Vonoprazan versus lansoprazole in the treatment of artificial gastric ulcers after endoscopic submucossal dissection: a randomized, open-label trial
Tóm tắt
Vonoprazan is more potent and longer acting than traditional proton pump inhibitor. Although vonoprazan is expected to be superior to proton pump inhibitor, its efficacy in the treatment of gastric ulcers following endoscopic submucosal dissection (ESD) is not fully understood. The aim of this study was to evaluate the effectiveness of vonoprazan in artificial ulcer healing following ESD. Patients with gastric tumors were randomly assigned to the vonoprazan group (group V) or lansoprazole group (group L) after ESD. Patients received intravenous lansoprazole (30 mg) twice on the day of ESD. Thereafter, patients were treated with vonoprazan (20 mg/day) in group V or lansoprazole (30 mg/day) in group L. Esophagogastroduodenoscopy was performed 4 and 8 weeks after the ESD. A total of 168 patients were analyzed. The 4-week healing rate for artificial ulcer was not significantly higher in group V versus group L (17/85, 20.0% vs. 14/83, 16.9%, respectively). In addition, there were no significant differences between the 4-week shrinkage rates between the two groups. Postoperative bleeding occurred in none of the patients in group V and three in group L. One patient in group V presented delayed perforation 2 days after ESD. Vonoprazan might not be superior to lansoprazole in the healing of artificial gastric ulcer after ESD. Trial registration: University hospital Medical Information Network (registration number: UMIN000016642), Registered 27 February 2015, https://www.umin.ac.jp/ctr/index-j.htm.
Tài liệu tham khảo
citation_journal_title=Gut; citation_title=Endoscopic mucosal resection for treatment of early gastric cancer; citation_author=H Ono, H Kondo, T Gotoda, K Shirao, H Yamaguchi, D Saito; citation_volume=48; citation_publication_date=2001; citation_pages=225-229; citation_doi=10.1136/gut.48.2.225; citation_id=CR1
citation_journal_title=Gastrointest Endosc; citation_title=Successful outcomes of a novel endoscopic treatment for GI tumors: endoscopic submucosal dissection with a mixture of high-molecular-weight hyaluronic acid, glycerin, and sugar; citation_author=M Fujishiro, N Yahagi, M Nakamura, N Kakushima, S Kodashima, S Ono; citation_volume=63; citation_publication_date=2006; citation_pages=243-249; citation_doi=10.1016/j.gie.2005.08.002; citation_id=CR2
citation_journal_title=Gastrointest Endosc; citation_title=Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study; citation_author=IK Chung, JH Lee, SH Lee, SJ Kim, JY Cho, WY Cho; citation_volume=69; citation_publication_date=2009; citation_pages=1228-1235; citation_doi=10.1016/j.gie.2008.09.027; citation_id=CR3
citation_journal_title=Endoscopy; citation_title=Endoscopic submucosal dissection in gastric neoplasia-experience from a European center; citation_author=A Probst, B Pommer, D Golger, M Anthuber, H Arnholdt, H Messmann; citation_volume=42; citation_publication_date=2010; citation_pages=1037-1044; citation_doi=10.1055/s-0030-1255668; citation_id=CR4
citation_journal_title=Clin Endosc; citation_title=Complications related to gastric endoscopic submucosal dissection and their managements; citation_author=I Saito, Y Tsuji, Y Sakaguchi, K Niimi, S Ono, S Kodashima; citation_volume=47; citation_publication_date=2014; citation_pages=398-403; citation_doi=10.5946/ce.2014.47.5.398; citation_id=CR5
citation_journal_title=J Pharmacol Exp Ther; citation_title=Characterization of a novel potassium-competitive acid blocker of the gastric H, K-ATPase, 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438); citation_author=JM Shin, N Inatomi, K Munson, K Munson, D Strugatsky, E Tokhtaeva; citation_volume=339; citation_publication_date=2011; citation_pages=412-420; citation_doi=10.1124/jpet.111.185314; citation_id=CR6
citation_journal_title=J Pharmacol Exp Ther; citation_title=1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438), a novel and potent potassium-competitive acid blocker for the treatment of acid-related diseases; citation_author=Y Hori, A Imanishi, J Matsukawa, Y Tsukimi, H Nishida, Y Arikawa; citation_volume=335; citation_publication_date=2010; citation_pages=231-238; citation_doi=10.1124/jpet.110.170274; citation_id=CR7
citation_journal_title=Biochem Pharmacol; citation_title=A comparative study on the modes of action of TAK-438, a novel potassium-competitive acid blocker, and lansoprazole in primary cultured rabbit gastric glands; citation_author=J Matsukawa, Y Hori, H Nishida, M Kajino, N Inatomi; citation_volume=81; citation_publication_date=2011; citation_pages=1145-1151; citation_doi=10.1016/j.bcp.2011.02.009; citation_id=CR8
citation_journal_title=Contemp Clin Trials; citation_title=Minimization method for balancing continuous prognostic variables between treatment and control groups using Kullback-Leibler divergence; citation_author=A Endo, F Nagatani, C Hamada, I Yoshimura; citation_volume=27; citation_publication_date=2006; citation_pages=420-431; citation_doi=10.1016/j.cct.2006.05.002; citation_id=CR9
citation_title=Endoscopic diagnosis; citation_inbook_title=Ulcer of the stomach and duodenum; citation_publication_date=1971; citation_pages=198-208; citation_id=CR10; citation_author=T Sakita; citation_author=H Fukutomi; citation_publisher=Nankodo
citation_journal_title=Hepatogastroenterology; citation_title=Comparison of an ecabet sodium and proton pump inhibitor (PPI) combination therapy with PPI alone in the treatment of endoscopic submucosal dissection (ESD)-induced ulcers in early gastric cancer: prospective randomized study; citation_author=Y Asakuma, M Kudo, S Matsui, M Okada, M Kawasaki, Y Umehara; citation_volume=56; citation_publication_date=2009; citation_pages=1270-1273; citation_id=CR11
citation_journal_title=J Gastroenterol; citation_title=Clinical trial: rebamipide promotes gastric ulcer healing by proton pump inhibitor after endoscopic submucosal dissection—a randomized controlled study; citation_author=T Kato, H Araki, F Onogi, T Ibuka, A Sugiyama, E Tomita; citation_volume=45; citation_publication_date=2010; citation_pages=285-290; citation_doi=10.1007/s00535-009-0157-0; citation_id=CR12
citation_journal_title=Dig Dis Sci; citation_title=Comparison of the effects of vonoprazan and lansoprazole for treating endoscopic submucosal dissection-induced artificial ulcers; citation_author=A Hirai, T Takeuchi, Y Takahashi, S Kawaguchi, K Ota, S Harada; citation_volume=63; citation_publication_date=2018; citation_pages=974-981; citation_doi=10.1007/s10620-018-4948-0; citation_id=CR13
citation_journal_title=Intern Med; citation_title=Randomized controlled trial comparing the effects of vonoprazan plus rebamipide and esomeprazole plus rebamipide on gastric ulcer healing induced by endoscopic submucosal dissection; citation_author=T Ichida, S Ueyama, T Eto, F Kusano, Y Sakai; citation_volume=58; citation_publication_date=2019; citation_pages=159-166; citation_doi=10.2169/internalmedicine.1146-18; citation_id=CR14
Ishii Y, Yamada H, Sato T, Sue S, Kaneko H, Irie K, et al. Effects of vonoprazan compared with esomeprazole on the healing of artificial postendoscopic submucosal dissection ulcers: a prospective, multicenter, two-arm, randomized controlled trial. Gastroenterol Res Pract. 2018;1615092.
citation_journal_title=Dig Endosc; citation_title=Effect of vonoprazan on the treatment of artificial gastric ulcers after endoscopic submucosal dissection: prospective randomized controlled trial; citation_author=I Tsuchiya, Y Kato, E Tanida, Y Masui, S Kato, A Nakajima; citation_volume=29; citation_publication_date=2017; citation_pages=576-583; citation_doi=10.1111/den.12857; citation_id=CR16
citation_journal_title=Dig Endosc; citation_title=Vonoprazan is superior to proton pump inhibitors in healing artificial ulcers of the stomach post-endoscopic submucosal dissection: a propensity score-matching analysis; citation_author=D Maruoka, M Arai, S Kasamatsu, H Ishigami, T Taida, K Okimoto; citation_volume=29; citation_publication_date=2017; citation_pages=57-64; citation_doi=10.1111/den.12705; citation_id=CR17
citation_journal_title=Scand J Gastroenterol; citation_title=Short-term efficacy of potassium-competitive acid blocker following gastric endoscopic submucosal dissection: a propensity score analysis; citation_author=Y Horikawa, H Mizutamari, N Mimori, Y Kato, S Fushimi, S Sato; citation_volume=53; citation_publication_date=2018; citation_pages=243-251; citation_doi=10.1080/00365521.2017.1410569; citation_id=CR18
citation_journal_title=Digestion; citation_title=Vonoprazan is superior to rabeprazole for healing endoscopic submucosal dissection: induced ulcers; citation_author=A Yamasaki, T Yoshio, Y Muramatsu, Y Horiuchi, A Ishiyama, T Hirasawa; citation_volume=97; citation_publication_date=2018; citation_pages=170-176; citation_doi=10.1159/000485028; citation_id=CR19
citation_journal_title=Surg Endosc; citation_title=Comparative efficacy of various anti-ulcer medications after gastric endoscopic submucosal dissection: a systematic review and network meta-analysis; citation_author=EH Kim, SW Park, E Nam, JG Lee, CH Park; citation_volume=33; citation_publication_date=2019; citation_pages=1271-1283; citation_doi=10.1007/s00464-018-6409-4; citation_id=CR20
citation_journal_title=Medicine (Baltimore); citation_title=Vonoprazan versus proton pump inhibitors for the management of gastric endoscopic submucosal dissection-induced artificial ulcer: a systematic review with meta-analysis; citation_author=H Kang, BJ Kim, G Choi, JG Kim; citation_volume=98; citation_publication_date=2019; citation_pages=e15860; citation_doi=10.1097/MD.0000000000015860; citation_id=CR21
citation_journal_title=J Gastroenterol; citation_title=Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers: a prospective randomized phase II study; citation_author=K Hamada, N Uedo, Y Tonai, M Arao, S Suzuki, T Iwatsubo; citation_volume=54; citation_publication_date=2019; citation_pages=122-130; citation_doi=10.1007/s00535-018-1487-6; citation_id=CR22