Proton pump inhibitors and vonoprazan (a potassium-competitive acid blocker) are recommended as first-line treatments for gastroesophageal reflux disease (GERD). However, few reports have investigated the onset of action of these agents for GERD symptom relief. The present study compared the symptom relief of esomeprazole with that of vonoprazan via monitoring self-reported GERD symptoms after treatment initiation.
This was a prospective, multicenter, randomized, open-label, parallel group, comparative clinical study between esomeprazole (20 mg/day) and vonoprazan (20 mg/day) administered for 4 weeks to patients with GERD symptoms. Patients who had scores ≥ 8 on the Gastroesophageal Reflux Disease Questionnaire (GerdQ) were defined as having GERD and enrolled in this study. Sixty patients were randomly assigned to either the esomeprazole group (n = 30) or the vonoprazan group (n = 30). Treatment response rates in each drug group were evaluated according to the GerdQ. The Frequency Scale for the Symptoms of GERD (FSSG) scores from the 1st day after treatment initiation and the Global Overall Symptom (GOS) scale scores during treatment were also evaluated.
At 4 weeks, the treatment response rates for symptom relief according to the GerdQ were 88.0% in the esomeprazole group and 81.8% in the vonoprazan group. The GOS scales, which reflect the impact of GERD symptoms, were similar for both groups. The FSSG scores decreased from the 1st to the 14th day in both groups.
There were no substantial differences in the symptom relief between the two groups at any time point in this short-term study.
Fujiwara Y, Arakawa T. Epidemiology and clinical characteristics of GERD in the Japanese population. J Gastroenterol. 2009;44:518–534. CrossRef
Altomare A, Guarino MP, Cocca S, Emerenziani S, Cicala M. Gastroesophageal reflux disease: update on inflammation and symptom perception. World J Gastroenterol. 2013;19:6523–6528. CrossRef
Hongo M, Kinoshita Y, Miwa H, Ashida K. The demographic characteristics and health-related quality of life in a large cohort of reflux esophagitis patients in Japan with reference to the effect of lansoprazole: the REQUEST study. J Gastroenterol. 2008;43:920–927. CrossRef
Pace F, Negrini C, Wiklund I, Rossi C, Savarino V, The Italian One Investigators Study Group. Quality of life in acute and maintenance treatment of non-erosive and mild erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2005;22:349–356. CrossRef
Iwakiri K, Kinoshita Y, Habu Y, et al. Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015. J Gastroenterol. 2016;51:751–767. CrossRef
Miner P Jr, Katz PO, Chen Y, Sostek M. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study. Am J Gastroenterol. 2003;98:2616–2620. CrossRef
Fass R, Shapiro M, Dekel R, Sewell J. Systematic review: proton-pump inhibitor failure in gastro-oesophageal reflux disease—where next? Aliment Pharmacol Ther. 2005;22:79–94. CrossRef
Furuta T, Sugimoto M, Shirai N. Individualized therapy for gastroesophageal reflux disease: potential impact of pharmacogenetic testing based on CYP2C19. Mol Diagn Ther. 2012;16:223–234. CrossRef
Andersson K, Carlsson E. Potassium-competitive acid blockade: a new therapeutic strategy in acid-related diseases. Pharmacol Ther. 2005;108:294–307. CrossRef
Drug approval review for vonoprazan fumarate (in Japanese). The Pharmaceuticals and Medical Devices Agency of Japan. 2014. Available at: http://www.pmda.go.jp/drugs/2014/P201400173/index.html. Accessed May 28, 2015.
The Interview Form for Vonoprazan Fumarate (Takecab Tablets 10 mg and 20 mg) ver. 3, (in Japanese). Takeda Pharmaceutical Company Limited. 2015. Available at: http://www.info.pmda.go.jp/go/interview/1/400256_2329030F1020_1_005._1F. Accessed May 28, 2015.
Prescribing information of Takecab tablets 10 mg and 20 mg ver.2 (in Japanese). 2015. Available at: http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSet. Accessed May 28, 2015.
Jenkins H, Sakurai Y, Nishimura A, et al. Randomised clinical trial: safety, tolerability, Pharmacokinetics and pharmacodynamics of repeated doses of TAK-438 (vonoprazan), a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2015;41:636–648. CrossRef
Ashida K, Sakurai Y, Hori T, et al. Randomised clinical trial: vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the healing of erosive oesophagitis. Aliment Pharmacol Ther. 2016;43:240–251. CrossRef
Jones R, Junghard O, Dent J, et al. Development of the Gerd Q, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009;15:1030–1038. CrossRef
Suzuki H, Matsuzaki J, Okada S, Hirata K, Fukuhara S, Hibi T. Validation of the GerdQ questionnaire for the management of gastro-oesophageal reflux disease in Japan. U Eur Gastroenterol J. 2013;1:175–183. CrossRef
Kusano M, Shimoyama Y, Sugimoto S, et al. Development and evaluation of FSSG: frequency scale for the symptoms of GERD. J Gastroenterol. 2004;39:888–891. CrossRef
Veldhuyzen Van Zanten SJ, Chiba N, Armstrong D, et al. Validation of a 7-point global overall symptom scale to measure the severity of dyspepsia symptoms in clinical trials. Aliment Pharmacol Ther. 2006;23:521–529. CrossRef
Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999;45:172–180. CrossRef
Miwa H, Yokoyama T, Hori K, et al. Interobserver agreement in endoscopic evaluation of reflux esophagitis using a modified Los Angeles classification incorporating grades N and M: a validation study in a cohort of Japanese endoscopists. Dis Esophagus. 2008;21:355–363. CrossRef
Kimura K, Takemoto T. An endoscopic recognition of the atrophic border and its significance in chronic gastritis. Endoscopy. 1969;1:87–97. CrossRef
Sakurai Y, Mori Y, Okamoto H, et al. Acid-inhibitory effects of vonoprazan 20 mg compared with esomeprazole 20 mg or rabeprazole 10 mg in healthy adult male subjects—a randomised open-label cross-over study. Aliment Pharmacol Ther. 2015;42:719–730. CrossRef
Tobey NA, Carson JL, Alkiek RA, Orlando RC. Dilated intercellular spaces: a morphological feature of acid reflux–damaged human esophageal epithelium. Gastroenterology. 1996;111:1200–1205. CrossRef
Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005;128:771–778. CrossRef
Fass R, Naliboff BD, Fass SS, et al. The effect of auditory stress on perception of intraesophageal acid in patients with gastroesophageal reflux disease. Gastroenterology. 2008;134:696–705. CrossRef
Souza RF, Huo X, Mittal V, et al. Gastroesophageal reflux might cause esophagitis through a cytokine-mediated mechanism rather than caustic acid injury. Gastroenterology. 2009;137:1776–1784. CrossRef
Shan J, Oshima T, Fukui H, Watari J, Miwa H. Acidic deoxycholic acid and chenodeoxycholic acid induce interleukin-8 production through p38 mitogen-activated protein kinase and protein kinase A in a squamous epithelial model. J Gastroenterol Hepatol. 2013;28:823–828. CrossRef
Aziz Q, Fass R, Gyawali CP, Miwa H, Pandolfino JE, Zerbib F. Functional Esophageal disorders. Gastroenterology. 2016;150:1368–1379. CrossRef
Fennerty MB, Johnson DA. Heartburn severity does not predict disease severity in patients with erosive esophagitis. Med. Gen Med. 2006;8:6.
Miwa H, Uedo N, Watari J, et al. 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. 2017;45:240–252. CrossRef
Mizokami Y, Oda K, Funao N, et al. Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study. Gut. 2018;67:1042–1051. CrossRef
- Short-Term Symptomatic Relief in Gastroesophageal Reflux Disease: A Comparative Study of Esomeprazole and Vonoprazan
- Springer US
Digestive Diseases and Sciences
Print ISSN: 0163-2116
Elektronische ISSN: 1573-2568
Neu im Fachgebiet Innere Medizin
Meistgelesene Bücher aus der Inneren Medizin
Mail Icon II