Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Background/Aims: Fexuprazan is a novel potassium-competitive acid blocker that could be of benefit to patients with gastric mucosal injury. The aim of this study was to assess the 2-week efficacy and safety of fexuprazan in patients with acute or chronic gastritis. Methods: In this study, 327 patients with acute or chronic gastritis who had one or more gastric erosions on endoscopy and subjective symptoms were randomized into three groups receiving fexuprazan 20 mg once a day (q.d.), fexuprazan 10 mg twice a day (b.i.d.), or placebo for 2 weeks. The posttreatment assessments were the primary endpoint (erosion improvement rate), secondary endpoints (cure rates of erosion and edema and improvement rates of redness, hemorrhage, and subjective symptoms), and drug-related adverse events. Results: Among the patients, 57.8% (59/102), 65.7% (67/102), and 40.6% (39/96) showed erosion improvement 2 weeks after receiving fexuprazan 20 mg q.d., fexuprazan 10 mg b.i.d., and placebo, respectively. Both fexuprazan 20 mg q.d. and 10 mg b.i.d. showed superior efficacy to the placebo (p=0.017 and p<0.001, respectively). Likewise, both fexuprazan 20 mg q.d. and 10 mg b.i.d. also showed higher erosion healing rates than the placebo (p=0.033 and p=0.010, respectively). No difference was noted in the edema healing rate and the improvement rates for redness, hemorrhage, and subjective symptoms between the fexuprazan and placebo groups. No significant difference was noted in the incidence of adverse drug reactions. Conclusions: Fexuprazan 20 mg q.d. and 10 mg b.i.d. for 2 weeks showed therapeutic efficacy superior to that of placebo in patients with acute or chronic gastritis
Abstract
Background/Aims: Fexuprazan is a novel potassium-competitive acid blocker that could be of benefit to patients with gastric mucosal injury. The aim of this study was to assess the 2-week efficacy and safety of fexuprazan in patients with acute or chronic gastritis. Methods: In this study, 327 patients with acute or chronic gastritis who had one or more gastric erosions on endoscopy and subjective symptoms were randomized into three groups receiving fexuprazan 20 mg once a day (q.d.), fexuprazan 10 mg twice a day (b.i.d.), or placebo for 2 weeks. The posttreatment assessments were the primary endpoint (erosion improvement rate), secondary endpoints (cure rates of erosion and edema and improvement rates of redness, hemorrhage, and subjective symptoms), and drug-related adverse events. Results: Among the patients, 57.8% (59/102), 65.7% (67/102), and 40.6% (39/96) showed erosion improvement 2 weeks after receiving fexuprazan 20 mg q.d., fexuprazan 10 mg b.i.d., and placebo, respectively. Both fexuprazan 20 mg q.d. and 10 mg b.i.d. showed superior efficacy to the placebo (p=0.017 and p<0.001, respectively). Likewise, both fexuprazan 20 mg q.d. and 10 mg b.i.d. also showed higher erosion healing rates than the placebo (p=0.033 and p=0.010, respectively). No difference was noted in the edema healing rate and the improvement rates for redness, hemorrhage, and subjective symptoms between the fexuprazan and placebo groups. No significant difference was noted in the incidence of adverse drug reactions. Conclusions: Fexuprazan 20 mg q.d. and 10 mg b.i.d. for 2 weeks showed therapeutic efficacy superior to that of placebo in patients with acute or chronic gastritis
참고문헌 (23)
- Laine L, "Interobserver agreement and predictive value of endoscopic findings for H. pylori and gastritis in normal volunteers", Gastrointest Endosc, 42, pp.420~423 (1995)
- Park HK, "The distribution of endoscopic gastritis in 25, 536 heath check-up subjects in Korea", Korean J Helicobacter Up Gastrointest Res, 12, pp.237~243 (2012)
- 김광하, "Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, Double-Blind, Active Control, Noninferiority, Multicenter, Phase 3 Study", Gut and Liver, 15(6), pp.841~850 (2021), 거트앤리버 소화기연관학회협의회[DOI]
- 최명규, "위염에 대한 레바프라잔 정제의 제3상 임상시험", Clinical Endoscopy, 33(4), pp.212~219 (2006), 대한소화기내시경학회
- Sunwoo J, "Pharmacodynamics of tegoprazan and revaprazan after single and multiple oral doses in healthy subjects", Aliment Pharmacol Ther, 52, pp.1640~1647 (2020)
- Oshima T, "Randomised clinical trial : vonoprazan versus lansoprazole for the initial relief of heartburn in patients with erosive oesophagitis", Aliment Pharmacol Ther, 49, pp.140~146 (2019)
- Xiao Y, "Phase III, randomised, doubleblind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis", Gut, 69, pp.224~230 (2020)
- Lee KJ, "Randomised phase 3 trial : tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis", Aliment Pharmacol Ther, 49, pp.864~872 (2019)
- Miwa H, "Randomised clinical trial : efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers : results from two phase 3, non-inferiority randomised controlled trials", Aliment Pharmacol Ther, 45, pp.240~252 (2017)
- Sunwoo J, "Safety, tolerability, pharmacodynamics and pharmacokinetics of DWP14012, a novel potassium-competitive acid blocker, in healthy male subjects", Aliment Pharmacol Ther, 48, pp.206~218 (2018)
- Kayaçetin S, "What is gastritis? What is gastropathy? How is it classified?", Turk J Gastroenterol, 25, pp.233~247 (2014)
- 최윤진, "Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study", Journal of Korean Medical Science, 32(11), pp.1807~1818 (2017), 대한의학회
- 심기남, "The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis", The Korean Journal of Internal Medicine, 34(5), pp.1008~1021 (2019), 대한내과학회[DOI]
- 정정조, "위염 환자에서 글립타이드？정(Sulglycotide 200 mg)의 치료 효과를 평가하기 위한 단일맹검, 무작위 배정, 비교약 대조, 다기관 임상시험", Clinical Endoscopy, 35(3), pp.125~132 (2007), 대한소화기내시경학회
- Adam B, "Validation of the gastrointestinal symptom score for the assessment of symptoms in patients with functional dyspepsia", Aliment Pharmacol Ther, 22, pp.357~363 (2005)
- Kim SH, "DA-9601, Gastrointestinal agent from Artemisiae herba extract", Ministry of Health and Welfare, ~ (2001)
- Min DS, "Development of botanical new drug for gastritis", Ministry of Health and Welfare, ~ (2012)
- Baek HI, "Effectiveness of Hizikia fusiformis extract on erosive gastritis : a 4-week, randomized, double-blind and placebo-controlled trial", Int J Pharmacol, 11, pp.719~725 (2015)
- Yeo M, "Pharmacologic actions of proton pump inhibitors and acid pump antagonists; implication in the treatment of Helicobacter pylori-associated gastric diseases", Korean J Helicobacter Up Gastrointest Res, 5, pp.113~123 (2005)
- Lee JS, "Revaprazan, a novel acid pump antagonist, exerts anti-inflammatory action against Helicobacter pylori-induced COX-2 expression by inactivating Akt signaling", J Clin Biochem Nutr, 51, pp.77~83 (2012)
- Ford AC, "Systematic review and network meta-analysis : efficacy of drugs for functional dyspepsia", Aliment Pharmacol Ther, 53, pp.8~21 (2021)
- Tadayuki Oshima, "Potent Potassium-competitive Acid Blockers: A New Era for the Treatment of Acid-related Diseases", Journal of Neurogastroenterology and Motility (JNM), 24(3), pp.334~344 (2018), 대한소화기 기능성질환∙운동학회[DOI]
- Hwang JG, "Pharmacodynamics and pharmacokinetics of DWP14012(fexuprazan)in healthy subjects with different ethnicities", Aliment Pharmacol Ther, 52, pp.1648~1657 (2020)