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The Toronto Consensus for the Treatment of Helicobacter Pylori Infection in Adults Carlo A
Gastroenterology 2016;151:51–69 CONSENSUS STATEMENT The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults Carlo A. Fallone,1 Naoki Chiba,2,3 Sander Veldhuyzen van Zanten,4 Lori Fischbach,5 Javier P. Gisbert,6 Richard H. Hunt,3,7 Nicola L. Jones,8 Craig Render,9 Grigorios I. Leontiadis,3,7 Paul Moayyedi,3,7 and John K. Marshall3,7 1Division of Gastroenterology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada; 2Guelph GI and Surgery Clinic, Guelph, Ontario, Canada; 3Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada; 4Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; 5Department of Epidemiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas; 6Gastroenterology Service, Hospital Universitario de la Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; 7Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada; 8Division of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, Departments of Paediatrics and Physiology, University of Toronto, Toronto, Ontario, Canada; and 9Kelowna General Hospital, Kelowna, British Columbia, Canada This article has an accompanying continuing medical education activity, also eligible for MOC credit, on page e25. Learning Objective: Upon completion of this examination, successful learners will be able to establish a treatment plan for patients with H pylori infection. BACKGROUND & AIMS: Helicobacter pylori infection is lthough the prevalence of H pylori is decreasing in increasingly difficult to treat. The purpose of these consensus A some parts of the world, the infection remains pre- statements is to provide a review of the literature and specific, sent in 28% to 84% of subjects depending on the population updated recommendations for eradication therapy in adults. -
Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG . -
Seven-Day Vonoprazan and Low-Dose Amoxicillin Dual Therapy As First-Line
Helicobacter pylori ORIGINAL RESEARCH Gut: first published as 10.1136/gutjnl-2019-319954 on 8 January 2020. Downloaded from Seven- day vonoprazan and low- dose amoxicillin dual therapy as first- line Helicobacter pylori treatment: a multicentre randomised trial in Japan Sho Suzuki ,1,2 Takuji Gotoda ,1 Chika Kusano,1 Hisatomo Ikehara,1 Ryoji Ichijima,1 Motoki Ohyauchi,3 Hirotaka Ito,3 Masashi Kawamura,4 Yohei Ogata,4 Masahiko Ohtaka,5 Moriyasu Nakahara,6 Koichi Kawabe7 1Division of Gastroenterology ABSTRact and Hepatology, Department Objective To date, no randomised trials have compared Significance of this study of Medicine, Nihon University the efficacy of vonoprazan and amoxicillin dual therapy School of Medicine, Tokyo, What is already known on this subject? Japan with other standard regimens for Helicobacter pylori 2Department of treatment. This study aimed to investigate the efficacy ► Macrolides, including clarithromycin, readily Gastroenterology, Yuri Kumiai of the 7- day vonoprazan and low- dose amoxicillin dual induce changes in the resistome of Helicobacter General Hospital, Yurihonjo, therapy as a first-line H. pylori treatment, and compared pylori, and the clarithromycin resistance of H. Akita, Japan pylori is high and increasing worldwide. 3Department of this with vonoprazan-based triple therapy. Gastroenterology, Osaki Citizen Design This prospective, randomised clinical trial ► Usage of clarithromycin should be discontinued Hospital, Osaki, Miyagi, Japan was performed at seven Japanese institutions. Patients as an empirical -
Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated with Reflux Esophagitis - Exploratory Evaluation (VISTAEXE)
Title: Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated with Reflux Esophagitis - Exploratory Evaluation (VISTAEXE) NCT Number: NCT03116841 Protocol Approve Date: 28-Mar-2017 Certain information within this protocol has been redacted (ie, specific content is masked irreversibly from view with a black/blue bar) to protect either personally identifiable information or company confidential information. This may include, but is not limited to, redaction of the following: Named persons or organizations associated with the study. Patient identifiers within the text, tables, or figures or in by-patient data listings. Proprietary information, such as scales or coding systems, which are considered confidential information under prior agreements with license holder. Other information as needed to protect confidentiality of Takeda or partners, personal information, or to otherwise protect the integrity of the clinical study. If needed, certain appendices that contain a large volume of personally identifiable information or company confidential information may be removed in their entirety if it is considered that they do not add substantially to the interpretation of the data (eg, appendix of investigator’s curriculum vitae). Note; This document was translated into English as the language on original version was Japanese. Vonoprazan-4006 Page 1 of 72 Version 1.0 March 28, 2017 PROTOCOL Vonoprazan study of investigating the effect on sleep disturbance associated with reflux esophagitis- exploratory evaluation (VISTAEXE) Sponsor Takeda Pharmaceutical Company Limited 12-10, Nihonbashi 2-chome, Chuo-ku, Tokyo Protocol number Vonoprazan-4006 (MACS-2016-101812) Version Number 1.0 Study drug: Vonoprazan fumarate Creation date March 28, 2017 CONFIDENTIAL Vonoprazan-4006 Page 2 of 72 Version 1.0 March 28, 2017 CONFIDENTIAL PROPERTY OF TAKEDA This document is a confidential communication of Takeda. -
Rhubarb Tions of Bismuth Compounds (P.1712), and Ranitidine (P.1766)
1768 Gastrointestinal Drugs trolav; Gastrulcer; Pep-Rani; Peptab; Peptifar; Quardin†; Ran†; Ranitine; Sta- 3. Anonymous. Pylorid, H. pylori and peptic ulcer. Drug Ther Bull Revaprazan (rINN) cer; Ulcecur†; Ulcerol†; Zantac; Rus.: Aciloc (Ацилок); Histac (Гистак); 1996; 34: 69–70. Ranigast (Ранигаст); Ranisan (Ранисан); Rantac (Рантак); Ulran (Ульран)†; 4. van der Wouden EJ, et al. One-week triple therapy with raniti- Révaprazan; Revaprazán; Revaprazanum. N-(4-Fluorophenyl)- Zantac (Зантак); Zoran (Зоран); S.Afr.: GI-Tak†; Histak; Ranihexal; Ran- dine bismuth citrate, clarithromycin and metronidazole versus 4,5-dimethyl-6-[(1RS)-1-methyl-3,4-dihydroisoquinolin-2(1H)- teen†; Ulcaid; Ultak; Zantac; Singapore: Gastran†; Histac; Hyzan; Lumaren; two-week dual therapy with ranitidine bismuth citrate and clari- yl]pyrimidin-2-amine. Neoceptin-R; Rani†; Ranidine; Ratic; Xanidine; Zantac; Zendhin; Zoran†; thromycin for Helicobacter pylori infection: a randomized, clin- Spain: Alquen; Arcid; Ardoral; Coralen; Denulcer; Fagus; Lake; Meticel†; ical trial. Am J Gastroenterol 1998; 93: 1228–31. Ревапразан Quantor; Ran H2; Ranidin; Ranix; Ranuber; Rubiulcer; Tanidina; Terposen; Toriol; Underacid; Zantac; Swed.: Artonil; Inside; Rani-Q; Zantac; Switz.: Preparations C22H23FN4 = 362.4. Ranimed; Ranisifar; Ulcidine; Zantic; Thai.: Aciloc; Histac; Radine†; Ranicid; CAS — 199463-33-7. Ranidine; Rantac; Ratic; Ratica; Utac; Xanidine; Zanamet; Zantac; Zantidon; Proprietary Preparations (details are given in Part 3) Zardil; Turk.: Ranitab; Ranitine; Ranobel; Rozon; Santanol; Ulcuran; Zandid; Arg.: Pylorid†; Austria: Helirad; Pylorisin; Belg.: Pylorid†; Braz.: Pylorid; Zantac; UAE: Rantag; UK: Gavilast; Ranitic; Ranitil; Rantec; Ranzac; Vivatak†; Cz.: Eradipak†; Denm.: Pylorid†; Fin.: Pylorid; Gr.: Pylorid; Hong Kong: Zaedoc†; Zantac; USA: Zantac; Venez.: Aplom; Enteral; Gastac; Ranibloc; Pylorid†; Hung.: Pylorid†; Irl.: Pylorid†; Ital.: Elicodil†; Pylorid; Mex.: Ranifesa†; Ranix†; Ranizan†; Retamin; Vizerul; Zantac; Zoran†. -
Comparative Efficacy of Various Anti-Ulcer Medications After Gastric Endoscopic Submucosal Dissection: a Systematic Review and Network Meta-Analysis
Surgical Endoscopy (2019) 33:1271–1283 and Other Interventional Techniques https://doi.org/10.1007/s00464-018-6409-4 Comparative efficacy of various anti-ulcer medications after gastric endoscopic submucosal dissection: a systematic review and network meta-analysis Eun Hye Kim1 · Se Woo Park2 · Eunwoo Nam3 · Jae Gon Lee4 · Chan Hyuk Park4 Received: 4 May 2018 / Accepted: 24 August 2018 / Published online: 30 August 2018 © Springer Science+Business Media, LLC, part of Springer Nature 2018 Abstract Background The comparative efficacy of various anti-ulcer medications after gastric endoscopic submucosal dissection (ESD) has not been fully evaluated. Recently, vonoprazan, a novel potassium-competitive acid blocker, has also been used in ulcer treatment after ESD. Methods We searched for all relevant randomized controlled trials examining the efficacy of anti-ulcer medications after gastric ESD, published through October 2017. Healing of iatrogenic ulcers was investigated at 4–8 weeks after ESD. A network meta-analysis was performed to calculate the network estimates. Results Twenty-one studies with 2005 patients were included. Concerning the comparative efficacy for ulcer healing at 4 weeks after ESD, no network inconsistency was identified (Cochran’s Q-test, df = 10, P = 0.13; I2 = 34%). A combination therapy of proton-pump inhibitor (PPI) and muco-protective agent was superior to PPI alone [risk ratio (RR) (95% confi- dence interval, CI) 1.69 (1.20–2.39)]. The combination therapy of PPI and muco-protective agents tended to be superior to vonoprazan [RR (95% CI) 1.98 (0.99–3.94)]. There was no difference of ulcer healing effect between PPI and vonoprazan [RR (95% CI) PPI vs. -
Evidence-Based Clinical Practice Guidelines for Peptic Ulcer Disease 2015
J Gastroenterol DOI 10.1007/s00535-016-1166-4 SPECIAL ARTICLE Evidence-based clinical practice guidelines for peptic ulcer disease 2015 1,2 2 2 2 Kiichi Satoh • Junji Yoshino • Taiji Akamatsu • Toshiyuki Itoh • 2 2 2 2 Mototsugu Kato • Tomoari Kamada • Atsushi Takagi • Toshimi Chiba • 2 2 2 2 Sachiyo Nomura • Yuji Mizokami • Kazunari Murakami • Choitsu Sakamoto • 2 2 2 2 Hideyuki Hiraishi • Masao Ichinose • Naomi Uemura • Hidemi Goto • 2 2 2 2 Takashi Joh • Hiroto Miwa • Kentaro Sugano • Tooru Shimosegawa Received: 25 December 2015 / Accepted: 6 January 2016 Ó Japanese Society of Gastroenterology 2016 Abstract The Japanese Society of Gastroenterology bleeding is first treated by endoscopic hemostasis. If it (JSGE) revised the evidence-based clinical practice fails, surgery or interventional radiology is chosen. Second, guidelines for peptic ulcer disease in 2014 and has created medical therapy is provided. In cases of NSAID-related an English version. The revised guidelines consist of seven ulcers, use of NSAIDs is stopped, and anti-ulcer therapy is items: bleeding gastric and duodenal ulcers, Helicobacter provided. If NSAID use must continue, the ulcer is treated pylori (H. pylori) eradication therapy, non-eradication with a proton pump inhibitor (PPI) or prostaglandin analog. therapy, drug-induced ulcer, non-H. pylori, non-nons- In cases with no NSAID use, H. pylori-positive patients teroidal anti-inflammatory drug (NSAID) ulcer, surgical receive eradication and anti-ulcer therapy. If first-line treatment, and conservative therapy for perforation and eradication therapy fails, second-line therapy is given. In stenosis. Ninety clinical questions (CQs) were developed, cases of non-H. -
Refractory Gastroesophageal Reflux Disease: Pathophysiology, Diagnosis, and Management
Refractory Gastroesophageal Reflux Disease: Pathophysiology, Diagnosis, and Management My Editor’s Pick for this edition is Nabi et al.’s review on the topic of refractory gastroesophageal reflux disease in the context of its pathophysiology, diagnosis, and treatment. The authors explore these elements in great detail, offering a timely and helpful update on this common gastrointestinal complaint. Authors: *Zaheer Nabi, Arun Karyampudi, and D. Nageshwar Reddy Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India *Correspondence to [email protected] Disclosure: The authors have declared no conflicts of interest. Received: 10.05.19 Accepted: 02.07.19 Keywords: Antireflux surgery, endoscopy, gastroesophageal reflux, proton pump inhibitors (PPI). Citation: EMJ Gastroenterol. 2019;8[1]:62-71. Abstract Gastroesophageal reflux disease (GERD) is one of the most commonly encountered gastrointestinal diseases in clinical practice. Proton pump inhibitors (PPI) remain the cornerstone of the treatment of GERD. Up to one-third of patients do not respond to optimal doses of PPI and fall into the category of refractory GERD. Moreover, the long-term use of PPI is not risk-free, as previously thought. The pathophysiology of refractory GERD is multifactorial and includes reflux related and unrelated factors. It is therefore paramount to address refractory GERD as per the aetiology of the disease for optimal outcomes. The management options for PPI refractory GERD include optimisation of PPI, lifestyle modifications, and the addition of alginates and histamine-2 receptor blockers. Neuromodulators, such as selective serotonin reuptake inhibitors or tricyclic antidepressants, may be beneficial in those with functional heartburn and reflux hypersensitivity. Laparoscopic antireflux surgeries, including Nissen’s fundoplication and magnetic sphincter augmentation, are useful in patients with objective evidence of GERD on pH impedance studies with or without a hiatal hernia. -
New and Future Drug Development for Gastroesophageal Reflux Disease
J Neurogastroenterol Motil, Vol. 20 No. 1 January, 2014 pISSN: 2093-0879 eISSN: 2093-0887 http://dx.doi.org/10.5056/jnm.2014.20.1.6 JNM Journal of Neurogastroenterology and Motility Review New and Future Drug Development for Gastroesophageal Reflux Disease Carla Maradey-Romero and Ronnie Fass* The Esophageal and Swallowing Center, Division of Gastroenterology and Hepatology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio, USA Medical therapy remains the most popular treatment for gastroesophageal reflux disease (GERD). Whilst interest in drug devel- opment for GERD has declined over the last few years primarily due to the conversion of most proton pump inhibitor (PPI)’s to generic and over the counter compounds, there are still numerous areas of unmet needs in GERD. Drug development has been focused on potent histamine type 2 receptor antagonist’s, extended release PPI’s, PPI combination, potassium-competitive acid blockers, transient lower esophageal sphincter relaxation reducers, prokinetics, mucosal protectants and esophageal pain modulators. It is likely that the aforementioned compounds will be niched for specific areas of unmet need in GERD, rather than compete with the presently available anti-reflux therapies. (J Neurogastroenterol Motil 2014;20:6-16) Key Words Erosive esophagitis; Gastroesophageal reflux; Heartburn; Proton pump inhibitors Most patients with GERD fall into 1 of 3 categories: non- erosive reflux disease (NERD), erosive esophagitis (EE), and Introduction Barrett’s esophagus (BE). The 2 main phenotypes of GERD, Gastroesophageal reflux disease (GERD) is a common con- NERD and EE, appear to have different pathophysiological and dition that develops when reflux of stomach contents cause trou- clinical characteristics. -
Management of Gastroesophageal Reflux Disease
Gastroenterology 2018;154:302–318 GERD Management of Gastroesophageal Reflux Disease C. Prakash Gyawali1 Ronnie Fass2 1Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri; and 2Division of Gastroenterology and Hepatology, Esophageal and Swallowing Center, Case Western Reserve University, MetroHealth Medical Center, Cleveland, Ohio Management of gastroesophageal reflux disease (GERD) therapy. The presence of erosive esophagitis is associated commonly starts with an empiric trial of proton pump with response to antireflux therapy.6 Additionally, increased inhibitor (PPI) therapy and complementary lifestyle mea- distal esophageal acid exposure time (AET) predicts symp- sures, for patients without alarm symptoms. Optimization tom improvement following antireflux therapy; positive of therapy (improving compliance and timing of PPI doses), symptom association probability complements increased or increasing PPI dosage to twice daily in select circum- AET in this setting.6,7 Using these 2 parameters, GERD can stances, can reduce persistent symptoms. Patients with be characterized into distinct phenotypes that have continued symptoms can be evaluated with endoscopy and management implications.8 More than two-thirds of patients tests of esophageal physiology, to better determine their with increased AET have a symptomatic response to medi- disease phenotype and optimize treatment. Laparoscopic cal or surgical antireflux therapy.8 On the other hand, fundoplication, magnetic sphincter augmentation, and physiologic reflux metrics indicate a functional basis for endoscopic therapies can benefitpatientswithwell- symptoms,9,10 and fewer than 50% of patients with physi- characterized GERD. Patients with functional diseases that ologic reflux burden and negative symptom-reflux associa- overlap with or mimic GERD can be treated with tion report reduced symptoms. -
2 12/ 35 74Al
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 22 March 2012 (22.03.2012) 2 12/ 35 74 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 9/16 (2006.01) A61K 9/51 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 9/14 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/EP201 1/065959 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 14 September 201 1 (14.09.201 1) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, (25) Filing Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, (26) Publication Language: English TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/382,653 14 September 2010 (14.09.2010) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, NANOLOGICA AB [SE/SE]; P.O Box 8182, S-104 20 ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, Stockholm (SE). -
Pharmacological Considerations and Step-By-Step Proposal for the Treatment Of
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Institutional Research Information System University of Turin Pharmacological considerations and step-by-step proposal for the treatment of Helicobacter pylori infection in the year 2018 Rinaldo PELLICANO 1, Rocco Maurizio ZAGARI 2, Songhua ZHANG 3, Giorgio Maria SARACCO 1,4, Steven F. MOSS 3 1Unit of Gastroenterology, Molinette-SGAS Hospital, Turin, Italy 2Department of Medical and Surgical Sciences, University of Bologna, Bologna. Italy 3Department of Medicine and Division of Gastroenterology, Warren Alpert Medical School of Brown University, Providence, RI, USA 4 Department of Medical Sciences, University of Turin, Italy Conflicts of interest—The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Corresponding author: Rinaldo Pellicano, MD, Unit of Gastroenterology, Molinette-SGAS Hospital, Via Cavour 31, 10126 Turin, Italy. E-mail: [email protected] 1 ABSTRACT Over the past 30 years, multidrug regimens consisting of a proton pump inhibitor (PPI) and two or three antibiotics have been used in treating Helicobacter pylori (H. pylori) infection. In clinical practice, the optimal regimen to cure H. pylori infection should be decided regionally. Considering the first treatment, the Maastricht V/Florence Consensus Report and the American College of Gastroenterology Clinical Management Guideline highlight that in countries with low clarithromycin resistance rates (<15%), an empiric clarithromycin-based regimen can be used. In countries with high clarithromycin resistance rates or, in the American Guideline, with a previous exposure to clarithromycin, a bismuth-containing quadruple therapy (with metronidazole and tetracycline) is the first choice.