BackgroundElbasvir (EBR) in combination with grazoprevir (GZR) has demonstrated efficacy in patients with hepatitis C virus (HCV) infections in trials primarily conducted in the USA and Europe. We investigated the safety and efficacy of EBR in combination with GZR in Japanese patients with chronic HCV infection, with or without cirrhosis.MethodsThe study was conducted in two parts. In part 1, noncirrhotic patients were randomized 1:1 to receive EBR (50 mg) in combination with GZR (50 or 100 mg) once daily for 12 weeks. In part 2, noncirrhotic patients were randomized 3:1 to receive immediate or deferred treatment with EBR (50 mg) and GZR (100 mg, determined in part 1) for 12 weeks; cirrhotic patients received open-label immediate treatment. The primary efficacy end point was the rate of sustained virologic response 12 weeks after completion of the study treatment.ResultsIn part 1, 63 patients were randomized to receive EBR in combination with GZR at a dose of 50 mg (n = 31) or 100 mg (n = 32). The SVR12 rates were 100% with GZR at a dose of 50 mg and 96.8% with GZR at a dose of 100 mg. Tolerability was similar in both arms. In part 2, 301 noncirrhotic patients were randomized to receive immediate treatment (n = 227) or deferred treatment (n = 74), and 35 cirrhotic patients were enrolled. The SVR12 rates were 96.5% and 97.1% after immediate treatment in noncirrhotic and cirrhotic patients respectively. Safety was generally similar between immediate and deferred treatment.ConclusionTreatment with EBR in combination with GZR for 12 weeks is effective and well tolerated in Japanese patients with chronic HCV infection.ClinicalTrials.gov identifierNCT02203149.Electronic supplementary materialThe online version of this article (doi:10.1007/s00535-016-1285-y) contains supplementary material, which is available to authorized users.
BACKGROUND: In recent years, numerous reports demonstrating the relationship between an increase in the concentration of fine particulate matter (PM2.5) and daily mortality have been released in the United States and Europe. There have been few studies that clearly characterize the short-term effects of particulate matter on the mortality in Japan. We conducted data analysis to investigate the short-term effects of suspended particulate matter (SPM) on mortality in Japan.METHODS: In this study, we used data sets from the 13 largest cities containing data on the daily mortality of residents aged 65 years or older, concentrations of air pollutants including SPM, temperature, and humidity. Risk ratios for mortality resulting from respiratory diseases, cardiovascular diseases, and all causes other than accidents, from 1990 through 1994, were summarized using a generalized additive model (GAM) and a meta-analysis of random effect model. RESULTS: The risk ratios for an increase of 10 ug/m3 in SPM concentrations adjusted for SO2, NO2, CO, Ox, temperature, and humidity were 1.0077 for all causes of mortality, 1.0109 for respiratory diseases, and 1.0091 for cardiovascular diseases, and the lower limits of the 95% confidence intervals for the risk ratios were greater than one for all cases. With regards to the effects of time lag, risk ratios were higher for the SPM concentrations on the day when the mortality was recorded, and the preceding day.CONCLUSIONS: These results suggest a positive relationship between SPM concentrations and daily mortality in Japan.
Weekly odanacatib treatment for 52 weeks increased BMD at the lumbar spine and at all hip sites in a dose-dependent manner and was well tolerated in Japanese patients with osteoporosis.
BackgroundDirect-acting anti-viral agents have improved the treatment of chronic hepatitis C virus (HCV) infection, but this treatment is challenging for patients using co-medications because of potential drug–drug interactions. This study aimed to examine the comorbidities and co-medications of Japanese chronic HCV patients by age group, compared with a non-HCV patient population.MethodsThis was a retrospective observational study using a hospital-based medical claims database. We extracted data of patients with chronic HCV aged ≥18 years, and age-, sex-, and hospital-matched patients without HCV, for the period from January 2015 to November 2016, and then examined chronic comorbidities, long-term co-medications, and medications prescribed at least once during the study period.ResultsWe analysed data from 128,967 chronic HCV patients and 515,868 non-HCV patients. The median age was 70 years, and 51.0% of patients were male. More chronic HCV patients than non-HCV patients (70.5% vs. 47.1%) had at least one comorbidity, and older patients had more comorbidities than younger patients. The most common comorbidities in chronic HCV patients were diseases of oesophagus, stomach and duodenum (41.7%), followed by hypertensive diseases (31.4%). Chronic HCV patients used co-medications more commonly than non-HCV patients, and older patients used more co-medications. The most common long-term co-medications in chronic HCV patients were proton pump inhibitors (14.0%), which were prescribed to 31.9% of chronic HCV patients at least once during the study period.ConclusionsPatients with chronic HCV in Japan had more comorbidities than patients without chronic HCV regardless of age. Particularly older patients, who constitute the majority of the HCV patient population in Japan, commonly had multiple comorbidities and used co-medications. To optimise HCV treatment, physicians need to know the exact medication profiles of patients and take appropriate action to manage drug–drug interactions.Electronic supplementary materialThe online version of this article (10.1186/s12879-018-3148-z) contains supplementary material, which is available to authorized users.
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