ABSTRACT
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.
ABSTRACT
Objective To evaluate the efficacy and safety of sorafenib in combination with interferon-alpha(IFN-α)as the first-line treatment in patients with advanced renal cell carcinoma.Methods Since Dec 2007 to Jun 2008,137 legal patients with advanced renal cell carcinoma (RCC)were enrolled in the trail from 22 hospitals in China.All the patients continuously received the treatment of sorafenib plus IFN-α untill disease progressed or patients were unable to tolerate.The primary end points were objective response,disease control rate and adverse effects rate.Results This interim analysis was based on the data collected from the study initiation date to 2009/3/20.The overall response rate(ORR),including complete response (CR) and partial response(PR),was 32.8%(45/137).The median follow-up time was 11.9 months,only 25 patients progressed at the cut off time.The most common adverse events were hand-foot skin reaction(48.2%),alopecia(23.4%),rash (20.4%),diarrhea(19.7 0A),fever(16.8%),lassitude(10.2%),etc.The incidence of 3 or 4 grade hand-foot skin reaction was 8.8%.Conclusions Sorafenib in combination with IFN-α as the firstline treatment in patient with advanced RCC could be effective and safe.