Michael F. Vaezi’s research while affiliated with Vanderbilt University and other places

What is this page?


This page lists works of an author who doesn't have a ResearchGate profile or hasn't added the works to their profile yet. It is automatically generated from public (personal) data to further our legitimate goal of comprehensive and accurate scientific recordkeeping. If you are this author and want this page removed, please let us know.

Publications (462)


Featured Cover
  • Article

April 2025

·

6 Reads

Alimentary Pharmacology & Therapeutics

·

Michael Vaezi

·

Peter Unge

·

[...]

·


Study design. b.d., twice daily; E, endoscopy; EoS, end of study; LA grade, Los Angeles classification system grade; LAN, lansoprazole; LG, linaprazan glurate; q.d., once daily; R, randomisation; S, screening.
Flow diagram showing progression of patients through the study. AE, adverse event; LAN, lansoprazole; LG, linaprazan glurate; n, number.
Disposition of patients in the study. ITT, intention‐to‐treat; LA grade, Los Angeles classification system grade; n, Number; PPI, proton‐pump inhibitor; PPS, per protocol set.
Reclassification of LA grades as the outcome of the retrospective central review of screening endoscopies.
Proportion of patients with healing at Week 4 by Baseline LA grade, as shown by endoscopy assessed by central review in (a) ITT LA grade C/D, (b) PPS LA grade C/D and (c) PPS LA grade A/B. The investigator reading was imputed as central review if the central review was missing. Clopper Pearson CI was used. If LA grading of GERD was neither A, B, C or D at Week 4, the patient was considered as having oesophageal mucosa healing. If Week 4 assessment was completely missing, the patient was considered as Not healed (ITT specific). Error bars represent 95% CI. CI, confidence interval; ITT, intention‐to‐treat; LA grade, Los Angeles classification system grade; LAN, lansoprazole; LG, linaprazan glurate; n, number; PPS, per protocol set.

+1

Clinical Trial: Dose‐Finding Study of Linaprazan Glurate, A Novel Potassium‐Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis
  • Article
  • Full-text available

April 2025

·

18 Reads

Alimentary Pharmacology & Therapeutics

Background Linaprazan glurate, a potassium‐competitive acid blocker, is in development for the treatment of erosive oesophagitis and other acid‐related diseases. Aim To evaluate the 4‐week healing rate and safety of four linaprazan glurate dosing regimens in patients with erosive oesophagitis. Methods This double‐blind, dose‐finding study compared linaprazan glurate to lansoprazole. We included patients with endoscopically confirmed erosive oesophagitis (validated by a central review board) if they had Los Angeles (LA) grade C/D or LA grade A/B with partial response to at least 8 weeks of proton pump inhibitor therapy. Patients were randomised to 4 weeks of linaprazan glurate (25, 50, 75 or 100 mg twice daily) or lansoprazole (30 mg once daily), followed by 4 weeks of open‐label lansoprazole. Results Of 248 patients randomised, central review confirmed erosive oesophagitis in 182 at screening endoscopy. Across all doses, linaprazan glurate achieved a 4‐week healing rate of 71.1% in intention‐to‐treat (ITT) analysis and 80.9% in per protocol (PP) analysis. In comparison, lansoprazole achieved healing rates of 60.6% (ITT) and 59.1% (PPS). The best performing linaprazan glurate dosing group outperformed lansoprazole by 28% in patients with LA grade A/B with partial PPI response and by more than 50% in patients with LA grade C/D. Conclusions Linaprazan glurate demonstrated high 4‐week healing rates compared to lansoprazole, with a good safety profile, supporting its further development. Trial Registration ClinicalTrials.gov: NCT05055128; EudraCT: 2020‐003319‐91

Download

Management of Patients With Refractory Reflux‐Like Symptoms Despite Proton Pump Inhibitor Therapy: Evidence‐Based Consensus Statements

December 2024

·

137 Reads

·

2 Citations

Alimentary Pharmacology & Therapeutics

Background Many patients diagnosed with gastro‐oesophageal reflux disease (GERD) have persistent symptoms despite proton pump inhibitor (PPI) therapy. Aims The aim of this consensus is to provide evidence‐based statements to guide clinicians caring for patients with refractory reflux‐like symptoms (rRLS) or refractory GERD. Methods This consensus was developed by the International Working Group for the Classification of Oesophagitis. The steering committee developed specific PICO questions pertaining to the management of PPI rRLS. Methodologists conducted systematic reviews of the literature. The quality of evidence and strength of recommendations were rated using the GRADE approach. Results Consensus was reached on 13 of 17 statements on diagnosis and management. For rRLS, suggested diagnostic strategies included endoscopy, ambulatory reflux testing and oesophageal manometry. The group did not reach consensus on the role of oesophageal biopsies or the use of reflux‐symptom association in patients undergoing reflux testing. The group suggested against increasing the PPI dose in patients who had received 8 weeks of a twice‐daily PPI. Adjunctive alginate or antacid therapy was suggested. There was no consensus on the role of adjunctive prokinetics. There was little role for adjunctive transient lower oesophageal sphincter relaxation (TLESR) inhibitors or bile acid sequestrants. Endoscopic or surgical anti‐reflux procedures should not be performed in patients with rRLS in the absence of objectively confirmed GERD. Conclusions The management of rRLS should be personalised, based on shared decision‐making regarding the role of diagnostic testing to confirm or rule out GERD as a basis for treatment optimisation. Anti‐reflux procedures should not be performed without objective confirmation of GERD.









Citations (40)


... This indirectly suggests that antral mill may not be an important factor in promoting GERD. Further, the role of prokinetics in refractory GERD is not backed by evidence [7]. ...

Reference:

Surgeons Performing Sleeve Gastrectomy Fret too much about the Antral Mill!
Management of Patients With Refractory Reflux‐Like Symptoms Despite Proton Pump Inhibitor Therapy: Evidence‐Based Consensus Statements

Alimentary Pharmacology & Therapeutics

... In this regard, SP can act through neurokinin 1 receptor 80 and vasoactive intestinal peptide through the chemoattractant receptor-homologous molecule expressed on T H 2 cells and VPAC-2. 81 Other molecular mechanisms that induce histamine release from human and animal MCs and basophils include stem cell factor:KIT, platelet-activating factor:platelet-activating factor receptor (in lung and peripheral blood-derived MCs), and Histamine and other preformed mediators of MCs, mainly proteases, are packed in granules through binding to GAGs; these molecules are attached to core protein of serglycin made by repeats of Ser-Gly units. (B) Amounts of histamine required for cell biofunctions are supplied by histamine transport into many cells that express extracellular histamine transport molecules. ...

Vasoactive Intestinal Peptide Receptor, CRTH2, Antagonist Treatment Improves Eosinophil and Mast Cell-Mediated Esophageal Remodeling and Motility Dysfunction in Eosinophilic Esophagitis

... Laryngopharyngeal reflux (LPR) is defined as a disease of the upper aerodigestive tract resulting from the direct and/or indirect effects of gastroduodenal content reflux, inducing morphological and/or neurological changes in the upper aerodigestive tract [1]. The clinical diagnosis is still challenging according to the non-specific laryngeal and extra-laryngeal symptoms and findings that can be found in many other otolaryngological conditions [2,3]. ...

In Response to The Dubai Definition and Diagnostic Criteria of Laryngopharyngeal Reflux: The IFOS Consensus
  • Citing Article
  • February 2024

... The measurement of esophageal acid exposure and the evaluation of the temporal correlation between symptoms and acid reflux events are made possible by wireless esophageal pH monitoring. Patients with rGERD are frequently evaluated using this pH monitoring method [13]. ...

Optimizing ambulatory reflux monitoring: current findings and future directions
  • Citing Article
  • December 2023

... The experimental patients did not undergo hypopharyngealesophageal multichannel intraluminal impedance-pH testing. 29 While it would provide an objective evaluation, it is invasive, expensive, and not easily available to mass numbers of patients in the public healthcare system of Quebec, Canada. Additionally, we did not assess the responsiveness of the Q-Fr-RSI to changes in symptoms over time following treatment. ...

The Dubai Definition and Diagnostic Criteria of Laryngopharyngeal Reflux: The IFOS Consensus

... 8 We previously reported that interferon response signature genes (ISGs) are upregulated in biopsy tissue from adults and children with EoE. 7 This was recently replicated in a large reanalysis of 137 EoE patient biopsy transcriptomes. 9 In addition, Ding et al identified 60 cell subsets in the esophageal mucosa of patients with EoE, finding that most subsets showed elevated IFN response gene signatures. 10 Here, we utilize complementary datasets to interrogate IFN signaling in EoE. ...

A synthesis and subgroup analysis of the Eosinophilic Esophagitis tissue transcriptome

Journal of Allergy and Clinical Immunology

... Notably, approximately 10 % of the difference between vonoprazan and placebo occurred at one dose and 20 % at the second dose, indicating a rapid therapeutic effect [ 14 ]. In a phase 2 study, vonoprazan provided complete and sustained relief of heartburn episodes within three hours in 56 % (10 mg), 60.6 % (20 mg), and 70 % (40 mg) of cases compared to 27.3 % with placebo [ 15 ]. The rapid action of PCABs makes them suitable for on-demand therapy, which is particularly beneficial for patients with NERD who experience episodic heartburn. ...

Randomised clinical trial: Efficacy and safety of on‐demand vonoprazan versus placebo for non‐erosive reflux disease

Alimentary Pharmacology & Therapeutics

... Heavy physical labor was defined as work in agriculture or heavy industry. The diagnostic criteria for GERD included the following : (1) GERD Q score ≥ 8; (2) diagnosis of reflux esophagitis classified as LA-B or higher based on EGD [12]; and (3) the presence of typical GERD symptoms (such as acid regurgitation and heartburn) requiring continuous use of acid-suppressive medication. The diagnostic criteria for hiatal hernia included the following: measurement of the distance between the squamocolumnar junction and the esophageal hiatus impression being > 2 cm during EGD [13,14], or the presence of longitudinal gastric mucosal folds extending above the diaphragmatic indentation, and the identification of a gastric pouch herniating cranially across the crural impression. ...

Updates to the modern diagnosis of GERD: Lyon consensus 2.0

Gut

... On July 18, 2024, the FDA approved vonoprazan for heartburn relief associated with NERD. Findings from clinical trials showed that vonoprazan is an effective therapy in alleviating the symptoms of heartburn in patients with NERD, with benefits appearing on the very first day of therapy (Fass et al., 2022;Laine et al., 2024). Additionally, vonoprazan provided rapid and sustained heartburn relief, with a greater number of 24 hr heartburn-free days and a higher percentage of days without daytime or nighttime heartburn, as well as reduced need for rescue antacid use Miwa et al., 2016). ...

S390 Efficacy and Safety of On-Demand Vonoprazan versus Placebo in the Treatment of Heartburn in Symptomatic Nonerosive Reflux Disease (NERD) Patients: A Phase 2 Randomized Controlled Trial
  • Citing Article
  • October 2022

The American Journal of Gastroenterology

... The testing protocol involves placing the FLIP at the EGJ approximately 2-3 cm from its distal end and incrementally distending the bag with saline to various volumes (usually 40 mL-70 mL) in steps of 10 mL and held at constant volume for approximately 60 seconds [20]. This induces a unique secondary peristaltic contractile response called repetitive antegrade contractions (RACs) in normal motility subjects [23]. Based on the contractile response and the nature of EGJ opening during distension at 60 and 70 mL, patients are diagnosed into different categories as described below. ...

Inter‐ and intra‐rater agreement of interpretation of functional lumen imaging probe in healthy subjects