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Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance the J-PREDICT study rationale, study design, and clinical characteristics of 1269 patients



Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance the J-PREDICT study rationale, study design, and clinical characteristics of 1269 patients



Diabetology International 2(3): 134-140



The Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance (J-PREDICT study) is an open-label randomized controlled study in a population with impaired glucose tolerance (IGT) to evaluate the effect of the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) pitavastatin on new onset of diabetes. Research design and methods Patients with IGT by World Health Organization (WHO) criteria [2-h plasma glucose ?14 and <2 mg/dl and fasting plasma glucose (FPG) <126 mg/dl] were randomly assigned in a 1:1 ratio to either the control group receiving lifestyle modification or the pitavastatin group receiving pitavastatin 1 2 mg/day in addition to lifestyle modification. The primary endpoint is cumulative incidence of diabetes based on the 75-g oral glucose tolerance test (OG). This study will be completed in March 215. A total of 1269 patients enrolled at 149 study sites in Japan were randomly assigned to two groups. The characteristics of these participants were: men 62.4%, age ?6 years 4.8%, body mass index (BMI) ?25 kg/m2 48.3%, concomitant hypertension 44.5%, and 2-h plasma glucose ?17 mg/dl 36.6%. This population had a mean FPG level of 14.2 1.7 mg/dl, mean 2-h plasma glucose level of 163.6 17. mg/dl, mean hemoglobin (Hb) A1c) level of 5.85 .37%, and mean low-density lipoprotein cholesterol (LDL-C) level of 129.8 23.8 mg/dl at screening. The J-PREDICT study is a world first to evaluate the effect of a statin on the onset of diabetes as the primary endpoint and will providing useful information regarding the controversial effect of statins on new-onset of diabetes.

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Accession: 036170906

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DOI: 10.1007/s13340-011-0032-0


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