashboard Cite

show abstract

“…However, to date, a randomized placebo-controlled study has not been undertaken. Only one study has investigated the efficacy of acotiamide in combination with esomeprazole for FD refractory to proton-pump inhibitor monotherapy [14]. As a randomized controlled pilot study, our study is the first to examine the efficacy of combination therapy with a prokinetic and acid-suppressive drug for FD.…”

Section: Discussionmentioning

confidence: 99%

A Randomized, Double-Blind, Pilot Study of the Effect of Famotidine on Acotiamide Treatment for Functional Dyspepsia

et al. 2017

View full text Add to dashboard Cite

Background/Aims: Acotiamide, a prokinetic drug, is used to treat functional dyspepsia (FD), especially postprandial distress syndrome (PDS). However, a treatment for FD patients with PDS and/or epigastric pain syndrome (EPS) has not been established. We investigated the efficacy of famotidine in combination with acotiamide for FD. Methods: Fifty blindly randomized FD patients received placebo with acotiamide, or famotidine with acotiamide, for 4 weeks. Treatment efficacy was assessed by overall treatment effects (OTE), total, PDS and EPS symptom scores, and impairment of quality of life (QOL). Results: After OTE assessment, patients who felt affected by treatment comprised 40.9 and 57.9% of famotidine and placebo groups, respectively, after 4 weeks' treatment, with no significant difference between groups. A significant decrease was seen in total, PDS, and EPS symptom scores, and in QOL impairment, after 4 weeks' treatment compared with pretreatment scores for famotidine and placebo groups, but was not observed between groups. The proportion of patients showing a ≥50% decrease in EPS symptom scores was greater in the famotidine than that in the placebo group for every observation point, with the greatest difference observed after 2 weeks' treatment. Conclusion: The effectiveness of famotidine and acotiamide combination therapy in FD was similar to the effectiveness of acotiamide therapy alone.

show abstract

“…26,50 On the other hand, there are limited reports on the use of the modified FSSG in placebo-controlled double-blind controlled trials in patients with FD, 51 and further verification is necessary. In addition, many doctors use the revised FSSG to diagnose FD and evaluate the effects of FD treatment in daily medical care.…”

Section: Modified Fssg Scores After Treatment Amentioning

confidence: 99%

Effects of acotiamide on functional dyspepsia patients with heartburn who failed proton pump inhibitor treatment in Japanese patients: A randomized, double‐blind, placebo‐controlled crossover study

Funaki

Ogasawara

Kawamura

et al. 2019

Neurogastroenterology Motil

View full text Add to dashboard Cite

Background: Functional dyspepsia (FD) and non-erosive reflux disease (NERD) are gastrointestinal disorders that often overlap. In this randomized, double-blind, placebo-controlled crossover study, the effects of adding acotiamide to treatment with proton pump inhibitors (PPI) were investigated in FD patients with heartburn who failed PPI treatment, corresponding to PPI-resistant NERD. Methods:The subjects included 16 FD patients with heartburn who failed PPI treatment, and they were administered acotiamide or a placebo for 28 days. After suspending medication for 28 days, the trial drug and placebo were crossed over and administered for 28 days. Before the study began and after each administration period, high-resolution impedance manometry (HRiM) was performed, and the modified frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) questionnaire was administered.Key Results: Postprandial fullness in the FD assessment and all modified FSSG items were significantly lower in the acotiamide group than in the placebo group.Esophagogastric junction pressure was significantly higher in the acotiamide group.The distal contractile integral (DCI) pressure and the highest DCI pressure both increased significantly in the acotiamide group. Moreover, in the acotiamide group, the frequency of abnormal primary peristalsis decreased to normal levels; complete bolus transit (CBT), an indicator of esophageal clearance, increased; and CBT time decreased. Conclusions & Inferences:Acotiamide was considered to improve upper gastrointestinal functions not only in the stomach but also in the esophagus. Adding acotiamide to PPI therapy appears to improve upper abdominal symptoms in FD patients with heartburn who failed PPI treatment.

show abstract

Efficacy of Acotiamide in Combination with Esomeprazole for Functional Dyspepsia Refractory to Proton-Pump Inhibitor Monotherapy

Cited by 19 publications

References 14 publications

Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study

Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study

A Randomized, Double-Blind, Pilot Study of the Effect of Famotidine on Acotiamide Treatment for Functional Dyspepsia

Effects of acotiamide on functional dyspepsia patients with heartburn who failed proton pump inhibitor treatment in Japanese patients: A randomized, double‐blind, placebo‐controlled crossover study

Contact Info

Product

Resources

About