Large-scale Randomized Clinical Study on Functional Dyspepsia Treatment With Mosapride or Teprenone

Japan Mosapride Mega-study (JMMS)

Michio Hongo; Shigeru Harasawa; Tetsuya Mine; Iwao Sasaki; Kei Matsueda; Motoyasu Kusano; Nobuyoshi Hanyu; Koji Nakada; Chikashi Shibata

Disclosures

J Gastroenterol Hepatol. 2012;27(1):62-68. 

In This Article

Abstract and Introduction

Abstract

Background and Aim: Functional dyspepsia (FD) is a common condition seen in primary gastroenterology practice. The present study was conducted to compare the clinical effectiveness of mosapride and teprenone in patients with FD.
Methods: Prospective clinical comparative study with random allocation of open labeled medications was performed as a multicenter trial in Japan. 1042 patients presenting symptoms of FD, either with gastric stasis (GSS) and/or epigastric pain (EPS), were enrolled. After initial endoscopic evaluation, medication either with mosapride 5 mg tid or teprenone 50 mg tid was started. Severity and frequency of GSS and EPS, health-related quality of life (HR-QOL) by the SF-36 Japanese version, and patients' compliance to medication was evaluated.
Results: Organic lesions were found in 90 patients (9%) in the 1027 patients examined by endoscopy. Among those without any specific lesions detected by endoscopy, gastrointestinal symptoms were resolved within one week after the endoscopy in 264 (28%) patients before initiating medication. 618 patients who remained symptomatic were randomized to medication either with mosapride (n = 311) or teprenone (n = 307). Two-week treatment with mosapride significantly improved GSS and EPS, while teprenone tended to improve only GSS. Mosapride also improved HR-QOL. 91% of patients treated with mosapride favored their medication, while only 52% of patients treated with teprenone favored their medication.
Conclusions: Endoscopic evaluation at patients' presentation was effective to find active lesions and to improve FD symptoms. Mosapride was more favorably accepted than teprenone by the patients with sufficient safety and efficacy

Introduction

Functional dyspepsia (FD), also called "non-ulcer dyspepsia," is characterized by the symptoms such as epigastric pain and burning, postprandial fullness, and early satiation. The symptoms are believed to originate from the gastroduodenal region in the absence of any organic, systemic, or metabolic disease.[1–3] Although FD is a common disorder in gastroenterology primary practice,[4] the pathophysiology of this condition is poorly understood and optimal therapeutic approaches are yet to be determined. Previous studies in Japan reported that FD is associated with chronic gastritis.[5] However, it is increasingly clear that the histopathologic changes in gastritis are not consistent with the symptoms of FD.

Whether to treat FD patients with pharmacological reagents has been controversial. A meta-analysis of studies on pharmacotherapy in FD patients showed beneficial effects of both prokinetics and H2 receptor antagonists.[5,6] However, efficacy of prokinetics was studied only in small populations. Data on H2 receptor antagonists and proton pump inhibitors may have been biased as patients with gastroesophageal reflux disease (GERD) were included in the meta-analysis.[7] We previously found that primary care physicians in Japan prefer to prescribe prokinetics to patients with dyspepsia. The decision was supported by the better outcomes experienced by physicians in treating gastrointestinal symptoms of FD by prokinetics.[8]

Mosapride is a novel prokinetic agent that has a common chemical structure of benzamides.[9] As a serotonin 5-HT4 receptor selective agonist, mosapride improves delayed gastric emptying[9,10] and visceral hypersensitivity,[11] relieving dyspeptic symptoms.

To uncover an appropriate initial approach to treat FD patients, we first determined the prevalence of organic disorders in previously uninvestigated FD patients and then, evaluated the effects of endoscopy performed at early timing and the efficacy of mosapride and teprenone in relieving symptoms of FD. No drugs, including proton pump inhibitors, are approved for treatment of the FD symptoms in Japan. Gastric mucosa-protecting agents are frequently used to treat dyspepsia that causes heaviness or pain in stomach. Teprenone is one such gastric mucosa-protecting agent widely prescribed at the time the present study was conducted. In other countries, proton pump inhibitors are the first choice medication for FD. However, in Japan, proton pump inhibitors are less commonly prescribed, due to their cost, which is three to five times higher than prokinetics.

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