Abstract
Objective: 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 ≥140 and <200 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 (OGTT). This study will be completed in March 2015. Results: 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 ≥60 years 40. 8%, body mass index (BMI) ≥25 kg/m2 48. 3%, concomitant hypertension 44. 5%, and 2-h plasma glucose ≥170 mg/dl 36. 6%. This population had a mean FPG level of 104. 2 ± 10. 7 mg/dl, mean 2-h plasma glucose level of 163. 6 ± 17. 0 mg/dl, mean hemoglobin (Hb) A1c) level of 5. 85 ± 0. 37%, and mean low-density lipoprotein cholesterol (LDL-C) level of 129. 8 ± 23. 8 mg/dl at screening. Conclusions: 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.
| Original language | English |
|---|---|
| Pages (from-to) | 134-140 |
| Number of pages | 7 |
| Journal | Diabetology International |
| Volume | 2 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Oct 1 2011 |
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All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
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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. / Yamazaki, Tsutomu; Kishimoto, Junji; Ito, Chikako; Noda, Mitsuhiko; Odawara, Masato; Terauchi, Yasuo; Shiba, Teruo; Kitazato, Hiroji; Iwamoto, Yasuhiko; Akanuma, Yasuo; Kadowaki, Takashi.
In: Diabetology International, Vol. 2, No. 3, 01.10.2011, p. 134-140.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance (the J-PREDICT study)
T2 - Rationale, study design, and clinical characteristics of 1269 patients
AU - Yamazaki, Tsutomu
AU - Kishimoto, Junji
AU - Ito, Chikako
AU - Noda, Mitsuhiko
AU - Odawara, Masato
AU - Terauchi, Yasuo
AU - Shiba, Teruo
AU - Kitazato, Hiroji
AU - Iwamoto, Yasuhiko
AU - Akanuma, Yasuo
AU - Kadowaki, Takashi
PY - 2011/10/1
Y1 - 2011/10/1
N2 - Objective: 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 ≥140 and <200 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 (OGTT). This study will be completed in March 2015. Results: 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 ≥60 years 40. 8%, body mass index (BMI) ≥25 kg/m2 48. 3%, concomitant hypertension 44. 5%, and 2-h plasma glucose ≥170 mg/dl 36. 6%. This population had a mean FPG level of 104. 2 ± 10. 7 mg/dl, mean 2-h plasma glucose level of 163. 6 ± 17. 0 mg/dl, mean hemoglobin (Hb) A1c) level of 5. 85 ± 0. 37%, and mean low-density lipoprotein cholesterol (LDL-C) level of 129. 8 ± 23. 8 mg/dl at screening. Conclusions: 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.
AB - Objective: 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 ≥140 and <200 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 (OGTT). This study will be completed in March 2015. Results: 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 ≥60 years 40. 8%, body mass index (BMI) ≥25 kg/m2 48. 3%, concomitant hypertension 44. 5%, and 2-h plasma glucose ≥170 mg/dl 36. 6%. This population had a mean FPG level of 104. 2 ± 10. 7 mg/dl, mean 2-h plasma glucose level of 163. 6 ± 17. 0 mg/dl, mean hemoglobin (Hb) A1c) level of 5. 85 ± 0. 37%, and mean low-density lipoprotein cholesterol (LDL-C) level of 129. 8 ± 23. 8 mg/dl at screening. Conclusions: 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.
UR - http://www.scopus.com/inward/record.url?scp=84858851273&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84858851273&partnerID=8YFLogxK
U2 - 10.1007/s13340-011-0032-0
DO - 10.1007/s13340-011-0032-0
M3 - Article
AN - SCOPUS:84858851273
VL - 2
SP - 134
EP - 140
JO - Diabetology International
JF - Diabetology International
SN - 2190-1678
IS - 3
ER -