| Autor: |
Lim, Phei Ching, Lim, Shueh Lin, Khaw, Chong Hui, Lim, Yen Li, Hassali, Mohamed Azmi, Chong, Chee Ping |
| Zdroj: |
Journal of Pharmacy Practice & Research; Jun2019, Vol. 49 Issue 3, p224-233, 10p, 5 Charts |
| Abstrakt: |
Background: Currently, comparison studies on glycaemic control by originator versus generic fixed‐dose antidiabetic drugs are limited. Aim: This study assessed the efficacy, adherence and adverse effects between originator and generic fixed‐dose glibenclamide/metformin after switching from gliclazide coadministered with metformin, and after interchanging the originator and generic fixed‐dose tablets between the study groups. Methods: A prospective randomised cross‐over study was conducted among type 2 diabetes mellitus patients treated with stable doses of at least 240 mg gliclazide plus 1000 mg metformin in the Out‐Patient Clinic, Penang Hospital. Patients were randomised to receive either originator (Group A) or generic (Group B) glibenclamide/metformin 2.5/500 mg, two tablets twice daily for 12 weeks. After 12 weeks, Group A and Group B were switched to generic and originator, respectively, for another 12 weeks. HbA1c, pill count and hypoglycaemic episodes were measured at baseline and at 12 and 24 weeks. Results: The mean (±SD) age of the 84 patients in the study was 58.01 ± 7.87 years, and the median duration of diabetes was 10.00 years (interquartile range 7.00–16.75 years). Baseline characteristics were similar between the two groups. Mean HbA1c decreased significantly from 0 to 12 weeks in Groups A and B (−0.76% and −0.56%, respectively), but increased significantly from 12 to 24 weeks (+0.39% and +0.33%, respectively). There was no significant difference in the mean change in HbA1c between the two groups. Adherence improved significantly by 11% when patients were switched to fixed‐dose glibenclamide/metformin regardless of whether it was originator or generic. There was no significant difference between originator and generic in the number of hypoglycaemic episodes (11 vs 32; p = 0.825) after switching to fixed‐dose glibenclamide/metformin. Conclusion: Generic glibenclamide/metformin was therapeutically equivalent to its originator. [ABSTRACT FROM AUTHOR] |
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