Efficacy and Safety of DWJ1252 Compared With Gasmotin Treatment: Once Met 3 Times Tablets

Abstract

c 2021 The Korean Society of Neurogastroenterology and Motility J Neurogastroenterol Motil, Vol. 27 No. 1 January, 2021 www.jnmjournal.org Previously, functional dyspepsia (FD) was divided into 3 categories of reflux-like, ulcer-like, and dysmotility-like FD. A paradigm shift has occurred in FD, subdividing FD into epigastric pain syndrome and post-prandial discomfort. According to the American and Canadian guidelines of FD management, in Helicobactyer pylori-positive patients, H. pylori eradication therapy should be considered the first-line treatment. However, considering the high prevalence of H. pylori in Korea, H. pylori eradication therapy is recommended when proton pump inhibitors (PPIs) and prokinetics are not effective. Meta-analysis shows significant but modest efficacy of H. pylori eradication on long-term resolution of FD symptoms. H. pylori eradication therapy can be applied in cases where PPIs and prokinetics are not effective, or in young patients with chronic dyspeptic symptoms in Korea. In contrast, in patients with FD who do not respond to PPIs, H. pylori eradication therapy, or tricyclic antidepressant therapy, treatment with prokinetics should be tried according to the American and Canadian guidelines. Where does this difference come from? Postprandial fullness is the most troublesome symptom in FD patients, aggravated by a meal. Therefore, prokinetics, improving gastric emptying, relaxing the fundus, and increasing gastric accommodation, may have a role in the treatment of FD. However, most studies on prokinetics had significant and unexplained heterogeneity. Small studies showed positive results but larger trials could not demonstrate significant efficacy. In the Journal of Neurogastroenterology and Motility, a randomized clinical trial of 119 patients with FD (by Rome III criteria) conducted by Park et al evaluated the efficacy and safety of once-a-day DWJ1252 (Gasmotin SR; Daewoong Pharm Co, LTD, Seoul, Korea), a sustained-release formulation of Gasmotin, compared with Gasmotin 3-times-a-day, in patients with FD. The primary endpoint was the change in gastrointestinal symptom (GIS) scores from baseline, assessed by GIS questionnaires on a 5-point Likert scale after 4 weeks of treatment. The study showed that the GIS scores at week 4 were significantly reduced –10.04 ± 4.45 points in the Gasmotin SR group and –10.86 ± 5.53 in the Gasmotin 3-times-a-day group (P < 0.001). The GIS changes from baseline were not different between the 2 groups (difference, 0.82 points; 95% CI, –1.17 to 2.81; P = 0.643). The other outcomes of interest demonstrated that dyspepsia-specific quality of life scores significantly increased in the 2 groups after week 4 of treatment (+63.82 ± 82.91 and +67.12 ± 81.11, P < 0.001), with no difference between the test JNM J Neurogastroenterol Motil, Vol. 27 No. 1 January, 2021 pISSN: 2093-0879 eISSN: 2093-0887 https://doi.org/10.5056/jnm20260 Editorial Journal of Neurogastroenterology and Motility