Two-year effect of rosiglitazone in chinese poorly controlled type 2 diabetic patients.
BACKGROUND
The goal of this study is to assess the 24-week efficacy of the addition of rosiglitazone 4 mg to existing full dose sulfonylurea (SU) and metformin (MET) therapy in patients with inadequately controlled type 2 diabetes, and to observe the continued follow-up efficacy and safety of this drug for up to two years.


METHODS
This study consists of 32 patients. Fasting plasma glucose (FPG), free fatty acid (FFA), high sensitive C-reactive protein (HS-CRP), adiponectin, insulin and C-peptide were measured every four weeks up to week 24. After that time, the FPG continued to be checked every month. Glycated hemoglobin (HbA1c) and lipid profiles were also checked every 12 weeks for more than two years.


RESULTS
HbA1c was reduced by 1.4% at week 12 and by 1.1% at week 24. However HbA1c was still above 9% throughout the whole study period. FPG was reduced significantly when comparing the baseline value to the value after treatment. The FPG values after one year and two years follow-up were similar to the value at week 24. The serum total cholesterol and low density lipoprotein (LDL) cholesterol levels increased significantly. Serum triglycerides were reduced significantly. Significant reductions in serum FFA from baseline to week 24 were observed. A gradually decrease of serum HS-CRP was noted from baseline to week 24. Serum adiponectin levels increased maximally at week 12 and then it decreased gradually, showing a significant change. Serum insulin and C-peptide levels showed significant changes from baseline to week 24. There were no acute cardiocerebral peripheral vascular disease events or liver damage within the entire study period.


CONCLUSIONS
Clinical improvement in glycemic control was observed after the addition of rosiglitazone to type 2 diabetic patients receiving full dose SU and MET therapy. The maximal effect was observed at week 12 and the effect continued for at least two years. Further, the combination therapy also resulted in an improvement in lipid profiles, decreased HS-CRP and increased adiponectin levels in the short term (24 weeks). This combination therapy is also safe and beneficial for at least two years because no acute episodes of cardiocerebral peripheral vascular disease were seen.
Lee
Jenn-Kuen
JK
Division of Endocrinology and Metabolism, Kaohsiung Veterans General Hospital. 386, Ta-Chung First Road, Tso-Ying, Kaohsiung, Taiwan 813, ROC. jklee@isca.vghks.gov.tw
Chu
Chih-Hsun
CH
Chuang
Ming-Ju
MJ
Lin
Shiu-Chu
SC
Wang
Mei-Chun
MC
Lu
Chih-Chen
CC
Sun
Chun-Chin
CC
Lam
Hing-Chung
HC
D052242:Adiponectin / Q000097:blood; D001786:Blood Glucose / Q000032:analysis; D002097:C-Reactive Protein / Q000032:analysis; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005230:Fatty Acids, Nonesterified / Q000097:blood; D005260:Female; D006801:Humans; D007333:Insulin Resistance; D008297:Male; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000627:therapeutic use*
D052242:Adiponectin; D001786:Blood Glucose; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D005230:Fatty Acids, Nonesterified; D045162:Thiazolidinediones; D000077154:Rosiglitazone; D002097:C-Reactive Protein