Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study

Objective To assess the non-inferiority of vonoprazan to lansoprazole for secondary prevention of non-steroidal anti-inflammatory drug (NSAID)-induced peptic ulcer (PU) and the safety of vonoprazan during extended use.Design A phase 3, 24-week, multicenter, randomised, double-blind (DB), active-controlled study, followed by a phase 3, ≥28 week, multicenter, single-blind, parallel-group extension study (EXT) in outpatients (n=642) receiving long-term NSAID therapy who are at risk of PU recurrence. The patients received vonoprazan (10 mg or 20 mg) or lansoprazole 15 mg once daily. For DB, non-inferiority of the proportion of patients with recurrent PU within 24 weeks was analysed by Farrington and Manning test (significance level 2.5%, non-inferiority margin 8.3%; primary endpoint), recurrent PU within 12 weeks, bleeding and time-to-event of PU (secondary endpoint) and treatment-emergent adverse events (TEAEs). For EXT, TEAEs (primary endpoint), recurrent PU and safety (secondary) were assessed up to 104 weeks for patients in the extension study.Results The non-inferiority of vonoprazan 10 mg and 20 mg to lansoprazole 15 mg was verified (percentage difference –2.2%,95% CI –6.2% to 1.8%, p<0.001; –2.1%,95% CI –6.1% to 2.0%, p<0.001, respectively). The proportion of patients with endoscopically confirmed recurrent PU within 24 weeks was 3.3%, 3.4% and 5.5%, for vonoprazan 10 mg, 20 mg and lansoprazole 15 mg, respectively. No significant safety concerns were identified.Conclusion The non-inferiority of vonoprazan (10 and 20 mg) was verified in patients receiving long-term NSAIDs in DB; it was effective and well tolerated in EXT for longer than 1 year, with a safety profile similar to lansoprazole (15 mg)

Suppression of insolation heating using paint admixed with silica spheres – An approach from infrared band electromagnetic scattering

The temperature of materials would be raised when the materials are exposed to the sunlight. Recently, it has been experimentally confirmed that such temperature rise may be restrained when coating the materials with paint admixed with fine silica spheres. Experimental consideration of this type of paint has been conducted, but how the paint controls the temperature rise has merely been clarified theoretically. The best diameter of the silica spheres to be admixed is not well understood, either. In this study, we hypothesized that the scattering of light would be attributed to restrain the temperature rise and tried to estimate the optimum size of the silica spheres. We confirmed that our hypothesis would be justified. In the calculation of the scattering intensity, the diameter of spheres in conjunction with the wavelength of incident lights would be the predominant parameter to the scattering effects. Our results might explain that our experimentally observed phenomenon is caused by the scattering of light, i.e., electromagnetic waves

Japan’s Experience with Human Resources for Health Policies

This report mainly reviews the years from 1945 to 1980. According to the historical statistics of per capita GDP in 1990 International Geary Khamis dollars by Angus Maddison, Japan‟s economy expanded ten times from $1,300 to$13,000 during this period. This change corresponds to a shift from a low to an upper middle income country in the world today. The values of per capita GDP of 2008 in the same statistics are $1,000 or below in Somalia, Afghanistan and Haiti;$1,000 to $2,000 in Sudan, Laos and Nicaragua;$2,000 to $3,000 in Mozambique, Vietnam and Bolivia;$3,000 to $4,000 in Egypt, Myanmar and Ecuador;$4,000 to $5,000 in South Africa, Indonesia and Guatemala;$5,000 to $10,000 in Turkey, Thailand, China and Brazil; and$10,000 to $13,000 in Malaysia and Argentina.2 This report focuses on Japan‟s policy experience in the said period to draw some lessons for developing countries in respective stages corresponding to those of economic growth in Japan, although their social situation and level ofavailable current technologies are different from those of Japan at respective periods in the past

Effect of intensive granulocyte and monocyte adsorptive apheresis in patients with ulcerative colitis positive for cytomegalovirus.

[Background and aim]Cytomegalovirus (CMV) exacerbates ulcerative colitis (UC) refractory to immunosuppressive therapies. The conditions under which CMV reactivation occurs in patients with UC, however, is unclear. In addition, the diagnostic and treatment strategies for UC positive for CMV have not been established. Granulocyte and monocyte adsorptive apheresis (GMAA) is natural biological therapy for UC in which the granulocytes/macrophages producing inflammatory cytokines are removed. We investigated the rate of colonic CMV reactivation and the efficacy of GMAA in active UC patients positive for CMV without concomitant corticosteroid (CS) therapy. [Methods]Fifty-one active UC patients without concomitant CS therapy were enrolled. Colonic CMV reactivation was examined by real-time polymerase chain reaction (PCR) using biopsy specimen and/or histological examination. All patients were treated with intensive GMAA (twice per week). Rates of clinical remission and mucosal healing were compared between UC patients positive and negative for CMV. [Results]Of 51 patients, 15 (29.4%) were diagnosed as CMV positive. The clinical remission rates following intensive GMAA did not differ between UC patients positive and negative for CMV (73.3% vs 69.4%, p = 0.781). Proportion of patients achieving mucosal healing was also similar between these two groups. CMV-DNA became negative in all UC patients positive for CMV who achieved clinical remission 1 week after completion of intensive GMAA. [Conclusions]Intestinal inflammation might trigger CMV reactivation in a subpopulation of active UC patients without CS treatment. GMAA could be a promising option for active UC positive for CMV

Albumin and apolipoprotein H mRNAs in human plasma as potential clinical biomarkers of liver injury: analyses of plasma liver-specific mRNAs in patients with liver injury

<p><i>Context</i>: Plasma liver-specific mRNAs are useful biomarkers of hepatotoxicity in rats.</p> <p><i>Objective</i>: To investigate the potential application of liver-specific mRNAs as biomarkers for liver injury in humans.</p> <p><i>Methods</i>: We determined the plasma levels of liver-specific mRNAs by real-time qRT-PCR in healthy donors and patients with liver injury.</p> <p><i>Results</i>: Plasma levels of albumin (ALB) and apolipoprotein H (APOH) mRNAs increased in patients with elevated serum alanine aminotransferase. These mRNAs also increased in plasma after transcatheter arterial chemoembolization, which induces specific injury to liver.</p> <p><i>Conclusions</i>: We demonstrated the potential application of plasma ALB and APOH mRNAs as clinical biomarkers for liver injury.</p