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International Journal of Molecular... Sep 2022Proton pump inhibitors (PPIs) are an antacid drug often used in acid-related disorders. They decrease acid secretion in the stomach by blocking an enzyme called H+/K+... (Review)
Review
Proton pump inhibitors (PPIs) are an antacid drug often used in acid-related disorders. They decrease acid secretion in the stomach by blocking an enzyme called H+/K+ ATPase which controls acid production. Introduced to the market in 1989, their use has increased rapidly worldwide and they are now among the top 10 most prescribed drugs in the United States. As of 2015, the FDA has already approved six drugs of this class (omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole and rabeprazole). Recently, the risks and benefits of long-term PPI use were questioned and many studies indicated that their use should be carefully considered, especially in young patients, whose treatment with these drugs could last many years. Even greater concerns have been raised about a potential positive association between PPIs and osteoporotic fracture risk including the hip, spine and wrist. Although based on observational studies, there is substantial evidence associating the long-term use of PPIs and fracture. This relationship is only partially admitted due to the lack of consistent effects of PPIs on bone mineral density loss. Therefore, this narrative review aimed to discuss the recent findings pertaining to the risk of osteoporotic fracture associated with PPIs, in particular prolonged use, and to call for further research to elucidate the mechanisms associated with this bone fragility.
Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adenosine Triphosphatases; Antacids; Bone Density; Dexlansoprazole; Esomeprazole; Humans; Lansoprazole; Omeprazole; Osteoporotic Fractures; Pantoprazole; Proton Pump Inhibitors; Rabeprazole; United States
PubMed: 36142643
DOI: 10.3390/ijms231810733 -
Veterinary Journal (London, England :... 2022Many domesticated horses have gastric ulcers which can be diagnosed and graded during gastroscopy. A distinction should be made between equine squamous gastric disease... (Review)
Review
Many domesticated horses have gastric ulcers which can be diagnosed and graded during gastroscopy. A distinction should be made between equine squamous gastric disease (ESGD), which is caused by exposure of the mucosa to acid, and equine glandular gastric disease (EGGD), thought to occur when mucosal defence mechanisms are compromised. Horses with gastric ulcers may, but do not always, show clinical signs such as poor appetite, mild colic, discomfort during girthing, behavioural changes and reduced performance. The mainstay of treatment is blocking acid production using the proton pump inhibitor omeprazole. Treatment is usually successful in cases of ESGD, but less so for EGGD, where treatment duration is longer and for which sucralfate may be added or alternatives necessary, such as misoprostol, a prostaglandin analogue. To prevent recurrence of ulcers known risk factors, such as high concentrate diets, intense exercise and stress should be avoided or minimized.
Topics: Animals; Gastric Mucosa; Gastroscopy; Horse Diseases; Horses; Omeprazole; Stomach Ulcer
PubMed: 35472513
DOI: 10.1016/j.tvjl.2022.105830 -
The American Journal of Gastroenterology Nov 2023In the treatment of upper GI endoscopy-negative patients with heartburn and epigastric pain or burning, antacids, antireflux agents, and mucosal protective agents are... (Randomized Controlled Trial)
Randomized Controlled Trial
Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial.
INTRODUCTION
In the treatment of upper GI endoscopy-negative patients with heartburn and epigastric pain or burning, antacids, antireflux agents, and mucosal protective agents are widely used, alone or as add-on treatment, to increase response to proton-pump inhibitors, which are not indicated in infancy and pregnancy and account for significant cost expenditure.
METHODS
In this randomized, controlled, double-blind, double-dummy, multicenter trial assessing the efficacy and safety of mucosal protective agent Poliprotect (neoBianacid, Sansepolcro, Italy) vs omeprazole in the relief of heartburn and epigastric pain/burning, 275 endoscopy-negative outpatients were given a 4-week treatment with omeprazole (20 mg q.d.) or Poliprotect (5 times a day for the initial 2 weeks and on demand thereafter), followed by an open-label 4-week treatment period with Poliprotect on-demand. Gut microbiota change was assessed.
RESULTS
A 2-week treatment with Poliprotect proved noninferior to omeprazole for symptom relief (between-group difference in the change in visual analog scale symptom score: [mean, 95% confidence interval] -5.4, -9.9 to -0.1; -6.2, -10.8 to -1.6; intention-to-treat and per-protocol populations, respectively). Poliprotect's benefit remained unaltered after shifting to on-demand intake, with no gut microbiota variation. The initial benefit of omeprazole was maintained against significantly higher use of rescue medicine sachets (mean, 95% confidence interval: Poliprotect 3.9, 2.8-5.0; omeprazole 8.2, 4.8-11.6) and associated with an increased abundance of oral cavity genera in the intestinal microbiota. No relevant adverse events were reported in either treatment arm.
DISCUSSION
Poliprotect proved noninferior to standard-dose omeprazole in symptomatic patients with heartburn/epigastric burning without erosive esophagitis and gastroduodenal lesions. Gut microbiota was not affected by Poliprotect treatment. The study is registered in Clinicaltrial.gov (NCT03238534) and the EudraCT database (2015-005216-15).
Topics: Humans; Omeprazole; Heartburn; Anti-Ulcer Agents; Esophagitis; Proton Pump Inhibitors; Dyspepsia; Peptic Ulcer; Abdominal Pain; Treatment Outcome; Double-Blind Method
PubMed: 37307528
DOI: 10.14309/ajg.0000000000002360 -
The Turkish Journal of Gastroenterology... Dec 2017Gastroesophageal reflux disease (GERD) is frequently seen during pregnancy. In the medical treatment of pregnant women with GERD, alginic acid and sucralfate can be...
Gastroesophageal reflux disease (GERD) is frequently seen during pregnancy. In the medical treatment of pregnant women with GERD, alginic acid and sucralfate can be used. Calcium- and magnesium-based antacids can also be used, particularly for patients with preeclampsia. In particular, ranitidine -a histamine-2 receptor blocker- is preferred. In the case of non-responsiveness to the abovementioned treatments, proton pump inhibitors (PPIs), except omeprazole, can be given considering the benefit-harm ratio for the mother and fetus after the first trimester. In cases with GERD during the lactation period, drugs having minimum systemic absorption, such as sucralfate and alginic acid, are preferable but there is no data.
Topics: Alginates; Antacids; Female; Gastroesophageal Reflux; Glucuronic Acid; Hexuronic Acids; Humans; Lactation; Omeprazole; Pregnancy; Pregnancy Complications; Proton Pump Inhibitors; Ranitidine; Sucralfate
PubMed: 29199169
DOI: 10.5152/tjg.2017.14 -
British Journal of Clinical Pharmacology Jul 2022Nocturnal acid breakthrough has been considered an unmet need of proton-pump inhibitors. Tegoprazan, a novel potassium-competitive acid blocker, is expected to show... (Randomized Controlled Trial)
Randomized Controlled Trial
AIMS
Nocturnal acid breakthrough has been considered an unmet need of proton-pump inhibitors. Tegoprazan, a novel potassium-competitive acid blocker, is expected to show improved properties for this unmet need. This study was aimed to compare night-time acid suppression by tegoprazan with that by vonoprazan or esomeprazole, and to explore the effect of CYP2C19 phenotypes on acid-suppressive effects.
METHODS
A randomized, open-label, 3-period, 6-sequence crossover study was conducted. A single oral dose of tegoprazan 50 mg, vonoprazan 20 mg or esomeprazole 40 mg was administered at night in each period. Continuous intragastric pH was monitored at baseline and after each dosing.
RESULTS
Sixteen healthy subjects (6 CYP2C19 extensive metabolizers, 5 intermediate metabolizers, 5 poor metabolizers) completed the study. After a single dose of tegoprazan, intragastric pH increased more rapidly to over 4 at approximately 1 hour compared to the other treatments, and elevated intragastric pH was maintained stably at night. Tegoprazan exhibited night-time acid suppression for slightly but not significantly longer than vonoprazan, and greater than esomeprazole; % time at pH ≥ 4 at night was 66.0%, 60.5% and 36.1% for tegoprazan, vonoprazan and esomeprazole, respectively. Night-time acid suppression by tegoprazan and vonoprazan was not dependent on CYP2C19 phenotypes, while that by esomeprazole tended to be influenced by CYP2C19 phenotypes.
CONCLUSION
Tegoprazan produced more rapid, potent and well sustained night-time acid suppression vs. vonoprazan or esomeprazole when administered at night. Furthermore, tegoprazan showed no CYP2C19 phenotype dependency in acid suppression. It suggests the potential of tegoprazan, especially in preventing nocturnal acid breakthrough.
Topics: Benzene Derivatives; Cross-Over Studies; Cytochrome P-450 CYP2C19; Esomeprazole; Gastric Acid; Humans; Hydrogen-Ion Concentration; Imidazoles; Proton Pump Inhibitors; Pyrroles; Sulfonamides
PubMed: 35146797
DOI: 10.1111/bcp.15268 -
Digestion 2023Vonoprazan, a novel potassium-competitive acid blocker, has a strong acid suppression effect and potent efficacy in acid-associated diseases, including Helicobacter... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Vonoprazan, a novel potassium-competitive acid blocker, has a strong acid suppression effect and potent efficacy in acid-associated diseases, including Helicobacter pylori eradication. We performed a systematic review and meta-analysis to investigate the efficacy and safety of vonoprazan/amoxicillin dual therapy for H. pylori eradication.
METHODS
We conducted a systematic literature search through PubMed, Web of Science, EMBASE, and the Cochrane Library up to June 2022, to identify randomized controlled trials and cohort studies comparing vonoprazan/amoxicillin dual therapy and triple therapies for H. pylori eradication. Primary outcomes were cure rates and relative efficacy. Secondary outcomes included adverse events, dropout rate, and subgroup analysis.
RESULTS
Five studies with 1,852 patients were included in the analysis. The cure rates of vonoprazan/amoxicillin dual therapy were 85.6% with 95% confidence interval (CI) of 79.7-91.5% and 88.5% (95% CI: 83.2-93.8%) in the intention-to-treat and per-protocol analyses. The efficacy of vonoprazan/amoxicillin dual therapy was not inferior to that of triple therapy with pooled risk ratio (RR) of 1.03 (95% CI: 0.97-1.10) and 1.02 (95% CI: 0.98-1.08) in intention-to-treat and per-protocol analyses; while it was significantly superior to the omeprazole or lansoprazole-based triple therapy (RR = 1.15, 95% CI: 1.05-1.25, p = 0.001). For clarithromycin-resistant strains, vonoprazan/amoxicillin dual therapy showed superiority to vonoprazan-based triple therapy (86.7% vs. 71.4%, RR = 1.20, 95% CI: 1.03-1.39, p = 0.02); however, vonoprazan/amoxicillin dual therapy was significant inferior to vonoprazan-based triple therapy for clarithromycin-sensitive strains (83.0% vs. 92.8%, RR = 0.90, 95% CI: 0.85-0.95, p = 0.0002). The adverse effects of vonoprazan/amoxicillin dual therapy were lower than those of triple therapy (21.2% vs. 26.5%, RR = 0.86, 95% CI: 0.73-1.01, p = 0.06), especially the incidence of diarrhea (p = 0.01).
CONCLUSIONS
The efficacy of vonoprazan/amoxicillin dual therapy is noninferior to vonoprazan-based triple therapy but superior to the omeprazole or lansoprazole-based triple therapy and has less side effects. Patients with clarithromycin-resistant strains are particularly expected to benefit from vonoprazan/amoxicillin dual therapy.
Topics: Humans; Amoxicillin; Clarithromycin; Helicobacter pylori; Anti-Bacterial Agents; Helicobacter Infections; Proton Pump Inhibitors; Drug Therapy, Combination; Pyrroles; Lansoprazole; Omeprazole; Treatment Outcome
PubMed: 37015201
DOI: 10.1159/000529622 -
Basic & Clinical Pharmacology &... Mar 2016A number of studies have linked omeprazole, a commonly used acid reducer under the brand name Prilosec, with semen quality. This MiniReview systematically addresses and... (Review)
Review
A number of studies have linked omeprazole, a commonly used acid reducer under the brand name Prilosec, with semen quality. This MiniReview systematically addresses and summarizes the effect of omeprazole on semen quality, and male infertility. We searched the MEDLINE electronic database for English-language articles using the keywords 'omeprazole' versus 'sperm' and 'testosterone' and the references from selected articles were reviewed, if relevant. In summary, omeprazole does not appear to change semen quality. This may be because, at least in part, it does not alter the basal levels of pituitary-gonadal hormones; in addition, it counteracts the damaging effect of reactive oxygen species. However, further research is still required to confirm this effect.
Topics: Databases, Factual; Humans; Infertility, Male; Male; Omeprazole; Oxidative Stress; Reactive Oxygen Species; Semen; Semen Analysis; Testis
PubMed: 26572503
DOI: 10.1111/bcpt.12529 -
Chinese Medical Journal Jul 2022High-dose dual therapy (HDDT) with proton pump inhibitors (PPIs) and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
High-dose dual therapy (HDDT) with proton pump inhibitors (PPIs) and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of high-dose PPI-amoxicillin dual therapy and bismuth-containing quadruple therapy for H. pylori rescue treatment.
METHODS
This was a prospective, randomized, multicenter, non-inferiority trial. Patients recruited from eight centers who had failed previous treatment were randomly (1:1) allocated to two eradication groups: HDDT (esomeprazole 40 mg and amoxicillin 1000 mg three times daily; the HDDT group) and bismuth-containing quadruple therapy (esomeprazole 40 mg, bismuth potassium citrate 220 mg, and furazolidone 100 mg twice daily, combined with tetracycline 500 mg three times daily; the tetracycline, furazolidone, esomeprazole, and bismuth [TFEB] group) for 14 days. The primary endpoint was the H. pylori eradication rate. The secondary endpoints were adverse effects, symptom improvement rates, and patient compliance.
RESULTS
A total of 658 patients who met the criteria were enrolled in this study. The HDDT group achieved eradication rates of 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) asdetermined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses, respectively. The eradication rates were similar to those in the TFEB group: 78.1% (257/329), 84.2% (257/305), and 85.1% (257/302). The lower 95% confidence interval boundary (-9.19% in the ITT analysis, - 9.21% in the MITT analysis, and -9.73% in the PP analysis) was greater than the predefined non-inferiority margin of -10%, establishing a non-inferiority of the HDDT group vs. the TFEB group. The incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group (11.1% vs. 26.8%, P < 0.001). Symptom improvement rates and patients' compliance were similar between the two groups.
CONCLUSIONS
Fourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy, with fewer adverse effects and good treatment compliance, suggesting HDDT as an alternative for H. pylori rescue treatment in the local region.
TRIAL REGISTRATION
Clinicaltrials.gov, NCT04678492.
Topics: Amoxicillin; Anti-Bacterial Agents; Bismuth; Drug Therapy, Combination; Esomeprazole; Furazolidone; Helicobacter Infections; Helicobacter pylori; Humans; Potassium Citrate; Prospective Studies; Proton Pump Inhibitors; Tetracycline; Treatment Outcome
PubMed: 36193978
DOI: 10.1097/CM9.0000000000002289 -
Alimentary Pharmacology & Therapeutics Apr 2019Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in acid-related disorders.
AIM
To confirm the non-inferiority of tegoprazan to esomeprazole in patients with erosive oesophagitis (EE).
METHODS
In this multicentre, randomised, double-blind, parallel-group comparison study, 302 Korean patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either tegoprazan (50 or 100 mg) or esomeprazole (40 mg) treatment groups for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed EE confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms, safety and tolerability were also assessed.
RESULTS
The cumulative healing rates at week 8 were 98.9% (91/92), 98.9% (90/91) and 98.9% (87/88) for tegoprazan 50 mg, tegoprazan 100 mg and esomeprazole 40 mg, respectively. Both doses of tegoprazan were non-inferior to esomeprazole 40 mg. The incidence of adverse events was comparable among the groups, and tegoprazan was well-tolerated.
CONCLUSION
Once daily administration of tegoprazan 50 or 100 mg showed non-inferior efficacy in healing EE and tolerability to that of esomeprazole 40 mg.
Topics: Adult; Aged; Anti-Ulcer Agents; Benzene Derivatives; Double-Blind Method; Esomeprazole; Esophagitis; Female; Humans; Imidazoles; Male; Middle Aged; Potassium; Proton Pump Inhibitors; Treatment Outcome; Wound Healing; Young Adult
PubMed: 30843245
DOI: 10.1111/apt.15185 -
World Journal of Gastroenterology Nov 2022Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K/H-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K/H-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner.
AIM
To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE).
METHODS
Korean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8. The secondary endpoints included the healing rate of EE at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were compared between the groups.
RESULTS
Of the 263 randomized, 218 completed the study per protocol (fexuprazan 40 mg, = 107; esomeprazole 40 mg, = 111). Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) 99.1% (110/111)]. There were no between-group differences in the EE healing rate at week 4 [90.3% (93/103) 88.5% (92/104)], symptom responses, and quality of life assessments. Additionally, serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups.
CONCLUSION
Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8. We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.
Topics: Adult; Humans; Esomeprazole; Gastrins; Quality of Life; Esophagitis; Peptic Ulcer; H(+)-K(+)-Exchanging ATPase; Drug-Related Side Effects and Adverse Reactions
PubMed: 36504556
DOI: 10.3748/wjg.v28.i44.6294