1.Oxidative Stress Markers and the Risk of Incident Stroke and Ischemic Heart Disease: A Case-Cohort Study
Shuai GUO ; Hitomi KIMURA ; Kazumasa YAMAGISHI ; Tomomi KIHARA ; Isao MURAKI ; Yoshihiro KOKUBO ; Isao SAITO ; Hiroshi YATSUYA ; Hiroyasu ISO ; Taiki YAMAJI ; Manami INOUE ; Shoichiro TSUGANE ; Norie SAWADA ; Motoki IWASAKI ;
Journal of Stroke 2026;28(2):273-282
Background:
and Purpose To investigate the association between derivatives of reactive oxygen metabolites (d-ROMs), biological antioxidant potential (BAP) and the risk of stroke by subtype, and ischemic heart disease (IHD).
Methods:
We employed a case cohort design consisting of cardiovascular disease cases (n=1,521; stroke, n=1,271; IHD, n=265) and a random sub-cohort (n=4,761) in a large Japanese population-based study. d-ROMs and BAP were measured in plasma samples collected between 1995 and 1999. Hazard ratios (HRs) were estimated using weighted Cox proportional hazards methods according to d-ROMs and BAP quartiles, adjusted for age, sex, area, and potential confounding factors.
Results:
Analysis revealed a positive association between d-ROMs and the risk of total stroke, ischemic stroke, IHD, and the composite outcome of ischemic stroke and IHD. The multivariable HRs and 95% confidence intervals (CIs) for the highest versus lowest quartiles for d-ROMs were 1.34 (95% CI: 1.11–1.63) for total stroke (P for trend<0.001), 1.47 (1.16–1.86) for ischemic stroke (P for trend<0.001), 1.47 (1.02–2.11) for IHD (P for trend=0.072), 1.47 (0.87–2.49) for subarachnoid hemorrhage (P for trend=0.101), and 1.01 (0.72–1.41) for intraparenchymal hemorrhage (P for trend=0.618). In contrast, no significant association was detected between BAP levels and the risk of cardiovascular disease.
Conclusions
Analysis revealed that d-ROMs levels were positively associated with the risk of ischemic stroke and heart disease but not with hemorrhagic stroke.
2.Comparative Clinical Evaluation of the Efficacy and Safety between the Original Drug and Generic Products (II)
Yukinaga Kishikawa ; Tomomi Iwasaki ; Megumi Ito ; Kazuki Ishikura ; Kaoko Ikeda ; Keigo Sato ; Yumiko Kon-no ; Tomomi Yagi ; Soh Katsuyama ; Masaaki Shindo ; Daichi Minakawa ; Tetsuo Togo ; Hitoshi Nakamura ; Michinao Mizugaki
Japanese Journal of Drug Informatics 2011;13(3):86-94
Objective: The purpose of this study is to compare the clinical efficacy between original drugs and generic products. Candidate drugs included two types of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors, simvastatin and pravastatin, because of their importance at reducing the health expenditure for hyperlipidemia.
Design: We retrospectively evaluated the efficacy (total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein levels), safety (biochemical parameters), and medication adherence based on patient data. We set the follow-up period at 6 months before and after substitution. Data were analyzed by paired-sample t-tests (statistical significance level of 0.05).
Methods: The subjects included in this study were ambulatory patients visiting Nakajima Hospital for dyslipidemia treatment. Selected patients included those taking both the original drug and the generic product; i.e., patients who had substituted the original drug Lipovas® for the generic product Simvastatin OHARA, or those who had substituted the original drug Mevalotin® for the generic drug Pravatin®.
Results: A total of 118 patients in the simvastatin study and 43 patients in the pravastatin study were candidates for the present study. We found that there were no significant differences before and after substitution. Even though there were differences in some of the biochemical parameters, the range remained within normal levels. With regard to medication adherence, we found no significant differences.
Conclusion: In this study, we found no significant differences before and after substituting medications with generic drugs. Additionally, we found no subjective symptom changes after substitution. To develop clinical information on generic products and to store such information, it is important that pharmaceutical products be used appropriately.


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