RESUMEN
Objective To evaluate the effect of pitavastatin on blood glucose in patients with hypercholesterolemia,and to investigate the efficacy of pitavastatin in diabetic patients combined with hypercholesterolemia.Method This study was a 12-week,multi-center,open-label,without parallel-group comparison,phase Ⅳ clinical trail.Results Contrasting to baseline,the prevalences at week 4 and 12 post-treatment of abnormal fasting plasma glucose (FPG) and glycosylated hemoglobin Alc (HbA1c)( FPG:14.2％ vs 14.1％ and 11.0％ ; HbA1c:14.3％ vs 15.1％ and 16.1％ ) in the safety set subjects without diabetes mellitus (DM),as well as in those with DM but not taking glucose-lowering drugs (FPG:7/7 vs 4/7 and 5/7; HbAlc:5/5 vs 4/4 and 5/5) had no significant changes (all P vaules ＞0.05).Contrasting to baseline,the levels of TC [ (6.51±0.94) mmol/L vs (5.12 ±0.93) mmol/L and (4.54 ±1.00) mmol/L],LDL-C [(4.11 ±0.79)mmol/L vs (3.02 ±0.81) mmol/L and (2.51 ±0.70)mmol/L] and TG [2.10(1.53,2.54) mmol/L vs 1.62(1.26,2.00) mmol/L and 1.35(1.10,1.86)mmol/L]at week 4 and 12 post-treatment in the per protocol set 55 subjects with DM were significantly reduced (all P values ＜ 0.05 ) ; 33.3％ of subjects at high risk and 10.0％ of subjects at very high risk had achieved a TC target value; 55.6％ of subjects at high risk and 40.0％ of subjects at very high risk had achieved a LDL-C target value.Conclusion Pitavastatin has a safe effect on blood glucose and it could be used to treat diabetic patients combined with hypercholesterolemia in China.