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

Abstract

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.

Non-steroidal anti-inflammatory drug (NSAID) therapy in patients with hypertension, cardiovascular, renal or gastrointestinal comorbidities: joint APAGE/APLAR/APSDE/APSH/APSN/PoA recommendations

“…However, the actual incidences of the above-mentioned complications are small. The pooled result of two RCTs showed that PPI is significantly more effective than prokinetics for the treatment of functional dyspepsia 197–199. On the balance of risk and efficacy, we conclude that antacids or H2 receptor antagonists are not recommended for the treatment of NSAID-related dyspepsia.…”

Clinical Practice Guidelines for Functional Dyspepsia in Korea

“…In a study in which 389 patients were divided into 3 groups (motilitone-treated, PPI-treated, and PPI with motilitone-treated), all 3 groups showed significant improvement in dyspeptic symptoms and in quality of life measurements. 85 However, there was no difference among the groups except for the status of H. pylori. Of the H. pylori-positive patients, the improvement of dyspeptic symptoms was significantly higher in the PPI alone group or in the PPI with the motilitone group than in the motilitone alone group.…”

“…Of the H. pylori-positive patients, the improvement of dyspeptic symptoms was significantly higher in the PPI alone group or in the PPI with the motilitone group than in the motilitone alone group. 85 For patients with poor symptom control, increasing the dose of prokinetics or combining 2 types of prokinetic agents, such as metoclopramide and domperidone, was found to be effective. 86,87 Mechanisms, doses, special comments, and adverse effects of prokinetics for FD are summarized in Table 3.…”

Acupuncture of different treatment frequency in postprandial distress syndrome: A pilot randomized clinical trial

“…The current pharmacologic treatments for patients with FD are limited and unsatisfactory, and a standard management paradigm has not been established . The typical medications used for it include proton pump inhibitors, antacids, antidepressants and anxiolytics and prokinetics, with only limited symptomatic or QoL benefits in some cases .…”