Abstract

ASSESSMENT OF SAFETY AND EFFICACY OF GENERIC AND BRANDED METFORMIN

Ainan Fathima*, Mahendra Kumar Betur Jayappa, Mohammed Sadath Shariff, Fulchan Ali

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Abstract

Branded drugs are the original products developed by a pharmaceutical company. Generic drugs are equivalents of branded drugs and have same active ingredients and dosage form. Type II Diabetes Mellitus is usually treated with oral hypoglycemics, Metformin being the most prescribed; either in combination or as monotherapy. This study was conducted to assess the safety and efficacy of both branded and generic Metformin. Data regarding adverse effects, laboratory parameters: Random Blood Sugar and Glycosylated Hemoglobin was collected at regular intervals. To evaluate safety, participants were enquired about the Adverse Drug Reactions (ADRs) they faced after starting metformin. The most common ADRs reported was diarrhoea (56.7%), followed by acidity and sour stomach (43.3%), pain or numbness in knees and joints (40%), dizziness (23.3%) light headedness and tiredness (13.3%.) To compare the efficacy of branded versus generic metformin, participants’ baseline RBS and HbA1c values were recorded and compared to understand the difference over a period of three months. There was a mean difference of 63.53 in branded users RBS over a period of 3 months and 49.733 difference in generic metformin users, this difference was found statistically significant, which indicates that branded metformin showed a slightly better action on RBS levels. Comparing HbA1c values, branded users showed a mean difference of 0.766 over 3 months, whereas generic users showed a difference of 0.4 over 3 months, obtaining their p values the difference found out was statistically insignificant implying that the action of both branded and generic metformin was same in HbA1c levels. According to analysis of the data obtained, we infer that the safety of both branded and generic metformin is same. Branded metformin showed marginally better action on RBS levels and there was no difference in HbA1c levels of both branded and generic metformin users.

Keywords: Generics, Branded, Metformin, Awareness, Safety, Efficacy, Quality.