1st DIA Annual Japan Workshop for Pharmacogenomics in Tokyo.
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Biomedical subjects
Publications and source records attributed to Kiichiro Tsutani.
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BACKGROUND: Although angiotensin-converting enzyme (ACE) inhibitors have appeared to be useful for secondary prevention after acute myocardial infarction (AMI) in Western countries, that has not been confirmed in non-western countries. We investigated whether ACE inhibitors improve survival rates in patients who have survived an AMI in Japan. METHODS: A randomized controlled trial, the first non-pharmaceutical company-supported multicenter trial of a medication in Japan, was carried out in 48 institutions from 1993 to 2000. A total of 888 of 1163 patients with AMI were eligible for the full analysis set (FAS). The mean patient age was 62 years, and 78% of patients were men. Subjects were randomized to 2 groups; 422 received ACE inhibitors and 466 did not receive ACE inhibitors. The primary end point was combined cardiac events, which was defined as cardiac or non-cardiac death, recurrent non-fatal myocardial infarction, coronary revascularization, and hospitalization because of worsening angina or congestive heart failure. The mean follow-up period was 5.8 years. RESULTS: There were no significant differences in the 2 groups in baseline data. During the follow-up period, 3 patients were lost to follow-up. With Kaplan-Meier analysis, the annual rate of total cardiac events was 32% in both groups. After adjustment for clinical baseline data, ACE inhibitor administration was not revealed with Cox regression analysis to have a significant prognostic effect in our study. CONCLUSION: We did not show a significant improvement in outcome with ACE inhibitor administration in subjects who survived after AMI in a Japanese study population. Further evaluations with a larger population or in subjects who are at a higher risk for AMI are necessary to confirm our findings.
It is well known that genetic polymorphisms, such as SNPs, vary between races so that not only Western populations' pharmacogenetic/pharmacogenomic data but also data from Asians are viewed as vital to drug development and clinical practice. For this report, the current state of pharmacogenetic/pharmacogenomic-related activities in five Asian countries (China, Japan, the Republic of Korea, Singapore, and Taiwan) were researched and analyzed. The results show that there are multiple efforts underway in all of these countries, including the examination of guidelines, the implementation of projects to establish foundations for pharmacogenetics/pharmacogenomics, and several clinical trials, that have hardly been recognized up to now.
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OBJECTIVE: The aim of this study was to assess beneficial and harmful effects of medicinal herbs for hepatitis C virus (HCV) infection. METHODS: The databases of the Cochrane Collaboration, MEDLINE, EMBASE, and BIOSIS were searched combined with manual searches of five Chinese and one Japanese journals. We included randomized trials comparing medicinal herbs with placebo, no intervention, nonspecific treatment, other herbs, or interferon and/or ribavirin. Trials of herbs with or without other drug(s) were included. Methodological quality of the trials was evaluated by randomization, double blinding, and the Jadad scale. RESULTS: Thirteen randomized trials (n = 818) evaluated 14 medicinal herbs. Four trials had adequate methodology. Compared with placebo, none of the herbs showed effects on HCV RNA or liver enzyme, except for silybin, which showed a significant reduction of serum AST and gamma-glutamyltranspeptidase levels in one trial. Oxymatrine showed effects on clearance of HCV RNA (relative risk = 9.20, 95% CI = 1.26-67.35) compared with vitamins. The herbal mixture Bing Gan Tang plus interferon-alpha showed better effects on clearance of HCV RNA (relative risk = 2.54, 95% CI = 1.43-4.49) and on normalization of serum ALT (relative risk = 2.54, 95% CI = 1.43-4.49) than interferon-alpha alone. The herbal mixture Yi Zhu decoction showed better effects on clearance of HCV RNA and normalization of ALT compared with glycyrrhizin plus ribavirin. Yi Er Gan Tang showed effects on normalizing serum ALT compared with silymarin plus glucurolactone. The herbs were associated with adverse events. CONCLUSIONS: There is no firm evidence supporting medicinal herbs for HCV infection, and further randomized trials are justified.