Takihata M.,Yokohama City University |
Nakamura A.,Yokohama City University |
Tajima K.,Yokohama City University |
Inazumi T.,Yokohama City University |
And 7 more authors.
Diabetes, Obesity and Metabolism | Year: 2013
Aims: To compare the efficacy and safety of these two agents and the impact on surrogate markers related to diabetic complications in Japanese type 2 diabetic patients. Methods: In a multicenter, open-label trial, 130 patients whose diabetes had been inadequately controlled (HbA1c, 6.9-9.5%) with metformin and/or sulphonylurea were randomly assigned to a sitagliptin group (50mg/day) or a pioglitazone group (15mg/day) and were followed up for 24weeks. At 16weeks, if the patient's HbA1c level was ≥6.5%, the dose of sitagliptin or pioglitazone was increased up to 100 or 30mg/day, respectively. Main outcome measure was the difference in the mean changes in the HbA1c level from baseline at 24weeks between these two groups. Results: Of the 130 patients who were enrolled, 115 subjects (sitagliptin group: 58 patients, pioglitazone group: 57 patients) completed this trial. At 0weeks, the mean HbA1c level was 7.47±0.66% in the sitagliptin group and 7.40±0.61% in the pioglitazone group. At 24weeks, the mean changes in the HbA1c level from baseline were -0.86±0.63% versus -0.58±0.68% (p=0.024). Hypoglycaemia (2 patients, 3.4% vs. 2 patients, 3.5%), gastrointestinal symptoms (3 patients, 5.2% vs. 1 patient, 1.8%) and pretibial oedema (0 patients, 0% vs. 39 patients, 68.4%, p<0.001) were observed for 24weeks. Conclusions: Sitagliptin was not only more tolerable, but also more effective than pioglitazone in Japanese type 2 diabetic patients who had been treated with metformin and/or sulphonylurea. © 2012 Blackwell Publishing Ltd.
Nozue T.,Yokohama Sakae Kyosai Hospital |
Michishita I.,Yokohama Sakae Kyosai Hospital
Lipids in Health and Disease | Year: 2015
Background: The effects of statins on serum n-3 to n-6 polyunsaturated fatty acids (PUFAs) levels have not been fully evaluated. We examined the effects of two types of statins (rosuvastatin and pitavastatin) on serum PUFAs levels and their ratios in patients with dyslipidemia. Findings: A total of 46 patients who were not receiving lipid-lowering therapy were randomly assigned to receive either 2.5 mg/day of rosuvastatin or 2 mg/day of pitavastatin. Serum PUFAs levels were measured at baseline, at 4 weeks, and at 12 weeks. Rosuvastatin was used to treat 23 patients, and the remaining 23 patients were treated using pitavastatin. Serum docosahexaenoic acid (DHA) levels decreased significantly at 12 weeks in both groups (rosuvastatin: from 169.6 to 136.3 μg/mL, p = 0.006; pitavastatin: from 188.6 to 153.9 μg/mL, p = 0.03). However, serum levels of eicosapentaenoic acid (EPA) and arachidonic acid (AA) did not change. In addition, the EPA/AA ratio did not change, whereas the DHA/AA ratio decreased significantly at 12 weeks in both groups (rosuvastatin: from 0.99 to 0.80, p = 0.01; pitavastatin: from 1.14 to 0.91, p = 0.003). No adverse events were observed during the study period. Conclusions: In this small, open-label, pilot study, rosuvastatin and pitavastatin decreased serum DHA levels and the DHA/AA ratio in patients with dyslipidemia. © 2015 Nozue and Michishita.
Comparison of haemodialysis patients and non-haemodialysis patients with respect to clinical characteristics and 3-year clinical outcomes after sirolimus-eluting stent implantation: Insights from the Japan multi-centre post-marketing surveillance registry
Otsuka Y.,Japan National Cardiovascular Center Research Institute |
Ishiwata S.,Toranomon Hospital |
Inada T.,Red Cross |
Kanno H.,Katta Hospital |
And 4 more authors.
European Heart Journal | Year: 2011
Aims Long-term outcomes after sirolimus-eluting stent (SES) implantation in haemodialysis (HD) patients have remained controversial. We investigated the impact of HD on outcomes after SES implantation. Methods and resultsWe analysed the data on 2050 patients who underwent SES implantation in a multi-centre prospective registry in Japan. Three-year clinical outcomes were compared between the HD group (n 106) and the non-haemodialysis (NH) group (n 1944). At the 3-year clinical follow-up, the rates of unadjusted cardiac mortality (HD: 16.3 vs. NH: 2.3) and target-lesion revascularization (TLR) (HD: 19.4 vs. NH: 6.6) were significantly higher in the HD group than the NH group (P < 0.001). Although HD group had a numerically higher stent thrombosis rate, the difference in stent thrombosis between the two groups (HD: 2.0 vs. NH: 0.7) did not reach statistical significance. Using Coxs proportional-hazard models with propensity score adjustment for baseline differences, the HD group had higher risks of TLR [HD: 16.3 vs. NH: 6.1; hazard ratio, 2.83; 95 confidence interval (CI): 1.624.93, P 0.0003] and cardiac death (HD: 12.3 vs. NH: 2.3; hazard ratio, 5.51; 95 CI: 2.5811.78, P < 0.0001). The consistent results of analyses, whether unadjusted or adjusted for other baseline clinical and procedural differences, identify HD as an independent risk factor for cardiac death and TLR. ConclusionsPercutaneous coronary intervention with SES in HD patients has a higher incidence of repeat revascularization and mortality compared with those in NH patients. Haemodialysis appears to be strongly associated with mortality and repeat revascularization even after SES implantation. © 2011 The Author.
Vallejo-Vaz A.J.,St Georges, University of London |
Kondapally Seshasai S.R.,St Georges, University of London |
Kurogi K.,Miyazaki Prefectural Nobeoka Hospital |
Michishita I.,Yokohama Sakae Kyosai Hospital |
And 5 more authors.
Atherosclerosis | Year: 2015
Aims: Whether adverse effect of statins on glycaemic indices is common to all statins remains controversial and as yet data for pitavastatin are limited. We sought to assess the effects of pitavastatin on glycaemia and new-onset diabetes (NOD) in non-diabetic individuals using data from RCT pooled together by means of a meta-analysis. Materials and methods: We searched Medline, Cochrane, Embase and clinical trials registries websites until November-2014 for ≥12-week follow-up placebo or statin-controlled RCT of pitavastatin that included participants without diabetes and reported on fasting blood glucose (FBG), HbA1c or NOD. We additionally sought studies by consulting with Kowa Ph. Ltd. The association of pitavastatin with the outcomes were estimated by random-effects meta-analyses. Heterogeneity was assessed by the I2 statistic and sensitivity and subgroup analyses, and publication bias with funnel plots and Egger and Harbord Tests. Results: 15 studies (approx. 1600 person-years) were included. No significant differences associated with pitavastatin (vs. control) were observed for FBG (MD -0.01 mg/dL [95%CI -0.77, 0.74], I2 = 0%), HbA1c (MD -0.03% [95%CI -0.11, 0.05], I2 = 43%) or NOD (RR 0.70 [95%CI 0.30, 1.61]; RD 0.0 [95%CI -0.004, 0.003]; I2 = 0%). Sensitivity and subgroup analyses (including type of control [placebo or other statin], pitavastatin dose or follow-up] did not yield significant results. Potential publication bias may occur for NOD. Conclusions: In the present meta-analysis pitavastatin did not adversely affect glucose metabolism or diabetes development compared with placebo or other statins. © 2015 Elsevier Ireland Ltd.
Nozue T.,Yokohama Sakae Kyosai Hospital |
Michishita I.,Yokohama Sakae Kyosai Hospital |
Mizuguchi I.,Yokohama Sakae Kyosai Hospital
Journal of Atherosclerosis and Thrombosis | Year: 2010
Aim: Ezetimibe is a novel cholesterol absorption inhibitor that reduces the level of low-density lipoprotein (LDL)-cholesterol (C). The effects of ezetimibe on remnant-like particle (RLP)-C, lipoprotein (a) [Lp(a)], and oxidized LDL (Ox-LDL) levels have not been examined. Methods: Fifty patients with dyslipidemia were treated with 10 mg/day of ezetimibe. At baseline and 12 weeks after treatment with ezetimibe, we measured the levels of RLP-C, Lp(a), Ox-LDL, and high-sensitivity C-reactive protein (hs-CRP). Results: The mean levels of total cholesterol (TC), LDL-C, triglycerides (TG), and apolipoprotein (apo) B, respectively, showed a significant decrease from 229±39 to 191±37 mg/dL (-16%, p< 0.0001), from 151±34 to 118±33 mg/dL (-22%, p<0.0001), from 162±82 to 135±55 mg/dL (-7%, p<0.01), and from 116±22 to 94±21 mg/dL (-18%, p<0.0001) after 12 weeks of treatment with ezetimibe. The mean level of RLP-C and median level of hs-CRP also decreased significantly from 6.8±4.0 to 4.8±2.5 mg/dL (-21%, p<0.0001) and from 0.6 to 0.4 mg/L (-33%, p<0.05). The median level of Lp(a) decreased significantly from 14 to 10 mg/dL (-29%, p<0.05) in patients treated with ezetimibe monotherapy. Conclusions: Ezetimibe was effective for reducing the levels of TC, LDL-C, TG, and RLP-C. Ezetimibe could be a potential therapeutic option for decreasing the Lp(a) level.