China Protection Trial of Glucose Metabolism by Pitavastatin in Patients With Prediabetes and Hypertension

Inclusion Criteria:

1. Age 18-80 years old;

2. IFG: 5.6mmol/L (100mg/dl)≤FPG＜7.0mmol/L (126mg/dl), or IGT: 7.8mmol/L (140mg/dl)≤OGTT 2-h PG＜11.1mmol/L (200mg/dl), or HbA1C 5.7-6.4% (39-47mmol/mol);

3. 2.6mmol/L (100mg/dl)≤LDL-C≤5.2mmol/L (200mg/dl), and TG＜5.7mmol/L (500mg/dl);

4. 130mmHg≤SBP＜180mmHg, or 80mmHg≤DBP＜110mmHg or ongoing anti-hypertensive therapy;

5. Patients volunteered for the study and signed informed consent.

Exclusion Criteria:

1. Past history of hypersensitivity to the study drug;

2. Diagnosed diabetes;

3. Severe liver disease (including ALT or AST≥2.5-fold the normal upper limit), biliaryobstruction;

4. Ongoing treatment with cyclosporine within 2 weeks;

5. Renal dysfunction, including endogenous creatinine clearance male＜120ml/min,female＜105ml/min, serum creatinine≥2mg/dl (186umol/L), Renal function progressivedecline, GFR＜30ml•min-1•1.73m-2;

6. Diagnosed or past history of ASCVD (including ACS, SCAD, revascularization, ICM,ischemic stroke, TIA, PASD, etc.

7. SBP≥180mmHg, or DBP≥110mmHg;

8. Ongoing treatment with Beta blockers, Diuretic;

9. Secondary hypertension, including SAS, PA, RAS, pheochromocytoma, Cushing's syndrome,aorta diseases, drug induced hypertension;

10. Ongoing treatment with statins, fibrates, and/or cation exchange resins within 2weeks;

11. Pancreatic disease;

12. History of gastrectomy, short bowel syndrome;

13. Ongoing hormone replacement therapy;

14. Diagnosed or suspected malignant tumor;

15. Familial hypercholesterolemia;

16. Any diseases may limit the efficacy or safety of the study;

17. Pregnant or possibly pregnant woman, or breastfeeding woman, or woman who wishes tobecome pregnant during study participation;

18. Patient who was not judged as eligible by the investigator/coinvestigator.

• IFG impaired fast glucose, FPG fasting plasma glucose, IGT impaired glucosetolerance, OGTT oral glucose tolerance test, PG plasma glucose, HbA1C hemoglobinA1C, LDL-C low-density lipoprotein cholesterol, TG triglycerides, SBP systolicblood pressure, DBP diastolic blood pressure, ALT alanine aminotransferase, ASTaspartate aminotransferase, GFR glomerular filtration rate, ASCVDarteriosclerotic cardiovascular disease, ACS acute coronary syndrome, SCAD stablecoronary artery disease, ICM ischemic cardiomyopathy, TIA transient ischemicattack, PASD peripheral atherosclerotic disease, SAS sleep apnea syndrome, PAprimary aldosteronism, RAS renal arterial stenosis