匹伐他汀对血糖的效应及其治疗糖尿病高胆固醇血症的疗效

The effect of pitavastatin on blood glucose and its efficacy in diabetic patients with hypercholesterolemia

目的评价匹伐他汀对高胆固醇血症患者血糖的效应及其治疗糖尿病高胆固醇血症的疗效。方法以多中心、非盲、不设平行对照的方式开展为期12周的Ⅳ期临床试验。结果用药期间，与基线比较治疗4周和12周，空腹血糖（FPG）、糖化血红蛋白（HbAlc）异常率在安全集非糖尿病受试对象（FPG：14．2％比14．1％和11．0％；HbAlC：14．3％比15．1％和16．1％）、未服用降糖药物的糖尿病受试对象（FPG：7／7比4／7和5／7；HbAlc：5／5比4／4和5／5）差异均无统计学意义（P值均〉0．05）。与基线相比，治疗4周和12周时符合方案集55例糖尿病高胆固醇血症患者的血清Tcl（6．51±0．94）mmol／L比（5．12±0．93）mmol／L和（4．54±1．00）mmol／L]、LDL．CI（4．11±0．79）mmol／L比（3．02±0．81）mmol／L和（2．51±0．70）mmoL／Ll、TG[2．10（1．53，2．54）mmol／L比1．62（1．26，2．00）mmol／L和1．35（1．10，1．86）mmo]／L]水平明显下降（P值均〈0．05）；33．3％高危患者和10．0％极高危患者的TC值达到治疗目标值；55．6％高危患者和40．0％极高危患者的LDL-C值达标。结论匹伐他汀对患者血糖无明显影响，可用于我国糖尿病高胆固醇血症患者的长期治疗。

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 （HbAlc） （FPG：14. 2%vs 14. 1% and 11.0% ; HbAlc： 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 ofTC [ （6. 51 ±0. 94） mmol/L vs （5.12 ±0. 93） mmol/L and （4. 54 ± 1.00） mmol/Ll, 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.