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Drugs Mar 2015Vonoprazan (Takecab(®)) is an orally bioavailable potassium-competitive acid blocker (P-CAB) being developed by Takeda for the treatment and prevention of acid-related... (Review)
Review
Vonoprazan (Takecab(®)) is an orally bioavailable potassium-competitive acid blocker (P-CAB) being developed by Takeda for the treatment and prevention of acid-related diseases. The drug is approved in Japan for the treatment of acid-related diseases, including erosive oesophagitis, gastric ulcer, duodenal ulcer, peptic ulcer, gastro-oesophageal reflux, reflux oesophagitis and Helicobacter pylori eradication. Phase III development is underway for the prevention of recurrence of duodenal and gastric ulcer in patients receiving aspirin or NSAID therapy. Phase I development was conducted in the UK for gastro-oesophageal reflux; however, no further development has been reported. This article summarizes the milestones in the development of vonoprazan leading to this first approval for acid-related diseases.
Topics: Animals; Drug Approval; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Pyrroles; Randomized Controlled Trials as Topic; Sulfonamides
PubMed: 25744862
DOI: 10.1007/s40265-015-0368-z -
Abdominal Radiology (New York) May 2018
Review
Topics: Duodenal Ulcer; Duodenum; Humans; Radiography
PubMed: 28755072
DOI: 10.1007/s00261-017-1275-4 -
Clinical and Translational... Jul 2023Keverprazan is a novel potassium-competitive acid blocker for the treatment of acid-related disorders requiring potent acid inhibition. This study aimed to establish the... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Keverprazan is a novel potassium-competitive acid blocker for the treatment of acid-related disorders requiring potent acid inhibition. This study aimed to establish the noninferiority of keverprazan to lansoprazole in the treatment of patients with duodenal ulcer (DU).
METHODS
In this phase III, double-blind, multicenter study, 360 Chinese patients with endoscopically confirmed active DU were randomized 1:1 to take either keverprazan (20 mg) or lansoprazole (30 mg) treatment for up to 6 weeks. The primary end point was DU healing rate at week 6. The secondary end point was DU healing rate at week 4. Symptom improvement and safety were also assessed.
RESULTS
Based on the full analysis set, the cumulative healing rates at week 6 were 94.4% (170/180) and 93.3% (166/178) for keverprazan and lansoprazole, respectively (difference: 1.2%; 95% confidence intervel: -4.0%-6.5%). At week 4, the respective healing rates were 83.9% (151/180) and 80.3% (143/178). In the per protocol set, the 6-week healing rates in keverprazan and lansoprazole groups were 98.2% (163/166) and 97.6% (163/167), respectively (difference: 0.6%; 95% confidence intervel: -3.1%-4.4%); the 4-week healing rates were respectively 86.8% (144/166) and 85.6% (143/167). Keverprazan was noninferior to lansoprazole in DU healing after the treatment for 4 and 6 weeks. The incidence of treatment-emergent adverse events was comparable among groups.
DISCUSSION
Keverprazan 20 mg had a good safety profile and was noninferior to lansoprazole 30 mg once daily for DU healing.
Topics: Humans; Lansoprazole; Duodenal Ulcer; Anti-Ulcer Agents; Double-Blind Method
PubMed: 37235793
DOI: 10.14309/ctg.0000000000000602 -
Pediatric Emergency Care Mar 2017
Topics: Adolescent; Contrast Media; Duodenal Ulcer; Duodenum; Female; Humans; Peptic Ulcer Perforation; Tomography, X-Ray Computed
PubMed: 28248764
DOI: 10.1097/PEC.0000000000001060 -
La Revue Du Praticien May 2019
Review
Topics: Duodenal Ulcer; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans
PubMed: 31626472
DOI: No ID Found -
Chinese Medical Journal Dec 2022The pharmacokinetic and clinical behaviors of many proton pump inhibitors (PPIs) in peptic ulcer treatment are altered by CYP2C19 genetic polymorphisms. This... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The pharmacokinetic and clinical behaviors of many proton pump inhibitors (PPIs) in peptic ulcer treatment are altered by CYP2C19 genetic polymorphisms. This non-inferiority study evaluated the efficacy and safety of the novel PPI anaprazole compared with rabeprazole. We also explored the influence of Helicobacter pylori ( H. pylori ) infection status and CYP2C19 polymorphism on anaprazole.
METHODS
In this multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled, phase III study, Chinese patients with duodenal ulcers were randomized 1:1 to receive rabeprazole 10 mg + anaprazole placebo or rabeprazole placebo + anaprazole 20 mg once daily for 4 weeks. The primary efficacy endpoint was the 4-week ulcer healing rate assessed by blinded independent review. Secondary endpoints were the proportion of patients with improved overall and individual duodenal ulcer symptoms at 4 weeks. Furthermore, exploratory subgroup analysis of the primary endpoint by H. pylori status and CYP2C19 polymorphism was conducted. Adverse events were monitored for safety. Non-inferiority analysis was conducted for the primary endpoint.
RESULTS
The study enrolled 448 patients (anaprazole, n = 225; rabeprazole, n = 223). The 4-week healing rates were 90.9% and 93.7% for anaprazole and rabeprazole, respectively (difference, -2.8% [95% confidence interval, -7.7%, 2.2%]), demonstrating non-inferiority of anaprazole to rabeprazole. Overall duodenal ulcer symptoms improved in 90.9% and 92.5% of patients, respectively. Improvement rates of individual symptoms were similar between the groups. Healing rates did not significantly differ by H. pylori status or CYP2C19 genotype for either treatment group. The incidence of treatment-emergent adverse events was similar for anaprazole (72/220, 32.7%) and rabeprazole (84/219, 38.4%).
CONCLUSIONS
The efficacy of anaprazole is non-inferior to that of rabeprazole in Chinese patients with duodenal ulcers.
REGISTRATION
ClinicalTrials.gov, NCT04215653.
Topics: Humans; Rabeprazole; Duodenal Ulcer; Cytochrome P-450 CYP2C19; Omeprazole; Anti-Ulcer Agents; Amoxicillin; Proton Pump Inhibitors; Helicobacter Infections; Helicobacter pylori; Drug Therapy, Combination
PubMed: 36580650
DOI: 10.1097/CM9.0000000000002508 -
International Journal of Cancer Apr 2024Infection by certain pathogens is associated with cancer development. We conducted a case-cohort study of ~2500 incident cases of esophageal, gastric and duodenal...
Infection by certain pathogens is associated with cancer development. We conducted a case-cohort study of ~2500 incident cases of esophageal, gastric and duodenal cancer, and gastric and duodenal ulcer and a randomly selected subcohort of ~2000 individuals within the China Kadoorie Biobank study of >0.5 million adults. We used a bead-based multiplex serology assay to measure antibodies against 19 pathogens (total 43 antigens) in baseline plasma samples. Associations between pathogens and antigen-specific antibodies with risks of site-specific cancers and ulcers were assessed using Cox regression fitted using the Prentice pseudo-partial likelihood. Seroprevalence varied for different pathogens, from 0.7% for Hepatitis C virus (HCV) to 99.8% for Epstein-Barr virus (EBV) in the subcohort. Compared to participants seronegative for the corresponding pathogen, Helicobacter pylori seropositivity was associated with a higher risk of non-cardia (adjusted hazard ratio [HR] 2.73 [95% CI: 2.09-3.58]) and cardia (1.67 [1.18-2.38]) gastric cancer and duodenal ulcer (2.71 [1.79-4.08]). HCV was associated with a higher risk of duodenal cancer (6.23 [1.52-25.62]) and Hepatitis B virus was associated with higher risk of duodenal ulcer (1.46 [1.04-2.05]). There were some associations of antibodies again some herpesviruses and human papillomaviruses with risks of gastrointestinal cancers and ulcers but these should be interpreted with caution. This first study of multiple pathogens with risk of gastrointestinal cancers and ulcers demonstrated that several pathogens are associated with risks of gastrointestinal cancers and ulcers. This will inform future investigations into the role of infection in the etiology of these diseases.
Topics: Adult; Humans; Cohort Studies; Duodenal Ulcer; Ulcer; Duodenal Neoplasms; Seroepidemiologic Studies; Epstein-Barr Virus Infections; Herpesvirus 4, Human; Cardia; Gastrointestinal Neoplasms; Hepatitis C; Helicobacter Infections; Helicobacter pylori
PubMed: 38108203
DOI: 10.1002/ijc.34814 -
BMC Pediatrics Mar 2023This study aims to summarize our experience in diagnosis and treatment of pediatric duodenal ulcer perforation in a National Center for Children's Health.
BACKGROUND
This study aims to summarize our experience in diagnosis and treatment of pediatric duodenal ulcer perforation in a National Center for Children's Health.
METHODS
Fifty-two children with duodenal perforation hospitalized in Beijing Children's Hospital Affiliated to Capital Medical University from January 2007 to December 2021 were retrospectively collected. According to the inclusion and exclusion criteria, patients with duodenal ulcer perforation were included in the group. They were divided into the surgery group and the conservative group according to whether they received surgery.
RESULTS
A total of 45 cases (35 males and 10 females) were included, with a median age of 13.0 (0.3-15.4) years. Forty cases (40/45, 88.9%) were over 6 years old, and 31 (31/45, 68.9%) were over 12 years old. Among the 45 cases, 32 cases (32/45, 71.1%) were examined for Helicobacter pylori (HP), and 25 (25/32, 78.1%) were positive. There were 13 cases in the surgery group and 32 cases in the conservative group, without a significant difference in age between the two groups (P = 0.625). All cases in the surgery group and the conservative group started with abdominal pain. The proportion of history time within 24 h in the two groups was 6/13 and 12/32 (P = 0.739), and the proportion of fever was 11/13 and 21/32 (P = 0.362). The proportion of pneumoperitoneum in the surgery group was higher than that in the conservative group (12/13 vs. 15/32, P = 0.013). The fasting days in the surgery group were shorter than those in the conservative group (7.7 ± 2.92 vs. 10.3 ± 2.78 days, P = 0.014). There was no significant difference in the total hospital stay (13.6 ± 5.60 vs14.8 ± 4.60 days, P = 0.531). The operation methods used in the surgery group were all simple sutures through laparotomy (9 cases) or laparoscopy (4 cases). All patients recovered smoothly after surgery.
CONCLUSION
Duodenal ulcer perforation in children is more common in adolescents, and HP infection is the main cause. Conservative treatment is safe and feasible, but the fasting time is longer than the surgery group. A simple suture is the main management for the surgery group.
Topics: Male; Female; Adolescent; Humans; Child; Duodenal Ulcer; Retrospective Studies; Helicobacter Infections; Laparoscopy; Peptic Ulcer Perforation
PubMed: 36997985
DOI: 10.1186/s12887-023-03957-8 -
Journal of Global Antimicrobial... Sep 2018Helicobacter pylori induces chronic gastritis and duodenal ulcer in a small fraction of the colonised population. Three decades after the discovery of H. pylori and... (Review)
Review
Helicobacter pylori induces chronic gastritis and duodenal ulcer in a small fraction of the colonised population. Three decades after the discovery of H. pylori and disclosure of an urgent need for eliminating the bacterium in patients, it seems that we are still in the first steps of dealing with this mysterious organism. Treatment of H. pylori is a complex dilemma for clinicians, a repeating sentence by many scientists who spend years on this research topic. Apart from many modifications in initial first-line treatment of H. pylori, gastroenterologists are unable to overcome the problem of therapeutic failure. Choosing the best regimen in any region depends on many factors, which have been the focus of many randomised clinical trials. A potential increase in efficacy of future therapies may be influenced by adding the novel potassium-competitive acid blocker vonoprazan. Undeniably, in-depth analysis is necessary to propose more effective therapeutic regimens. Meanwhile, we recommend the performance of antimicrobial susceptibility testing before any antimicrobial prescription.
Topics: Anti-Bacterial Agents; Drug Resistance, Bacterial; Drug Therapy, Combination; Duodenal Ulcer; Helicobacter Infections; Helicobacter pylori; Humans; Pyrroles; Randomized Controlled Trials as Topic; Sulfonamides; Treatment Failure
PubMed: 29581076
DOI: 10.1016/j.jgar.2018.03.005 -
Khirurgiia 2020To study the outcomes of fast-track recovery in patients with perforated duodenal ulcer (PDU).
OBJECTIVE
To study the outcomes of fast-track recovery in patients with perforated duodenal ulcer (PDU).
MATERIAL AND METHODS
There were 138 patients with PDU who underwent surgical treatment for the period from January 1, 2015 to December 31, 2019. Patients were divided into 3 groups: main group, control group 1 (CG-1) and control group 2 (CG-2). The main group (fast-track group, FT-group) included 51 patients who underwent laparoscopic suturing of PDU followed by enhanced recovery (fast-track). CG-1 comprised 44 patients who underwent open suturing of PDU and conventional perioperative treatment. CG-2 consisted of 43 patients who underwent laparoscopic suturing and conventional perioperative treatment. Complications were assessed using Clavien-Dindo grading system.
RESULTS
In the FT group, postoperative complications were observed in 2 patients (3.92%). Anemia of mixed genesis (Clavien-Dindo grade II) was diagnosed in 1 patient and left-sided lower lobe pneumonia in another one (grade II). There were no deaths. Mean length of hospital-stay was 3.86 days. In the 1 control group, the largest number of complications was observed (=12, 27.27%) including 9 extra-abdominal complications (pulmonary disorders (II) - 7 patients (15.9%); sepsis (IVB) - 1 (2.27%), delirium (IVA) - 1 patient (2.27%), postoperative wound seroma (IIIA) - 1 (2.27%) patient). Intra-abdominal complications consisted of compensated pyloroduodenal stenosis (II) in 1 (2.27%) case, recurrent bleeding from acute gastric and duodenal ulcers (IIIB) in 1 (2.27%) patient. Mortality rate was 4.54% (=2) in this group (progressive multiple organ failure). Mean length of hospital-stay was 7.56 days. In the 2 control group, postoperative complications included extra-abdominal (pulmonary disorders (II) - pneumonia in 4 (9.3%) cases, spontaneous pneumothorax (IIIA) in 1 (2.32%) case) and intra-abdominal events (duodenitis (II) in 1 (2.32%) patient and compensated pyloroduodenal stenosis (II) in another 1 (2.32%) patient). There were no lethal outcomes in this group. Mean length of hospital-stay was 6.7 days.
CONCLUSION
Treatment outcomes in patients with perforated duodenal ulcer confirmed an effectiveness of laparoscopic suturing and complete abdominal sanitation. These measures create the prerequisites for fast track recovery in urgent surgical practice. FT-protocol of inpatient management is followed by reduced hospital-stay and less incidence of postoperative complications. Moreover, this approach promotes early and safe discharge of patients.
Topics: Digestive System Surgical Procedures; Duodenal Ulcer; Enhanced Recovery After Surgery; Humans; Laparoscopy; Peptic Ulcer Perforation; Suture Techniques; Treatment Outcome
PubMed: 33301249
DOI: 10.17116/hirurgia202012122