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Fulltext Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis

Xiao Y, Zhang S, Dai N, Fei G, Goh KL, Chun HJ, et al.

Gut, 2020 02;69(2):224-230.
PMID: 31409606 DOI: 10.1136/gutjnl-2019-318365

OBJECTIVE: To establish the non-inferior efficacy of vonoprazan versus lansoprazole in the treatment of Asian patients with erosive oesophagitis (EO).
DESIGN: In this phase III, double-blind, multicentre study, patients with endoscopically confirmed EO were randomised 1:1 to receive vonoprazan 20 mg or lansoprazole 30 mg, once daily for up to 8 weeks. The primary endpoint was EO healing rate at 8 weeks. The secondary endpoints were EO healing rates at 2 and 4 weeks. Safety endpoints included treatment-emergent adverse events (TEAEs).
RESULTS: In the vonoprazan (n=238) and lansoprazole (n=230) arms, 8-week EO healing rates were 92.4% and 91.3%, respectively (difference 1.1% (95% CI -3.822% to 6.087%)). The respective 2-week EO healing rates were 75.0% and 67.8% (difference 7.2% (95% CI -1.054% to 15.371%)), and the respective 4-week EO healing rates were 85.3% and 83.5% (difference 1.8% (95% CI -4.763% to 8.395%)). In patients with baseline Los Angeles classification grade C/D, 2-week, 4-week and 8-week EO healing rates were higher with vonoprazan versus lansoprazole (2 weeks: 62.2% vs 51.5%, difference 10.6% (95% CI -5.708% to 27.002%); 4 weeks: 73.3% vs 67.2%, difference 6.2% (95% CI -8.884 to 21.223); and 8 weeks: 84.0% vs 80.6%, difference 3.4% (95% CI -9.187% to 15.993%)). Overall, EO healing rates appeared higher with vonoprazan versus lansoprazole. TEAE rates were 38.1% and 36.6% in the vonoprazan and lansoprazole group, respectively.
CONCLUSION: Our findings demonstrate the non-inferior efficacy of vonoprazan versus lansoprazole in terms of EO healing rate at 8 weeks in this population. Safety outcomes were similar in the two treatment arms.
TRIAL REGISTRATION NUMBER: NCT02388724.

Matched MeSH terms: Lansoprazole/administration & dosage; Lansoprazole/adverse effects; Lansoprazole/therapeutic use*
Gastro-oesophageal reflux disease in chronic laryngitis: prevalence and response to acid-suppressive therapy

Qua CS, Wong CH, Gopala K, Goh KL

Aliment Pharmacol Ther, 2007 Feb 1;25(3):287-95.
PMID: 17269990

Gastro-oesophageal reflux is thought to cause chronic laryngitis through laryngopharyngeal reflux. Response of laryngitis to treatment with acid-suppressive therapy supports this causal link.

Matched MeSH terms: Lansoprazole
Fulltext Does oral lansoprazole really reduce gastric acidity in VLBW premature neonates?

Tham SY, Rogers IM, Samuel KF, Singh A, Ong KK

Med J Malaysia, 2012 Jun;67(3):284-8.
PMID: 23082418 MyJurnal

Premature neonates of very low birth weight (VLBW) whose treatment required the use of naso-gastric tube feeding were investigated. 10 infants suspected of having GERD (gastroesophageal reflux) received oral lansoprazole therapy by tube administration. 9 other infants formed a control group. In the treated group a fasting pH was determined before treatment and again after 7 days treatment. The control group was similarly assessed at an interval of 7 days. Despite acid reduction, the post-treatment pH mean of 1.31 would continue to pose a threat to the esophageal mucosa. The physiology of neonatal acid secretion is discussed to explain these findings.

Matched MeSH terms: Lansoprazole
Fulltext Gastro-oesophageal reflux disease in 'difficult-to-control' asthma: prevalence and response to treatment with acid suppressive therapy

Wong CH, Chua CJ, Liam CK, Goh KL

Aliment Pharmacol Ther, 2006 May 1;23(9):1321-7.
PMID: 16629937 DOI: 10.1111/j.1365-2036.2006.02888.x

BACKGROUND: The causal association between gastro-oesophageal reflux disease (GERD) and difficult-to-control asthma is unclear.
AIM: To determine the prevalence of GERD and response to proton pump inhibitor therapy in patients with difficult-to-control asthma.
METHODS: Consecutive patients with difficult-to-control asthma as defined by persistent and recurrent symptoms despite on optimal asthmatic medications were recruited for the study. GERD was diagnosed by symptoms, gastroscopy and 24-h oesophageal pH monitoring. All patients were prescribed a course of lansoprazole 30 mg daily for 8 weeks. Improvement to treatment was assessed by a change in pulmonary symptom score and also by patient's subjective assessment of improvement.
RESULTS: Seventeen of 30 (56.7%) patients with difficult-to-control asthma were diagnosed with GERD. Pulmonary symptom score improved significantly only in patients with GERD (35.0 to 21.0; P = 0.002). Twelve of 16 (75%) patients with GERD reported an improvement in asthma symptoms; 1 of 11 (9.1%) without GERD reported mild symptom improvement. There was no significant change in peak expiratory flow rate and forced expiratory volume.
CONCLUSIONS: More than half of patients with difficult-to-control asthma were diagnosed with GERD. In these patients the severity of asthma improved significantly with potent acid suppression therapy. This underlines the critical role of acid reflux in this subset of patients with difficult-to-control asthma.
Study site: Respiratory clinic, University Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia

Matched MeSH terms: Lansoprazole
Helicobacter pylori eradication with lansoprazole, amoxycillin and clarithromycin: testing an ideal regimen in a multicultural south east Asian population and examining factors potentially influencing eradication

Kaushik SP, Vu C

Aust N Z J Med, 2000 Apr;30(2):231-5.
PMID: 10833116

BACKGROUND: From European and North American data, it is recommended in the Asia Pacific consensus statement, that one week therapy with a proton pump inhibitor, amoxycillin and clarithromycin be used for Helicobacter pylori eradication, in areas of high metronidazole resistance. The efficacy of this regimen is unknown in Singapore.
AIM: To assess the efficacy, safety and compliance of an H. pylori eradication regimen and examine clinical factors that potentially determine eradication.
METHODS: Consecutive outpatients from a multicultural, south east Asian, population with H. pylori infection, with or without peptic ulcer, were treated with lansoprazole 30 mg, amoxycillin 1 gm, clarithromycin 500 mg, twice a day for seven days. Eradication was assessed by either rapid urease, histology or urea breath test. Compliance and side effects were recorded. The eradication rate and effect of ethnicity, age, sex, usage of alcohol, smoking and non-steroidal anti-inflammatory drugs, history of ulcer and endoscopic diagnosis on eradication were examined by univariate and multivariate analysis.
RESULTS: Of 113 patients, the eradication rate by intention to treat was 98/113 (87%) (95% confidence interval [CI] 80-93%) and per protocol was 98/106 (92%) (95% CI 87-97%). Using Fisher's exact test, eradication was more successful in Chinese (intention to treat and per protocol respectively p=0.02 and p<0.001) compared to non-Chinese. By logistic regression analysis ethnicity was an independent factor associated with eradication success (p=0.0025). Side effects occurred in five (4.4%), resulting in cessation of treatment.
CONCLUSIONS: This one week eradication regimen is safe and effective in south east Asians. Chinese ethnicity may be associated with a higher likelihood of eradication success.

Matched MeSH terms: Lansoprazole
Fulltext Problem based review: The patient with a pyrexia of unknown origin

Woolley AK, Hedger NA, Veettil RP

Acute Med, 2013;12(2):107-10.
PMID: 23732136

Pyrexia of unknown origin (PUO) is a frequent presentation to the Acute Medical Unit, and is a source of significant morbidity, both the psychological burden of an uncertain diagnosis and prognosis and untreated complications of the underlying pathology. We present a problem based review of the management of PUO, illustrated by a patient who recently presented to our unit with fever and systemic malaise after returning from abroad and in whom no cause could be found for more than two months. We describe a structured approach making use of complex modern techniques such as Positron Emission Tomography-Computed Tomography (PET-CT) which ultimately provided the diagnosis for our patient.

Matched MeSH terms: Lansoprazole