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

Tsutomu Yamazaki, Junji Kishimoto, Chikako Ito, Mitsuhiko Noda, Masato Odawara, Yasuo Terauchi, Teruo Shiba, Hiroji Kitazato, Yasuhiko Iwamoto, Yasuo Akanuma, Takashi Kadowaki

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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 languageEnglish
Pages (from-to)134-140
Number of pages7
JournalDiabetology International
Volume2
Issue number3
DOIs
Publication statusPublished - Oct 1 2011

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Glucose Intolerance
Japan
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Glucose
Life Style
Fasting
Glucose Tolerance Test
LDL Cholesterol
Population
Oxidoreductases
Hemoglobins
Body Mass Index
Research Design
Clinical Studies
pitavastatin
Hypertension
Control Groups
Incidence

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 journalArticle

Yamazaki, Tsutomu ; Kishimoto, Junji ; Ito, Chikako ; Noda, Mitsuhiko ; Odawara, Masato ; Terauchi, Yasuo ; Shiba, Teruo ; Kitazato, Hiroji ; Iwamoto, Yasuhiko ; Akanuma, Yasuo ; Kadowaki, Takashi. / 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. In: Diabetology International. 2011 ; Vol. 2, No. 3. pp. 134-140.
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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.",
author = "Tsutomu Yamazaki and Junji Kishimoto and Chikako Ito and Mitsuhiko Noda and Masato Odawara and Yasuo Terauchi and Teruo Shiba and Hiroji Kitazato and Yasuhiko Iwamoto and Yasuo Akanuma and Takashi Kadowaki",
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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

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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.

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