英文摘要 |
Purposes: Pioglitazone, an anti-diabetic thiazolidinedione that is commonly used to control diabetes, was studied to determine whether brand-name and generic preparations were therapeutic equivalents by comparing the glycated hemoglobin (HbA1c) levels of the same patients. Methods: In this retrospective study, data were collected from a regional teaching hospital in Taichung from August 17 to October 17, 2010 (one month before and after September 17, 2010, the day of the switch from the brand-name to the generic drug). Study subjects must have taken the brand-name drug from March 1 to September 17, 2010, and continually taken the generic drug from September 17, 2010 and September 1, 2011. Two HbA1c levels were taken from March 1, 2010 ~ September 1, 2010 and March 1, 2011 ~ September 1, 2011 as representative values for before and after the switch. A two-tailed paired t-test was used to determine whether there was a significant difference between HbA1c levels before and after switching from the brand-name to the generic drug. Results: Initially, 158 patients were included in this study; however, after patients who did not meet the study criteria were excluded, 37 remained. There was no statistical difference (p=0.863) between the mean levels of HbA1c before and after the switch from the brandname to the generic drug. Conclusions: The two pioglitazone products did not a show statistical difference in HbA1c levels of diabetic patients. Therefore, concern about a difference in blood sugar control between these drugs is unwarranted. |