Evaluation Of Glycaemic Control Comparing Original Versus Generic Fixed Dose Glibenclamide/Metformin Tablet Among Diabetes Mellitus Patients In An Outpatient Clinic
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Date
2016-06
Authors
Lim, Phei Ching
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Abstract
Generic drugs provide cheaper alternative and proven to be equal as originator drugs through bioequivalence but the data on the efficacy and safety were limited. This study aimed to evaluate the differences in glycaemic control, adherence, adverse events and cost-effectiveness between original and generic fixed dose glibenclamide/metformin after switched from gliclazide co-administered metformin and after interchanged from each other. This prospective randomized cross over study was conducted from September 2014 to August 2015 among type 2 diabetes patients treated with stable dose of at least 240 mg of gliclazide plus 1000 mg of metformin. They were randomly divided into two groups. Group A received original glibenclamide/metformin 2.5/500 mg tablets (Glucovance®) whereas Group B received generic glibenclamide/metformin 2.5/500 mg tablets (Diamide®) for 12 weeks. After 12-week, patients in Group A were changed to generic while patients in Group B switched to original glibenclamide/metformin. Baseline glycosylated haemoglobin (HbA1c), pill count, Morisky Medication Adherence Scale (MMAS) and number of hypoglycaemic episodes were measured. The tests were repeated at 12-week and 24-week. Incremental cost-effectiveness ratio (ICER) was calculated. Eighty four patients (59.5% females; 51.2% in Group A) with mean age of 58.01 ± 7.87 years and had diabetes for 10 (IQR 9.75) years were included. Baseline characteristics were no significant difference between the groups. Mean HbA1c reduced significantly in both groups (Group A -0.76%, p<0.01 and Group B -0.56%,
p<0.01) from 0-week to 12-week but increased significantly in both groups (Group A +0.39%, p<0.01 and Group B +0.33%, p<0.01) from 12-week to 24-week. However, there was no difference between the groups (p>0.05). Nevertheless, the switch from gliclazide co-administered metformin to fixed dose glibenclamide/metformin reduced mean HbA1c (-0.30%, p<0.01) significantly from 0-week to 24-week. Both pill count and MMAS showed significant improvement in adherence after the switch to fixed dose glibenclamide/metformin regardless of original or generic (p<0.01). Besides, adherence improved significantly, p<0.05 when changed from generic to original glibenclamide/metformin in Group B. There was no significant difference in number of hypoglycaemic episodes after switched to fixed dose glibenclamide/metformin. However, significantly less episodes of hypoglycaemia (p=0.03) occurred when changed from generic to original glibenclamide/metformin in Group B. Six patients complained of drowsiness with generic glibenclamide/metformin. More patients achieved target HbA1c ≤ 6.5% with original compared to generic (10.7% vs. 1.2%, p<0.05). The ICER showed an additional RM 282.95 was required to treat patient to achieve target HbA1c with generic glibenclamide/metformin. In conclusion, the switch to original or generic fixed dose glibenclamide/metformin improved glycaemic control and adherence significantly and well tolerated. Generic fixed dose glibenclamide/metformin was therapeutically equivalent as original in glycaemic control but treatment with original was more cost-effective.
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Keywords
The differences in glycaemic control, adherence, adverse events and cost-effectiveness , between original and generic fixed dose glibenclamide/metformin