EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

AN OPEN-LABEL, PROSPECTIVE, OBSERVATIONAL STUDY OF EFFICACY AND SAFETY OF GLIMEPIRIDE VERSUS VILDAGLIPTIN AS AN ADD-ON TO METFORMIN IN PATIENTS NOT ACHIEVING TARGET WITH METFORMIN MONOTHERAPY IN TYPE II DIABETES MELLITUS

Dr. Abhijit Das*, Dr. Agnimitra Bhattacharya, Dr. Sourav Chakrabarty, Dr. Saugata Ghosh, Dr. Apurba Kr. Mukherjee and Dr. Anup Kr. Das

ABSTRACT

Introduction: Diabetes is considered nowadays a global epidemic affecting more than 8% of adult population worldwide. Glimepiride and Vildagliptin are considered as standard second line agent after metformin as per American Diabetic Association guideline for the treatment of Type-II diabetes. Few studies have been done comparing the efficacy and safety of these two well prescribed drugs. Methodology: It was an open-label, prospective, parallel group, observational study. Type 2 diabetic patients (in whom glycemic control not achieved by Metformin alone) were enrolled. They were divided into two groups, group 1 getting Metformin + Vildagliptin and group 2 getting Metformin + Glimepiride. Fasting Plasma glucose, Post-prandial plasma glucose and HBA1C were recorded at baseline and after 6 months. Result and Discussion: A total 110 patients were included in the study. A total of 100 patients could be followed having 50 patients in each treatment arm. In both groups, FPG, PPPG and HBA1C levels decreased significantly (p value <0.0001) over 6 months. Vildagliptin-Metformin treatment showed an FPG, PPPG and HbA1c reduction comparable to that of the Glimepiride-Metformin treatment over a period of 6 months. Statistically significant wt gain is noted in the Group 2. Relative Risk of developing neuro-glycopenic symptoms in Group 2 was 8 fold compared to Group 1. In each groups, only 11 patients (22%) reached target HBA1C level. Conclusion: Vildagliptin-Metformin combination treatment offered comparable efficacy in terms of HbA1c, FPG & PPPG reduction but significantly less weight gain, and a lower risk of hypoglycemia in comparison to Glimepiride-Metformin combination. When safety is considered along with effectiveness, the Vildagliptin has an edge over glimepiride as second line agent.

Keywords: Type II Diabetes, Metformin, Vildagliptin, Glimepiride, Efficacy, Hypoglycemia, Weight gain.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database Academia