Volume 39,
Issue 11,
2011
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扉・目次
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Source:
薬理と治療 39巻11号, 919-920 (2011);
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TOPICS
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第10回CRCと臨床試験のあり方を考える会議 2010 in別府
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Source:
薬理と治療 39巻11号, 925-934 (2011);
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第19回肝病態生理研究会
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Source:
薬理と治療 39巻11号, 939-945 (2011);
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ORIGINAL ARTICLES
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Source:
薬理と治療 39巻11号, 949-960 (2011);
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Aripiprazole orally disintegrating tablet is a new formulation that was developed for easierswallowing by schizophrenia patients with dysphagia and for use in patients in whom treatmentusing a conventional tablet or powder formulation is difficult or adherence is unreliable,such as patients who tend to refuse drug therapy because they cannot understand the necessityof taking the drug due to their clinical state.The two trials were conducted using a randomized, two-treatment, two-period, openlabelcrossover method to verify the bioequivalence of 3-mg of aripiprazole orally disintegratingtablets to 3-mg of aripiprazole conventional tablets, under fasting conditions, in 44healthy adult male subjects. One trial was the without-water trial which the orally disintegratingtablets was administered without water in. Another trial was the with-water trialwhich the orally disintegrating tablets was administered with water in. A washout period of35 days was set between study drug administration in Periods Ⅰ and Ⅱ.In the without-water trial, the 90% CI(confidence intervals)for the differences in themean log-transformed AUC168h and Cmax values between the orally disintegrating tablet withoutwater and the conventional tablet were log(0.96)to log(1.04)and log(0.97)to log(1.07)respectively. In the with-water trial, the 90% CI for the differences in the mean logtransformedAUC168h and Cmax values between the orally disintegrating tablet with water andthe conventional tablet were log(0.92)to log(1.04)and log(0.88)to log(1.02)respectively.As both 90% CI in both trials were within the bioequivalence criteria range of log(0.8)to log(1.25), it was judged that the two formulations were bioequivalent.All of the adverse drug reactions observed in this study have been previously reported as adverse drug reactions for aripiprazole in prior oral aripiprazole studies conducted inJapan, and aripiprazole orally disintegrating tablet is therefore considered to pose no particularsafety problems. No deaths or serious adverse events occurred.
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Source:
薬理と治療 39巻11号, 961-966 (2011);
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Background and Objective Insufficient absorption of proton pump inhibitor(PPI)might bea treatment refractory factor, however, limited evidences were reported on the effect of pharmacokineticparameter of PPI when taking the drug after food intake. The aim of this studywas to compare the pharmacokinetic parameter of lansoprazole orally dispersing(LPZ-OD)tablet between conditions of taking the drug after food intake and under fasting conditions.Methods Nine healthy male volunteers took LPZ-OD(TakepronOD)tablet 30 mg either15 minutes after breakfast or under fasting conditions in a cross-over fashion. The wash-outperiod of each term was 7 days at least. Blood samples were taken for measurement of pharmacokineticparameter of LPZ.Results The AUC0-inf, Cmax, and tmax in the drug administration after food intake were significantlydecreased than that of fasting conditions. The respective AUC0-inf was 4512±1958ng・h/mL and 3083±1688 ng・h/mL(p<0.05), Cmax was 1275±528 ng/mL and 624±307ng/mL(p<0.05), and tmax was 2.0±0.8 h and 3.3±1.0 h(p<0.05). No significant differencein t1/2 was observed.Conclusions This study suggested food intake may affect pharmacokinetic parameters(AUC0-inf, Cmax, and tmax)of LPZ-OD tablet.
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Source:
薬理と治療 39巻11号, 967-979 (2011);
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Background Patients with rheumatoid arthritis(RA)have difficulty in performing activitiesof daily living and suffer decreased quality of life due to the progression of joint destruction.The recombinant biologic drug tocilizumab has been used for RA treatment since 2008 inJapan. Although clinical trials have demonstrated that tocilizumab significantly improves diseaseactivity and inhibits progressive dysfunction, the high prescription expense is of potentialconcern in terms of cost-effectiveness. We therefore investigated the cost-effectivenessof tocilizumab compared with methotrexate, the current anchor drug in RA treatment, byusing Markov modeling, a major pharmacoeconomic method.Methods Markov states were defined based on the levels of dysfunction according to theJapanese version of the Health Assessment Questionnaire(J-HAQ), and transition probabilitiesbetween those states were assumed to differ with treatment strategy(with tocilizumab,or methotrexate). Most parameters in the model including direct medical costs were basedon clinical data from the Institutes of Rheumatology Rheumatoid Arthritis cohort study. Hospitalizationcosts and costs for patient’s own productivity loss were estimated based on thedata from Ministry of Health, Labour and Welfare and Ministry of Internal Affairs and Communicationsin Japan. A Monte Carlo simulation was conducted for calculating lifetime costsand quality adjusted life year(QALY)in both treatment strategies. Results The incremental cost-effectiveness ratio for the tocilizumab group compared with the methotrexate group was 5.39 million JPY, indicating that tocilizumab is cost-effective in Japan based on the reported threshold(5.40 million JPY). QALY in the tocilizumab group was 11.70, higher than that in the methotrexate group(9.24). These resulted from the earlier increase in proportion of patients with lower dysfunction(J-HAQ<1.1). Conclusion This study demonstrated the cost-effectiveness of tocilizumab for the first time based on data from a large observational cohort representing daily clinical practice in Japan.