ObjectiveTo establish the non-inferior efficacy of vonoprazan versus lansoprazole in the treatment of Asian patients with erosive oesophagitis (EO).DesignIn 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).ResultsIn 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.ConclusionOur 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 numberNCT02388724.

BackgroundAnnual trivalent influenza vaccines (TIV) containing three influenza strains (A/H1N1, A/H3N2, and one B) have been recommended for the prevention of influenza. However, worldwide co-circulation of two distinct B lineages (Victoria and Yamagata) and difficulties in predicting which lineage will predominate each season have led to the development of quadrivalent influenza vaccines (QIV), which include both B lineages. Our analysis evaluates the public health benefit and associated influenza-related costs avoided which would have been obtained by using QIV rather than TIV in Australia over the period 2002–2012.MethodsA static model stratified by age group was used, focusing on people at increased risk of influenza as defined by the Australian vaccination recommendations. B-lineage cross-protection was accounted for. We calculated the potential impact of QIV compared with TIV over the seasons 2002–2012 (2009 pandemic year excluded) using Australian data on influenza circulation, vaccine coverage, hospitalisation and mortality rates as well as unit costs, and international data on vaccine effectiveness, influenza attack rate, GP consultation rate and working days lost. Third-party payer and societal influenza-related costs were estimated in 2014 Australian dollars. Sensitivity analyses were conducted.ResultsUsing QIV instead of TIV over the period 2002–2012 would have prevented an estimated 68,271 additional influenza cases, 47,537 GP consultations, 3,522 hospitalisations and 683 deaths in the population at risk of influenza. These results translate into influenza-related societal costs avoided of $46.5 million. The estimated impact of QIV was higher for young children and the elderly. The overall impact of QIV depended mainly on vaccine effectiveness and the influenza attack rate attributable to the mismatched B lineage.ConclusionThe broader protection offered by QIV would have reduced the number of influenza infections and its related complications, leading to substantial influenza-related costs avoided.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-3297-1) contains supplementary material, which is available to authorized users.

Background and Aim Duodenal ulcers, especially caused by increasingly drug‐resistant Helicobacter pylori, are a concern in Asia. We compared oral vonoprazan versus lansoprazole for efficacy (healing duodenal ulcers) and safety in non‐Japanese Asian patients. Methods In this phase 3, randomized (1:1), double‐blind, double‐dummy, parallel‐group, non‐inferiority study (April 5, 2017, to July 19, 2019), patients with ≥ 1 endoscopically confirmed duodenal ulcer, at 52 hospitals (China, South Korea, and Taiwan), received vonoprazan 20 mg once daily (QD) or lansoprazole 30 mg QD for 6 weeks maximum. Patients with H. pylori received bismuth‐containing quadruple therapy including vonoprazan 20 mg twice daily (BID) or lansoprazole 30 mg BID, for 2 weeks, followed by vonoprazan or lansoprazole monotherapy QD (4 weeks maximum). Endpoints were endoscopically confirmed duodenal ulcer healing (Week 4/6; primary) and H. pylori eradication (4 weeks post‐treatment; secondary); non‐inferiority margins were −6% and −10%, using a two‐sided 95% confidence interval (CI). Results Of 533 enrolled patients, one was lost to follow‐up and one withdrew (full analysis set: 531 patients [vonoprazan, n = 263; lansoprazole, n = 268]; 85.4% = H. pylori positive). Vonoprazan was non‐inferior to lansoprazole for duodenal ulcer healing (96.9% vs 96.5%; difference 0.4% [95% CI −3.00, 3.79]). H. pylori eradication rates were 91.5% (vonoprazan) and 86.8% (lansoprazole; difference 4.7% [95% CI −1.28, 10.69]). Vonoprazan and lansoprazole were well tolerated, with similar safety profiles, no new safety signals; no deaths occurred. Conclusions Vonoprazan was well tolerated and non‐inferior to lansoprazole for duodenal ulcer healing and achieved H. pylori eradication above the clinically meaningful threshold (90%), in non‐Japanese Asian patients.

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